A COMPARATIVE STUDY REPORT OF
EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
EU AND CHINA INTEGRATED REPORT
Prepared by:
Charles Barker, Consultant to The British Standards Institution (BSI)
and
Fei Yang, Bian Jing, Wei Dong, Xue Yan, Huang Xu and Zhou Jie, as an expert team provided by China
National Accreditation Service for Conformity Assessment (CNAS)
July 2009
A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
Table of Contents
Table of Contents .................................................................................................................................... 2
Executive Summary................................................................................................................................. 6
Terminology, Acronyms and Definitions................................................................................................. 9
1.0
General Introduction................................................................................................................. 11
1.1 Project Aims ................................................................................................................................ 11
1.2 Specific Objectives ...................................................................................................................... 11
1.3 Project Purpose .......................................................................................................................... 12
1.4 Investigation Procedure.............................................................................................................. 12
1.5 China Conformity System ........................................................................................................... 14
1.6 EU General Administrative and Legal Framework ...................................................................... 14
1.6.1
The organisation of the EU ............................................................................................... 15
1.6.2
The Council of the European Union .................................................................................. 16
1.6.3
The European Commission ............................................................................................... 17
1.6.4
The European Parliament ................................................................................................. 17
1.6.5
Legislative and non legislative measures .......................................................................... 18
1.6.5.1 Primary Law (Primary law is found mainly in the Treaties).............................................. 18
1.6.5.2 Secondary Law .................................................................................................................. 18
1.6.5.3 Case Law ........................................................................................................................... 20
1.6.5.4 General Description of the EU Quality Infrastructure ...................................................... 21
1.7 International Framework ............................................................................................................ 21
1.7.1
ISO ..................................................................................................................................... 21
1.7.2
WTO .................................................................................................................................. 22
1.7.3
China achievements after WTO Accession ....................................................................... 23
2.0
Conformity Assessment System EU and China ......................................................................... 24
2.1 China Quality Infrastructure and Conformity Assessment System ............................................ 24
2.1.1
Regulation on the certification sector .............................................................................. 26
2.1.2
Supervision over the certification market ........................................................................ 28
2.2 Conformity Assessment .............................................................................................................. 29
2.2.1
Introduction to the Chinese System ................................................................................. 29
2.2.1.1 China Laws ........................................................................................................................ 29
2.2.1.1.1
China Administrative Regulations ............................................................................ 29
2.2.1.1.2
China Ministerial Regulations ................................................................................... 30
2.2.2
Description of China main Conformity assessment systems ............................................ 30
2.2.2.1 CCC System ....................................................................................................................... 30
2.2.2.2 A non-exhaustive overview of other regulatory requirements ....................................... 33
2.2.2.2.1
Special Equipment Licensing ................................................................................ 33
2.2.2.2.2
Calibration Apparatus Manufacturing/Repairing Licensing ................................. 34
2.2.2.2.3
Industrial Product Manufacturing Licensing ........................................................ 34
2.2.2.2.4
Others ................................................................................................................... 35
2.2.3
Introduction to the EU system .......................................................................................... 35
2.2.3.1 Technical Harmonisation Directives ................................................................................. 39
2.2.3.2 New Approach Directive................................................................................................... 40
2.2.3.3 The Global Approach Directive......................................................................................... 41
2.2.3.4 EU Legislation ................................................................................................................... 42
2.2.3.5 Adoption of Directives ...................................................................................................... 42
3.0
Standards in China and the EU.................................................................................................. 44
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
3.1 Standardization System in China ................................................................................................ 44
3.1.1
Composition of Chinese standards ................................................................................... 44
3.1.2
China’s Policies towards International Standards............................................................. 46
3.2 Standardisation System in the EU .............................................................................................. 47
3.2.1
European Committee for Standardisation (CEN) .............................................................. 48
3.2.2
European Committee for Electrotechnical Standardisation (CENELEC) ........................... 51
3.2.3
European Telecommunications Standards Institute (ETSI)............................................... 52
3.2.4
The Principle of Harmonised Standards in the EU ............................................................ 53
4.0
Conformity Assessment Process China and the EU .................................................................. 54
4.1 China Compulsory Product Certification System (CCC) .............................................................. 54
4.1.1
Principles for the establishment of CCC............................................................................ 54
4.1.2
Framework of the compulsory product certification........................................................ 54
4.1.3
Documentation of compulsory certification system ........................................................ 54
4.1.3.1 Laws and regulations ........................................................................................................ 54
4.1.3.2 Ministerial regulations...................................................................................................... 55
4.1.3.3 Other specifications.......................................................................................................... 55
4.1.4
Organizational structure for implementing CCC ............................................................... 56
4.2 The EU product certification system .......................................................................................... 57
4.2.1
Regulated Conformity Assessment ................................................................................... 58
4.2.2
Decision 768 / 2008 .......................................................................................................... 65
4.2.3
Non Regulated Conformity Assessment ........................................................................... 69
4.2.3.1 Technical requirements .................................................................................................... 70
5.0
Accreditation ............................................................................................................................. 76
5.1 General ....................................................................................................................................... 76
5.1.1
International Cooperation ................................................................................................ 77
5.2 Standardisation in Accreditation and Conformity Assessment in the EU and China ................. 78
5.2.1
General .............................................................................................................................. 78
5.2.2
Conformity Assessment activities ..................................................................................... 79
5.2.3
China Standardisation of conformity assessment activities ............................................. 80
5.3 European Accreditation .............................................................................................................. 84
5.3.1
Regulation 765 / 2008 ....................................................................................................... 84
5.3.2
European Co-operation for Accreditation (EA) ................................................................. 86
5.4 China accreditation system for conformity assessment............................................................. 88
5.4.1
China National Accreditation Service (CNAS) ................................................................... 88
5.4.2
Accreditation fields of certification bodies ....................................................................... 89
5.4.3
Accreditation fields of laboratories .................................................................................. 89
5.4.4
Accreditation fields of inspection bodies.......................................................................... 90
5.4.5
International Cooperation in accreditation ...................................................................... 90
6.0
Conformity Assessment Bodies of China and the European Union .......................................... 91
6.1 China ........................................................................................................................................... 91
6.1.1
Administrative approval for the establishment of certification bodies............................ 91
6.1.2
Qualification Recognition of laboratories and inspection bodies..................................... 92
6.1.3
Designated conformity assessment bodies ...................................................................... 93
6.1.3.1 Conditions for designated certification bodies ................................................................ 93
6.1.3.2 Conditions for designated laboratories ............................................................................ 95
6.1.3.3 Conditions for designated inspection bodies ................................................................... 95
6.1.4
Cooperation with foreign conformity assessment bodies ................................................ 96
6.2 European Union (Notified Bodies conditions for assessments) ................................................. 96
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
7.0
Market Surveillance ................................................................................................................ 101
7.1 China ......................................................................................................................................... 101
7.2 European Union ........................................................................................................................ 102
8.0
China and EU Compulsory Markings and Documentation...................................................... 105
8.1 China ......................................................................................................................................... 105
8.1.1
The issuing and controlling of CCC mark......................................................................... 105
8.1.2
Implementation requirements of CCC ............................................................................ 105
8.2 European Union ........................................................................................................................ 105
8.2.1
Manufacturers Declaration of Conformity ..................................................................... 106
8.2.2
Technical File ................................................................................................................... 106
9.0
International Dimension ......................................................................................................... 107
9.1 General ..................................................................................................................................... 107
9.2 World Trade Organisation ........................................................................................................ 107
9.3 China and the World Trade Organisation ................................................................................. 107
9.4 Organisation for Economic Co-operation and Development (OECD)....................................... 109
9.5 Mutual Recognition Agreements.............................................................................................. 110
9.5.1
General ............................................................................................................................ 110
9.5.2
The EU Structure for MRA’s ............................................................................................ 110
9.5.3
China: Inter-governmental arrangements & agreements ............................................. 115
9.6 European Union Schemes and Agreements ............................................................................. 117
9.6.1
ENEC Agreement ............................................................................................................. 117
9.6.2
The CCA (CENELEC Certification Agreement) Scheme .................................................... 118
9.6.3
The Keymark ................................................................................................................... 118
9.6.4
The HAR mark ................................................................................................................. 119
9.6.5
CENCER Mark .................................................................................................................. 119
9.6.6
European Products Certification Association (EEPCA) .................................................... 119
9.7 International Schemes .............................................................................................................. 119
9.7.1
IECQ Scheme ................................................................................................................... 119
9.7.2
The CB scheme ................................................................................................................ 121
9.7.3
The IECEx Scheme ........................................................................................................... 123
10.0 Conclusions ............................................................................................................................. 126
10.1 Legislation ................................................................................................................................. 126
10.2 Standards .................................................................................................................................. 127
10.3 Accreditation ............................................................................................................................ 128
10.4 Conformity Assessment ............................................................................................................ 128
10.5 Market Surveillance .................................................................................................................. 130
10.6 International Dimension ........................................................................................................... 130
10.7 General ..................................................................................................................................... 130
11.0 Recommendations .................................................................................................................. 131
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
Tables
Table 1 Description of Conformity Assessment
Table 2 Conformity Assessment Procedures for various Directives
Table 3 List of voluntary certification Schemes and Marks
Table 4 ISO and China Identical Standards
Table 5 List of EU Standards replaced at international level
59
68
73
83
98
Figures
Figure 1 China Conformity Assessment
Figure 2 House of Conformity Assessment
Figure 3 Overview of relevant EU legislation concerning Conformity Assessment
Figure 4 Procedure for adoption of a Directive
Figure 5 Number of CEN Standard
Figure 6 CEN / ISO Identical standards 2006
Figure 7 Pie Diagram of EU harmonised standards identical or based on IEC Standards
Figure 8 Risk and Conformity Assessment
Figure 9 Conformity Modules
Figure 10 Definitions
Figure 11 Accreditation Structure
Figure 12 Standards for assessment of Accreditation bodies and CAB’s
Figure 13 Requirements of the Regulation with respect to accreditation bodies
Figure 14 Regulation main requirements for market surveillance
Figure 15 Mutual Recognition System
27
36
42
43
50
50
52
57
65
76
77
78
84
104
115
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
Executive Summary
The purpose of this project was to undertake a comparative study between the Chinese conformity
assessment framework and the EU and international conformity assessment framework.
A team of EU and Chinese experts were employed to undertake the abovementioned study.
This initial survey and comparison will serve as platform for discussion about possible next steps to
better harmonise EU and Chinese conformity assessment procedures. Any follow-up activities will be
developed as separate projects.
The quality infrastructure (including: legislation regime, standardisation, accreditation, conformity
assessment, conformity assessment bodies and market surveillance) and also the international aspects
of each economy was assessed by each team of experts.
Both markets have the relevant legislation covering the needs with respect to the quality infrastructure
of each economy.
Both markets have the relevant standardisation systems; the standards organisations encourage the
adoption of international standards. Both systems are signatories to the WTO TBT Annex 3 the “code
of good Practice”.
Chinese national standards and sectoral standards are classified into voluntary standards and
mandatory standards whose implementation is enforced by laws and regulations. In such sense
mandatory standards can be deemed as a part of technical regulations (subject to being in accordance
with WTO rules).
The EU uses the principle of “presumption of compliance” to harmonised standards that support the
Directives; this means that if manufacturers use the EN standards the burden of proof of non
compliance falls on the market surveillance authorities and not on the manufacturer, thus being a
strong incentive to use these standards.
Accreditation is at the centre of all quality infrastructure systems in any economy, without trust in the
accreditation body performing its duties and accrediting conformity assessment bodies the whole
system of belief in certificates issued by these bodies fails.
It is noted that both systems are considered equivalent to each other for accreditation purposes and in
many cases use identical product standards for conformity assessments purposes.
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
Given that the accreditation systems are considered equivalent, it is recommended to carry out further
studies to explore the potentials of establishing EU-China mutual recognition agreements.
Chinese compulsory certification (CCC) is a third party product certification system in line with ISO/IEC
Guide 67 System 5 and ISO/IEC Guide 28. It is based on the principle that products concerning human
health or safety, animal or plant life or health life, environment protection and public security are
subject to compulsory certification enforced by the State, as described in Administrative Rules for the
Compulsory Product Certification (see 2.2.1 and 2.2.1.1.2).
In the European Union the Global Approach and the Decision 768/2008/EC for conformity assessment
are an extension of ISO/IEC Guide 67 and is used based on the risk posed by the product in the relevant
sector thus the higher the risk the higher the third party intervention.
It is recommended to carry out further case studies on particular product categories under CCC and EU
sectoral Directives to analyze the determinants of product risks and the correlation between product
risks and the associated conformity assessment models, by taking account of respective technical,
social and economic circumstances of EU and China, so as to gain an insight into the rationales of each
economy on what is considered RISK and what conformity assessment models should be used to
mitigate this.
With regards to conformity assessment bodies in both economies these have to be approved by the
state authority and in the case of the EU “notified” to the Commission. Any conformity assessment
body (CAB) legally incorporated in China may apply for designation to carry out conformity assessment
activities for compulsory product certification.
This means an EU conformity assessment body can set up its business in China and become a
designated body for CCC after it satisfies required conditions, though no foreign body has formally
applied for designation at the moment. The same is applicable in reverse for the EU.
The rules for appointment of conformity assessment bodies in China and the EU have to be analysed in
detail to ensure that there are no difficulties or problems in each economy with respect to appointing
CAB’s in each other jurisdiction.
Market surveillance in each market is undertaken but in depth investigation needs to be conducted to
compare the principles, processes, and methods etc. used in EU and China for market surveillance.
In China, the CCC mainly covers consumer-related products. There are also regulatory requirements
for other products enforced by laws and regulations, for which this report provides some examples,
but more comprehensive information will require further studies supported by expertise in those areas.
The EU has many Directives, Decisions and Regulations that oblige the member state to undertake
market surveillance, these regulations cover all the products placed on the market, this together with
accreditation underpins the whole safety regime of the EU market.
It is necessary to undertake further in depth study into the market surveillance systems in each market
and how these operate to ensure that only safe products are placed on the market.
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
On the international dimension, China are members of the same international organisation as the EU
(e.g. WTO, ISO, IEC, OECD and others) and also are members of the same international schemes as the
member states of the EU (e.g. IECEE CB, IEC Ex and others).Therefore from this perspective there are
no barriers to trade. On the contrary, it is considered that by using the international schemes it
facilitates manufacturers from both regions to trade.
In general on paper and based on the investigation as outlined in the procedures in section 2, although
in some cases different, the Chinese system has all the quality infrastructure elements in place and
some are similar to those of the EU so as to be said that these should not pose a barrier to exporting to
China and the reverse can be said for the EU.
It was recommended that further in-depth studies be undertaken to compare each of the elements of
the quality infrastructure (legislation, standards, accreditation, conformity assessment, conformity
assessment bodies, metrology and market surveillance) between the EU and China.
The studies should be undertaken for food and non food products.
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
Terminology, Acronyms and Definitions
Accreditation
third-party attestation related to a conformity assessment body conveying formal
demonstration of its competence to carry out specific conformity assessment tasks
Conformity
Assessment
demonstration that specified requirements relating to a product, process, system,
person or body are fulfilled; conformity assessment covers activities such as testing,
inspection and certification.
CAB
Conformity
marking
conformity assessment body (body that performs conformity assessment services)
marking on products for information mainly to market surveillance authorities
Designation
governmental authorisation of a conformity assessment body to perform specified
conformity assessment activities
MRA
Mutual Recognition Agreement (bilateral agreement established between a
community or country government and the government of a third country)
Technical
specification
document that lays down characteristics, performance, safety, dimensions, name
sold, terminology, symbols, testing and methods, packaging, marking or labelling and
assessment procedures,
Standard
technical specification approved by a recognised standardisation body where
compliance is not compulsory, but one of the following: International standard,
European standard and National standard
Technical specification the observance of which is compulsory, these include,
laws, regulations or administrative provisions, Voluntary agreements to which a
Public authority is a contracting party or technical specification linked to fiscal or
financial measures.
Technical
regulation
Acquis
This is the collection of Treaties, legislation and European Court rulings that make up
the legal identity the European Community
Accreditation Authoritative body that carries out accreditation
Body
CA
competent authority
CASCO
Committee on Conformity Assessment
CEN
European Committee of Standardization
CENELEC
European Committee for Electrotechnical Standardization
EEC
European Economic Community
EN
European Standard
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
EU
GATT
European Union
General Agreement on Tariffs and Trade
GDP
Gross domestic product
HSE
HSEQ
Health, Safety and Environment
Health, Safety, Environment and Quality
IEC
International Electrotechnical Commission
ISO
International Organization for Standardization
ITU
NGO
International Telecommunication Union
Non-governmental organization
OECD
OHS
OHSAS
PPE
QMS
REACH
SC
SDS
SME
TBT
TC
WG
Organisation for Economic Co-operation and Development
Occupational Health and Safety
Occupational Health and Safety Assessment Series
Personal Protective Equipment directive
Quality Management System
Registration, Evaluation and Authorisation of Chemicals
(regulation)
Subcommittee
Safety Data Sheet
small and medium-sized enterprise
Agreement on Technical Barriers to Trade
Technical Committee
Working Group
WTO
World Trade Organization
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
1.0 General Introduction
The expansion of foreign trade and investment has played a crucial role in China’s economic
development and growth over the last twenty years. Trade has expanded rapidly as the Chinese
economy has been opened to international competition and as foreign direct investment has surged
into the economy. China officially joined the WTO on 11 November, 2001.
1.1 Project Aims
The Project has the overall objective to support further the integration of China into the World
Economy, to assist the Chinese government in implementing its obligations under, and commitments
in, the WTO and to increase the capacity of China in the process of wider economic, regulatory, legal
and administrative reform necessary for further trade liberalisation in order to promote economic
development.
This project – Support to China’s Integration into the World Trading System – is implemented under
the EU-China Programme and has the overall objective to support the development of specialised
knowledge of, and capacity development in, international integration issues in China.
1.2 Specific Objectives
Conformity Assessment describes steps taken by both manufacturers and independent third parties
to determine fulfilment of standards requirements. Conformity assessment procedures can both
facilitate and impede international trade. However there is growing concern internationally about
the restrictive effects on trade of multiple testing and conformity assessment procedures. There is
ongoing discussion in the WTO TBT/SPS Committee on methods to improve conformity assessment.
China has accepted the Code of Good Practice (set forth in an annex to the WTO agreement relating
to technical barriers to trade) and agreed it would speed up its process of reviewing existing
technical regulations, standards and conformity assessment procedures and harmonizing them with
international norms.
Given this background, a study was conducted into the Chinese conformity assessment framework
and its interactions with the international conformity assessment framework at the horizontal level.
This was followed by a comparison of the conformity assessment procedures used by the China and
EU, identifying the key stages and reference points to international protocols.
A team of EU and Chinese experts drafted a study on EU and Chinese conformity assessment
procedures in the multilateral context of EU and China’s commitments to the WTO SPS/TBT
agreement.
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
The activity will comprise a baseline study into the EU and Chinese conformity assessment
framework and their interactions with the international conformity assessment framework at the
horizontal level. The report will identify key documents and make reference to ISO CASCO standards
and IEC Conformity Assessment schemes and the WTO Conformity Assessment dialogue.
The report will then provide a comparison of conformity assessment procedures used by China and
EU, identifying the key stages and reference points to international protocols.
This initial survey and comparison will serve as platform for discussion about possible next steps to
better harmonise EU and Chinese conformity assessment procedures. Any follow-up activities will be
developed as separate projects.
1.3 Project Purpose
To support the development of specialised knowledge of, and capacity development in, international
integration issues in China.
 To analyse and describe the current EU and Chinese conformity assessment framework and
procedures, and their interactions with the international conformity assessment framework.
 To identify and analyse the main differences between Chinese and EU conformity assessment
procedures.
1.4 Investigation Procedure
The study shall consider COMPULSORY conformity assessment requirements and will be limited to
the sectors in China where conformity requirements exist against those that exist in the EU.
The project is based on two simultaneous investigations, one based on the EU system for conformity
assessment and the second based on the Chinese system of conformity assessment.
The EU system is based on Council Resolutions, Decisions and Directives and these will be described
in this report.
The Chinese system is based on relevant national laws, administrative regulations and ministerial
regulations (see 2.2.1 of this Report).
The EU and Chinese system will be compared with each other; the international frameworks will also
be considered (WTO/ISO).
The investigation in the EU will be based on online research based on the Europa website which
contains all the information necessary to undertake the study e.g laws, standards, notified bodies
and guidelines. If required direct enquiries will be made with the relevant authorities or bodies to
obtain additional necessary information where applicable.
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The investigation will cover the following:
Legislation
What does the law requires? Identify primary or secondary legislation which refers
to conformity assessment or any other law that affects the function of conformity
assessment such as accreditation, standards etc. The relevant contents of the laws
are to be scanned to understand what they say and what are the requirements in
order to be able to compare these, national applications (if any) or province
additional or different requirements are to be identified and included in the
summary.
Standards
The principle of standards being used to determine the conformity requirements e.g
tests, what are the basis of the standards, international or national, how are
standards used to support conformity assessment.
Conformity
assessment
What procedures are used to establish conformance, who provides assessment
conformity assessment bodies, how is this done, to what standards are the
assessments procedure carried out, how does the government ensure conformance
is carried out.
Conformity
Assessment
Bodies
How are CAB’s assessed, what are the procedures and who is allowed to
become a CAB in each market, how are accreditation bodies appointed, what are
the competences and how these act at regional level (EU) and in China.
Markings
What are the marking that demonstrate conformance, who can issue these, how are
they and applied. What are the certificates required, can international certificates be
allowed and if so Certificates at what level.
MRA’s
Do MRA’s rules already exist in each market, how are these applied and what are are
the rules.
The investigation in China will be undertaken by a team of Chinese experts and the procedure will be
to attempt to describe the system in a similar manner as that in the EU wherever possible, in this
manner it will become easier to undertake direct comparisons between the two systems and obtain
relevant conclusions.
From the results and comparisons obtained from both investigations it will be possible to draw
conclusions and from these raise recommendations.
The recommendations will be based on the following:
1. What is identical and can easily be acceptable to both parties.
2. What is similar and can be considered equivalent.
3. Where perhaps an MRA or other type of agreement may be used.
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4. Road map for future discussions.
5. What is not found equivalent, similar or identical and because of infrastructure cannot be
changed.
1.5 China Conformity System
As early as 2001, China began to make a number of adjustments to the conformity assessment
system, in order to make it in line with the international norms and as well reflect the realities of
China.
For example, consolidation efforts were made to combine the multiple accreditation bodies,
previously affiliated to different departments of the government, into one single accreditation
authority at the national level, in an effort to establish a unified rule covering the nation’s
accreditation activities; this consequently eliminated the need for multiple accreditation and has put
the unified CCC (China Compulsory Certification) certification in place to supersede the former
“Great Wall Mark” used prior to the WTO accession, for domestic products, and the “CCIB Mark”
targeted at the imported goods.
All of results in the national treatment on market access. In the meantime, China has made headway
in promoting mutual recognition for conformity assessment results with other countries and regions.
For example, China recently signed a mutual recognition agreement with the New Zealand
government for conformity assessment for electrical & electronic equipment and components.
This report introduces various aspects of the conformity assessment system in China, including:
1.
2.
3.
4.
5.
6.
Laws and regulations on conformity assessment;
Standardisation system;
Administrative regulatory system;
Accreditation system;
Compulsory product certification system and other product certification activities; and
The involvement and contribution of China in the international activities related to
conformity assessment.
1.6 EU General Administrative and Legal Framework
In 1951 six countries (Belgium, Germany, France, Italy, Luxembourg and the Netherlands) founded
the original predecessor of the European Union, the European Coal and Steel Community
The European Union today consists of 27 Member States and these are:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom.
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In 1992 the European Community signed an agreement with the Member States of the European
Free Trade Association (EFTA) to establish the European Economic Area (EEA). The agreement
extends the four fundamental freedoms of the European single market to those EFTA States involved
in the agreement.
The EU and the European Free Trade Agreement (EFTA) countries make up what is know as the
European Economic Area (EEA), thus making up a community of 30 Countries, the EFTA countries are:
Liechtenstein, Iceland, Norway and Switzerland. Switzerland is not a member of the EEA. There are
many languages within the EU but there are only 23 official languages.
The objective of the common market in Europe originated with the Treaty of Rome in 1957, which
established the Common Market and instituted the four basic principles:
•
•
•
•
free movement of goods,
free movement of persons,
free movement of services and
free movement of capital
The Treaty of Rome was based on obtaining a common market and free trade between the member
state borders therefore in general forbids restrictions in trade between the countries within the
European Union. In 1985 a follow up treaty was signed namely the “Single European Act", the single
market is defined as “an area without internal frontiers in which the free movement of goods,
persons, services and capital is ensured”. A key task in the creation the single market was to remove
technical barriers to trade as possible.
These efforts were viewed as not being properly implemented therefore in 1985 the European
Community adopted a new package of reforms to solve the problem.
This package was called a “New Approach to technical harmonization and standards” and it was
followed by the “Global Approach to certification and testing” in 1989. The Global Approach was
completed by a Council Decision in 1993 and in 2008 new regulations and Decisions supporting and
strengthening the EU system was introduced and the 1993 decision was repealed. These Decisions
have increased the scope to remove technical barriers to trade in an efficient manner and complete
the European Single Market.
1.6.1
The organisation of the EU
The organisation of the EU is based on three pillars, these are:
• The Council of the European Union
• The European Commission
• The European Parliament
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A COMPARATIVE STUDY REPORT OF EU-CHINA CONFORMITY ASSESSMENT SYSTEMS
These three institutions between them in a process called co-decision issue all the European regional
binding legislation known as Directives, Decision and Regulations.
1.6.2
The Council of the European Union
The Council is the main decision-making body of the European Union and can be called the executive
power.
The ministers of each Member States meet within the Council. Depending on the issue, each country
is represented by the minister responsible for the specific subject (e.g. trade, foreign affairs, finance,
transport, agriculture, etc.).
The Council is responsible for:
• laws, jointly with the European Parliament.
• co-ordinating the broad economic policies of the Member States.
• defining and implementing the EU’s common foreign and security policy.
• concluding international agreements between the EU and other states or international
organisations.
• co-ordinating the actions of Member States and adopts measures in the area of police
and judicial co-operation in criminal matters.
The Council and the European Parliament constitute the budgetary authority that adopts
the Community’s budget.
The acts of the Council can take the form of regulations, directives, decisions, common actions or
common positions, recommendations or opinions. It can also adopt conclusions, declarations or
resolutions.
When the Council acts as a legislator, in principle it is the European Commission that makes
proposals. These are examined within the Council, which can make modifications before adopting
them.
The European Parliament is an active participant in this legislative process. On a broad range of
issues, Community legislation is adopted jointly by the Parliament and the Council using a procedure
known as «co-decision».
The number of votes each Member State can cast is set by the Treaties. The Treaties also define
cases in which a simple majority, qualified majority or unanimity are required.
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1.6.3
The European Commission
The word 'Commission' can refer to both the institution and to the college of Commissioners. Since
2005 the college of Commissioners has been made up of one Commissioner from each Member
State, these can be considered the civil service of the European Union and the commissioners are
the senior civil servants.
The European Commission is divided into 40 directorates-general (DGs) and services (can be
considered as ministries or government agencies), which are in turn divided into directorates and
directorates into units.
The European Commission was created to represent the European interest common to all Member
States. Its main role is as guardian of the Treaties and defender of the general interest, the
Commission has been given a right of initiative in the legislative process, proposing the legislation on
which the European Parliament and the Council decide.
The Commission is also responsible in other areas but the ones of interest to this report are trade
and enterprise so no other will be mentioned.
What exactly happens to a piece of legislation?
1. A draft for a piece of legislation — a regulation, a directive or a decision — is normally
prepared by the leading service only after internal consultation of all other services
concerned in the Commission and external consultation of national authorities, interested
parties and stakeholders.
2. The legislative decision-making procedure depends on what the Treaty provides for in the
relevant area of activity. In most of the cases the co-decision procedure is applied, which
means that the formal proposal, as adopted by the College of the Commissioners, is
examined by the European Parliament and the Council, who jointly have the role of EU
legislator.
3. The legislation finally adopted by the EU legislator is then transposed into national law (if it
is a directive) and applied by the Commission and by Member States.
1.6.4
The European Parliament
The European Parliament exercises democratic control over the Commission and there is also a
certain parliamentary oversight over the activities of the Council. It is the people’s representative for
each Member State.
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The European Parliament is the only supranational institution whose members are democratically
elected by direct voting. The European Parliament, which is elected every five years, is involved in
drafting of laws (directives, regulations etc.) that affect the daily life of every citizen.
Parliament approves or rejects proposed appointments of the President of the Commission. Then, in
accord with the President appointed, the Member States appoint the Commissioners. The College of
Commissioners must be endorsed as a whole by Parliament.
Parliament has the power to censure the Commission; this is a fundamental instrument that can be
exercised by the Members of the European Parliament to ensure democratic control within the
Union. Parliament can force the College of Commissioners as a whole to resign.
Parliament has a power of political initiative in that it can call on the Commission to submit a
proposal to the Council of the European Union. It regularly invites the Commission and the Council
of the European Union to develop existing policies or initiate new ones.
1.6.5
Legislative and non legislative measures
EU law is made up of three sources (which together form the "acquis communautaire" – the body of
EU law) the three sources are, primary legislation, secondary legislation, case law.
1.6.5.1
Primary Law (Primary law is found mainly in the Treaties)
Primary legislation includes in particular the Treaties and other agreements having similar status.
Primary legislation is agreed by direct negotiation between the governments of Member State. The
main Treaties are; , Treaty of Paris 1951, The Treaty of Rome (1957), the Single European Act (1987),
the Treaty on European Union 'The Maastricht Treaty' (1992), the Treaty of Amsterdam (1997) , the
Treaty of Nice (2001).
The Treaties also define the role and responsibilities of EU institutions and bodies involved in
decision-making processes and the legislative, executive and juridical procedures which characterise
Community law and its implementation.
1.6.5.2
Secondary Law
Secondary law are Regulations - binding in all the member states, Directives - binding as to result but
states may choose method of implementation, Decisions - binding on those to whom they are
addressed.
The secondary sources are laws passed by the 'institutions' under Article 249 EC of the Treaty of
Rome.
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"In order to carry out their task and in accordance with the provisions of this Treaty, the European
Parliament acting jointly with the Council, the Council and the Commission shall make [1] regulations
and issue [2] directives, take [3] decisions, make [4] recommendations or deliver [5] opinions.”
Regulations
A regulation shall have general application. It shall be binding in its entirety and directly applicable in
all Member States’.
General Application
General application means that Regulations apply to all member states often referred to as generally
applicable.
Directly Applicable
Regulations (and Treaty provisions) are "directly applicable" which means they have the force of law
within the all Member States without them having to be enacted by a member state. "Directly
applicable" means that the Member States need do nothing to implement the law, for example a
Regulation is automatically the law of the Member State.
Directives
"A directive shall be binding, as to the result to be achieved, upon each Member State to which it is
addressed, but shall leave to the national authorities the choice of form and methods."
A Directive orders a member state to change its domestic law to comply with EU policy. They are,
therefore, not 'directly applicable' and the method of implementation is left to the member state
with, usually, a time limit for implementation imposed.
Directives are addressed to the Member States and are binding on them as to their effect whilst
leaving the choice of means of implementation to national administrations. This means that unlike
most regulations and decisions, directives must be transposed into national law.
Decisions
"A decision shall be binding in its entirety upon those to whom it is addressed."
Community institutions order that a measure be taken in an individual case. The Community
institutions can thus require a Member State or an individual to perform or refrain from an action, or
can confer rights or impose obligations on them.
The basic characteristics of a decision can be summed up as follows.
•
It is distinguished from the regulation by being of individual application: the persons to
whom it is addressed must be named in it and are the only ones bound by it.
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•
•
It is distinguished from the directive in that it is binding in its entirety.
It is directly applicable to those to whom it is addressed.
Regulations, Directives and decisions are published in the Official Journal of the European
Communities.
Recommendations (not binding)
In recommendations, the party to whom they are addressed is called on, but not placed under any
legal obligation, to behave in a particular way. For example, in cases where the adoption or
amendment of a legal or administrative provision in a Member State causes a distortion of
competition within the Community, the Commission may recommend to the State concerned such
measures as are appropriate to avoid this distortion.
Opinions (not binding)
Opinions are issued by the Community institutions when giving an assessment of a given situation or
development in the Community or individual Member States. In some cases, they prepare the way
for subsequent, legally binding acts, or are a prerequisite for the institution of proceedings before
the Court of Justice. The real significance of recommendations and opinions is political and moral.
Recommendations and opinions can have indirect legal effect where they are a preliminary to
subsequent mandatory instruments or where the issuing institution has committed itself, thus
generating legitimate expectations that must be met.
In addition to the instruments listed in Article 249 of the EC Treaty, practice has led to the
development of a whole series of sui generis documents: inter-institutional agreements, resolutions,
conclusions, communications, green papers and white papers.
Common Position
This is the name given to the first (and most significant) Council agreed text on a legislative proposal
from the Commission. Most issues have been resolved by this stage, and all but (usually) minor
details have been finalised.
1.6.5.3
Case Law
Rulings on EC law by the European Court of Justice (ECJ) are also a source of law. Case-law includes
judgments of the European Court of Justice and of the European Court of First Instance, for example,
in response to referrals from the Commission, national courts of the Member States or individuals.
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1.6.5.4
General Description of the EU Quality Infrastructure
In general Directives, Decisions or Resolutions are be used to establish Community legislation which
affects all member country regulatory system.
Harmonised standards, these are used to determine the performance of the product and therefore
ensuring that there are requirements to demonstrate conformance. In many cases they are identical
to international standards e.g. ISO or IEC
Conformity assessments procedures are based on the relevant sector Directives or alternatively on
the General Product Safety Directive which covers all products not specifically dealt with by the
sector Directive and may have additional requirements on some sector Directives.
There is no harmonised accreditation system at present, by this it is meant that that each country
has its own accreditation body or bodies, but that there is a regional association called European Cooperation for Accreditation (EA) and the assessment of the national accreditation bodies is based on
peer reviews and inter-laboratory testing. There also exist Directives and Decisions pertaining to the
requirements which the EU demands.
Conformity assessment bodies are known in the EU in general as Notified Bodies (although they can
be called by other names), the notification is the act whereby a Member State informs the
Commission and the other Member States that a body, which fulfils the relevant requirements, has
been designated to carry out conformity assessment according to a directive. Notification of Notified
Bodies and their withdrawal are the responsibility of the notifying Member State.
There are requirements in EU Directives for the issuance of certificates and/or placing of marks on
products to signify compliance, the main mark is the CE marking and each Directive contains the
minimum requirement that the Declaration of Conformity should contain. Not all marking are CE
there are others such as the wheel, the Greek “p” letter and others based on old approach Directives.
1.7 International Framework
1.7.1
ISO
Conformity assessment plays a critical role in building confidence for sustainable development and
trade. ISO CASCO writes standards and guides for the effective operation of conformity assessment
bodies and activities. ISO CASCO also provides policy guidance to ISO on conformity assessment
matters.
International Standard ISO/IEC 17000 defines conformity assessment as a “demonstration that
specified requirements relating to a product, process, system, person or body are fulfilled.”
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Conformity assessment is specific to the object being assessed – it can be a product, a process or a
management system – and to the body undertaking the assessment. For example, it may be the first
party, such as the manufacturer of a product, which is making a supplier’s declaration of conformity
using its own internal testing system or a third-party certification or inspection, undertaken by an
independent service provider. The service provider could be a government agency or a private
company.
Accreditation is the “third-party attestation related to a conformity assessment body conveying
formal demonstration of its competence to carry out specific conformity assessment Tasks” (ISO/IEC
17000).
Establishing accreditation systems based on international standards and guides and linked with
membership of the ILAC and/or IAF mutual recognition arrangements can help provide assurance to
trading partners that suppliers of tests and certificates are competent.
At the same time it helps in overcoming technical trade barriers and in complying with the
requirements of the WTO/TBT Agreement.
Many national standards bodies of the member states in the European Union and China’s
accreditation body and conformity assessment bodies have all been actively participating in the
management and technical work of ISO/CASCO.
Currently, China has assigned members to in ISO/CASCO Chairman’s Policy and Coordination Group,
ISO/CASCO/WG21 (to draft ISO/IEC 17021-2 Conformity Assessment—requirements for third-party
certification auditing of management systems), ISO/CASCO/WG27 (to draft ISO/IEC 17007
Conformity assessment – Guidance for drafting normative documents suitable for use for conformity
assessment) and ISO/CASCO/WG29 (to draft ISO/IEC 17065 Conformity Assessment—Requirements
for bodies providing certification of product (including services) and processes).
1.7.2
WTO
Technical regulations and product standards may vary from country to country. Having many
different regulations and standards makes life difficult for producers and exporters. If regulations are
set arbitrarily, they could be used as an excuse for protectionism.
The Agreement on Technical Barriers to Trade tries to ensure that regulations, standards, testing and
certification procedures do not create unnecessary obstacles.
From the agreement on Technical Barriers to Trade the following Section and Articles will be
reviewed and used as the background against which all systems can be evaluated.
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CONFORMITY WITH TECHNICAL REGULATIONS AND STANDARDS
Article 5
Article 6
Article 7
Article 8
Article 9
1.7.3
Procedures for Assessment of Conformity by Central Government Bodies
Recognition of Conformity Assessment by Central Government Bodies
Procedures for Assessment of Conformity by Local Government Bodies
Procedures for Assessment of Conformity by Non-Governmental Bodies
International and Regional Systems
China achievements after WTO Accession
Since WTO accession in 2001, China has been praised for her efforts and achievements made in the
fulfilment of WTO commitments. Two decades ago, China imposed licensing requirements on over
half of imported and exported goods; in 2005, however, the country resolved to abolish such
requirements completely.
The import tariff has ever since taken a nosedive to the 10% level, the lowest among all the
developing countries. Service trade is now fully opened up.
The European Union is China’s No. 1 trading partner. In 2007, China’s exports to the EU reached
US$245.2 billion, while imports were US$110.9 billion.
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2.0 Conformity Assessment System EU and
China
2.1 China Quality Infrastructure and Conformity Assessment
System
Certification and Accreditation Administration of the People's Republic of China, or CNCA, is China’s
unitary competent authority for the administration, supervision and comprehensive coordination of
certification and accreditation and related conformity assessment activities. CNCA is established by
the decision of, and authorized by, the State Council.
CNCA’s regulatory activities are mandated by Regulations of the People’s Republic of China on
Certification and Accreditation, which is an administrative regulations issued by the State Council
(see 2.2.1 of this Report and Figure 1).
The main functions and responsibilities of CNCA include:
1.
To draft and implement national laws, regulations and rules on certification and
accreditation, safety and quality licensing, sanitation registration and related conformity
assessment, and to establish and organize the implementation of administrative system
and specifications for certification and accreditation and related conformity assessment.
2.
To research, propose and organize the implementation of policies, rules and work
specifications for certification and accreditation and related conformity assessment; to
coordinate and direct the certification and accreditation activities all over the country, and
to supervise the accreditation body and certification bodies.
3.
To research, and develop the product catalogue subject to the national compulsory
certification (CCC certification) and safety and quality licensing requirements, and
formulate and issue related certification marks (identifications), conformity assessment
procedures and technical rules, and to organize the implementation of compulsory
certification and safety and quality licensing.
4.
To take charge of the evaluation and registration work for the sanitation registration of
manufacturing and processing enterprises of imported/ exported food and cosmetics, and
to handle issues related to the registration notification and recommendation to foreign
countries.
5.
To supervise and regulate the certification market according to laws, and supervise and
administer such intermediary services and technical assessment activities as voluntary
certification, certification consulting and training;
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I. to be responsible for the approval and supervision of certification bodies and the
supervision of testing laboratories involved in certification business, including those
partly or solely invested by foreign business, or based on cooperation between
Chinese and foreign business;
II. to supervise and administer activities conducted in China by relevant bodies in
foreign economies;
III. to receive the complaints and appeals related to certification and accreditation, and
organize investigations;
IV. to regulate and supervise certification activities in the market according to laws, and
guide and promote the innovation of certification-related intermediary service
providers.
6.
To be responsible for designating the certification bodies that undertake compulsory
certification and safety and quality licensing tasks and the testing laboratories and
inspection bodies that undertake compulsory-certification-related testing or inspection
activities; to be responsible for organizing the implementation of technical evaluation and
qualification recognition of the testing laboratories and inspection bodies that provide
attesting data and results to the society.
These certification bodies, laboratories and inspection bodies include those bodies partly
or solely invested by foreign business, or based on cooperation between Chinese and
foreign business.
7.
To administer and coordinate and promote international cooperation and exchange and
mutual recognition related to certification, accreditation and conformity assessment; to
support and delegate relevant bodies to participate in international or regional
organizations such as:
•
•
•
•
•
International Accreditation Forum (IAF),
Pacific Accreditation cooperation (PAC),
International Personnel Certification Association (IPC),
International Laboratory Accreditation Cooperation (ILAC)
Asia-Pacific Laboratory Accreditation Cooperation (APLAC),
or in the conformity assessment related activities of ISO and IEC, and to sign treaties,
agreements or protocols related to conformity assessment.
8.
To be responsible for researching, advocating and implementing international criteria,
guides and standards for certification and accreditation and related conformity assessment;
to administer statistical work regarding certification and accreditation and related
conformity assessment; to carry out WTO/TBT-SPS notification and advisory activities
related to certification and accreditation.
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2.1.1
Regulation on the certification sector
CNCA regulates certification sector in accordance with Regulations of the People’s Republic of China
on Certification and Accreditation and its associated administrative rules, measures and
specifications that are in line with the principles and requirements of relevant international
standards and guides and have taken full account of China’s actual conditions.
In the meantime, CNCA also authorizes provincial quality and technical supervision bureaus, as well
as the local entry-exit inspection and quarantine bureaus of AQSIQ, to carry out, according to their
respective delegation of authority, regulatory actions on the certification activities in its locality, and
to fulfil their duties at their respective level.
The method for regulation may mainly include:
1.
administrative approval for the establishment of certification bodies
2.
supervision over the certification market.
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Standards and Conformity Assessment Bodies - China
FAO
Codex
Inquiry point
AGRI
International Inspection and Quarantine Standards and
Technical Regulations Research Centre
Ministry of
Agriculture
WTO/SPS
WTO/TBT
CNAS (National Accreditation Service for Conformity
OIML
APLMF
APEC/
SCSC
AQSIQ
State
Administration of
Quality
Supervision,
Inspection and
Quarantine
Assessment)
IAF
CNCA
Administration
of Certification
& Accreditation
of China
PAC
Certification Bodies, e.g. CCIC (China Certification &
Inspection Group)
APLAC
SAC
IEC
Standardization
Administration
of China
JTC1
ISO
PASC
CAS (China Association For Standardization)
CNIS (China National Institute of Standardization)
SPC (Standards Press of China)
NIM (National Institute of Metrology)
National Secretariat for
JTC1 & IEC TC3/SC3D
ITU
ILAC
MIIT
Ministry of
industry and
Information
Technology
BIPM
APMP
CESI (China Electronics Standardization Institute)
CCSA (China Communication Standards Association)
NITS (National Information Technology
Standardization Technical Committee)
Regional
Government
International
Non-Government
CWTS (China Wireless Telecommunication
Standards working Group)
Figure 1 China Conformity Assessment
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2.1.2
Supervision over the certification market
Beside its duties to examine and approve the establishment of certification bodies, CNCA also fulfils
a role in supervising, by various means, the certification bodies which carry out market activities. The
supervisory approaches mainly include:
1.
carrying out special-purpose administrative and supervisory checks on the conformity and
effectiveness of the certified management system, or on the conformity of the certified
products, in order to determine if the conformity of certification body in question;
2. performing sampling checks on the certification archives of these bodies;
3. conducting a satisfaction survey among the certified organizations and their customers, or
other users of a certification service on the certification bodies’ conformity and performance;
4. investigating complaints, and addressing them; and
5. organising peer assessments among the relevant conformity assessment bodies, and
requiring the certification bodies to report regularly on their operational status, or relevant
data about certified organisations.
The administrative supervision of CNCA makes full use of technical assistance from the national
accreditation body, which is CNAS. In fact, many administrative supervision activities are conducted
together with the surveillance activities of CNAS, which creates critical input and grounds for the
accreditation authority to improve and develop accreditation supervisory measures.
The self-discipline mechanism of the China Certification and Accreditation Association（CCAA）also
provides key input and support for the administrative supervision of CNCA. CCAA is a non-profit
nationwide trade association comprised of representatives from certification and accreditation
bodies, certification training institutions, certification consulting institutions, inspection bodies,
some certified organizations and employees of the certification sector.
One of its core tasks is to formulate the industrial self-discipline codes for the certification industry,
and promote effective implementation of these industrial self-discipline codes through peer
assessment, in order to lay down a solid basis for administrative supervision, accreditation activities
and provide the public with well-founded and admissible evidence.
Self-discipline specifications that have been developed and implemented by CCAA include Selfdiscipline Convention for the Certification and Accreditation Sector in China, Specifications for Fair
Competition in Certification Bodies: Prices for Management System Certification, and Interim Control
Measures on Certification Auditor’s Changing of Affiliating Certification Body.
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2.2 Conformity Assessment
2.2.1
Introduction to the Chinese System
The Chinese laws and regulations relevant to conformity assessment may basically be categorized
into the following hierarchies:
•
•
•
laws,
administrative regulations,
ministerial regulations,
1.
laws are enacted and adopted by the National People’s Congress (NPC) and promulgated by
way of a presidential order signed by the state president;
2.
administrative regulations are enacted and adopted by the State Council and promulgated by
way of a State Council order signed by the premier;
3.
ministerial are enacted and adopted by the relevant ministries and commissions of the State
Council within their respective functions and duties, and promulgated by the chief responsible
person of the respective ministry or commission by way of an “order” on his signature,
2.2.1.1
1.
2.
3.
4.
China Laws
Product Quality Law of the People’s Republic of China ( by Order No.33 of the President of
the People’s Republic of China)
Law of the People's Republic of China on Import and Export Commodity Inspection (By
Order No.67 of the President of the People’s Republic of China)
Standardisation Law of the People’s Republic of China (by Order No.11 of the President of
the People’s Republic of China)
Metrology Law of the People's Republic of China (by Order No.28 of the President of the
People’s Republic of China)
2.2.1.1.1
1.
2.
3.
China Administrative Regulations
Regulations of the People’s Republic of China on Certification and Accreditation (by Order
No. 390 of the State Council of the People’s Republic of China )
Regulations for the Implementation of the Law of the People’s Republic of China on Import
and Export Commodity Inspection (by Order No. 447 of the State Council of the People’s
Republic of China )
Regulations for the Implementation of the Standardisation Law of the People's Republic of
China (by Order No. 53 of the State Council of the People’s Republic of China )
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2.2.1.1.2
1.
2.
3.
4.
5.
6.
7.
8.
9.
China Ministerial Regulations
Administrative Rules for the Compulsory Product Certification (by Order No.5 [2001] of
AQSIQ of the People’s Republic of China)
Administrative Measures for the Nuisance-free Agricultural Products (by Order No.12 [2002]
of Ministry of Agriculture and AQSIQ)
Administrative Rules for the Registration of Foreign Production Enterprises of Imported
Food (by Order No.16 [2002] of AQSIQ)
Administrative Rules for the Sanitation Registration and List Entry of Export Food
Manufacturing Enterprises (by Order No.20 [2002] of AQSIQ)
Interim Administrative Rules for the Sanctions of Illicit Acts in Certification (by Order No.29
[2002] of AQSIQ)Measures for the Administration of the Personnel of Certification and
Certification Related Training and Consulting (by Order No.61 [2004] of AQSIQ)
Administrative Measures for the Certification Certificates and Certification Marks (by Order
No.63 [2004] of AQSIQ)
Administrative Measures for the Compulsory Products Certification Bodies, Inspection
bodies and Laboratories (by Order No.65 [2004] of AQSIQ)
Administrative Measures for Organic Product Certification (by Order No.67 [2004] of AQSIQ)
Administrative Measures for the Energy Efficiency Labels (by Order No.17 [2004] of NDRC
and AQSIQ)
2.2.2
Description of China main Conformity assessment systems
2.2.2.1
CCC System
The system requires manufacturers of 172 types of products to obtain the China Compulsory
Certification (CCC) mark before exporting to or selling in the China market.
The application process for the CCC mark:

For those applications that do not involve factory inspection, the turnaround time is
normally within sixty days, and for those involve factory inspection, the turnaround time is
within ninety days;

requires testing at designated laboratories;

generally does not permit self declaration of conformity;

requires submission of technical documents;

requires submission of product sample(s) to a designated testing laboratory;

pre-license factory inspection is required when it is the first time that a factory and a type of
product apply for CCC. It is carried out by auditors assigned by designated certification
bodies.
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The factory inspection is at the applicant's expense, which is the same as certification
practice worldwide;

requires follow-up inspections every twelve months;
The CCC Mark is administered by CNCA. There are 11 certification bodies designated by CNCA to
process CCC mark applications.
Step One: Determine Whether Your Products Require CCC Marking
•
First, examine CNCA's product catalogue and determine whether your products, or
component parts within your finished goods, require CCC marking. The product catalogue is
a list, divided into 23 broad product categories and 172 types of products, of all the products
requiring CCC marking.
•
If the short descriptions in the product catalogue are not specific enough to determine
whether the CCC mark applies to your product, you have two other options:
•
Review CNCA's "Implementation Rules" booklets. The booklets each provide a "scope"
section which in some cases provide a more detailed description of which products
require the CCC mark.
•
Review CNCA's "Table for CCC Product Category Description and Clarification” and other
documents
defining
product
categories
at
CNCA
website:
http://www.cnca.gov.cn/cnca/rdht/qzxcprz/rzml/default.shtml (in Chinese).
•
Component parts of a manufacturer's finished products may in some cases require CCC
certification; in those cases, the end product manufacturer is recommended to request its
component suppliers to apply for the CCC mark or to select components bearing CCC mark.
•
Spare parts and replacement parts shipments may in some cases require CCC certification,
or application for an exemption.
Step Two: Get the Implementing Regulations
CNCA has published "Implementation Rules for Compulsory Certification" For different product
categories.
CNCA's Implementation Rules give information on certification procedure, applicable standards,
requirements for factory inspection etc. For CCC, most of the applicable standards are China
mandatory national standards i.e. "GB Standards". For electro-technical equipment, most of the GB
standards are identical or technically equivalent to corresponding IEC standards.
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Step Three: Determine if the product is exempted
Products exempted from CCC are listed in CNCA Announcement No. 3, of 2005, and include: goods
for personal use by diplomatic staff; goods for commercial exhibition (but not for marketing in
China); and products for the purpose of research and conducting tests.
In addition, spare parts and components listed in the catalogue are exempt from separate CCC if
incorporated in manufactured products; however, if spare parts and components listed in the
catalogue are sold separately, the component manufacturer must apply for the CCC mark. For these
exempted products, a Special Exempt Approval is required. However, exemption from CCC does not
mean exemption from import inspection.
Step Four: Apply
There are five major steps in the CCC mark application process
The five-step application process includes:
1. Application. Submission of an application and supporting materials, including user guides,
component list, electrical circuit diagram etc. IECEE CB Scheme Test Certificate and Test
Report within the scope granted to China by IECEE CB Scheme, are recognized for CCC mark.
For the details of above scope please refer to the IECEE website:
http://members.iecee.org/IECEE/IECEEMembers.nsf/%28$All%20by%20Cledoc%20for%20in
tro%29/intro~~ADMN-6YNGKW?OpenDocument&OpenerdocID=ADMN-6YNGKW.
2. Type Testing. A CNCA-designated test laboratory in China will test product samples.
3. Factory Inspection. Designated certification bodies will send representatives to inspect the
manufacturing facilities for your product. They will inspect each factory producing your
product (e.g. If your company manufactures Product Z in five separate factories, all of which
ship product to China, you will need to have five separate factory inspections).
4. Evaluation of certification results, and approval (or failure or retesting).
5. Follow-up Factory Inspection. Manufacturing facilities for the product will be re-inspected
every 12 months.
The status quo and development of compulsory product certification:
Currently there are 172 types of products grouped in 23 product categories that are included in the
CCC Catalogue. 368,000 CCC certificates have been issued, among which 232,000 certificates are
valid, including 208,000 for Chinese products and 24,000 for imported products. CCC has also
recognized 15,000 testing certificates issued under IECEE-CB scheme.
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2.2.2.2
A non-exhaustive overview of other regulatory requirements
In China, besides CCC certification system operated by CNCA, there are also other regulatory
requirements implemented by relevant competent authorities which involve product conformity
assessment.
The scope of expertise of the Chinese writers of this report mainly covers the certification and
accreditation and related conformity assessment activities under CNCA regulation, therefore, in
consideration of the accuracy and appropriateness of information provided, this report only provides
hereunder an overview of some of the other regulatory requirements.
For a relatively complete picture and more in-depth understanding of the other regulatory
requirements, it is recommended to carry out further study with extra expertise, preferably with the
involvement of experts from relevant competent authorities.
2.2.2.2.1
Special Equipment Licensing
Special Equipment (referring to boilers, pressure vessels, pressure piping, elevators, lifting
appliances, passenger ropeways and large amusement devices) Licensing is based on Article 14 of
Regulations on Safety Supervision of Special Equipment of P. R. China, which specifies
“Organizations carrying out manufacturing, installation or modification of boilers, pressure-vessels,
elevators, lifting appliances, passenger ropeway, large amuse devices and safety accessories, safety
protection devices, and the manufacturer of pipes, pipe fittings, valves, flanges, compensator and
safety protection devices to be used by pressure pipes, shall be approved by the State Council’s
competent authority for special equipment safety prior to conducting above activities”.
Special Equipment Licensing is operated by the Department of Special Equipment Safety Supervision
in the General Administration of Quality Supervision, Inspection and Quarantine of P. R. China
(AQSIQ).
Under this Department, there is the Special Equipment Licensing Office (SELO) of AQSIQ as the
window office for handling all the applications for Special Equipment Licensing. The predecessor of
SELO was the previous Safety Quality Licensing Office (SQLO) for Import Boiler & Pressure Vessel.
As the sole window for Special Equipment Licensing, SELO is responsible for receiving, sorting and
transmitting application materials and inspection reports to AQSIQ, establishing licensing data base,
printing and mailing licenses etc.
The requirements and rules of procedure for Special Equipment Licensing are detailed in relevant
ministerial regulations and associated specifications issued by AQSIQ in accordance with the
Regulations on Safety Supervision of Special Equipment of P. R. China. The procedure for obtaining
Special Equipment Licensing mainly involves:
1. The applicant submits the required application documents to SELO.
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2. SELO checks the completeness and correctness of application documents, and then submits
them to the Department. The Depart will review the application, and then decide whether to
accept the application. SELO will notify the applicant whether the application is accepted.
3. For accepted application, if trial-manufactured product or type testing is required, the
applicant shall prepare the trial-manufactured product or have the type testing conducted
by laboratory approved by AQSIQ.
4. The applicant shows the proof of application acceptance and, as appropriate, the type
testing report to inspection body approved by AQSIQ to make appointment for on-site
inspection. The inspection body then will carry out on-site inspection according to relevant
specifications and then submit inspection report and associated documents to SELO.
5. SELO checks the completeness of inspection documents, and then submits them to the
Department for review and approval. SELO will issue the licence to the approved applicant.
2.2.2.2.2
Calibration Apparatus Manufacturing/Repairing Licensing
Calibration Apparatus Manufacturing/Repairing Licensing is based on the Article 12 of Metrology
Law of the People's Republic of China, which specifies “Organization manufacturing or repairing
calibration apparatus shall have facilities, personnel and calibration devices and equipment which
are appropriate to the calibration apparatus manufactured or repaired by such organization, and
shall be evaluated as competent by metrology administration authority that is at or above countylevel and obtain the License for Manufacturing Calibration Apparatus or the License for Repairing
Calibration Apparatus”.
The “metrology administration authority that is at or above county-level” refers to metrology
administration departments of county, municipal or provincial Quality and Technical Supervision
Bureaus.
2.2.2.2.3
Industrial Product Manufacturing Licensing
Industrial Product Manufacturing Licensing is mandated by Regulations on Industrial Product
Manufacturing Licensing of P. R. China. This Licensing covers processed foods directly related to
human health, products that may jeopardize the safety of human life and property, products related
to financial security and communication quality and safety, products for working safety protection,
and products that may affect working safety or public safety etc.
This implementation of Licensing is carried out AQSIQ and provincial Quality and Technical
Supervision Bureaus with the participation of relevant authorities and industrial associations. Quality
and Technical Supervision Bureaus at various local levels also carry out surveillance related to the
Licensing.
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2.2.2.2.4
Others
Besides AQSIQ, following Chinese ministries also implement regulatory requirements involving
product conformity assessment:
1. Ministry of Industry and Information Technology (http://www.miit.gov.cn)
2. State Food and Drug Administration (http://www.sfda.gov.cn)
3. National Development and Reform Commission (http://www.ndrc.gov.cn)
4. Ministry of Public Security (http://www.mps.gov.cn)
5. Ministry of Environment Protection (http://www.mep.gov.cn)
For example, Ministry of Industry and Information Technology regulates telecom and internet
equipment, and for certain equipment requires manufacturers to obtain a "Network Access License"
and "Network Access Identifier Mark," which includes requirements for testing in approved test
laboratories. Similarly, China's State Food and Drug Administration require product registration for
certain medical devices.
Above list may not be complete. It is recommended by the writers of this report to carry out further
studies involving experts from relevant competent authorities.
2.2.3
Introduction to the EU system
The ever-increasing technical complexity of business means that it is increasingly important to be
able to demonstrate that what is supplied actually meets the requirements specified or claimed.
Such a demonstration is called conformity assessment.
Conformity assessment can be applied to a product or service, a process, a system, a body or
persons and includes activities such as testing, inspection and certification. As such, conformity
assessment is an indispensable part of the nation’s business, technology and standardisation
infrastructure.
The EU conformity system is based on two key principles:
•
•
Mutual recognition, which means that any product which is lawfully manufactured and sold
in one Member State can be sold throughout the EU, and
Technical harmonisation through EC directives which replace non-uniform national
regulations.
Articles 28 and 29 of the EC Treaty prohibit restrictions on imports, exports or goods in transit and all
measures having equivalent effect between Member States.
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All measures capable of hindering directly or indirectly, actually or potentially, such imports are
considered as measures having equivalent effect to restrictions subject to prohibitions being
justified on grounds of public morality, public policy or public security, the protection of health and
life of humans, animals or plants, or the protection of industrial and commercial property
In 1985 the European Council adopted a new approach to technical harmonisation followed by a
global approach to conformity assessment in 1989. These decisions have radically increased the
scope to remove technical barriers to trade in a more efficient way and to complete the European
Single Market and fulfilling one of the key principles.
Figure 2 House of Conformity Assessment
Figure 2 shows the basic construct of conformity assessment in the EU, which shows that it is based
on community legislation and harmonised standards and supported by accreditation (provides trust
on CAB’s), Notified Bodies (provides trust on product safety), procedures (Modules) which provide a
means of undertaking conformity, markings and declarations which provide a visual means of trust
on the products or services and market surveillance (pre and/or post market) to ensure that
products are and continue to be safe in the market.
The concept of technical harmonisation directives which all Member States must enact in their
national legislation is based on Article 100 of the Treaty of Rome which allows for harmonisation of
the laws of Member States that affect the functioning of the common market.
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The principle of mutual recognition requires that “any product legally manufactured and marketed in
one member State must be allowed free circulation in the Community as a whole.” This case was
supported by Case Law known as “Cassis de Dijon”
It follows from this case that in the absence of harmonised Community rules the Member States
retain the power to lay down their own legislation relating to product and services.
However, they are required to admit to their territory products lawfully produced and marketed in
the other Member States.
The importation and marketing of products lawfully produced and marketed in another Member
State may only be restricted, in the absence of harmonisation by such rules where they affect
requirements such as the effectiveness of fiscal supervision, the protection of public health, the
fairness of commercial transactions and the defence of the consumer, and are proportionate to the
desired objective, and are the means of achieving that objective which least hinders trade. There
exist many other cases that support the above case.
In 2008 a new Regulation was introduced, 764/2008/EC of the European Parliament and of the
Council of 9 July 2008 laying down procedures relating to the application of certain national
technical rules to products lawfully marketed in another Member State and repealing Decision No
3052/95/EC, this Regulation came into force in May 2009.
The objective is to strengthen the internal market by improving the free movement of goods within
the Community.
The objective of this Regulation is to improve the free movement of goods in the Community. It
establishes rules and procedures which should be followed by the authorities of Member States
when they take or intend to take a decision which could hinder the free movement of a product
lawfully marketed in another Member State and not covered by harmonised rules at Community
level.
Scope
This Regulation shall apply to administrative decisions based on a technical rule which has the direct
or indirect effect of:
• the prohibition of the placing on the market of a product;
• the modification or additional testing of that product before it can be placed on the market;
• the withdrawal of that product.
This Regulation does not apply to:
• judicial decisions;
• systems covered by Directives 96/48/EC and 2001/16/EC;
• the procedure for authorisation of the placing in service of rolling stock provided for in
Directive 2004/49/EC;
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• certain measures related to products posing a serious risk detailed in Directive 2001/95/EC;
• certain measures related to food posing a risk taken under Regulations 178/2002 and
882/2004.
Procedures
This Regulation frames the assessment of product conformity with national technical rules.
Competent authorities in the Member States must comply with the rules and procedures on:
• gathering information on the product concerned;
• the recognition of certificates or test reports issued by an accredited conformity-assessment
body in accordance with Regulation No 765/2008: Member States cannot reject certificates
or test reports on grounds related to the competency of that body;
• an evaluation of the need to apply a technical rule: the decision should be based on
technical or scientific elements proving the proportionality of the envisaged measure, should
be notified to the enterprise concerned and can be legally challenged;
• the temporary suspension of the marketing of a product: this is forbidden during the
evaluation procedure, except in cases where the product poses a serious risk or is prohibited
in a Member State on grounds of public morality or public security.
Product Contact Points
Each Member State shall designate one or more Product Contact Points in their territories and shall
communicate their contact details to the Commission and to the other Member States. The task of
the Product Contact Points is to provide information on the technical rules applicable in the territory
in which they are established, on the contact details of the competent authorities and on the
remedies available.
A summary of the “Mutual Recognition” regulation is as follows:
• Denial of mutual recognition becomes the exception and not the rule.
• Definition of rights and obligations:
 Burden of proof is on the receiving Member State
 Tight deadlines for receiving Member State
• Product Contact Points in Member States will provide information to enterprises and
competent authorities
Administrative decisions have to:
 Addressed the economic operator
 Directly or indirectly deny access to the market
 Be based on a “technical rule”
 Denial of market access - effect of the decision:
 Prohibition
 Modification (1 or more characteristics)
 Additional Testing
 Withdrawal of a product
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Mutual recognition is the basic rule (EC Treaty)
 Both actual and possible denial of mutual recognition is governed by Regulation
If denial is introduced there is an obligation for national authorities to start dialogue with the
economic operator and to follow the procedural requirements established by the Regulation.
2.2.3.1
Technical Harmonisation Directives
The earliest legislation within the EU was to harmonise national technical requirements by adopting
similar, very specific and detailed technical directives which had to be unanimously decided by the
European Council. These directives are now referred to as “old approach” directives.
Old approach directives frequently covered only one product or even only one of the elements
involved in the manufacture of a product and included all the technical requirements, conformity
procedure, testing and inspection.
An example of old approach Directives can be found in motor vehicle legislation in the EU, Technical
harmonisation for motor vehicles, implemented at Community level pursuant to Article 95 of the
Treaty establishing the European Community, is based on the Community's WVTA (whole vehicle
type-approval) system.
Under this system, manufacturers can obtain certification for a vehicle type in one Member State if
it meets the EC technical requirements and then market it EU-wide with no need for further tests.
There is also worldwide technical harmonisation in the context of the United Nations Economic
Commission for Europe (UN/ECE).
Adoption of old approach directives proved to be cumbersome and slow since any changes due to
technical progress resulted in the amendment of the Directive. In 1985 the European Council
adopted a new approach to technical harmonisation and standards to simplify the removal of
technical barriers to trade.
This meant that the European Council of Ministers was no longer required to deal with detailed
technical requirements, but only needed to define the essential requirements necessary to protect
the public interest.
These New Approach Directives introduced a number of new concepts such as the basic principle of
voluntary standards, products manufactured to conform to voluntary European harmonised
standards (ENs) are presumed to comply with the essential requirements of applicable directives.
Also instead of the Directives being specific to a product the new approach covers industry sectors
or broad product areas which are stated in scope.
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In 1989 the Council adopted the COUNCIL RESOLUTION of 21 December 1989 on a global approach
to conformity assessment (90/C 10/01) with the aim of creating the conditions which enabled the
principle of mutual recognition of proofs of conformity to operate in both the regulatory and the
non-regulatory sphere.
It was completed in 1993 with the COUNCIL DECISION of 22 July 1993 concerning the modules for
the various phases of the conformity assessment procedures and the rules for the affixing and use of
the CE conformity marking, which are intended to be used in the technical harmonization directives,
this Decision has now been repealed and replaced with Decision 768/2008/EC, further description of
this legislation is given below.
2.2.3.2
New Approach Directive
A new regulatory strategy was laid down by the Council Resolution of 1985 on the New Approach to
technical harmonisation and standardisation, which required the following to be contained in each
Directive.
Section I
Sections II
Section III
Section IV
Section V
Section VI
Section VII
Section VIII
Section IX
Section X
Scope (what products are included or not included in the Directive)
Placing on the Market (allowed in all markets in the EU)
Essential Requirements (what are the requirements)
Free movement of Goods
Proof of Conformity (how is this demonstrated by declarations and markings)
Management of list of standards (harmonised standards)
Safeguard Clause (ensures member states can still stop unsafe goods)
Means of Attestation (how to achieve conformity)
Standing Committee (to have a committee that solves problems of application)
Tasks and operation of the committee
The principles that the above Directives establishes are as follows:
•
•
•
•
•
Legislative harmonisation is limited to essential requirements that products must meet.
The technical specifications of products meeting the essential requirements are laid down in
harmonised standards.
Application of harmonised or other standards remains voluntary.
Products manufactured in compliance with harmonised standards benefit from a
presumption of conformity with the corresponding essential requirements.
The operation of the New Approach requires that the standards offer a guaranteed level of
protection with regard to the essential requirements established by the directives, and that
the national authorities carry out their responsibilities for the protection of safety or other
interests covered by the directive. Further, a safeguard clause procedure is necessary to
allow the possibility of contesting the conformity of a product, or failures or shortcomings of
harmonised standards.
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2.2.3.3
The Global Approach Directive
The term “conformity assessment procedures" covers the various methods of examining a product to
determine if it complies with the essential requirements of new approach directives, including any
requirements relating to the design and manufacture of products.
The global approach introduced by Council Resolution of 21 December 1989 establishes a new policy
for how manufacturers can demonstrate that their products meet the legally binding technical
requirements in new approach directives. The global approach promotes attention to quality in
European production and stresses the fact that manufacturers always have total responsibility for
their products.
The main principles of the global approach are as follows:
•
•
•
•
•
•
Establishes modules (how to)
Designation and notification of bodies
Sets up an accreditation system
Use of EU standards on quality (EN 29000 and EN 45000 these are now mostly replaced by
ISO/IEC 17000 series of standards)
Promotion of mutual recognition agreements
Manufacturers’ issues an EC Declaration of Conformity, declaring that the product satisfies
the requirements of the applicable directives or conforms with an approved type.
The policy identifies options to be applied by new approach directives. These range from
manufacturer’s declarations of conformity without intervention of a notified body (for products
assessed as low risk) to a requirement that the manufacturer implement a full quality assurance
system which is approved and supervised by a notified body (for products where there is a
perception of high risk).
The Global Approach was completed by Council Decision 90/683/EEC, which was replaced and
brought up to date by Decision 93/465/EEC. These decisions lay down general guidelines and
detailed procedures for conformity assessment that are to be used in New Approach directives, In
addition to laying down guidelines for the use of conformity assessment procedures, Decision
93/465/EEC harmonises the rules for the affixing and use of the CE marking. This Decision
93/463/EEC has now been replaced by Decision 768/2008/EC on a common framework for the
marketing of products.
Thus, conformity assessment is based on, manufacturers’ internal design and production control
activities; third party type examination combined with manufacturers’ internal production control
activities; third party type or design examination combined with third party approval of product or
production quality assurance systems, or third party product verification; third party unit verification
of design and production; or third party approval of full quality assurance systems.
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2.2.3.4
EU Legislation
Figure 3 Overview of relevant EU legislation concerning Conformity Assessment
2.2.3.5
Adoption of Directives
Figure 4 below shows the process that is followed when a proposal for a new Directive is started.
This is shown so that the readers can be informed as to how the system works in achieving
consensus from all stakeholders, at all stages in each country the relevant stakeholders like industry,
commerce, consumers are consulted, in this manner agreed regional legislation is developed.
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Figure 4 Procedure for adoption of a Directive
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3.0 Standards in China and the EU
3.1 Standardization System in China
Due to the fundamental supportive role of standard in China’s social and economic development,
China’s standardization system is featured by the focus on the needs of social and economic
development, and coordinated, coordination, direction and oversight by the government, as well as
the substantial participation of stakeholders such as industries, professional bodies, scientific
research bodies and consumer groups etc.
China’s standard system is dominated by national standards and sectoral standards. A provincial
local standard can only be developed when there is a need for certain unified safety or hygiene
requirements within a province, while there is no corresponding national or sectoral standard
available.
As soon as corresponding national or sectoral standard is published, such provincial local standard
shall be superseded by such national or sectoral standard. In all the cases, the national standard
always take the precedence over the standards at lower levels (industrial, provincial or company).
The CCC certification system only uses national or sectoral standards as certification criteria, no
provincial local standard or company standard.
3.1.1
Composition of Chinese standards
Chinese standards are composed of national standards, sectoral standards, provincial local standards
and company standards:
1.
National standards are the large majority of Chinese standards. They specify those technical
requirements to be consistently implemented all over the country. National standards are
predominantly developed by more than 500 national standardization technical committees
(TCs), then submitted to Standardization Administration of China (SAC) for formality check
and numbered and published by SAC.
TCs are established by subjects or disciplines and consisting of members representing
relevant stakeholders such as industries, competent authorities, professionals, scientific
organizations, consumers etc.
TCs are authorized and supervised by SAC who is the competent authority mandated by the
Standardization Law of P. R. China to provide oversight, coordination and direction on
standardization activities.
The development of national standard is a consensus-based approach, normally involving
following steps:
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2.
• Working group (WG) set up by TC drafts the standard.
• TC sends the draft to stakeholders for public consultation.
• WG revises the draft according to public consultation results. If necessary, TC will
conduct further public consultation.
• TC reviews and ballots on the revised draft.
• If the draft succeeds in the TC ballot, WG will prepare a final draft. If not, WG will
revise the draft for further ballot.
• TC submits the final draft to SAC for formality check. Usually SAC only suggests
necessary editorial changes to the final draft.
• SAC assigns reference number to the standard and formally publishes the standard.
• Normally a standard will be systematically reviewed every 5 years for necessary
revision.
Sectoral standards are also of a significant number in Chinese standards. The sectoral
standard is developed to harmonize technical requirements to be consistently implemented
within a particular industrial or economic sector upon the condition that there is no
corresponding national standard available, and shall be withdrawn upon the publication of
corresponding national standard.
It is usually developed by the sectoral standardization technical committee formed by
stakeholders for that sector and published by the competent ministry, who will also submit
the sector standard to SAC for recording purpose.
3.
A provincial local standard can only be developed when there is a need for certain unified
safety or hygiene requirements within a province, while there is no corresponding
national or sectoral standard available.
Once corresponding national or sectoral standard is published, such provincial local standard
shall be superseded by such national or sectoral standard.
The development of provincial local standards are coordinated by provincial quality and
technical bureaus, who are also responsible for publishing provincial local standards and
submitting them to SAC and competent ministries for recording purpose.
Although local standards are developed locally and published by provincial Quality and
Technical Supervision Bureaus, SAC still supervises the development of local standards and
ensures that local standards are developed in line with WTO TBT Code of Good Practice, as
follows:
i)
SAC is mandated by Standardization Law of P. R. China to supervise standardization
activities all over the country.
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ii)
For local standards, there is the "Administrative measures for local standards",
which is an AQSIQ ministerial regulation developed according to Standardization
Law of P. R. China and enforced by SAC. It requires that local standards shall be
developed and published in accordance with National Standard GB/T 1 Directives for
Standardization, which is consistent with ISO/IEC Directives. Moreover, it requires
local standards shall be reported to SAC for record, and entitles SAC to suspend or
terminate any local standard which is not complying with relevant laws and
regulations.
iii)
SAC also supervises, coordinates and directs provincial Quality and Technical
Supervision Bureaus with regarding to local standardization activities.
A local standard is only applicable within the publishing province.
4.
A company standard may be developed by a company in case there is no corresponding
national and sectoral standard for the company’s product, or the company intends to
follow requirements higher than corresponding national or sectoral standard.
Company standards need to be reported to local quality and technical supervision bureau
for recording purpose.
National standards and sectoral standards are further classified into voluntary standards and
mandatory standards. The implementation of mandatory standards is enforced by laws and
regulations. Standards specifying requirements for the safety of the human life or property, human
health, public safety and security, environment protection or consumer protection etc. and other
standards whose implementation is enforced by relevant laws and regulations are mandatory
standards. The others are voluntary standards.
Provincial local standards specifying safety and sanitary requirements are mandatory for respective
provinces.
CCC certification is based on national standards or sectoral standards only, no provincial local
standard or company standard is used for CCC certification.
3.1.2
China’s Policies towards International Standards
SAC encourages the adoption of international standards and advanced foreign standards. National
standards should normally be drafted in accordance with the corresponding international standards
(including those under development).
Whenever possible, international standards shall be adopted identically. If any modification is
necessary due to national differences in climate or geographical conditions or fundamental technical
issues, the modification shall be as minimum and as reasonable and necessary, and shall be clearly
stated in the standard (normally in the forward of a standard).
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The ratio of Chinese national standards that are identical to corresponding international standards
has been increasing continuously and rapidly in last decade.
China has been actively participating in the development of international standards. SAC represents
China in ISO, IEC and other international and regional standardisation organizations, and organizes,
coordinates and promotes Chinese TCs and stakeholders to participate in the technical work of ISO
and IEC.
3.2 Standardisation System in the EU
Harmonized Standards are European Standards (EN) prepared in accordance with the General
Guidelines agreed between the European Commission and the European Standards Organizations
following a mandate issued by the Commission after consultation with the EU Member States.
A harmonised standard must match the essential requirements of the relevant directive. A European
standard may contain provisions relating not only to essential requirements but also to other
matters. In such a case, these provisions should be clearly distinguished from those covering the
essential requirements.
The elaboration and adoption of harmonised standards is based on the General Guidelines for
cooperation between the European standards organisations and the Commission signed on 13
November 1984
On 18 October 2004, the Commission adopted a Communication on “the Role of European
Standardisation in the Framework of European Policies and Legislation” accompanied by a staff
working paper dealing with “the challenges for European Standardisation”.
Both documents analyse and identify the key areas where the European standardisation system and
the instruments available to European standardisation policy should be improved. Both documents
are a response to the Council Conclusions of March 2002 and the Council Resolution of October
1999 on ”the Role of Standardisation in Europe” in which the Council had acknowledged the
important role of standards and invited the Commission to analyse the current situation of European
standardisation and to respond to the challenges the European standards system is faced with.
In order for EU standards to be considered harmonised they have to be developed in accordance
with a mandate and demonstrate that it reflects the essential requirements of the respective
Directive and have to be published in the Official Journal of the European Community.
Once the above happens it is an obligations of all national standards bodies of the member countries
of the EU to adopt the standard in full (without any changes, unless national applications have been
agreed) and to withdraw all conflicting national standards. The harmonised standards are the only
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type of standards that provide presumption of compliance with the relevant Directive(s) in
accordance with the EU legal framework.
Standards, whether harmonized or not, are voluntary. A manufacturer may use a harmonised
standard or follow other methods for compliance with the essential requirements, including the
essential requirements themselves, as long as the product is safe it can be placed on the market, but
if harmonised standards are not used the burden of proof is on the manufacturer to show that the
product complies with the Directive.
There are three main organisations in the EU which are charged with the development of
harmonised standards, these are;
1) European Committee for Standardisation (CEN)
2) European Committee for Electrotechnical Standardisation (CENELEC) and,
3) European Telecommunications Standards Institute (ETSI)
There also exists the “general guidelines --- for the co-operation between cen, cenelec and etsi and
the european commission and the european free trade association 28 march 2003” which outlines
the basic principles of behaviour between the standardisation bodies and the EU authorities.
3.2.1
European Committee for Standardisation (CEN)
The European Committee for Standardisation, was founded in 1961 by the national standards bodies
in the European Economic Community and EFTA countries. The main objectives were to develop
voluntary technical standards which promote free trade, the safety of workers and consumers. CEN
is a non-profit making technical organization set up under Belgian law.
CEN is a system of formal processes to produce standards. The responsibilities are shared principally
between: 30 National Members and the representative expertise they assemble from each country.
These members vote for and implement European Standards (ENs). CEN works closely with CENELEC,
ETSI and ISO.
Members:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
CEN produces a number of different standards publications. All European Standards (EN) and drafts
(prEN), Technical Specifications (CEN TS), Technical Reports (CEN TR) and CEN Workshop
Agreements (CWA). So far, CEN has published 12903 publications (end December 2007).
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The Vienna Agreement Cooperation with ISO
In January 1989 the CEN Administrative Board approved an agreement on the exchange of technical
information between ISO and CEN (called the Lisbon Agreement) as a response to the ISO Council
resolution 11/1987.
Subsequently, an agreement on technical co-operation between ISO and CEN was approved by the
ISO Council resolution 18/1990 and the CEN General Assembly resolution 3/1990. This agreement
(called the Vienna Agreement) was published in June 1991. It is accompanied by common ISO-CEN
"Guidelines for the TC/SC Chairmen and Secretariats for implementation", approved in 1992 and
revised in September 1998. This text below is a simplified version of the agreement setting out the
basic principles.
The agreement recognises the primacy of international standards (stipulated in the WTO Code of
Conduct), it also recognises that particular needs (of the Single European Market might require the
development of standards for which a need or speed has not been recognized at the international
level.
As a result, the agreement sets out two essential modes for collaborative development of standards:
the mode under ISO lead and the mode under CEN lead, in which documents developed within one
body are notified for the simultaneous approval by the other.
The benefits expected are:
•
•
•
increasing transparency of work ongoing in CEN to ISO members, and their possibility to
influence the content of CEN standards;
avoidance of duplication of work and structures, thus allowing expertise to be focused and
used in an efficient way to the benefit of international standardization;
increasing the speed of elaboration, availability and maintenance of standards through a
need to establish consensus only once.
Technical co-operation is possible at various levels:
•
•
•
•
•
by regular exchange of information at the level of the CEN Management Centre (CMC) and
the ISO Central Secretariat (ISO/CS), such as catalogue, work programme, resolutions, (draft)
standards;
by the adoption of existing international standards as European standards;
through working by correspondence;
through (mutual) representation at meetings of technical entities;
when ISO and CEN agree to submit relevant and approved work items within the same scope
to parallel procedures, with agreement on leadership (ISO-lead decided by CEN, CEN-lead
decided by ISO).
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Figure 5 below show in which sectors have there been development of standards in accordance with
mandates from the Commission and support the Directives essential requirements.
Services
Information society standardization system
Environment
Heating, cooling, ventilation and air conditioning
Food
33
86
188
212
238
Utilities and energy
357
Household goods, sports and leisure
372
General health and safety
424
464
General Standards
495
Healthcare
619
Chemistry
1425
Materials
1594
Transport and packaging
1622
Building and civil engineering
1775
Mechanical engineering
Figure 5 Number of CEN Standard
CEN standards identical to ISO standards
27%
73%
identical to ISO
not identical to ISO
Figure 6 CEN / ISO Identical standards 2006
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3.2.2
European Committee for Electrotechnical Standardisation
(CENELEC)
CENELEC was created in 1973 as a result of the merger of two previous European organizations,
CENELCOM and CENEL. Nowadays, CENELEC is a non-profit technical organization set up under
Belgian law and composed of the National Electrotechnical Committees of 30 European countries.
The mission is to prepare voluntary electrotechnical standards that help develop the Single
European Market/European Economic Area for electrical and electronic goods and services removing
barriers to trade, creating new markets and cutting compliance costs.
Members:
Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom.
There are two major deliverables: The European Standard (EN) and the Harmonization Document
(HD). These two documents are referred to commonly as "standards" and must be implemented in
all CENELEC member countries, who must also withdraw any conflicting standards.
There are a few differences in the implementation process of EN's and HD's. Basically, the EN must
be transposed as it is, not adding or deleting anything. The process for HD's is a bit more flexible. It is
the technical content that must be transposed, no matter the wording or how many documents are
made of it.
In addition to these two major deliverables, CENELEC also produces the following type of documents:
TS - Technical Specification, TR - Technical Report , G – Guides and CWA - CENELEC Workshop
Agreement.
The numbering of CENELEC standards is as follows:
40000 to 44999 cover domains of common CEN/CENELEC activities in the IT field
45000 to 49999 cover domains of common CEN/CENELEC activities outside the IT field
50000 to 59999 cover CENELEC activities
60000 to 69999 refer to the CENELEC implementation of IEC documents with or without changes
Dresden Agreement Cooperation with the IEC
On the international level, CENELEC has worked hand-in-hand with the IEC since the signature of the
Dresden Agreement in 1996. One clause of the Dresden Agreement calls for common planning of
new work. In 2004, an evaluation of the situation pointed to the need for a better organization of
the work offer from CENELEC’s side, through its New Work Items (NWIs). CENELEC Central
Secretariat and IEC Central Office thus developed a two-step procedure in order to improve the
efficiency of the process.
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From now on, CENELEC will offer “raw topics” (new work item proposals) together with a summary
on the topic to the IEC. If the IEC states an interest in the work, CENELEC will deliver a more detailed
documentation in the prospect of future developments.
The agreement complies in principle and essence the intent of the WTO Annex 3 Code of Good
Practice where it states that all members are to use where ever possible international standards and
these standards will not be considered barriers to trade. By using this agreement CENELEC and IEC
commit to work together in order to harmonise the EU regional standards into international
standards.
CENELEC Statistics
Identical to the IEC standards
Based on the IEC standards
Purely European standards
Total
3974
380
1171
5525
72%
7%
21%
100%
Figure 7 Pie Diagram of EU harmonised standards identical or based on IEC Standards
In overall terms, 79% of CENELEC Standards are identical to or based upon IEC’s.
3.2.3
European Telecommunications Standards Institute (ETSI)
The European Telecommunications Standards Institute produces globally-applicable standards for
Information and Communications Technologies (ICT), including fixed, mobile, radio, converged,
broadcast and internet technologies.
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TSI is officially recognized by the European Commission as a European Standards Organization.
ETSI is a not-for-profit organization with almost 700 ETSI member organizations drawn from 60
countries world-wide.
3.2.4
The Principle of Harmonised Standards in the EU
The New Approach framework have in their requirements that all harmonised standards in the EU
provide for presumption of conformity with the essential requirements of the Directive and for the
transposition of the standards by each national standards body in each member state and the
withdrawal of all conflicting standards.
Standardisation Procedure
1
2
3
4
5
6
7
8
9
10
11
12
A mandate is drawn up, following consultation with the Member States.
The mandate is transmitted to European standards organisations.
European standards organisations accept the mandate (80).
European standards organisations elaborate a (joint) programme.
The technical committee elaborates a draft standard.
European standards organisations and national standards bodies organise a public enquiry.
The technical committee considers comments.
National standards bodies vote/European standards organisations ratify.
European standards organisations transmit references to the Commission.
The Commission publishes the references.
National standards bodies transpose the European standard.
National authorities publish references of national standards.
The Commission gives financial support to the secretariats of the European standards organisations
and can also fund special groups to take part in standardisation to represent, for example, consumer,
SME and environmental views. Where necessary, the Commission contributes towards the costs of
developing some specific standards and often helps to fund related research projects
The International and European standards bodies have facilitated the use of conformity assessment
by the development of standards for the operation of various types of conformity assessment bodies
and for accreditation bodies.
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4.0 Conformity Assessment Process China
and the EU
4.1 China Compulsory Product Certification System (CCC)
4.1.1
1.
2.
3.
Principles for the establishment of CCC
Integration of previous two separate mandatory product certification systems (CCIB mark
certification for imported products and “Great Wall” mark certification for domestic products)
into one (two former systems into one) without duplications in testing/inspection;
Four “unifications”, i.e. unified product catalogue, unified standards and technical
specifications and conformity assessment procedures, unified mark and unified fee schedule;
In line with internationally recognized conformity assessment practices:
(a)
(b)
4.1.2
1.
2.
3.
4.
5.
4.1.3
4.1.3.1
The establishment of the certification system conforms to the requirements of
WTO/TBT on the conformity assessment system;
Certification standards are based on national standards or sectoral standards that are
identical or equivalent to international standards.
Framework of the compulsory product certification
It is established by the central government (to regulate the market and serve the trade
and the development of the economy).
Designated certification bodies are responsible for performing certification activities and
are liable for the certification results.
Authorized organization is responsible for the issuance of certification marks and the
examination and approval of the proposed usage.
Manufacturers, distributors, importers and operators of business and service locations are
responsible for the products that are manufactured, distributed, imported and used.
Local certification supervision authorities carry out surveillance on products listed in the
CCC Catalogue.
Documentation of compulsory certification system
Laws and regulations
China’s compulsory product certification system is established on the basis of the Product Quality
Law of the People’s Republic of China, the Law of the People’s Republic of China on Import and
Export Commodity Inspection, the Standardisation Law of the People’s Republic of China and the
Regulations of the People’s Republic of China on Certification and Accreditation.
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4.1.3.2
Ministerial regulations
1. The Administrative Rules for Compulsory Product Certification that was promulgated on
3rd December 2001 in Order No. 5 of the Chief of the State Administration of Quality
Supervision, Inspection and Quarantine, serves as a basic document for the
implementation of the compulsory product certification system at present.
2. The Administrative Measures for the Administration of Compulsory Products Certification
Bodies, Inspection bodies and Laboratories (Order No. 65 of 2004 of the Chief of the State
Administration of Quality Supervision, Inspection and Quarantine): it stipulates the
conditions and procedures for designating certification bodies, inspection bodies and
testing laboratories that carry out conformity assessment activities for compulsory
product certification as well as supervision and administration requirements.
4.1.3.3
Other specifications
1. Administrative Specifications for the Compulsory Product Certification Mark: it stipulates
the pattern of and usage requirements for the compulsory product certification mark and
rules for printing, applying for, issuing and supervising the mark.
2. Catalogue of Products Subject to CCC Mark
3. CCC certification implementation rules for products listed in the Catalogue: There are 74
such implementation rules stipulating the scope of certification of relevant products;
i.
ii.
iii.
iv.
v.
vi.
vii.
viii.
principles for the classification of product units,
standards against which the certification is performed,
requirements for samples, requirements for type testing,
list of key parts and components,
factory inspection requirements,
certification decision and post-certification surveillance,
post-certification modification,
certification extension and usage requirements for CCC mark, etc.
4. Specifications for the Fees for Compulsory Products Certification: it is reviewed, approved
and promulgated by the former National Planning Commission, now the National
Development and Reform Commission, specifying the fee items and rates of compulsory
product certification and relevant administration requirements.
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4.1.4
Organizational structure for implementing CCC
1. CNCA
CNCA is responsible for the overall administration of compulsory product certification
system and the supervision of the effectiveness of its implementation, including:
i. Drafting/revising the Catalogue and promulgating it together with AQSIQ;
ii. Formulating and promulgating the implementing rules for the compulsory
certification of products listed in the Catalogue Products;
iii. Designing and promulgating certification marks and defining the requirements for
CCC certificates;
iv. Designating certification bodies, testing laboratories and inspection bodies carrying
out conformity assessment activities for CCC certification, and designating the
organization that issues CCC certification marks;
v. Publishing the directory of certified products and associated enterprises;
vi. Directing local certification supervision authorities to investigate and act on breaches
of CCC certification rules;
vii. Receiving and handling complaints and appeals related to compulsive product
certification.
2. Local certification supervision authorities
CNCA also authorize local Quality and Technical Supervision Bureaus and Local Entry-exit
Inspection and Quarantine Bureaus to carry out following responsibilities as local
certification supervision authorities:
i. Surveillance on products listed in CCC Catalogue products in areas under their
administration. The surveillance focuses on non-certified products, products that
have not been applied CCC marks, fraudulent use of CCC mark, use of forfeited
marks, or products against which complaints have been received from consumers;
ii. Preventing products listed in the Catalogue but not certified form entering the areas
under their administration;
iii. Investigating and acting on breaches of compulsory certification rules by
manufacturers, distributors or importers of products listed in the Catalogue;
iv. Reporting the breaches or non-compliance of designated certification bodies, testing
laboratories and inspection bodies and their personnel to CNCA. CNCA then will
investigate and act on reported breaches or non-compliances with the assistance of
local certification supervision authorities.
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4.2 The EU product certification system
The procedures for conformity assessment are given in each New Approach Directive and are based
on the Global Approach, the degree of intervention by a third party known as a Notified Body within
the community is based on the relevant risk that a product or market sector has on society, the
consumer or health and safety at work.
An example of this is that electrical products in general are thought to have a low risk whilst
electrical products to be placed in explosive atmospheres are considered to carry very high risk
therefore requires full third party certification in accordance with standards.
Figure 8 below shows a model of the risk approach which the community holds.
Figure 8 Risk and Conformity Assessment
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4.2.1
Regulated Conformity Assessment
The actual procedure for conformity assessment from the point of view of the manufacturer’s within
the EU is as follows:
1) Identify all community legislation that is applicable to its product (generally this means the
New Approach Directives),
2) Follow the essential requirement (by undertaking this it means that the manufacturer
produces safe products from the regulator point of view)
3) Identify Harmonised Standards that may be used to attain compliance (provision of
presumption of compliance with the essential requirements)
4) From the relevant Directive identify and apply one of the conformity assessment procedures
5) Identify and request intervention of a Notified Body (if applicable, third party certification)
6) Prepare Technical File
7) Prepare a Declaration of Conformity
8) Affix the CE marking
The global approach completed the conformity assessment requirements and these introduced the
concept of assessment modules and their combination, Figure 9 below shows a representation of
the Modules that were introduced, Table 1 shows the responsibilities that the manufacturer or his
representative has and that of the notified body for each Module.
An overview of the CE marking Directives and their conformity assessment requirements based on
Council Decision 768/2008/EC are shown below. The actual conformity assessment procedures
together with the responsibilities are shown in Table 1.
It is the combination of the Modules described below which provide the conformity assessment
requirements in each New Approach Directive as shown in Table 2.
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Table 1 Description of Conformity Assessment
Module
Conformity
Assessment
Standards used
Title
A
EN 45004
(ISO/IEC 17020)
ISO/IEC 17025
Self
Declaration
Manufacturer or Representative
•
•
•
•
•
•
B
EN 45004
(ISO/IEC 17020)
ISO/IEC 17025
Type or
Design
examination
•
•
•
•
•
establishes a technical documentation as regards the
design, manufacture and operation of the product,
takes all measures necessary to ensure that the
manufacturing process assures compliance of the products
with the technical documentation and with the applicable
requirements (i.e. operates a quality system)
ensures and declares that the products concerned satisfy the
requirements
affixes the CE marking to each product
draws up a declaration of conformity
keeps a copy of the declaration of conformity and the
technical documentation at the disposal of the surveillance
authorities
establishes a technical documentation as regards the
design, manufacture and operation of the product
applies for the EC type examination
places at the disposal of the notified body one (or more)
specimen(s), which is (are) representative of the production
envisaged
informs the notified body of all modifications to the
approved product
keeps the technical documentation, including a copy of the
EC type-examination certificate, at the disposal of the
surveillance authorities
The Notify Body must:
Not involved but in some cases can review the
manufacturer’s documentation and processes.
•
•
•
•
Ascertains specimen meets all applicable
provisions and is manufactured in accordance with
the technical documents and has relevant testing
done.
Issues EC Type examination certificate or EC
Design Examination
Keeps copy of documents
Informs other Notified Bodies of relevant
information
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Module
Conformity
Assessment
Standards used
Title
C
EN 45004
(ISO/IEC 17020)
ISO/IEC 17025
Conformity
to type
Manufacturer or Representative
•
•
•
•
D
EN 45012
Production
Quality
Assurance
•
•
•
takes all measures necessary to ensure that the
manufacturing process assures compliance of the products
with the type as described in the EC type-examination
certificate and with the applicable requirements (i.e.
operates a quality system, which includes establishing the
necessary documentation)
ensures and declares that the products concerned are in
conformity with the EC type-examination certificate and
satisfy the applicable requirements
affixes the CE marking to each product • draws up a
declaration of conformity
keeps relevant technical information and a copy of the
declaration of conformity at the disposal of the surveillance
authorities
operates an approved quality system for production, final
product inspection and testing, which includes the drawing
up of a technical documentation (i.e. relevant information
for the product category envisaged, documentation
concerning the quality system and its updating, technical
documentation of the approved type, a copy of the EC
type-examination certificate, and the decisions and reports
from the notified body
applies for the assessment of the quality system for the
products concerned
ensures and declares that the products concerned are in
accordance with the EC type-examination certificate and
satisfy the applicable requirements
The Notify Body must:
•
•
•
•
•
•
•
•
ensure manufacturer performs assessment
monitors the manufacturer in the form of
unexpected visits
Take samples at the manufacturing or storage
premises to conduct checks.
Determines the number of samples and if it is
necessary to perform or have performed all or part
of the final assessment on the samples
Take appropriate measures should one or more of
the items not conform
The notified body must assess the quality system
to determine whether it satisfies the requirements.
The elements of the quality system which conform
to the relevant harmonised standard are presumed
to comply with the corresponding requirements.
The auditing team must have at least one member
with experience of assessing the relevant Directive
concerned. The assessment procedure must
include an inspection visit to the manufacturer’s
premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination.
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Module
Conformity
Assessment
Standards used
Title
Manufacturer or Representative
•
•
•
•
•
•
•
•
E
EN 45012
Product
Quality
Assurance
F
EN 45004
(ISO/IEC 17020)
ISO/IEC 17025
Product
Verification
undertakes to fulfil the obligations arising out of the
approved quality system and upholds it so that it remains
adequate and efficient
supports the action carried out by the notified body for
surveillance purpose
keeps at the disposal of the surveillance authority the
documentation concerning the quality system, details of
any updating of the quality system, the decisions and
reports of the notified body
affixes the CE marking to each product
affixes the notified body’s identification number to follow
the CE marking
draws up a declaration of conformity
informs the notified body of any intended updating of the
quality system
keeps a copy of the declaration of conformity at the
disposal of the surveillance authorities
As in module D, but operates an approved quality system for final
product inspection and testing
•
takes all measures necessary to ensure that the manufacturing
process assures conformity of the products with the type as
described in the EC type-examination certificate and with the
applicable requirements (i.e. operates a quality system, which
includes establishing the necessary documentation)
Where the statistical verification is used:
• presents the products in the form of homogeneous lots and
The Notify Body must:
•
•
•
•
•
The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the
manufacturer with an audit report.
The frequency of periodic audits must be such that
a full reassessment is carried out every three years.
In addition the notified body may pay unexpected
visits to the manufacturer.
During such visits the notified body may carry out
or have carried out tests to verify that the quality
system is functioning correctly.
The notified body must provide the manufacturer
with a visit report and, if a test has taken place,
with a test report.
•
As per Module D
•
examine and undergo tests as set out in the
harmonised standards in order to verify
conformity to type.
verify that the personnel are qualified
verify the materials certificate are suitable
Carry out final inspection and proof test.
•
•
•
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Module
Conformity
Assessment
Standards used
Title
Manufacturer or Representative
•
•
•
•
•
•
G
EN 45004
EN 45011
Verification
Unit
Verification
•
•
•
•
•
•
•
The Notify Body must:
takes all measures necessary in order that the
manufacturing process ensures the homogeneity of each lot
produced
applies for certification of conformity
checks and attests that the products are in conformity with the
type as described in the EC type-examination certificate and
satisfy the applicable requirements
affixes the CE marking to each product
affixes the notified body’s identification number to follow the
CE marking
draws up a declaration of conformity
keeps relevant technical information (e.g. the notified body’s
certificate of conformity) and a copy of the declaration of
conformity at the disposal of the surveillance authorities
•
affix its identification number or have it affixed to
each item and draw up a written certificate of
conformity relating to the tests carried out.
establishes a technical documentation as regards the design,
manufacture and operation of the product
ensures and declares that the product concerned conforms to the
applicable requirements
applies for certification of conformity
affixes the CE marking to each product • affixes the notified
body’s identification number to
follow the CE marking
draws up a declaration of conformity
keeps a copy of the declaration of conformity and the technical
documentation at the disposal of the surveillance authorities
•
Examine the design and construction of each item
of equipment and during manufacture perform
appropriate tests as set out in the harmonised
standards.
Examine the Technical File/Document with
respect to design and manufacturing procedures.
assess the materials used when these are not in
conformity with harmonised standards.
approve procedures for joining of parts or check
that they have been previously approve.
verifies the qualifications or approvals.
carry out final inspection
perform or have performed proof tests.
•
•
•
•
•
•
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Module
H
Conformity
Assessment
Standards used
EN 45012
Title
Quality
Assurance
Manufacturer or Representative
•
•
•
•
•
•
•
operates an approved quality system for design, manufacture,
final product inspection and testing, which includes the
drawing up of a technical documentation (i.e. relevant
information for the design,
the product category envisaged, documentation concerning the
quality system and its updating, and the decisions and reports
from a notified body)
applies for the assessment of the quality system for the
products concerned
ensures and declares that the products concerned satisfy the
applicable requirements
undertakes to fulfil the obligations arising out of the approved
quality system and upholds it so that it remains adequate and
efficient
supports the action carried out by the notified body for
surveillance purpose
keeps at the disposal of the surveillance authority the
documentation concerning the quality system, details of any
updating of the quality system, the decisions and reports of the
notified body
The Notify Body must:
•
draw up a certificate of conformity for the tests
carried out.
•
The notified body must assess the quality system
to determine whether it satisfies the requirements.
The elements of the quality system which conform
to the relevant harmonised standard are presumed
to comply with the corresponding requirements.
The auditing team must have at least one member
with experience of assessing the relevant Directive
concerned. The assessment procedure must
include an inspection visit to the manufacturer’s
premises.
The decision must be notified to the manufacturer.
The notification must contain the conclusions of
the examination and the reasoned assessment
decision.
The notified body must carry out periodic audits to
make sure that the manufacturer maintains and
applies the quality system and provide the
manufacturer with an audit report. The frequency
of periodic audits must be such that a full
reassessment is carried out every three years.
In addition the notified body may pay unexpected
visits to the manufacturer.
During such visits the notified body may carry out
or have carried out tests to verify that the quality
system is functioning correctly.
•
•
•
•
•
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Module
Conformity
Assessment
Standards used
Title
Manufacturer or Representative
The Notify Body must:
•
The notified body must provide the manufacturer
with a visit report and, if a test has taken place,
with a test report.
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Decision 768/2008/EC Annex 2
Figure 9 Conformity Modules
4.2.2
Decision 768 / 2008
This framework Decision for the marketing of products sets out:
• common definitions;
• common conformity assessment procedures;
• obligations for economic operators
• rules for the use of the CE marking,
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• notification criteria for the conformity assessment bodies;
• safeguard procedures.
The common framework will be a toolbox for future sectoral regulations on the approximation of
legislation (harmonisation). It draws on the new approach, according to which legislation shall be
restricted to the setting of essential requirements and use of harmonised standards.
As far as possible, future sectoral legislation must therefore draw on the provisions of this Decision
and define essential requirements for the marketing of products. Where necessary, specific
legislation may nevertheless offer other solutions.
Definitions
This Decision establishes clear definitions of fundamental concepts such as "manufacturer",
"distributor", "importer", "harmonised standard", "placing on the market" and "conformity
assessment". The establishment of explicit, single definitions will make it easier to interpret and
correctly apply future laws in this field.
Obligations of manufacturers, importers and distributors
In order to be placed on the market, a product must comply with certain essential requirements. The
manufacturer must ensure that his products comply with the applicable requirements by carrying
out or commissioning a product conformity assessment procedure.
If the product complies with the essential requirements, the manufacturer affixes the CE marking on
the product and draws up an EC declaration of conformity. The manufacturer indicates his name,
registered trade name or registered trade mark, as well as his address on the product.
They shall ensure that series production remains in conformity. The product must be accompanied
by instructions and safety information in a language which can be easily understood. In the case
where an external conformity assessment body intervenes, the manufacturer shall affix the body's
identification number.
The importer and the distributor must ensure that the manufacturer has fulfilled his obligations, i.e.
check that the product has a conformity marking and that the required documents have been
supplied.
Manufacturers (or their authorised representative), distributors and importers must provide the
competent authorities with all necessary information on the product concerned in order to ensure
product traceability.
Product conformity
This Decision sets a clearer framework for conformity assessment. It establishes a number of
conformity assessment procedures (specified in the Annex), from which the legislator can choose the
most appropriate.
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Furthermore, it lays down the rules and conditions for affixing the "CE" marking, which is subject to
the general principles defined by Regulation No 765/2008. Member States shall ensure correct
application of the regime governing the "CE" marking and provide sanctions for infringements.
Conformity assessment
In certain conformity assessment procedures, the conformity assessment is carried out by the
conformity assessment bodies which are notified, i.e. declared, to the Commission by the Member
States.
This decision sets out common criteria for the notification of the conformity assessment bodies. The
conformity assessment bodies must offer all guarantees of independence, objectivity, impartiality,
confidentiality and professional integrity. In addition, they must possess the necessary technical
competencies and means in order to correctly carry out the tasks entrusted to them. The
Commission ensures appropriate coordination and cooperation between the notified bodies.
Safeguard procedures
A Community safeguard procedure applicable to all products which present a risk at national level is
also provided for. In particular, it provides for the Commission and the other Member States to be
informed. It can be initiated in the event of disagreement between Member States over measures
taken by one of them.
Context
This Decision repeals Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the
various phases of the conformity assessment procedures and the rules for the affixing and use of the
"CE" conformity marking, applicable to technical harmonisation Directives.
Below is a list of all of the modules:
Modula A
Module A1
Module A2
Module B
Module C
Module C1
Module C2
Module D
Module D1
Module E
Module E1
Module F
Module F1
internal production control (self certification)
internal production control plus supervised product testing
internal production control plus supervised product checks at random intervals
EC Type Examination
Conformity to Type based on internal production control
Conformity to Type based on internal production control plus supervised
product testing
Conformity to Type based on internal production control plus supervised
product checks at random intervals
Conformity to type based on the quality assurance of the production
process
Quality Assurance of the production process
Conformity to type based on product quality assurance
Quality Assurance of final product inspection and testing
Conformity to Type based on product verification
Conformity based on product verification
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Module G
Module H
Module H1
Conformity based on unit verification
Conformity based on full quality assurance
Conformity based on full quality assurance plus design examination
Directive
Number
Title of Directive
Modules
A
B+C B+D B+E B+F
G
*
*
*
* *
90/396/EEC
Appliances burning gaseous fuels
*
*
00/9/EC
*
*
89/106/EEC
Cableway installations designed to
carry persons
Construction products
2004/108/EC
Electromagnetic compatibility
94/9/EC
95/16/EC
Equipment and protective systems
in potentially explosive
atmospheres
Lifts
2006/95/EC
Low voltage equipment
98/37/EC
Machinery safety
2004/22/EEC
90/385/EEC
Measuring instruments
93/42/EEC
Medical devices: General
98/79/EC
Medical devices: In vitro diagnostic
92/42/EEC
96/98/EC
New hot-water boilers fired with
liquid or gaseous fluids (efficiency
requirements)
Non-automatic weighing
instruments
Marine Equipment
89/686/EEC
Personal protective equipment
97/23/EC
Pressure equipment
99/5/EC
94/25/EC
Radio and telecommunications
terminal equipment
Recreational craft
87/404/EEC
Simple pressure vessels
99/36/EC
Transportable Pressure Equipment
88/378/EEC
Toys safety
90/384/EEC
*
* *
* *
* * *
*
*
*
*
*
*
*
H
* *
*
*
*
* *
Medical devices: Active implantable
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
* *
*
*
* *
*
*
*
*
*
*
*
* *
*
*
*
*
*
* *
Table 2 Conformity Assessment Procedures for various Directives
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Module A distinguishes itself by relying on the manufacturers self declaration that the product is
compliant with the legal requirements as established by the EU and the New Approach Directives.
By making a self-declaration of conformity, a supplier organization avoids the costs of third-party
assessment but commits that they do in fact meet the criteria and should be able to demonstrate this
should they be so requested.
A supplier may decide to take this option if it believes that it enjoys a sufficiently high market
reputation for it to dispense with independent confirmation of conformity.
However, a supplier's declaration may not be appropriate in all cases, particularly where the health,
safety or environmental risks of the product concerned are high.
A self-declaration does not exempt the supplier from its responsibility to meet relevant regulations for example, in relation to product liability - and such declarations generally need to be accompanied
by effective post-market surveillance.
Decision 768/2008 Annex 3 shows the minimum required information that a Declaration of
Conformity should contain.
ISO/IEC 17050 specifies the general criteria for a supplier's declaration of conformity in relation to
International Standards.
4.2.3
Non Regulated Conformity Assessment
In the EU, there have been historically a great number of schemes, which were produced in each
country in an attempt to develop a trustworthy system for products and services which would
address the issues of product quality and factory quality processes.
These schemes became in a manner of speaking “unavoidable” that is to say that if a particular
scheme in the country was not used then the purchaser would not buy the product not having
confidence on the product or service.
This has lead to a number of markings in each country becoming necessary for trade which affect the
free movement of goods within the EU, but since these are voluntary, the person wanting to carry
out business in the country must comply with the requirements from the client.
Below a description of the various marks and their basic principles is provided for information
purposes.
There are many requirements for obtaining Marks of Conformity in the European Union, however
there are some common areas that will need consideration before seeking a mark or marks.
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4.2.3.1
Technical requirements
Design stage
At the design stage it should be taken into account the requirements for international approval. If
one takes the time to identify any possible standards/regulations that will, at some future point in
time, be relevant to the product being designed, any minor changes at this point may save expensive
major re-working later.
Cost/Financial Considerations
Organisations intending to apply for any approval mark will need to plan/budget for the expense.
The actual charges would need to be gathered from the individual testing authorities, since there will
be various scales of charges dependent on the amount of testing / re-testing required and the local
economy.
Logistics/Practical arrangements
It is worth while developing a good business relationship with the chosen testing laboratory. They
can be a valuable source of technical knowledge and local expertise. By establishing a dialogue,
advice can be sought into how to minimize and avoid duplication of tests. A test laboratory will need
to know of any special requirements to be able to test a product.
Time scales
The processes for gaining approval does not happen overnight, allow plenty of time for the approval
process. Time will be needed for information gathering and analysis, testing (and possible re-testing),
and preparing documentation.
Testing
Products may require testing for safety issues as well as environmental and qualityand it will depend
on the requirements of the standards to be used.
Licence/permits
An organization may be granted a licence or a permit by the controlling authority to use an approval
mark, once they have demonstrated conformity. There is frequently a levy to be paid and
licences/permits are validated for a set period of time (e.g. annually)
In some cases a fee will be paid based on the quantity of products distributed with the mark.
Inspection of products
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There will often be a need to supply samples of products for additional testing by the authority that
granted the use of a particular Approval mark. This is because not all authorities recognise, any but
their own nominated testing laboratories.
An organization submitting a sample can sometimes be asked to pay for their sample’s additional
examination.
Inspection of Factories
Some of the approval schemes, (ENEC for example) require a manufacturer to allow an on-site
examination of their factory. At this level of operation it will be necessary to have a quality
management system like ISO 9000 and sampling plans in place, to provide evidence of consistent
manufacture.
Documentation
Declarations of conformity, test reports, instruction sheets, operation and service manuals, technical
file, circuit diagrams, form the body of evidence, which allows to demonstrate that the organisation
is responsible and diligent.
The use of good independent test reports from authoritative, well-recognized accredited testing
laboratories, is excellent preparation, and will ease the product's passage, on to the market and
through customs/regulatory organizations inspections.
Translations
When thinking about the responsibilities for safety, consideration on the provision of instructions in
the language of the intended user, becomes highly important. Beyond this safety instructions,
maintenance manuals and related documentation also need due consideration.
Conformity Checklist
1.
2.
3.
4.
5.
6.
7.
8.
9.
What markets/countries might the product be sold into?
What standards/regulations/legislation might apply in specific countries?
What’s the electricity supply?
Appoint a compliance engineer who is responsible for products international compliance.
Start a library. Gather information on standards (national, european, international) details of
routes to conformity.
Choose a test laboratory.
Design with relevant standards in mind.
Remember national deviations, plugs and sockets, wiring and electrical supplies.
Document what you do, with explanations of why a particular course of action was taken. Other
considerations
— safety Documentation,
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— maintenance manuals
— translations where necessary.
10. Sampling plans will be required, as part of a quality control scheme.
11. Find out if there is a mutual recognition scheme.
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Table 3 List of voluntary certification Schemes and Marks
Country
Title of Marking
Austria
ON “ONORMEN”
Belgium
CEBEC Mark
Czech Republic
ESC Mark
Marking
Denmark
Finland
FI Mark
France
AFNOR NF Mark
Germany
VDE
TUV Rheinland
Hellenic Republic – Greece
ELOT
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Country
Hungary
Title of Marking
EMEI Mark
Italy
IMQ
Ireland
National Standards
Authority of Ireland
(NSAI)
Luxembourg
L SEE-Safety Mark
Netherlands
KEMA
Norway
NEMKO
Poland
B Mark
Slovenia
SIQ
Marking
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Country
Slovakia
Title of Marking
EVPU
Spain
AENOR
Sweden
SEMKO
Marking
Switzerland
UK
ASTA Certification
Services
BEAB
BSI Kite Mark
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5.0 Accreditation
5.1 General
The definition of the term for accreditation is given in EN ISO/IEC 17000:2004: Para 5.6 Accreditation
“Third-party attestation related to a conformity assessment body conveying formal demonstration of
its competence to carry out specific conformity assessment tasks.”
Further definitions related to the activity of accreditation are given below:
Figure 10 Definitions
In order for conformity assessment to work with confidence and provide benefits, it is important
that the market has an assurance that the conformity assessment bodies themselves operate to
acceptable standards. This is the purpose of accreditation. For accreditation to provide the required
level of confidence in conformity assessment services, it must be “authoritative”.
Within the context of conformity assessment, it is generally accepted that this means that
accreditation bodies must operate under the aegis of government.
Agreements within the regional and international accreditation fora (e.g. European cooperation for
Accreditation (EA), International Accreditation Forum (IAF) and International Laboratory
Accreditation Cooperation (ILAC)) have also facilitated the international acceptance of accredited
conformity assessment.
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These ‘multilateral arrangements’ are based on the peer assessment of national accreditation bodies
and help to establish the equivalence of accredited conformity assessment. In some sectors, mutual
acceptance schemes have been developed, based on the peer assessment of individual conformity
assessment bodies, negating the need for duplicate testing.
5.1.1
International Cooperation
The Fig 11 shows the international structure for accreditation bodies, in order for an accreditation
body to be recognised and trusted at international level it is necessary for the organisation to be
subject to stringent assessment in accordance with internationally recognised standards and be
subject to peer review. In order to facilitate this, international associations of accreditation bodies
exist, such as the:
– IAF International Accreditation Forum (Certification bodies / registrars, Inspection bodies)
– ILAC International Laboratory Accreditation Cooperation (Laboratories, inspection bodies)
IAF/ILAC facilitates the recognition of accredited conformity assessment services through a
Multilateral Recognition Arrangement (MLA).
ILAC
Figure 11 Accreditation Structure
The multilateral agreements under the auspices of IAF and ILAC require the following standards to
be used by accreditation bodies for the assessment of themselves as well as conformity assessment
bodies.
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5.2
Standardisation in Accreditation and Conformity
Assessment in the EU and China
5.2.1
General
Figure 12 Standards for assessment of Accreditation bodies and CAB’s
On the basis of the above it is possible for accreditation and conformity assessment bodies to
develop multinational / bilateral mutual recognition agreements that help in the acceptance of
testing, inspection results or the acceptance of the certification of enterprises by conformity
assessment bodies in one country by another country.
Without a reputable accreditation body which provides a stringent assessment of the organisations
undertaking the above mentioned activities there would not be possible the development of the
Notified Body concept in the European Union and the acceptance by all member states in the EU of
the conformity assessment bodies as appointed by member states authorities and notified to the
Commission, thus becoming Notified Bodies.
In 2008 the EU issued Regulation 765/2008/EC of the European Parliament and of the Council setting
out the requirements for accreditation and market surveillance relating to the marketing of products,
this Regulation come into effect in 2010.
This Regulation lays down rules on the organisation and operation of accreditation of conformity
assessment bodies performing conformity assessment activities.
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This regulation also provides a framework for the market surveillance of transformed products to
ensure that they respect a high level of protection of public interests such as health and safety in
general, of health and safety at the workplace, protection of consumers, of the environment, and of
security.
This Regulation further provides a framework for controls on products from third countries. It also
contains provisions on CE marking.
5.2.2
Conformity Assessment activities
Below follows a general description of each conformity assessment activity and the respective
international standard used in order to assess the conformity assessment bodies against these, there
are also guidelines issued by EA with respect to the application of the international standard in order
to ensure consistency.
Testing
This is the most common form of conformity assessment. Testing also provides the basis for other
types of conformity assessment like inspection and product certification. Here a product is tested
against a specified set of criteria. It can be used to make decisions on the performance of the
product.
The general requirements for laboratories or other organizations to be considered competent to
carry out testing calibration and sampling are specified in the in ISO/IEC 17025:2005 General
requirements for the competence of testing and calibration laboratories.
Inspection bodies
These organizations examine a huge range of products, materials, installations, plants, processes,
work procedures and services, in the private as well as the public sector, and report on such
parameters as quality, fitness for use and continuing safety in operation. The overall aim is to reduce
risk to the buyer, owner, user or consumer of the item being inspected.
The general requirements for the operation of various types of inspection body are given in ISO/IEC
17020:1998 General criteria for the operation of various types of bodies performing inspection.
Certification/registration
Certification/registration is when a third party gives written assurance that a product (including
services), process, personnel, organization or management system conforms to specific
requirements.
The terms certification and registration are interchangeable and the use of one over the other is
largely dependent on the geographical region.
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Management system certification
The most well-known examples are the certification of quality management systems and
environmental management systems as conforming, respectively, to ISO 9000 and ISO 14000
standards. It should be noted that ISO does not assess the conformity of quality or
environmental management systems to ISO 9000 or ISO 14000 standards. Certification is carried
out independently of ISO by the many certification or registration bodies active nationally or
internationally.
Product certification
ISO/IEC Guide 65:1996 General requirements for bodies operating product certification systems
can be used in combination with a number of related product standards and guides to
demonstrate that a product complies with specified criteria. There are other standards within
this family of standards that give guidance of the various types of product certification schemes
that can be used.
Product certification may consist of initial testing of a product combined with assessment of its
supplier's quality management system. This may be followed up by testing of samples from the
factory and/or the open market. Other product certification schemes comprise initial testing and
surveillance testing, while still others rely on the testing of a sample product - this is known as
type testing.
The type of product certification scheme chosen will depend on the level of risk to the consumer
as well as other factors. For a very low risk product you may have a once-off type test and for a
high risk product you may have a scheme which has type testing, requires an ISO 9001
management system in place with regular product testing from the factory and also products
taken from the outlets for testing.
Personnel certification
ISO/IEC 17024:2003 specifies requirements for a body certifying persons against specific
requirements, including the development and maintenance of a certification scheme for
personnel.
5.2.3
China Standardisation of conformity assessment activities
The National Standardisation Technical Committee on Certification and Accreditation (TC261）is the
Chinese mirror committee to ISO/CASCO, which takes the responsibility for the standardisation work
for conformity assessment activities in China.
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TC261 is authorized by SAC with its secretariat set up in CNCA. Members of TC261 come from all key
stakeholders involved in conformity assessment, comprising representatives from government
authorities, accreditation bodies, conformity assessment bodies, industry, scientific and academic
institutes and the general public.
One of the core tasks of TC261 is to represent China in tracking down and participating in all kinds of
ISO/CASCO activities. It develops Chinese national standards for conformity assessment by identical
adoption of ISO/CASCO standards and guides.
During the development of national standards, TC261 has followed the open, transparent and
consensus principles to solicit and take full account of the opinions and suggestions of all relevant
stakeholders.
At the present, among all the valid ISO/CASCO standards and guides, except for ISO/IEC Guide
7:1994 Guidelines for drafting of standards suitable for use for conformity assessment - which is
currently being revised by ISO/CASCO/WG27 into ISO/IEC 17007, and TC261 has assigned Chinese
experts to be in the members of ISO/CASCO/WG27 - all the others have been identically adopted as
Chinese national standards.
The following table shows the valid ISO/CASCO standards and guides and Chinese national standards
identical to them:
ISO/CASCO international standards and guides
Chinese national standards
Standard number and title (in English)
Standard number and title
ISO/IEC Guide 23:1982 Methods of indicating
conformity with standards for third-party
certification systems
GB/T 27023-2008 Conformity assessment Methods of indicating conformity with standards
for third-party certification systems
ISO Guide 27:1983 Guidelines for corrective action
to be taken by a certification body in the event of
misuse of its mark of conformity
GB/T 27027-2008 Conformity assessment Guidelines for corrective action to be taken by a
certification body in the event of misuse of its
mark of conformity
ISO/IEC Guide 28:2004 Conformity assessment Guidance on a third-party certification system for
products
GB/T 27028-2008 Conformity assessment Guidance on a third-party certification system for
products
GB/T 15483.1-1999 Proficiency testing by
ISO/IEC Guide 43-1:1997 Proficiency testing by
interlaboratory comparisons – Part 1: Development
and operation of proficiency testing schemes
interlaboratory comparisons--Part 1：
Development and operation of proficiency testing
schemes
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ISO/CASCO international standards and guides
Chinese national standards
Standard number and title (in English)
Standard number and title
ISO/IEC Guide 43-2:1997 Proficiency testing by
interlaboratory comparisons – Part 2: Selection and
use of proficiency testing schemes by laboratory
accreditation bodies
GB/T 15483.2-1999 Proficiency testing by interlaboratory comparisons--Part 2:Selection and use
of proficiency testing schemes by laboratory
accreditation bodies
ISO/IEC Guide 53:2005 An approach to the
utilization of a supplier’s quality system in third
party product certification
GB/T 27053-2008 Conformity assessment - An
approach to the utilization of a supplier’s quality
system in third party product certification
ISO/IEC Guide 60:2004 Conformity assessment –
Code of good practice
GB/T 27060-2006 conformity assessment - Code of
good practice
ISO/IEC Guide 65:1996 General requirements for
bodies operating product certification systems
GB/T 27065-2004 General requirements for bodies
operating product certification systems
ISO/IEC Guide 67:2004 Conformity assessment Fundamentals of product certification
GB/T 27067-2006 Conformity assessment Fundamentals of product certification
ISO/IEC Guide 68:2002 Arrangements for the
recognition and acceptance of conformity
assessment results
GB/T 27068-2006 Arrangements for the
recognition and acceptance of conformity
assessment results
ISO/IEC 17000:2004 Conformity assessment Vocabulary and general Principles
GB/T 27000-2006 Conformity assessment Vocabulary and general principles
ISO/IEC 17011:2004 Conformity assessment General requirements for accreditation bodies
accrediting conformity assessment bodies
GB/T 27011-2005 Conformity assessment—
General requirements for accreditation bodies
accrediting conformity assessment bodies
ISO/IEC 17020:1998 General criteria for the
operation of various types of bodies performing
inspection
GB/T 18346-2001 General criteria for the
operation of various types of bodies performing
inspection
ISO/IEC 17021:2006 Conformity assessment Requirements for bodies providing audit and
certification of management systems
GB/T 27021-2007 Conformity assessment—
Requirements for bodies providing audit and
certification of management systems
ISO/IEC 17024:2003 General requirements for
bodies operating certification of persons
GB/T 27024-2004 Conformity assessment—
General requirements for bodies operating
certification of persons
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ISO/CASCO international standards and guides
Chinese national standards
Standard number and title (in English)
Standard number and title
ISO/IEC 17025:2005 General requirements for the
competence of testing and calibration laboratories
GB/T 27025-2008 General requirements for the
competence of testing and calibration laboratories
（ISO/IEC 17025:1999 was identically adopted as
GB/T 15481-2000）
ISO/IEC 17030:2003 General requirements for third
party marks of conformity
GB/T 27030-2006 Conformity assessment General requirements for third-party marks of
conformity
ISO/IEC 17040:2005 Conformity assessment General requirements for peer assessment of
conformity assessment bodies and accreditation
bodies
GB/T 27040:2009 Conformity assessment General requirements for peer assessment of
conformity assessment bodies and accreditation
bodies
ISO/IEC 17050-1:2004 Conformity assessment –
Supplier’s declaration of conformity – part 1:
General requirements
GB/T 27050.1-2006 Conformity
assessment―Suppliers declaration of
conformity―part 1: General requirements
ISO/IEC 17050-2:2004 Conformity assessment –
Supplier’s declaration of conformity – part 2:
Supporting documentation
GB/T 27050.2-2006 Conformity
assessment―Suppliers declaration of
conformity―Part 2: Supporting documentation
Table 4 ISO and China Identical Standards
The application of these standards in the corresponding area and dimension of the Chinese
conformity assessment system makes China fully in line with internationally-recognized norms and
requirements when carrying out and administering conformity assessment activities.
For example, Regulations of the People’s Republic of China on Certification and Accreditation and its
associated administrative rules, measures and specifications (including all the implementing rules on
compulsory product certification) have all followed the principles and requirements of related
standards.
CNAS operates in accordance with ISO/IEC 17011, and provides accreditation against ISO/IEC
17020 、 17021 、 17024 、 17025 and ISO/IEC Guide 65, which successfully passed the peer
evaluation of IAF and ILAC.
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5.3 European Accreditation
5.3.1
Regulation 765 / 2008
This Regulation sets out the requirements for accreditation and market surveillance relating to the
marketing of products and should be seen as complementary to Decision 768/2008/EC. This
regulation will come into force in 2010.
The basic requirements are as follows See Figure 13:
Figure 13 Requirements of the Regulation with respect to accreditation bodies
This regulations has provisions for operation and organisation of accreditation at European level,
these requirements go beyond ISO/IEC standards and are basically:
•
•
•
•
one nationally recognised Accreditation Body per Member State
It is a Public authority
No competition
Not for profit
Body registered in Europe who wants to perform accreditation in mandatory or the voluntary field
within the Community must be the single national accreditation body of the country as recognised
by the state, otherwise it should be considered to be as a “certifier”
The regulation established the requirements for accreditation bodies in respect to general principles
(Article 4), operation of accreditation (Article 5), principles of non competition (Article 6), cross
border accreditation (Article 7) and Article 8 of the Regulation which requires the accreditation
bodies to comply with the following criteria;
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1)
it shall be organised in such a manner as to make it independent from the conformity
assessment bodies which it assesses and from commercial pressures and to ensure that no
conflicts of interest occur with conformity assessment bodies;
2)
it shall document the duties, responsibilities and authorities of personnel who could affect
the quality of the assessment and attestation of competence;
3)
it shall be organised and operated so as to safeguard the objectivity and impartiality of its
activities;
4)
it shall ensure that each decision relating to the attestation of competence is taken by
competent persons different from those who carried out the assessment;
5)
it shall have adequate arrangements to safeguard the confidentiality of the information
obtained;
6)
it shall identify the conformity assessment activities for which it is competent to perform
accreditation, referring, where appropriate, to relevant Community or national legislation
and standards;
7)
it shall set up the necessary procedures to ensure efficient management and appropriate
internal controls;
8)
it shall have a sufficient number of competent personnel at its disposal for the proper
performance of its tasks;
9)
it shall establish, implement and maintain procedures for monitoring the performance and
competence of the personnel involved;
10)
it shall verify that conformity assessments are carried out in an appropriate manner,
meaning that unnecessary burdens are not imposed on undertakings and that due account is
taken of the size of the undertaking, the sector in which it operates, the structure of the
undertaking, the degree of complexity of the product technology in question and the mass
nature of the production process;
11)
it shall publish annual audited accounts prepared in accordance with generally accepted
accounting principles.
Also compliance with requirements (Article 9), peer evaluation (Article 10), presumption of
conformity (Article 11) and information obligation (Article12).
Under Article 14 it requires the set up of a European Body for accreditation facilitation which is what
EA is and does today but in a voluntary fashion.
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5.3.2
European Co-operation for Accreditation (EA)
In the EU there exists an association of Accreditation bodies called the European co operation for
Accreditation and from their website the following information was obtained;
EA, European Co-operation for Accreditation, is a non profit association which was set up in
November 1997 and registered as an association in the Netherlands in June 2000 (Articles of
Association). EA results from the merger of EAC, European Accreditation of Certification and EAL,
European co-operation for Accreditation of Laboratories.
Under Regulation 765/2008 EA which becomes enforceable in 2010 EA is :
1. recognised as the official European infrastructure for cooperation in the field of
accreditation
2. the regional cooperation body member of ILAC and IAF
3. evaluations are based on Peer Evaluation system
EA and its MLA members equals to the signatories to ILAC MRA and IAF MLA.
Attestation of conformity issued by accreditation bodies who are signatories of ILAC MRA and IAF
MLA would be acceptable in the voluntary field but non signatories to EA MLA (if not part of the EEA)
or not based on bi-lateral agreements with EA would mean not complying with requirements of EU
Regulation and therefore it may be likely that their certificates would not be recognised by a
member state authority.
EA is the European network of nationally recognised accreditation bodies based in the European
geographical area.
In compliance with the European Commission's policy, EA members:
• cooperate in complete independence from commercial motivations.
• are authoritative and impartial bodies.
• are not involved in conformity activities for which they accredit other bodies.
• can demonstrate a high level of competence through participation in the EA peer
evaluation system.
EA covers accreditation of Laboratories (Testing and Calibration), Inspection bodies and
Certification bodies for
• Quality management systems (QMS)
• Environmental management systems (EMS)
• Products and services
• Persons
• EMAS verifiers according to the European regulation EMAS (European Management
and Audit Scheme)
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The EA missions are:
1. To ensure common interpretation of the standards they use
2. To manage a peer evaluation system, consistent with the international practice - EA as a
region is a member of ILAC (INTERNATIONAL LABORATORY ACCREDITATION COOPERATION)
and IAF (INTERNATIONAL ACCREDITATION FORUM)
3. To support and promote mutual recognition and acceptance of accredited conformity
assessment services and results.
It can be said the EA is the association of accreditation bodies and these have multi lateral
agreements through their membership to it, therefore individual EA members that are signatories
to the EA MLA are subject to regular and stringent multi-national peer evaluations.
The purpose of these routine on-site evaluations is to verify the signatories' continuing conformity
with the internationally accepted criteria (ISO/IEC 17011 and applicable guidance documents).
These peer evaluations ensure consistent, harmonised accreditation practices and also facilitate the
exchange of information and experience between the signatories.
The EA MLA being recognised at international level by ILAC and IAF, a test report or certificate
accredited by an EA MLA signatory can be recognised also by the signatories of the ILAC and IAF
multilateral agreements, the EA MLA acting then as an international passport to trade.
For accreditation bodies located outside the EU or EFTA, signing a bilateral agreement with EA under
the conditions applicable to EA MLA signatories, gives access to the European market to products
tested by laboratories accredited by non EU or EFTA accreditation bodies.
It enables recognition of test results in the regulatory area thus facilitating export and trade between
Europe and non European countries.
By resolution No 14 passed at the 22nd meeting of the General Assembly in November 2008, EA
recognises the technical equivalence between results issued by CABs accredited under the ILAC or
IAF MRA/MLA in accordance to ISO/IEC 17011 requirements and results issued by CABs accredited
under the EA multilateral or bilateral agreements.
It is expected that some of the guidelines which exist today will have to be amended to reflect the
new reality conferred on EA by Regulation 765/2009/EC.
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5.4 China accreditation system for conformity assessment
5.4.1
China National Accreditation Service (CNAS)
China National Accreditation Service for Conformity Assessment (hereinafter referred to as CNAS) is
the sole national accreditation body of China unitarily responsible for the accreditation of
certification bodies, laboratories and inspection bodies, which is established under the approval of
the Certification and Accreditation Administration of the People’s Republic of China (CNCA) and
authorized by CNCA in accordance with the Regulations of the People’s Republic of China on
Certification and Accreditation to perform accreditation of conformity assessment bodies.
CNAS has carried out its activities in accordance with GB/T 27011－2005（ISO/IEC 17011:2004）
Conformity assessment—General requirements for accreditation bodies accrediting conformity
assessment bodies,.
The organization structure of CNAS includes the Board, Executive Committee, Technical Committee
of Certification Bodies, Technical Committee of Laboratories, Technical Committee of Inspection
Bodies, Appraisal Committee, Appeal Committee, End-User Committee and the Secretariat.
The Board is the highest decision-making body of CNAS, which is composed of member from 64
organizations representing significant stakeholder including government, conformity assessment
bodies, direct clients of conformity assessment services, end-users of conformity assessment results,
professional institutions and technical experts.
According to the relevant laws and regulations and international practice, accreditation is done on a
voluntary basis. CNAS only performs accreditation assessment and make the accreditation decision
on the specific accreditation scope requested by the applicant pursuant to the defined requirements
of relevant accreditation standards.
The applicant shall satisfying following conditions:
1.
2.
3.
4.
the applicant shall be legally incorporated according to relevant laws and regulations and
be capable of undertaking legal responsibilities;
the applicant shall conform to the accreditation criteria issued by CNAS;
the applicant shall follow the relevant rules of procedures as specified in relevant
accreditation norms of CNAS and fulfil relevant obligations;
The applicant shall also meet other provisions as prescribed by laws and regulations.
Working procedures for CNAS accreditation basically include the following seven steps: intent
application, formal application, preparation for assessment, document review, office assessment,
witnessing assessment, accreditation appraisal and decision, and issuing accreditation documents.
By the end of July 2008, CNAS has issued 321 accreditations to126 certification bodies in various
fields. These certification bodies have issued about 500,000 accredited certificates; the numbers of
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accredited QMS certificates and the accredited enterprises are the highest in the world. CNAS has by
far accredited 3,355 laboratories, a world’s leader also in this field, and 109 inspection bodies.
5.4.2
Accreditation fields of certification bodies
Currently, CNAS provides accreditation of certification bodies under in the following fields:
1. Accreditation of management system certification bodies in accordance with GB/T
27021:2007, ISO/IEC 17021:2006）Conformity assessment—Requirements for bodies
providing audit and certification of management systems, including certification bodies
undertaking quality management system certification, environmental management
system certification, occupational health and safety management system certification,
information security management system certification (using ISO/IEC 27006 as additional
accreditation criteria) and food safety management system certification (using ISO/TS
22003 as additional accreditation criteria).
2. Accreditation of product certification in accordance with GB/T 27065－2004（ISO/IEC
Guide 65:1996）General requirements for bodies operating product certification systems,
which also includs certification bodies certifying organic products and China Good
Agricultural Practice (CHINAGAP, equivalent to GLOBALGAP) certification bodies. In
addition to GB/T 27065, organic product certification bodies and CHINAGAP certification
bodies also need to meet relevant specific accreditation criteria of CNAS.
3. Conducting accreditation on bodies providing certification of persons in accordance with
GB/T
27024－2004（ISO/IEC
17024:2003）Conformity
assessment—General
requirements for bodies operating certification of persons.
5.4.3
Accreditation fields of laboratories
Currently, CNAS provide accreditation of laboratories in the following fields:
1. Conducting accreditation of testing and calibration laboratories in accordance with GB/T
27025—2008 General requirements for the competence of testing and calibration
laboratories (ISO/IEC 17025:2005);
2. Conducting accreditation of medical testing laboratories in accordance with ISO 15189:
2003 Medical laboratories -- Particular requirements for quality and competence;
3. Conducting accreditation of bio-safety laboratories in accordance with GB 19489: 2004
Laboratories—General requirements for bio-safety;
4. Conducting accreditation of reference material providers in accordance with ISO Guide 34:
2000 General requirements for the competence of reference material providers;
5. Conducting accreditation of providers of proficiency testing schemes in accordance with
ILAC G13:2000 Accreditation Criteria for the Providers of Proficiency Testing Schemes.
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5.4.4
Accreditation fields of inspection bodies
Currently, CNAS implements accreditation on inspection bodies in accordance with GB/T 18346-2001
General criteria for the operation of various types of bodies performing inspection (ISO/IEC
17020:1998), covering the following fields as commodity inspection, special equipment, engineering
construction, hazardous cargo transportation, factory inspection, information security and health
examination.
5.4.5
International Cooperation in accreditation
China’s national accreditation system for conformity assessment has been integrated into the
international mutual recognition system for accreditation; it occupies an important position and
plays a significant role in the system. As a full member of the International Accreditation Forum (IAF)
and the Pacific Accreditation Cooperation (PAC), CNAS has signed the IAF Multilateral Recognition
Agreement (MLA) and PAC MLA on the following:
o
o
o
accreditation of quality management system certification bodies
accreditation of environment management system certification bodies
accreditation of product certification bodies;
As a full member of the International Laboratory Accreditation Cooperation (ILAC) and the Asia
Pacific Laboratory Accreditation Cooperation (APLAC), CNAS has signed ILAC Mutual Recognition
Arrangement (MRA) and APLAC MRA on:
o
o
accreditation of testing and calibration laboratories against ISO/IEC 17025
accreditation of medical testing laboratories against ISO 15189
CNAS has also signed APLAC MRA on:
o
o
accreditation of inspection bodies
accreditation of reference material providers
CNAS has also bi-lateral cooperation’s in terms of technical and information exchange, joint
assessment activities, joint-forum ect. with various foreign accreditation bodies such as JAB of Japan,
KAB of Korea, ANAB of USA, RVA o Netherlands, and the Australian and New Zealand Joint
Accreditation System (JAZ-ANZ). CNAS-JAB-KAB have signed a MOU on closer cooperation and
exchange in accreditation.
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6.0 Conformity Assessment Bodies of
China and the European Union
6.1 China
6.1.1
Administrative approval for the establishment of certification
bodies
The establishment of a certification body in China is subject to the administrative approval of CNCA,
which is mandated by the Article 9 of Regulations of the People’s Republic of China on Certification
and Accreditation, “the establishment of a certification body shall be approved by the certification
and accreditation administration authority of the State Council, and the certification activities shall
be carried out within the scope of approval after the certification body is legally incorporated.
Any organization or individual shall not undertake certification activities without approval”.
The conditions for obtaining approval are as follows:
1.
Having a fixed location and the necessary facilities;
2.
Having an management system meeting the requirements of certification and accreditation;
3.
The registered capital shall be no less than RMB 3 million Yuan; and
4.
Having at least 10 full time certification personnel in the corresponding fields.
5.
Certification bodies providing product certification activities shall also possess technical
capability of testing and inspection matching the intended product certification activities.
6.
The foreign investors shall have obtained the accreditation of the accreditation bodies in
their own economies;
7.
The foreign investors shall have more than 3 years’ business experiences in certification
activities.
8.
Foreign-invested certification body shall also satisfy relevant laws, regulations and state
requirements on foreign investment.
The procedure for obtaining approval is as follows:
1.
the applicant submits application to CNCA, along with the required materials;
2.
CNCA will decide on whether to accept or reject the application according to the
completeness and the compliance with legal formalities of the application materials;
3.
For accepted application, CNCA will review the application materials. If the review results
are satisfying, CNCA will publicize the applicant’s information on CNCA website for public
comments, and organize an expert panel to conduct technical assessment of application
materials;
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4.
CNCA will decide whether to grant the approval on basis of the results of public comments
and the recommendations of the expert panel.
As of the end of October 2008, CNCA has approved a total of 170 certification bodies, among which
115 are providing management system certification (including QMS, environmental management
system etc.), and 92 are providing product certification. Since December 2001, CNCA has also
withdrawn the approval of 42 certification bodies.
6.1.2
Qualification Recognition of laboratories and inspection bodies
CNCA also implements qualification recognition of laboratories and inspection bodies in accordance
with Administrative Measures for Qualification Recognition of Laboratories and Inspection Bodies
which is formulated and issued by CNCA in accordance with requirements set in following laws and
regulations:
•
•
•
•
Metrology Law of P. R. China
Standardization Law of P. R. China
Law on Product Quality of P. R. China
Regulations of P. R. China on Certification and Accreditation
According to the Administrative Measures for Qualification Recognition of Laboratories and
Inspection Bodies above laws, those testing laboratories and inspection bodies who provides
attesting data and results to the society are subject to qualification recognition by CNCA, such as:
•
•
•
•
Those providing attesting data or results on which the administrative decisions of
administrative authorities, or the legal finds of jurisdiction authorities, or the arbitration
decision of arbitration bodies will based;
Those providing attesting data or results of public interests;
Those providing attesting data to be used in trade or economic transcations;
Others specified by relevant laws and regulations.
Laboratories and inspection bodies shall meet following conditions to have their qualification
recognized by CNCA:
1.
It shall be legally established and perform testing, calibration and inspection activities
independently, objectively and impartially and shall be capable of assuming corresponding
legal liabilities;
2.
It shall have the technical and managerial personnel commensurate with the testing,
calibration and inspection activities it performs; If it tests or inspects special products, its
technical and managerial personnel shall also satisfy the requirements of relevant laws
and regulations.
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3.
It shall have fixed work site, the environment of which shall ensure the authenticity and
accuracy of testing, calibration and inspection data and results;
4.
It shall have the fixed or moveable testing or calibrating equipment or facilities as needed
by correctly performing testing, calibration and inspection, and shall be able to
independently dispose such equipment and facilities;
5.
it shall establish quality management system capable of safeguarding its impartiality and
independence and appropriate to the scope of testing, calibration and inspection activities
that it performs, and shall develop quality management system documentation in
accordance with recognition specifications or standards, and effectively implement such
documentation.
The procedure for obtaining recognition is as follows:
1.
Applicant laboratory or inspection body submits written application to CNCA or local
quality and technical supervision bureaus with required documents;
2.
Application review;
3.
Technical evaluation of applicant;
4.
Decision on whether to grant recognition to the applicant, according to the results of
technical evaluation.
CNCA or local quality and technical supervision bureaus publish the directory of recognized
laboratories and inspection bodies periodically. The recognition is valid for 3 years and the applicant
shall be re-evaluated for maintaining its recognition within 6 months before the end of validity.
The recognition process is also supported technically by CNAS. For accredited applicant, its
accreditation status will be considered in recognition process and may facilitate or streamline the
process.
6.1.3
Designated conformity assessment bodies
According to the Administrative Measures for Compulsory Product Certification Bodies, Inspection
Bodies and Laboratories, certification bodies, laboratories and inspection bodies to be utilized in
compulsory product certification (CCC) shall be designated by CNCA.
Any conformity assessment body legally incorporated in China may apply for the designation. The
conditions for designation are described hereunder.
6.1.3.1
Conditions for designated certification bodies
The main responsibilities of designated CB include:
1.
2.
Carrying out compulsory product certification on specific products in accordance with the
Implementation Rules for Compulsory Product Certification;
Issuing compulsory product certification certificates to certified products and relevant
enterprises;
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3.
4.
5.
Conducting post-certification surveillance on certified products and relevant
manufacturing enterprises;
Handling the suspension, cancelling and withdrawal of certification;
Handling complaints and appeals against certified products and relevant enterprises.
The conditions for designated certification body are specified in the Article 9 of Administrative
Measures for Compulsory Product Certification Bodies, Inspection Bodies and Laboratories, as follows:
1.
2.
3.
4.
5.
6.
The applicant CB shall be established in accordance with Regulations of P. R. China on
Certification and Accreditation, and shall have more than 2 years’ certification experiences
in relevant fields or shall have issued more than 20 certificates in relevant product
certification;
Accredited by the accreditation body specified by the State;
No records of improper behaviours within 6 months before the application;
The CB’s legal status, ownership and organizational structure are able to safeguard its
objectiveness and impartiality in intended compulsory certification activities;
The CB shall have the technical and managerial competence to perform compulsory
product certification activities in an impartial, independent and effective manner;
The CB shall have at its own disposal the inspection and testing resources and facilities as
needed by the intended compulsory product certification activities, and shall have
certification personnel matching the intended compulsory product certification and
complying to Regulations of P. R. China on Certification and Accreditation, and shall have
stable financial resources.
Currently there are 11 designated compulsory product certification bodies, including:
1.
2.
3.
China Quality Certification Centre (CQC);
China Certification Centre for Security and Protection (CSP);
China Certification Center for Agricultural Machinery (also called Beijing CAM Quality
Certification Center, or CAM);
4. China Building Material Testing and Certification Center (CTC);
5. Beijing Zhonghua Combination Quality Certification Co. (HQC)；
6. China Certification Centre for Fire Products (CCCF);
7. China Certification Centre for Automotive Products (CCAP)；
8. Guojian Lianxin Certification Center;
9. China Certification Center for Quality Mark (CQM);
10. Certification Centre of Light Industry Council (CCLC);
11. China Information Security Certification Center (ISCCC).
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6.1.3.2
Conditions for designated laboratories
The conditions for designated laboratories are specified in the Article 11 of Administrative Measures
for Compulsory Product Certification Bodies, Inspection Bodies and Laboratories, as follows:.
1.
2.
3.
4.
5.
6.
7.
The applicant laboratory shall have basic capabilities and competence required by laws and
regulations, and shall obtain the qualification recognition;
It shall have testing experiences in relevant fields and shall have performed testing for
more than 2 years or have issued more than 20 testing reports in relevant fields;
Accredited by accreditation bodies specified by the State;
No records of improper behaviours within 6 months before the application;
The applicant’s legal status, ownership and organizational structure are able to safeguard
its objectiveness and impartiality in testing service;
The applicant shall have all the equipment and facilities as needed by the intended product
testing, or shall have be authorized by the owner of needed equipment and facilities to
independently use such equipment and facilities;
Its personnel performing the test shall have education and training as necessary for
intended product testing, and shall understand the requirements of related standards,
technical specifications and implementation rules for compulsory product certification, and
shall have the necessary competence in product testing.
Currently there are 158 designated laboratories for compulsory product certification. Their directory
can be found in CNCA website.
6.1.3.3
Conditions for designated inspection bodies
The conditions for designated inspection bodies are specified in the Article 10 of Administrative
Measures for Compulsory Product Certification Bodies, Inspection Bodies and Laboratories, as
follows:
1.
2.
3.
4.
5.
6.
7.
The applicant body shall have basic capabilities and competence required by laws and
regulations, and shall obtain the qualification recognition;
It shall have inspection experiences in relevant fields and shall have performed inspection
for more than 2 years or have issued more than 20 inspection reports for related products;
Accredited by accreditation bodies specified by the State;
No records of improper behaviours within 6 months before the application;
The applicant’s legal status, ownership and organizational structure are able to safeguard
its objectiveness and impartiality in inspection service;
The applicant shall have all the facilities, personnel and other resources as needed by the
intended inspection activities for compulsory product certification;
Its personnel for the intended inspection activities for compulsory product certification
shall have necessary technical knowledge and have been registered as certification
inspector;
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8.
9.
6.1.4
Its full-time inspector shall have the technical competence required by the inspection
activities to be designated.
The ratio of its part-time inspector shall not exceed two thirds of its full-time inspectors.
Cooperation with foreign conformity assessment bodies
Designated conformity assessment bodies for compulsory product certification also cooperated with
relevant foreign conformity assessment bodies within the framework of MOUs signed between
CNCA and such foreign conformity assessment bodies.
The cooperation includes information exchanges, technical exchanges, mutual-assigning of
certification business and joint inspection etc. For instance, the cooperation with UL in USA has
provided quick and convenient certification services to 14,000 manufacturing enterprises of electric
and electronic products exported to USA.
CNCA has also signed cooperation agreements in the area of compulsory product certification with
17 foreign CABs in 12 countries. According to these agreements, these foreign CABs undertake
follow-up inspection for compulsory product certification. These foreign CABs include:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Germany: TUV, VDE
Sweden: SEMKO
Norway: NEMKO
Switzerland: SGS
Italy: IMQ
Belgium: CEBEC
US: UL
Canada: CSA
Australia: SAI
Japan: JET, JQA, A-PEX
Malaysia: SIRIM
Singapore: PSB
6.2 European Union (Notified Bodies conditions for
assessments)
The definition of the term for certification is given in EN ISO/IEC 17000:2004: Para 5.5 Certification
“Third-party attestation related to products, processes, systems or persons. “
The new approach directives introduce the concept of notified bodies. These are notified by the
Member States to carry out specific tasks with regard to conformity assessment of manufacturing
processes.
Each Member State is responsible for the notification of notified bodies within its territory, but often
assigns this responsibility to a governmental authority called a notifying authority.
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A notified body is designated for a defined range of conformity assessment procedures (known as
Modules). It acts on behalf of the notifying authority. The term notified body is only applicable in
the EU. The Member States notify the EC Commission and the Member States of each notification of
a notified body. The Commission publishes a list of all notified bodies in the Official Journal.
There is free competition between notified bodies. A manufacturer can choose between all notified
bodies in Europe which are designated for the same types of products and conformity assessment
procedures.
Extracts from “Certif_97_5 Working Document the EN 45000 Series of Standards and the Conformity
Assessment Procedures of the Global Approach”, this document is likely to be amended in due
course.
The sector directives lay down the minimum criteria to be fulfilled by the notified bodies. In general,
these criteria cover:
1. availability of personnel and equipment;
2. independence and impartiality, of the body, it’s management and staff, in carrying out the
conformity assessment procedures in relation to circles, groups or persons directly or
indirectly concerned with the product (e.g. designer, manufacturer, supplier, installer);
3. technical competence (training, knowledge and ability to carry out tests examinations, draw
up certificates etc.) and professional integrity of personnel (free from all pressures which
might influence their judgement or the results of tests, examinations etc., remuneration
shall not depend on number of tests carried out nor the result);
4. maintenance of professional secrecy by personnel;
5. subscription to a civil liability insurance unless that liability is covered by the state under
national law.
These criteria must be fulfilled and maintained by a body if it is to be notified by the Member State.
Code of Conduct for the operation of the system of notified bodies (see document Certif 97/1).
The EN 45000 series of standards and relationship with ISO/IEC 17000 series
The Council Decision states that notified bodies which can prove their conformity with the
harmonised standards (EN 45000 series), by submitting an accreditation certificate or other
documentary evidence, are presumed to conform to the requirements of the directives. This today is
applicable to the ISO/IEC 17000 series which has been adopted as EN standards and replace the
relevant EN 45000 series of standards as shown below in Table 4.
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Conformity Assessment bodies require to be assessed by the accreditation body in accordance with
the standards listed below.
Document Title
identifier
Replaced by
EN 45011
Will become ISO/IEC
17065
EN 45020 (2006-12)*EN
ISO/IEC 17000 (2004-11,
t)
EN ISO/IEC 17025 (200005)
EN 45020
General requirements for bodies operating product
certification systems (ISO/IEC Guide 65:1996)
Standardization and related activities - General vocabulary
(ISO/IEC Guide 2:2004)
EN 45001
General criteria for the operation of testing laboratories
EN 45002
EN 45003
General criteria for the assessment of testing laboratories
Calibration and testing laboratory accreditation system General requirements for operation and recognition
General criteria for laboratory accreditation bodies
General criteria for the operation of various types of bodies
performing inspection
General requirements for assessment and accreditation of
certification/registration bodies (ISO/IEC Guide 61:1996)
General criteria for certification bodies operating product
certification
General requirements for bodies operating assessment and
certification/registration of quality systems (ISO/IEC Guide
62:1996)
General criteria for certification bodies operating quality
system certification
General criteria for certification bodies operating
certification of personnel
General criteria for supplier's declaration of conformity
(ISO/IEC Guide 22:1996)
EN 45003
EN 45004
EN 45010
EN 45011
EN 45012
EN 45012
EN 45013
EN 45014
EN 45014
General criteria for suppliers' declaration of conformity
EN ISO/IEC 17011 (200409)
EN 45003 (1995-03)
EN ISO/IEC 17020 (200409)
EN ISO/IEC 17011 (200409)
EN 45011 (1998-02)
EN ISO/IEC 17021 (200609)
EN 45012 (1998-02)
EN ISO/IEC 17024 (200304)
EN ISO/IEC 17050-1
(2004-10)*EN ISO/IEC
17050-2 (2004-10)
EN 45014 (1998-02)
Table 5 List of EU Standards replaced at international level
There are only a limited number of EN 45000 series standards used in the European Union, this is
because where possible the EU will use international standards as the ones described in Fig 11
therefore a number of EN 45000 standards have been replaced, but the intent is always to use
standards for accreditation bodies and certification, laboratories and inspection bodies. The list of
these can be seen in Table 4.
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Furthermore the list of international standards available is given below:
1. ISO/IEC 17025:2000 General requirements for the competence of testing and calibration
laboratories
2. ISO/IEC 17020:2004 General criteria for the operation of various types of bodies performing
inspection
3. ISO/IEC Guide 65:1966 General requirements for bodies operating product certification
systems (to be ISO/IEC 17065)
4. ISO/IEC Guide 62:1996 General requirements for bodies operating assessment and
certification/registration of quality systems
5. ISO/IEC Guide 67 Conformity assessment – Fundamentals of product certification
6. ISO/IEC Guide 28 Conformity assessment – Guidance on a third-party certification system for
products
7. ISO/IEC Guide 53 Conformity assessment - An approach to the utilization of a suppliers
quality system in third-party product certification
8. ISO/IEC Guide 65 General requirements for bodies operating certification systems
9. ISO/IEC 17030 Conformity assessment — General requirements for third-party marks of
conformity
When using the harmonised conformity assessment standards to assess the technical competence,
independence, impartiality and integrity of bodies seeking notification one needs to relate the
criteria in the specific standards to the specific tasks to be performed according to the modules.
1. When doing this the following elements must be taken into account:
2. Ensure that the criteria in the directives are covered.
3. Knowledge of and capability of carrying out the conformity assessment procedures of the
directive.
4. Ensure link to the technology covered by the directive.
5. The application of the harmonised standards by the manufacturer is voluntary.
The modules reflect the need of ensuring that the harmonised standards have been applied or if
they have not been applied, the solutions adopted to meet the essential requirements. Here it must
be stressed that there is a fundamental difference between assessing a product against specific
technical requirements and against generally stated health and safety objectives. The corresponding
ability must be fully reflected in the competence of the notified body.
This means allowing for, if appropriate in relation to the health and safety objectives of the
directives, different types of conformity assessment bodies to act as a notified body under the same
module. This is important in order to ensure that the conformity services needed for the modules
can be adapted to different manufacturing and supply situations, e.g. innovative companies not
applying harmonised standards, companies producing in large series, companies manufacturing
customised products, and others.
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The Assessment Process for Bodies Seeking Notification
It is the assessment of the body seeking notification that will determine if it is technically competent,
independent and impartial.
The assessment process must determine if the body has adequately trained technical staff with
knowledge and experience of the relevant technology, suitable facilities and equipment, policies and
procedures to ensure integrity and impartiality, correct understanding of the directive, documented
procedures to carry out the conformity assessment procedures of the directive etc.
In this respect the determination of the technological knowledge and experience of the notified
body and its ability to carry out assessment and verification with regard to specific technical
specifications or general objectives or performance requirements is essential.
In order to do this the body performing the assessment must be able to demonstrate that it has the
capability, in terms of management, organisation, trained staff (e.g. assessors), procedures etc., of
evaluating the body seeking notification.
In order to build and maintain confidence between the Member States concerning the evaluation of
notified bodies, it is essential that they not only apply the same assessment criteria, in the form of
the EN ISO/IEC 17000 standards, but that the bodies performing the assessment demonstrate an
equivalent competence and operate according to the same criteria.
Most of the national accreditation bodies of the EU and EFTA states fulfil and operate according to
the requirements in these standards and have put into place peer evaluation schemes in order to
attain mutual recognition of the accreditation results.
The peer evaluation schemes should secure that the national accreditation bodies are operating on
the same basis and according to the same requirements thus providing confidence that the bodies
they accredit or assess operate according to the same rules and criteria. Furthermore, the national
authorities that are responsible for their accreditation infrastructure are expected to take necessary
measures to ensure their coherence with EU policy.
Furthermore in order to assist in procuring consistency of approach the EU DG III also wrote
guidelines CERTIF 94/6 Rev 6 Framework for coordination and cooperation between notified bodies,
member states and the European Commission under the community harmonisation directives based
on the new approach and the global approach.
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7.0 Market Surveillance
7.1 China
Market surveillance activities in China include surveillance on both the conformity of products and
the compliance and performance of conformity assessment bodies. These surveillance activities are
carried out by relevant competent authorities in accordance with relevant laws and regulations, as
introduced hereunder.
Market surveillance on products subject to compulsory product certification (CCC) are carried out by
CNCA and local Quality and Technical Supervision Bureaus and Entry-exit Inspection and Quarantine
Bureaus authorized by CNCA as the local certification supervision authorities, in accordance with
Regulations of P. R. China on Certification and Accreditation, with the close involvement of
designated conformity assessment bodies.
The surveillance include both routine checks by local authorities and ad-hoc surveillance specially
programmed and implemented by CNCA for specific areas or issues in accordance with input from
market feedback or routine monitoring.
CNCA also carries out market surveillance on the compliance and performance of certification bodies
and the conformity and effectiveness of certified management systems.
The routine surveillance is mainly implemented by local certification administration authorities
under the overall direction and coordination of CNCA. In addition, CNCA also annually plans and
carries out administrative checks in chosen areas, e.g. effectiveness of specific management system
certification. CNAS has been providing extensive technical support to CNCA surveillance on
conformity assessment bodies.
The General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) also carries
out surveillance on the conformity of products under its regulation, in accordance with the Product
Quality Law, Standardization Law and Metrology Law and their associated regulations.
The surveillance activities are mainly implemented by local Quality and Technical Supervision
Bureaus with the technical support from relevant conformity assessment bodies.
As described in 2.2.2.2 of this report, besides AQSIQ and CNCA, there also other ministries and
authorities imposing regulatory requirements on relevant products. These ministries and authorities
also carry out surveillance on such products in accordance with relevant laws and regulations.
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7.2 European Union
According to new approach directives, the Member States have ultimate responsibility for ensuring
that only products that meet the protection requirements of the directives are placed on the market.
Member States are also responsible for surveillance of their domestic markets.
Normally this responsibility is transferred to a market surveillance authority which performs periodic
inspections of products. If a product with CE marking is found that does not meet the essential
requirements of the applicable directive(s), the market surveillance authority must take actions to
remove a product from the market and inform the Commission.
Product Liability Directive
When developing the current policies on technical harmonisation within the EC, the 1985 directive
on product liability (85/374/EEC) was taken into account. The theory behind this directive is that “it
is the producer who has the possibilities to design and manufacture safe products and it is he rather
than the consumer who should take the economic risks for defective products".
According to the Directive on product liability "a product is defective when it does not provide the
safety which a person is entitled to expect, taking all circumstances into account". Manufacturers'
responsibility to pay compensation for injury or damages caused by defective products was
increased by the Directive.
Manufacturers were thereby believed to become more aware about safety aspects of their products
in general, which would contribute to the objective that only safe products exist on the market.
Consumers would have little confidence in the internal market if there was no possibility to claim
compensation in case of damages caused by defective products. This possibility is foreseen by the
Product Liability Directive.
General Product Safety Directive
In 1992 the European Council adopted a directive on general product safety (92/59EEC) which is
regarded as an addition to the technical directives. Through the general product safety directive,
Member States can intervene against unsafe consumer products which are not covered by technical
directives.
The European Commission DG III issued guidelines in 1997 “CERTIF 97/4 -EN Rev. 2 Accreditation
and the Community's Policy in the Field of Conformity Assessment” which remain current and may
be updated or withdrawn once the new Regulation becomes effective in 2010.
In 2001 a revised General Product Safety Directive (2001/95/EC) was introduced and it became
effective in 2004, it is aimed at ensuring that consumer products placed on the EEA market are safe.
The Directive obliges the EEA States to take the measures necessary to enforce the safety
requirements for which it provides and to notify any such measures taken. To that effect, the
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Directive sets up a system for rapid exchange of information (RAPEX) concerning products posing a
serious risk to consumers. Article 11 of the Directive also introduces a general safeguard procedure,
which is applicable insofar as there are no specific provisions in EEA law governing all the safety
aspects of products.
Under the GPSD, the Member States are obliged to enforce the requirements on producers and
distributors. They must appoint the authorities in charge of market surveillance and enforcement. In
addition to the power to impose penalties, the Directive gives the surveillance authorities a wide
range of monitoring and intervention powers.
The purpose of market surveillance is to ensure that the provisions of European legislation are
enforced across the EU.
For the purposes of enforcing the General Product Safety Directive (GPSD), the Member States must
nominate or establish authorities to be responsible for market surveillance. These authorities must
have the necessary resources and powers at their disposal for surveillance activities.
Surveillance authorities check that products meet the applicable safety requirements, that steps are
taken to make products compliant, and that sanctions are applied when necessary.
Customs authorities control the import of products from third countries and need to cooperate with
the market surveillance authorities in this respect.
Across the EU, there are different approaches, methods and actual practices used by surveillance
authorities and safety market surveillance varies from Member State to Member State.
Where EU-wide legislation or harmonised standards are in place, these potentially provide a
common basis for evaluating the risks associated with a product across the EU. Where legislation or
standards are adopted at the national level, there is clearly potential for different approaches
amongst Member States.
Member States may have different bodies responsible for assessing the safety of different products.
Some countries also have a cross-sector system of product safety surveillance where there may be
two or three authorities responsible for the safety of one product, albeit covering different safety
aspects.
.
Product tests generally incur costs for the authorities, who often have limited funds. The result is
that some Member States do not undertake product testing but rely mainly on enforcing
notifications by other Member State. Other Member States have the resources to focus on only a
limited number of products at any particular time (e.g. Belgium). Similarly, some authorities have
considerable expertise in risk assessment and have the ability to develop and apply reasonably
sophisticated approaches.
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As a result of the above the EU decided on a review of Community legislation and issued Regulation
No 765/2008/EC which will become effective in 2010 entitled “regulation of the European
Parliament and of the Council setting out the requirements for accreditation and market surveillance
relating to the marketing of products”
Articles 16 to 26 cover the issues related to market surveillance and this Regulation attempts to
ensure consistency between the market surveillance authorities of each member state in the EU.
In Article 16 General requirements, Member States shall organise and perform market surveillance
as set out in this Regulation.
As a result of this the following articles of the Regulation set up the framework under which each
market surveillance authority operates within the context of the European Community and below
the titles of each article are provided to indicate the areas of responsibility.
Article 17
Article 18
Article 19
Article 20
Article 21
Article 22
Article 23
Article 24
Article 25
Article 26
Information obligations
Obligations of the Member States as regards organisation
Market surveillance measures
Products presenting a serious risk
Restrictive measures
Exchange of information – Community Rapid Information System
General information support system
Principles of cooperation between the Member States and the Commission
Sharing resources
Co-operation with the competent authorities of third countries
Therefore between the requirements of each new approach Directive, the General Product Safety
Directive, the guidelines and the new Regulation (effective in 2010) all the obligations for market
surveillance of the member states are provided.
The regulation 765/2008 reinforces the requirement concerning member states market surveillance.
See Figure 14.
Figure 14 Regulation main requirements for market surveillance
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8.0 China and EU Compulsory Markings and
Documentation
8.1 China
8.1.1
The issuing and controlling of CCC mark
China Compulsory Certification mark, known as the CCC mark, is the market access identification for
products listed in the Catalogue. Its ownership belongs to CNCA, who authorizes the certified
applicant to use the mark.
CCC Mark Center is the body authorized by CNCA for administration of CCC certification marks. For
the purpose of facilitating market supervision and avoiding forgery, it is responsible for the
centralized issuance and administration of certification marks with specific tasks as issuance of
certification marks in accordance with certification certificates provided by enterprises.
It also examines and approves the proposed non-standardized usage of certification marks or other
forms of usage such as stamping, and provides information needed by local certification supervision
authorities for law-enforcement purposes.
8.1.2
Implementation requirements of CCC
Core requirements
Products to be placed in China market and listed in the Catalogue must be certified and granted CCC
certification certificates by designated certification bodies, and be affixed with CCC certification
marks before their sales, imports and utilizations in business activities.
Certification model
Type testing + factory inspection + post-certification surveillance
Basic processes of certification
1.
2.
3.
4.
5.
Certification application;
Type testing;
Initial factory inspection;
Review of testing and inspection results and decision on certification; and
Post-certification surveillance.
8.2 European Union
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The New Approach Directive requires that the manufacturer or his authorised representative place
the CE marking on the product or if this is not possible on the wrapping, box or manual.
This means that the manufacturer has complied with all relevant community legislation that is
applicable to the product and the marking is directed to the authorities of the Member States and
not to the consumers.
This marking is very important because if not placed it would be illegal to place the product on the
market.
There are other similar markings required by new approach type Directives like the Wheel marking
for Maritime Equipment and the Pie marking for transportable pressure equipment which have the
same function as the CE marking.
See Decision 768/2008/EC Annex 1 Articles R11 and R12 for new requirements on CE marking.
8.2.1
Manufacturers Declaration of Conformity
The New Approach Directives require the manufacturer to issue or make available a declaration of
conformity which contains information as required by the Directives and is signed by an authorised
signatory which states that the product is in accordance with the relevant Directives.
This declaration can be placed in the technical file or depending on the Directive must be provided
to the buyer, the minimum contents are given in each respective Directive.
See Decision 768/2008/EC Annex 1 Article R10 and Annex 3 for the minimum requirements.
8.2.2
Technical File
The New Approach Directives also have a further requirement on the manufacturer, his authorised
representative or the person who places the product on the market, and that is, if requested by the
authorities they must provide a technical file which includes all the relevant information on the
product to demonstrate that the product is safe.
The requirement and what should the technical file contain is included in guidelines provided by the
EU and also in some cases by Member States to assist the person placing the product on the market.
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9.0 International Dimension
9.1 General
Harmonizing conformity assessment procedures around the world has far-reaching benefits for
international trade in general. Agreements among nations or regions on the mutual acceptability
of requirements, assessment methods, inspection or test results, etc., can all help to reduce or
remove technical barriers to trade. These are procedures or requirements relating to
importation and market access that vary from country to country and may bar a foreign product
from entering a country.
9.2 World Trade Organisation
The World Trade Organization's Agreement on Technical Barriers to Trade was established to
ensure that technical regulations and standards, and the procedures for assessing conformity
with them, do not create unnecessary obstacles to international trade. The World Trade
Organization has increasingly recognized that technical barriers to trade are one of the main
hindrances to the free flow of goods and services.
The WTO TBT Agreement promotes the recognition of others' conformity assessment results as
a way of reducing barriers to trade. It emphasizes that confidence in the continued reliability of
conformity assessment results is a prerequisite to recognition of assessments.
The Agreement says that verifiable compliance with International Standards or Guides for the
operation of accreditation, testing, inspection and certification bodies is considered as an
indication of adequate technical competence. Many of the relevant standards and guides are
ISO/IEC publications produced under the auspices of CASCO, the ISO committee on conformity
assessment.
ISO and the World Trade Organization work increasingly closely to ensure that the above
benefits are realized. The importance of the International Standards and Guides on conformity
assessment developed by CASCO to removing technical barriers to trade and facilitating the flow
of goods and services is recognized by the World Trade Organization.
9.3 China and the World Trade Organisation
The World Trade Organization (WTO) came into existence in the ministerial conference of the
Uruguay Round Negotiations held in Marrakech, Morocco on April 15, 1994, as a more global
organisation to supersede the previous General Agreement on Tariffs and Trade (GATT), established
in 1947.
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As a permanent international organization independent of the United Nations, WTO’s cardinal
principle and primary purpose is to liberalize global trade through implementing principles of open
markets, non-discrimination and fair trade. WTO formally commenced its operations on January 1,
1995, to assume the responsibility of regulating the world economy and trade order, with the
headquarters based in Geneva, Switzerland.
The jurisdiction of the WTO covers not only the conventional and the newly-identified goods trade in
the Uruguay Round, but also areas such as intellectual property rights, investment measures and
non-goods trade (service trade). The organization, with a legal-person position, holds stronger
authority and effectiveness in mediating disputes among members.
WTO serves as a formal organization for international trade and enjoys an equal footing in legal
terms with international organizations such as the UN. Its scope of functions covers, in addition to
the multilateral trade agreements under the GATT and the provision of venues and a forum for
multilateral trade negotiations, also the regularly monitoring and reviewing of national trade policies,
settling trade disputes among members, and cooperating with International Monetary Fund (IMF)
and World Bank, in order to achieve uniformity in global economic decision-making.
Under the WTO framework, two committees, namely TBT and SPS, are responsible for conformity
assessment, with regular committee meetings held annually. The General Administration of Quality
Supervision, Inspection and Quarantine of the People’s Republic of China (AQSIQ) assumes the role
of the competent authority for conformity assessment in China, dispatches a delegation to attend
each meeting and participates in work related to, for example, the transitional review on China.
The Research Center for Standard Laws and Regulations of AQSIQ is charged with the work related
to the notification and enquiry of WTO members, with TBT National Notification & Enquiry Center,
and SPS National Notification & Enquiry Center responsible for external affairs.
The Chinese government attaches paramount importance to WTO related affairs. For the purpose of
comprehensively coordinating major operations concerning WTO, the Ministries-joint Meetings on
Trade-related Technical Measures were implemented on July 3, 2003, upon the approval of the State
Council, and the plenary and liaison meetings are convened regularly.
The Joint Meeting, initiated by AQSIQ and composed of members representing 18 ministries of the
State Council, establishes an efficient and effective mechanism for information communication and
coordination among government departments, serving to systemize and standardize the work
related to trade-related technical measures.
The primary functions of the mechanism include: information communication and resource sharing;
making the related research policies; and coordination and quick response in face of major WTO
trade-related technical measures.
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9.4 Organisation for Economic Co-operation and
Development (OECD)
This organisation is introduced by way of Chemical safety in the EU and relative to the Mutual
Acceptance of Data methodology as developed and used by the EU with respect to their regulation
REACH Registration, Evaluation, authorisation and restriction of chemicals.
30 Member countries and the OECD Secretariat have worked together to develop and co-ordinate
chemical and pesticide related activities on an international basis. Part of working together includes
Mutual Acceptance of Data.
The main objectives of the Chemicals Programme are to:
1. assist OECD Member countries' efforts to protect human health and the environment through
improving chemical safety;
2. make chemical control policies more transparent and efficient and save resources for
government and industry;
3. prevent unnecessary distortions in the trade of chemicals and chemical products.
While an important focus of the work is on the production, processing and use of industrial
chemicals, some aspects include work on pesticides, chemical accidents, and biotechnology. The
Chemicals Programme produces documents on all aspects of its work. These publications are
available to the general public and can be obtained on request from the Secretariat or downloaded
on line.
In general, there are two types of Council Act. A Council Decision, which is legally binding on OECD
Member countries, and a Council Recommendation, which is a strong expression of political will. In
the area of chemicals, for example, there is a Council Act relating to the Mutual Acceptance of Data
(MAD).
The testing of chemicals is labour-intensive and expensive. Often the same chemical is being tested
and assessed in several countries. Because of the need to relieve some of this burden, the OECD
Council adopted a Decision in 1981 stating that data generated in a Member country in accordance
with OECD Test Guidelines and Principles of Good Laboratory Practice (GLP) shall be accepted in
other Member countries for assessment purposes and other uses relating to the protection of
human health and the environment.
A further Council Act was adopted in 1989 to provide safeguards for assurance that the data is
indeed developed in compliance with the Principles of GLP. This Council Decision-Recommendation
on Compliance with GLP establishes procedures for monitoring GLP compliance through government
inspections and study audits as well as a framework for international liaison among monitoring and
data-receiving authorities.
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A 1997 Council Decision on the Adherence of Non-Member countries to the Council Acts related to
the Mutual Acceptance of Data in the Assessment of Chemicals sets out a step-wise procedure for
non-OECD countries with a significant chemical industry input to take part as full members in this
system.
The member are :
Australia, Austria, Belgium, Brasil, Canada, China, Denmark, EU, Finland, France, Germany, Ireland,
Italy, Japan, Korea, Netherlands, New Zealand, Norway, Portugal, Russia, South Africa, Spain,
Sweden, Switzerland, Thailand, United Kingdom and the United States.
9.5 Mutual Recognition Agreements
9.5.1
General
The primary objective of conformity assessment is to give its users confidence that requirements
applicable to products, services, systems, processes and materials have been met.
One of the reasons why internationally-traded goods and services are subject to repeated
conformity assessment controls is a lack of confidence by users of conformity assessment in one
country regarding the competence of bodies carrying out conformity assessment activities in
other countries.
Therefore, measures are needed to increase the confidence of both private and public sector
purchasers, and of regulators, in the work of conformity assessment bodies and accreditation
bodies - particularly those in other countries.
Such confidence can be achieved through cross-border cooperation among conformity
assessment bodies and also among accreditation bodies. This cooperation is formalized in what
are known as Mutual Recognition Agreements/Arrangements (MRAs) whereby the parties
involved agree to recognize the results of each other's testing, inspection, certification or
accreditation.
ISO/IEC Guide 68:2002 provides an introduction to the development, issuance and operation of
arrangements for the recognition and acceptance of results produced by bodies undertaking
similar conformity assessment and related activities.
9.5.2
The EU Structure for MRA’s
Mutual Recognition Agreements (MRAs) have the objective of promoting trade in goods between
the European Union and third countries by facilitating market access. They are bilateral agreements,
and aim to benefit industry by providing easier access to conformity assessment procedures.
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MRAs lay down the conditions under which the EU and the third country concerned will accept test
reports, certificates and marks of conformity issued by the conformity assessment bodies (CABs) of
the other party to the agreement, in conformity with the legislation of the other party.
MRAs include the finalisation of relevant lists of designated laboratories, inspection bodies and
conformity assessment bodies in both the EU and the third country.
Mutual Recognition Agreements are agreements on the mutual recognition of conformity
assessment of regulated products. Through an MRA, each importing party is given the authority to
test and certify products against the regulatory requirements of the other party, in its own territory
and prior to export.
In cases where countries require mandatory third-party certification of specific products, each
importing party agrees, by the terms of the MRA, to recognise the tests, certificates and approvals
issued by agreed conformity assessment bodies of the exporting party, and the products can be
exported and placed on the other party’s market without undergoing additional procedures.
The mandate received in 1992 by the European Commission on MRA and the following 1994 and
1998 negotiating directives authorised negotiations on a bilateral basis. This has made possible at
present MRAs with USA, Australia, and other countries and the consideration of developing MRA’s
with certain Middle East and North African countries (MEDA).
With respect to Mutual recognition the figure below shows a model for its operation, the EU does
not apply this model between the member states since the legislation, the standards and the
conformity assessment procedures are identical in all member states and the assessment of all
Notified bodies are based on the same rules.
The model is applicable to MRA reached with other countries outside the EU. In 1996 the EU wrote a
guidelines on these matters which have been revised and the latest version was written in 2001, the
European Commission Enterprise DG certif. 96/3 - rev. 6 Procedure for designation of conformity
assessment bodies (CABs) under mutual recognition agreements (MRAs) with non-member
countries, also they wrote further guidelines entitled CERTIF 96/1 specifications concerning the
assessment and supervision of systems applying to conformity assessment bodies with a view to
their designation under the mutual recognition agreements between the european union (eu) and
certain non-member countries.
The following countries have a mutual recognition agreement with the EU:
 Australia
 Canada
 Israel
 Japan
 New Zealand
 Switzerland
 USA
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The following are documents from the EU which provide and assist in understanding how the EU
manages it s affairs with respect to MRA and how the policy was developed:
General policy documents
Implementing Policy for External Trade in the Fields of Standards and Conformity Assessment: A Tool
Box of Instruments - Commission Working Paper SEC(2001) 1570 of 28/09/01.
Community External Trade Policy in the fields of Standards and Conformity Assessment Commission Communication COM (96) 564 def. of 13/11/96
Implementation of the Council Resolution of 24 June 1999 on the Management of Agreements on
Mutual Recognition - Council Conclusions, OJ C 8 of 11/01/01
Guide to the Implementation of Directives based on the New Approach and the Global Approach Second Edition: Chapter 9.2 - July 1999
Guidance documents & references of regulations
Conformity Assessment Guides for EC Designating Authorities, EC Conformity Assessment Bodies
and European Industry relating to Australia and New Zealand, Canada and the USA
Guide on the Mutual Recognition Agreement between the EC and Japan
Lists of EU Notified Bodies and MRA Conformity Assessment Bodies under the New Approach
directives are also available at http://ec.europa.eu/enterprise/newapproach/nando/. The lists
include the identification number of each Notified Body/Conformity Assessment Body as well as the
tasks for which it has been notified.
Framework for Coordination and Cooperation between Notified Bodies, Member States and the
European Commission under the Community Harmonisation Directives based on the New approach
and the Global Approach. Document Certif. 94/6 Rev. 6 of 20.02.1998.
Specifications concerning Assessment and Supervision of Systems applying to Conformity
Assessment Bodies (CABs) with a view to their Designation under MRAs. Document Certif. 96/1 of
26.06.1996.
Procedure for Designation of Conformity Assessment Bodies under an MRA and its Annexes.
Document Certif. 96/3 Rev. 6 of 14.06.2001.
Code of Conduct for the Functioning of the System of Notified Bodies. Document Certif. 97/1 Rev. 3
of 17.07.1998.
Accreditation and the Community's Policy in the Field of Conformity Assessment. Document Certif.
97/4 rev.2 of 15.12.1997.
The EN 45000 Series of Standards and the Conformity Assessment Procedures of the Global
Approach. Document Certif. 97/5 of 24.03.1998.
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The EN 45000 Standards, Accreditation and Notification of Notified Bodies. Document Certif. 98/4 of
25.03.1998.
Implementation of Mutual Recognition Agreements on Conformity Assessment (MRA) and Protocol
on European Conformity Assessment (PECA). Document Certif. 98/7 of 24.07.1998.
CAB designation
Designation of Conformity Assessment Bodies (CABs) represents a core function in the operation of
the MRA. EU Member States are enabled to designate CABs that will assess and certify products, in
specified sectors, which are exported to the third country signatory of an MRA with the EU. The
legislation of reference comprises the regulations and technical requirements of the third
country. Similarly, third country signatories can designate CABs that in practice will operate as
Notified Bodies in the context of the EU internal market.
(I) Designation of CABs by EU Member States
Designation enables European CABs to conduct assessments, in line with the legislation in a nonmember country, on products to be placed on the market in that country.
It will basically take the form of indicating the details (address, etc.) of the body, the country in
question and its legislation, and the detailed technical qualifications – as requested by the third
country - on the basis of which the designation is made. An identification number is not assigned to
an EU CAB, which may nevertheless already possess identification number as an EU notified body.
The specific requirements that need to be checked for CABs designated by the EU Member States
with respect to each MRA have to be listed in the designation dossier - in particular, evidence of the
knowledge by the applicant body of the applicable third country legislation/regulations and all other
relevant documentation needed to perform certification as indicated in the legislation.
For the purpose of designation, all relevant documentation and information, in line with the
requirements of the third country legislation, must be provided - in particular:
(1)
(2)
Details of the CAB - name, address, contact references;
The criteria used for designation, with evidence and/or certificates providing
information on all relevant qualifications (e.g. accreditation);
(3)
The scope of designation, with reference to the legislation and the type of products,
sectors or standards referred to in the legislation, when appropriate;
(4)
The indication of the standards to which the designated body is qualified to
test/certify.
This information/documentation will be requested for decision in the Joint Committee.
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(II) Designation of CABs by non-EU countries
Designation in this case enables non-EU CABs to assess, in line with EU directives and in accordance
with the provisions of the MRA, products to be placed on the EU market. In certain sectors these
CABs receive identification numbers (which will feature next to the CE marking where a CAB
intervenes during the production phase).
Such designation takes place according to the relevant terms of the MRA - broadly on the basis of
the same criteria as for Notified Bodies.
In certain sectors, according to the terms of the MRA Framework Agreement and the relevant
Sectoral Annexes, these CABs will be performing the same tasks as the EU Notified Bodies. In this
case, and in line with the European Commission procedures applicable for Notified bodies, they will
be included in the data base of Notified Bodies.
All relevant documentation and information, in line with the requirements of the EU legislation,
must be provided - in particular:
(1)
(2)
(3)
(4)
Details of the CAB - name, address, contact references;
The criteria used for designation, with evidence and/or certificates providing
information on all relevant qualifications (e.g. accreditation);
The scope of designation, with reference to the legislation and the type of products,
sectors or standards referred to in the legislation, when appropriate;
The indication of the standards to which the designated body is qualified to
test/certify.
This information/documentation will be requested for decision in the Joint Committee.
Documents:
Specifications concerning Assessment and Supervision of Systems applying to Conformity
Assessment Bodies (CABs) with a view to their Designation under MRAs.
Document Certif. 96/1 of 26.06.1996
Procedure for Designation of Conformity Assessment Bodies under an MRA and its Annexes.
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Figure 15 Mutual Recognition System
9.5.3
China: Inter-governmental arrangements & agreements
China has been actively engaged in bilateral exchanges and cooperation in the area of certification
and accreditation, and has established long-term consultative mechanism or bilateral cooperative
relations with governments and CABs/ABs in 42 economies, and signed 55 bilateral cooperation
agreements, memorandums of understanding and minutes of negotiation with 30 government
bodies and CABs/ABs in 25 economies.
There are two levels of cooperation:
1.
Cooperation between CNCA and the governments of the trade partners of China for mutual
recognition of certification and accreditation, which follows the principle of equality and mutual
benefits;
2.
Cooperation between CABs or ABs, which is encouraged by and under the direction of CNCA.
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Inter-governmental mutual recognition of certification and accreditation
New Zealand - The Agreement between the Government of the People’s Republic of China and the
Government of New Zealand on Cooperation in the Field of Conformity Assessment in Relation to
Electrical and Electronic Equipment and Components (hereafter referred to as the Agreement) was
finalised between the two governments on July 4, 2008. The Agreement is the first-ever
arrangement of mutual recognition in the field of product certification between the Chinese
government and a foreign government.
According to the Agreement, New Zealand will recognize the results of China Compulsory
Certification (CCC) for electrical and electronic equipment and components exported from China to
New Zealand, implementing no additional administrative admittance measures.
Electrical and electronic equipment and components exported from New Zealand to China should be
certified according to CCC requirements by New Zealand conformity assessment bodies accepted by
China, in accordance with China’s CCC requirements.
This is a new progress achieved by China in eliminating trade barriers and facilitating trade by mutual
recognition of certification and accreditation, after Chinese motor cycle products bearing CCC
certification were directly admitted in Vietnam market in 2002.
Russia - Under the framework of the Standing Working Group on Standards, metrology, Certification
and Inspection Supervision under the Economic and Trade Subcommittee of the Regular Meeting
Committee between the Chinese and Russian Premiers, the mutual recognition with Russia for
inspection and quarantine certificates and laboratory accreditation are promoted in order to provide
quicker, more convenient and more efficient customs clearance for goods to enter each other’s
market smoothly; and the mutual recognition mechanism for testing results between Chinese and
Russian laboratories is established through mutual recognition of laboratory accreditation.
USA - China has carried out exchanges and cooperation with the US Commerce Department and
Environment Protection Agency in the field of CCC, RoHS and certification of energy conservation
products; seminars on standard and conformity assessment were held for several times with related
departments such as Commerce Department of the US.
Memorandums of understanding were signed with the American National Standards Institute (ANSI)
on exchanges and cooperation of conformity assessment. A wide variety of workshops were held in
cooperation with the Toy Industry Association of US to promote the US standards and technical
requirements on toys among Chinese toy enterprises.
European Union - Given that the exchange and cooperation in the field of conformity assessment
plays a pivotal role in developing Sino-Europe trade relations, CNCA has been energetically exploring
cooperative opportunities with DG Enterprise and Industry of the EC, and has established a longterm dialogue mechanism, that is, the Working Group on Conformity Assessment under the
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framework of consultative mechanism between AQSIQ and DG Enterprise in the field of safety of
industrial products and WTO/TBT.
The WG convenes at least once per year, attended by officials from China and Europe and
representatives from technical bodies, industries and enterprises; it serves to coordinate and
organize exchange activities in various forms such as a workshops related to Sino-Europe
certification and accreditation.
It has become a solid platform and an effective channel for China and Europe to comprehensively
and timely receive information from the other side in the field of conformity assessment, openly and
honestly discuss and negotiate issues of common concern, and enhance the systemic and policy
transparency of both sides in this regard, and boost exchanges and cooperation.
Korea - Under the framework of Sino-Korean cooperative committee for standard and conformity,
cooperative activities are carried out with the Korean Institute of Technical Standards, orientations
on CCC are organized for Korean enterprises manufacturing products exported to China, and
orientations on EK marks for Chinese enterprises manufacturing products exported to Korea, which
benefits more nearly 500 enterprises.
In addition, CNCA is currently conducting information exchanges with countries such as Japan and
Singapore in the field of mutual recognition for certification and accreditation.
9.6 European Union Schemes and Agreements
9.6.1
ENEC Agreement
A programme administered by the European Manufacturers Association for Luminaries along with
the CENELEC Marks Committee. This scheme was ratified in 1992 as the “LUM Agreement” revised in
1996 as the “ENEC Agreement”: Statute ENEC – 301(PD).
This agreement was further extended in September 1997 to embrace not just lighting products, but
information technology equipment, transformers, appliance switches. To achieve compliance,
products must conform to European standards, to the satisfaction of a signatory agency, who can
issue certificates, permitting the use of the ENCE Mark.
Signatory Agencies
There are 22 agencies permitted to issue certificates in 20 countries:
Country
Austria
Belgium
ID no
ENEC 11
ENEC 02
Certification Body
OVE
CEBEC
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Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Luxembourg
Netherlands
Norway
Portugal
Slovenia
Spain
Sweden
Switzerland
United Kingdom
United Kingdom
United Kingdom
ENEC 21
ENEC 15
ENEC 16
ENEC 08
ENEC 10
ENEC 09
ENEC 18
ENEC 06
ENEC 03
ENEC 07
ENEC 05
ENEC 17
ENEC 04
ENEC 22
ENEC 01
ENEC 14
ENEC 13
ENEC 12
ENEC 19
ENEC 20
EZU
DEMKO
FIMKO
UTE
VDE
ELOT
MEEI
NSAI
IMQ
SEE
KEMA
NEMKO
IPQ
SIQ
AENOR
SEMKO
SEV
BSI
BEAB
ASTA
Products that have the ENEC mark are accepted without any qualms by the certification bodies in
other signatory countries.
9.6.2
The CCA (CENELEC Certification Agreement) Scheme
The CCA scheme is a European agreement among mark owning bodies.
There is one per country. It covers products the fall under the scope of the Low Voltage Directive, for
the purpose of facilitating the granting of a licence or mark of conformity in another country. Type
testing is carried out according to harmonized European Standards.
9.6.3
The Keymark
This is a pan-European certification mark owned by CEN/CENELEC, and administered by the
European Electrotechnical Sectoral Committee for testing and certification (ELSECOM).
It was created in 1997 for household electrical products within the scope of EN 60335 Specification
for safety of household and similar electrical appliances. It is used to show conformity to European
standards. It is a voluntary scheme that provides a safety certification mark, based on third party
certification in the following countries:
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Austria (ÖVE), Belgium (CEBEC), Czech Republic (EZU), Denmark (DEMKO), Finland (FIMKO), France
(LCIE), Hungary (MEEI), Italy (IMQ), Luxembourg (SEE), Netherlands (KEMA), Norway(NEMKO),
Portugal (IPQ), Spain (AENOR), Sweden (SEMKO), Switzerland (SEV), United Kingdom (BEAB)
9.6.4
The HAR mark
Another voluntary scheme, this time for Low voltage cables and cords which meet the harmonised
technical requirements.
The participants in this scheme are the National Certification Bodies for cables and cords in the
European Union.
HAR Agreement membership
AENOR (Spain), British Approvals Service for Cables (BASEC) (UK), CEBEC Registered Quality scrl
(Belgium), DEMKO (Denmark), Electrical Inspectorate (SETI), ELOT - Hellenic Organization for
Standardization, Istituto Italiano del Marchio di Qualita (IMQ), IPQ - Instituto Portugues da
Qualidade, KEMA Registered Quality Nederland B.V, LCIE S.A (France), MEEI (Hungar), National
Standards Authority of Ireland (NSAI), NEMKO (Norway), OVE Testing and Certification (Austria),
SwissElectrotechnical Association (SEV), SEMKO (Sweden), VDE Pruf-und Zertifizierungsinsitut
(Germany)
9.6.5
CENCER Mark
The CENCER Mark is a certification mark for demonstrating conformity of products to European
Standards or other specifications approved by CEN. The mark is owned by CEN.
Like the Keymark, the other European system for conformity assessment to European Standards, the
CENCER Mark is a voluntary third-party certification mark, providing confidence for the consumer
that a product complies with the requirements of approved documents.
9.6.6
European Products Certification Association (EEPCA)
The EEPCA assist the certification work of its members, in developing new, marks, licences,
certificates and quality labels.
9.7 International Schemes
9.7.1
IECQ Scheme
As early as the 1970s IEC began to prepare a global quality certification system for electrical
equipment and components; in 1981, it founded the IEC Quality Assessment System for Electronic
Components (IECQ). The certification mode of IECQ is composed of “initial factory inspection +
product appraisal and approval testing + supervision after certification,” putting more emphasis on
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the control of production process and quality system compared with the certification mode of the
IECEE CB system.
IECQ currently consists of 17 member nations including China. China became a participating country
in CMC of IECQ and an ICC negotiation member country in April 1983; It became a full member
country of ICC in May 1987.
At present, the National Authorized Institution of IECQ in China is CNCA; its National Certification
Body is China Electronic Product Reliability and Environmental Testing Research Institute (CEPREI）;
and its National Standards Organization is China Electronic Standardisation Institute (CESI).
IECQ has 20 years' experience as IEC's certification programme for electronic components, processes
and related materials.
In 2003, the European counterpart CECC, merged into IECQ, bringing with it the CECC Mark. This
Mark is used under IECQ by agreement between the IEC and CENELEC, which owns the Mark.
Recently, the IECQ has moved into process management certification for electronic components
used in aerospace. Today it is expanding into process management certification for electrical and
electronic components and products that comply with requirements for the restriction of hazardous
substances.
IECQ is the abbreviated name for the IEC Quality Assessment System for Electronic Components. The
abbreviations "IECQ-CECC" and "CECC" continue to be valid on certificates already issued.
Member Countries: Australia, Austria, China, Denmark, Finland, France, Germany, India, Japan,
Korea, Norway, Russia, Serbia, Singapore, UK and USA.
The approvals explained below are an important assurance that, throughout the chain of supply of
components, customer requirements will be met in full compliance with IECQ procedures.
Every approval granted under the IECQ references a standard or specification that has been
accepted for use in the System. Each approval carries the award of a certificate.
Supplier approval, which is applicable to manufacturers, distributors and specialist contractors, is
the first and obligatory level of approval. It exceeds the relevant requirements of ISO 9001.
Approvals already granted by appropriate certification bodies may be taken into account in any
assessment for supplier approval. A manufacturer, having achieved supplier approval, may apply for
product approval through one or more of the following routes:

Qualification Approval, which is applicable to a component or range of components which
meet the requirements of the accepted specifications.
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

Capability Approval, which defines a manufacturer’s ability in respect of his manufacturing
processes and quality control methods, which may include design, covering a specific
component technology within a generic specification.
Technology Approval, which focuses on process control, and the continuous improvement
of a manufacturing technology. The manufacturer has to demonstrate his quality
management system through the application of a formal system, such as TQM using inprocess control methods (of which Statistical Process Control (SPC) is an example) as
appropriate for the manufacturer of components in defined families.
Any component produced within the scope of the above approvals is recognized as IECQ certified,
and can be released with a Declaration of Conformity if the user and supplier so decide.
A specialist contractor, having achieved supplier approval, may proceed to:
 Specialist Contractor Approval, which allows firms serving the electronic component
industry to obtain approval under the IECQ as specialist contractors. Examples of activities
are ceramic package manufacture, printed board or integrated circuit design and
electroplating.
In association with supplier approval, the following provisions apply to distributors and independent
testing laboratories:
 Distributor approval is available to distributors of components acting independently of any
manufacturer’s production department and intending to stock and distribute approved
components under the authorization of an approved manufacturer.
 Testing laboratory accreditation is available to independent testing laboratories intending
to carry out tests on components within the IECQ. The accreditation covers the type of tests
to be carried out, the component ranges to be tested and the facilities available, and
exceeds the relevant requirements of ISO/IEC 17025. Account is taken of any existing and
relevant accreditation.
9.7.2
The CB scheme
This is a scheme set up by the International Electrotechnical Commission (IEC).
The IECEE CB Scheme (also known as the CB Scheme) is a mutual recognition system for testing
certificates of electrical equipment under the International Electro-technical Commission (IEC)
system of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE).
China is a key member of the IECEE-CB system. The late CCEE joined both the IECEE-MC and the
IECEE-CTL in September 1985. The late CCEE was designated as the National Certification Body (NCB)
of China at that time, with its nine electrical, electronic and household appliance testing centres
functioning as CB laboratories.
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The China Quality Certification Centre (CQC) functions as the NCB within the system of IECEE-CB,
with 16 contracted CB laboratories. CNCA explicitly stipulates that CCC recognize CB certificates for
the scope granted to China by the CB scheme.
For the last two decades, China has accumulatively issued more than 15,000 CB certificates,
providing a fast track for the export trade of Chinese enterprises. On the other hand, more than
20,000 CB certificates have been recognized in China’s compulsory certification, thus facilitating the
imports of foreign electronic and electrical equipment to China, and materializing China’s WTO
accession commitments.
In recognition of the need to facilitate international trade in electrical equipment intended for
consumers, and to provide convenience for manufacturers and other users of the services provided
by various National Certification Bodies (NCBs), an international Scheme is operated by the IECEE
(IEC System of Conformity Assessment Schemes for Electro-technical equipment and Components),
known as the CB Scheme (Scheme of the IECEE for Mutual Recognition of Test Certificates for
Electro-technical Equipment and Components).
The Scheme is based on the principle of mutual recognition (reciprocal acceptance) by its members
of test results for obtaining certification or approval at national level.
The Scheme is intended to reduce obstacles to international trade which arise from having to meet
different national certification or approval criteria. Participation of the various NCBs within the
Scheme is intended to facilitate certification or approval according to IEC standards.
Where national standards are not yet completely based on IEC standards, declared national
differences will be taken into account; however, successful operation of the Scheme presupposes
that national standards are reasonably harmonized with the corresponding IEC standards.
The operating units of the Scheme are the NCBs. Those NCBs employ testing laboratories, known as
CB Testing Laboratories (CBTLs).
The CB Scheme is based on the use of CB Test Certificates which provide evidence that
representative specimens of the product have successfully passed tests to show compliance with the
requirements of the relevant IEC standard.
A supplementary report providing evidence of compliance with declared national differences in
order to obtain national certification or approval may also be attached to the CB Test Report.
The operators of the CB Scheme are the National Certification Bodies (NCB's).
Currently, there are 52 countries represented by Member Bodies and NCBs participating in the CB
Scheme for one or more standards.
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As the title indicates, it is a process designed to aid the recognition of test result documentation
between member countries, using a commonly recognized format. The aim is, to cut down the need
for supplementary testing as an electrical product is placed on the international market.
This scheme can assist manufacturers by reducing testing costs and cutting down the time that it
takes to gain international approval.
There are 52 member countries:
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Croatia,
Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland,
Israel, Italy, Japan, Kenya, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan,
Poland, Portugal, Russia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa,
Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, Ukraine, United Kingdom,
United States and Uruguay.
The CB basic Procedure:
•
•
•
9.7.3
The product is tested for electrical safety against the relevant International Electrotechnical
Commission (IEC) standard.
Upon passing this test procedure the NCB can issue a CB test report and test certificate.
The test report and certificate can then be used by a manufacturer to gain national
certification in its chosen member countries.
The IECEx Scheme
The objective of the IECEx Scheme is to facilitate international trade in equipment and services for
use in explosive atmospheres, while maintaining the required level of safety:
•
•
•
•
•
reduced testing and certification costs to manufacturer
reduced time to market
international confidence in the product assessment process
one international database listing
maintaining International Confidence in equipment and services covered by IECEx
Certification
Ex areas can be known by different names such as “Hazardous Locations”, “Hazardous Areas”
“Explosive Atmospheres”, and the like and relate to areas where flammable liquids, vapours, gases
or combustible dusts are likely to occur in quantities sufficient to cause a fire or explosion. An
increased need to use equipment in Ex areas has resulted and such equipment is termed “Ex
equipment”
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IECEx International Certification Scheme is based on prepared International Standards, the IEC
facilitates the operation of Conformity Assessment Schemes. One such Scheme is the IECEx Scheme.
The IECEx Scheme comprises the following two Global Certification Programs
1. The IECEx Certified Equipment Program
2. The IECEx Certified Service Facilities Program
1. The IECEx Certified Equipment Program
This IECEx Program is an International Certification Scheme covering product that meets the
requirements of International Standards, e.g. IEC Standards prepared by TC 31.
The IECEx Certified Equipment Program provides both:
a) A single International Certificate of Conformity that requires manufacturers to successfully
complete:• Testing and Assessment of samples for compliance with Standards
• Assessment and auditing of manufacturers premises
• On-going surveillance audits of manufacturers premises
Or
b) A “fast-track” process for countries where regulations still require the issuing of national Ex
Certificates or approval. This is achieved by way of global acceptance of IECEx equipment Test and
Assessment Reports.
2. The IECEx Certified Service Facilities Program
This IECEx Program is an International Certification Scheme that covers the assessment and the onsite audit of organizations that provide a Repair and Overhaul service to the Ex industry.
The challenge for industry is to ensure that all the very unique Ex safety features, included in the
design and manufacturing of Ex equipment, are not compromised during the repair process.
Ex Repair and Overhaul Facilities and Workshops, certified under the IECEx Certified Service Facilities
Program, provide industry with the assurance that repairs and overhaul to Ex equipment will be
undertaken according to the strict requirements of IECEx Scheme to the International Standard IEC
60079-19
Ex equipment Manufacturers and Ex Service Providers can apply to existing IECEx Certification
Bodies (termed ExCBs), in any country.
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Countries and Certification Bodies can apply to become members of the IECEx Scheme with
Certification bodies able to issue IECEx Certificates once accepted according to the application
procedures.
National Member Bodies of the IEC Scheme make application for their country to participate in the
IECEx Scheme on a Standard-by-Standard basis. The application is made to the Secretary of the Ex
Management Committee.
Certification bodies and testing laboratories wishing to be accepted into the IECEx Scheme must
reside in a participating country. Their application for acceptance is made through their National
Member Body of the IECEx Scheme for the country in which they reside.
Certification bodies and testing laboratories are accepted into the IECEx Scheme after satisfactory
assessment of their competence. Assessors are selected who will provide confidence to regulatory
authorities, users, manufacturers and certification bodies.. ISO/IEC Standards and Guides 17025, 65
and IECEx Technical Guidance Documents are used as part of the IECEx assessment process.
In 2008 there are 26 National Member Body and these are:
Standards Australia, Canadian National Committee (CNC/IEC), Certification and Accreditation
Administration of the People's Republic of China CNCA Chinese National Committee of the IEC,
Czech Republic Physical technical Testing Institute, Dansk Standard, SESKO Standardization in
Finland, Laboratories Central des Industries Electriques LCIE (France), Deutsches Komitee der IEC,
Hungarian Standard Institution, Bureau of Indian Standards, CEI - Comitato Elettrotecnico Italiano,
Japanese Industrial Standards Commitee JISC, Korean Agency for Technology and Standards KATS,
Netherlands National Committee of the IEC, Standards New Zealand, Norsk Elektroteknisk Komite
(NEK) , Institute for Standardization of Serbia (ISS), INSEMEX PETROSANI (Romania), Federal Agency
for Technical Regulation and Metrology (GOST) (Rusia), Spring Singapore, Slovenian Institute of
Quality and Metrology, South African Bureau of Standards (SABS), SEK Svenska Elektriska
Kommissionen, Electrosuisse, British Electrotechnical Committee (BSI) and USA National Committee
of the IECEx NEMA.
As one of the founding countries of IECEx, China had been involved in the initial research work since
1995 before IECEx was established. Currently, CNCA, the member body, represents China to
participate in activities of the organization.
Before the founding of CNCA, the Chinese National Committee of IEC was the member body. The
Chinese certification body participating in IECEx is the China Certification Centre for Quality Mark
(CQM); the testing laboratories include CQST, Shanghai Inspection and Testing Institute of
Instruments and Automatic Systems (SITIIAS), Quality Inspection Centre for Petroleum and Chemical
Electric Explosion-Proof Products, and National Quality Inspection Centre for Coal Mine ExplosionProof Products, to name but a few.
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10.0
Conclusions
This report can be considered a general description of the conformity assessment systems in the EU
and China; it is not all inclusive or comprehensive and should be used as an initial review of the
systems geared towards a better understanding so that further detail studies can be identified so
that a comprehensive understanding of the systems can be achieved.
10.1
Legislation
In the China there are three levels of compulsory legislation, there are laws issued from the national
people’s congress, administrative regulations issued by the state council, ministerial regulations
issued by ministries.
The EU system has three types of compulsory laws; Directives, Regulations and Decisions all issued
from the same source. Below this can be found all the member states legislation but it is important
to note that the EU legislation has primacy over the member state legislation and all conflicting
legislation has to be withdrawn.
The EU new approach system is based in general on sector and not products and does not prescribe
the technical requirements or specifications of products or sectors, but only the essential
requirements which are in nature general.
The success of this approach can be seen in that many of the sector Directives although reviewed by
the Commission in later years have required little changes; an example of this being the Low Voltage
Directive which was written originally in 1973 and on the whole the same text has been applying
since then.
The use of prescriptive compulsory methods specifying all the technical requirements leads to
continuous intervention by the legislators in trying to maintain the legislation up to date due to
technical advances or alternatively risking the legislation becoming out of date, thus not providing
the required protection.
Another issue to consider is that the EU legislation regulates all products entering the market either
by using old approach, new approach or general products safety Directives; In China, the CCC mainly
covers consumer-related products, and there are also regulatory requirements for other products
enforced by laws and regulations, for which this report provides some examples, but more
comprehensive information will require further studies supported by expertise in those areas.
Therefore although not necessarily similar the legislative systems are relevant to each society and do
not appear to pose a barrier to trading with China.
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10.2
Standards
China encourages the adoption of international standards and advanced foreign standards, and is
actively participating in the development of international standards.
Whenever possible, an international standard shall be adopted identically. If any modification is
validated by national differences in climate or geographical conditions or fundamental technical
issues, the modification shall be the minimum as reasonable and necessary, and shall be clearly
stated in the standard (normally in the forward of a standard).
In general China uses international standards as the basis for the mandatory standards, in many
cases these are identical and in some these are modified but considered equivalent.
The rules of the WTO permits the use of international standards as technical regulations provided
that these are adopted by the country in identical basis or any modifications are clearly identified
and are based on safety or environmental adaptations.
China is in the process of increasing the number of identical ISO/IEC standards. Regarding conformity
assessment area in particular, up till now, all the published ISO/CASCO conformity assessment
standards and guides have been adopted identically as Chinese national standards, which have be
substantially referred by the conformity assessment system under the regulation of CNCA.
The principles and requirements of these standards are reflected by the Regulations on Certification
and Accreditation of People’s Republic of China and its associated regulations, and by the criteria,
rules and procedures etc. followed by the conformity assessment bodies and CNAS, which is the
national accreditation body.
The EU uses the principle of “presumption of compliance” to encourage the use of the European
standards, and as shown in this report over 77% of electrical standards and about 30% of all other
standards issued by ISO are either identical or based on international standards.
The EU through the Dresden and Vienna agreements seeks were possible to increase the above
figures only the essential requirements of Directives (which are based on WTO rules considering
safety or environmental grounds) may impede this being the case and modification having to be
made.
It should be noted that in the EU regional standards not all clauses need be used but only those that
reflect the essential requirements of the particular Directive, to assist manufacturers many of the EU
standards contain an annex which shows the relevant clauses of the standards against the clauses of
essential requirements in the particular Directive.
Therefore the EU and Chinese systems in essence are not much different to each other.
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China uses mandatory standards as a part of technical regulations, therefore the EU system based on
legislation and standards providing presumption of conformity with the legislation and the Chinese
system do not appear to pose a barrier to trade.
10.3
Accreditation
Accreditation is at the centre of all quality infrastructure systems in any economy, without trust in
the accreditation body performing its duties and accrediting conformity assessment bodies the
whole system of belief in certificates issued by these bodies fails and as result it means that foreign
markets would insist in the certification being undertaken by their own conformity assessment
bodies. This would increase the barriers to trade for the exporting enterprise.
For the accreditation body to be capable it must be subject to peer reviews based on international
standards and specific experience of the sector under for which it claims competence. If this fails
then the whole system of conformity assessment is called into question.
The accreditation system in China is considered equivalent to the system used in the EU, as
demonstrated by relevant IAF MLA and ILAC MRA, which are based on periodic peer evaluation
among IAF/ILAC member accreditation bodies (ABs) including most of the EA member ABs.
Both systems use the same standards for accreditation of conformity assessment bodies (CAB’s).
It is noted that both systems are considered equivalent to each other for accreditation purposes and
in many cases use identical product standards for conformity assessments purposes, given that the
accreditation systems are considered equivalent it is recommended to carry out further studies to
explore the potentials of establishing EU-China mutual recognition agreements.
Currently through the case of international schemes such as CB scheme or IEC Ex schemes and other
bi-lateral arrangements between CABs are certificates and tests accepted.
10.4
Conformity Assessment
Conformity assessment in China is based mainly in the triple C certification program which is based
on a CCC catalogue containing a list of products in 23 categories divided into 172 product types.
From previous knowledge it was known to the writer that there exists documentation
(implementation rules for compulsory certification) outlining the standards to be used and the
requirements for certification.
The mandatory Chinese standards (GB standard) are normally identical to the international
standards on which they are based. In case of any differences these are clearly indicated in the
forward of the standard (in Chinese).
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Products not listed in CCC catalogue may be subject to other conformity assessment requirements
from relevant regulatory bodies, for which this report has provided some examples such as Special
Equipment Licensing and other examples listed in this report.
Nevertheless, this report should be able to serve the purpose of initial study on Chinese conformity
assessment requirements for non food products. It should be noted that under the “General Product
Safety Directive” all products in the EU are regulated it is just the degree of third party intervention
which remains the difference.
Any conformity assessment body legally incorporated in China may apply for designation to carry out
conformity assessment activities for compulsory product certification.
This means an EU conformity assessment body can set up its business in China and become a
designated body for CCC after it satisfies required conditions, though no foreign body has formally
applied for designation at the moment.
However, 17 foreign CABs world-wide have received approval to carry out follow-up inspection on
the certification part of CCC.
This is the similar case in the EU where any conformity assessment body can become a Notified Body
(including Chinese organisations) as long as they set up operation in one member state of the EU and
are capable of meeting the requirements (stated in this report) to become a Notified Body for the
relevant Directives.
Chinese compulsory certification (CCC) is a third party product certification system in line with
ISO/IEC Guide 67 System 5 and ISO/IEC Guide 28. It is based on the principle that products
concerning human health or safety, animal or plant life or health life, environment protection and
public security are subject to compulsory certification enforced by the State, as described in
Administrative Rules for the Compulsory Product Certification (see 2.2.1 and 2.2.1.1.2).
In the European Union the Global Approach and the Decision 768/2008/EC for conformity
assessment are an extension of ISO/IEC Guide 67 and is used based on the risk posed by the product
in the relevant sector thus higher third party intervention the higher the risk.
It is recommended to carry out further case studies on particular product categories under CCC and
EU sectoral Directives to analyze the determinants of product risks and the correlation between
product risks and the associated conformity assessment models, by taking account of respective
technical, social and economic circumstances of EU and China, so as to gain an insight into the
rationales of each economy on what is considered RISK and what conformity assessment models
should be used to mitigate this.
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10.5
Market Surveillance
In the EU it is an obligation of all member states to undertake post market surveillance as indicated
in the new approach Directives and also reinforced in the General Product Safety Directive, although
as indicated no consistent at present all countries do carry out their obligations on this aspect.
The obligations of surveillance on Notified Bodies are the responsibility of each member state
government who appoint these organisations. It should be noted that Decision 765/2008/EC
provides further requirements on market surveillance as provided by each member state. It should
also be noted that all products are regulated in the EU with respect to market surveillance.
In China, regulatory bodies including AQSIQ, CNCA and others carry out post market surveillance on
the conformity of products regulated by laws and regulations. CNCA also carry out surveillance on
the compliance and performance of certification bodies and the conformity and effectiveness of
certified management systems.
10.6
International Dimension
China are members of the same international organisation as the EU (e.g. WTO, ISO, IEC, OECD and
others) and also are members of the same international schemes as the member states of the EU
(e.g. IECEE CB, IEC Ex and others).
Therefore from this perspective there are no barriers to trade. On the contrary, by using the
international schemes it facilitates manufacturers from both regions to trade.
10.7
General
In general on paper and based on the investigation as outlined in the procedures in section 2,
although in some cases different, the Chinese system has all the quality infrastructure elements in
place and some are similar to those of the EU so as to be said that these should not pose a barrier to
exporting to China and the reverse can be said for the EU.
There is an English colloquialism that states “the devil is in the detail” and there are many basic
differences and inconsistencies between both systems as outlined in this report that require further
in-depth investigation.
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11.0
Recommendations
It is recommended that in-depth comparative studies of the quality infrastructure of each economy
be made on food and non-food sectors on the following:
•
Legislation, detail comparison of the legislations EU-China, the results of this comparison
should propose if there is any need of changing legislation or can the existing legislation in
the manner in which it has been written can cope with the different concepts that may be
proposed.
•
Standards
o compare mandatory Chinese standards identical to international standards and EU
harmonised regional standards identical to international standards
o where modified identify the Chinese mandatory standards and difference with the
international standards and undertake same work with the EU regional standards
based on the same international standards as modified by the Chinese standards.
o Determine purely Chinese or EU standards which may affect trade or if based on
regulations instead of standards.
•
Metrology Comparison of the Legal, Scientific and industrial metrology with respect to trade
issues only
•
Accreditation (a review of the systems to ensure uniformity of application on both systems),
explore the possibility of bi-lateral agreement with EA under their cooperation scheme.
•
Undertake a full review of all regulatory requirements and schemes involving conformity
assessment in China and how these apply and compare to the EU, noted that support and
involvement of relevant Chinese competent authorities are needed.
•
Case studies on particular product categories under CCC and EU sectoral Directives to
analyze the determinants of product risks and the correlation between product risks and the
associated conformity assessment models, by taking account of respective technical, social
and economic circumstances of EU and China, so as to gain an insight into the rationale of
each economy on what is considered RISK and what conformity assessment should be used
to mitigate this.
•
Review exact methodology for designating conformity assessment bodies (CAB’s) in China
and Notified Bodies or equivalent in the EU, what are the conditions for accepting foreign
CAB’s in each country e.g. only have a legal entity in country with laboratories overseas or
other?
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•
How is post market surveillance undertaken and what model is used in China and to explain
the different models used in the EU with respect to their member states and how the new
Decision will affect these requirements.
•
Full comparison of technical documentation requirements both in China and the EU for the
acceptance of products in each market together with all markings required.
The above investigations and studies should be undertaken for the following sectors:
Food
1.
2.
3.
4.
Animal
Plant
Safety of food products
Health requirements in production
Non Food
1.
2.
3.
4.
Based on the full list of New Approach Directives
Motor vehicles and trailers
Chemicals
General product safety Directive and specific products based on market entry into both
markets
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