HANDS ON
STANDARDIZATION
A STARTER GUIDE TO STANDARDIZATION FOR
EXPERTS IN CEN TECHNICAL BODIES
December 2012
____________________________________________________________________
Table of contents
Foreword
III Introduction
1 What is CEN?
1 What is a standard?
1 Are standards mandatory?
2 What can be achieved with standards?
2 How does CEN manage its technical work?
2 What kinds of documents are developed by CEN?
3 How standards are produced
5 Who writes a standard?
5 What are the different steps in the development of a standard?
7 How long does it take to develop a standard?
8 What to do if it is not possible to stick to the established timeframe?
10 Does CEN co-operate with other standards organizations?
11 Drafting standards
13 How are standards written?
13 What is the typical structure of a standard?
14 How can environmental and other aspects be integrated into standards?
15 II
Foreword
The purpose of this document is to provide experts participating in CEN Technical and Project
Committees an easy-to-read guide to standardization. This guide outlines, in a simplified way
and with plain language, how the standardization process works and what needs to be taken
into account when drafting standards. This document may be especially useful for those
experts and observers that are participating in European Standardization for the first time.
Since this document is intended to be used by those participating in Technical and Project
Committees, it mainly focuses on the kinds of documents that can be developed by these two
groups. Other kinds of documents published by CEN are briefly mentioned.
Detailed information of the CEN procedures and rules can be found in the CEN Business
Operations Support System (BOSS). The BOSS is the on-line source of reference for all
operational rules of the CEN system.
The CEN BOSS can be consulted online (www.cen.eu/boss).
III
Introduction
What is CEN?
The European Committee for Standardization (CEN) is the European Standardization Body for
the development of standards in all areas with the exception of the telecommunications and the
electro-technical fields. Standards in these two fields are developed by CENELEC (electrotechnical) and ETSI (telecommunications).
The CEN Members are the National Standardization Bodies of 27 European Union countries,
Croatia, The Former Yugoslav Republic of Macedonia, and Turkey plus three countries of the
European Free Trade Association (Iceland, Norway and Switzerland).
Besides its national members CEN has seven Associate Members (Associates), which are
organisations representing the interests of different business sectors (construction, chemical
industry…), consumers, SMEs, trade unions, and the environment. CEN Associates can
participate as observers in the work of CEN Technical and Project Committees.
Beyond the above membership categories, CEN enables national standardization bodies from
neighbouring EU countries to participate in its technical work via the status of Affiliate.
National Standardization Bodies from other countries which are members of ISO (International
Organization for Standardization), but are unlikely to become CEN Members or Affiliates can also
get involved in the work of CEN via the status of Partner Standardization Body.
Further information:
™ CEN Members (www.cen.eu/CEN/members )
™ CEN Associates (www.cen.eu/go/associates)
™ CEN Affiliates (www.cen.eu/go/affiliates )
™ CEN Partner Standardization Bodies (www.cen.eu/go/PSBs )
What is a standard?
According to EN 45020:2006 (ISO/IEC Guide 2:2004), a standard is a document, established by
consensus and approved by a recognized body, that provides, for common and repeated use,
rules, guidelines or characteristics for activities or their results, aimed at the achievement of the
optimum degree of order in a given context.
Standards may include requirements and/or recommendations in relation to products, systems,
processes or services. Standards can also be used to describe a measurement or test method or
to establish a common terminology within a specific sector.
Some examples of existing standards
EN 13306:2010 - Maintenance terminology
EN 14804:2005 - Language study tour providers- Requirements
EN 14056:2003 - Laboratory furniture - Recommendations for design and installation
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EN 913:2008 - Gymnastic equipment - General safety requirements and test methods
A list of published standards and standards under development can be found on the CEN
Website (www.cen.eu/esearch).
Are standards mandatory?
Standards, unlike legislation, are voluntary in application unless called up in legislation or cited as
part of a contract.
Legislation can refer to a standard as means of compliance with regulatory requirements. This
means that compliance with the standard is recognised as a possible way of fulfilling regulatory
obligations. Other ways to comply with these obligations may be chosen, but those using the
standard have the presumption of being in conformity with legal requirements (presumption of
conformity).
Once ratified by CEN, a European Standard (EN) has to be implemented by CEN members as an
identical national standard and any conflicting national standards must be withdrawn. A European
standard, therefore, potentially substitutes 33 different national standards.
What can be achieved with standards?
Standards can:
™ improve competitiveness, increase efficiency and facilitate innovation. Standards can set a
benchmark against which businesses can measure the quality and performance of their own
services/products or of the services/products they are purchasing. Standards can also be
used to promote new technologies and best practices, spreading innovation and knowledge
throughout the market;
™ promote the interoperability of products and services;
™ increase the safety of products and foster the protection of health and the environment;
™ help trade by eliminating technical barriers;
™ help businesses to comply with existing legal obligations (see above).
How does CEN manage its technical work?
The technical work is carried out under the overall management of the CEN Technical Board
(BT). The BT is responsible for setting up the various technical and project committees and
monitoring the progress of the technical work. It is also responsible for setting up the rules for the
development of European standards.
Technical Committees (TC) are established by the BT in order to develop European standards
or other normative documents related to specific industries or generic subjects appropriate to the
needs of that sector. In cases where a limited number of standards (e.g. two or three) is needed
on a particular subject and in a new area, a Project Committee (PC) instead of a Technical
Committee can be established. Project Committees function in a similar way to Technical
Committees but they are not allowed to decide on the inclusion of new work items in their
2
programme and they are disbanded once they have finished the standardization work for which
they were created.
Technical Committees may set up one or more working groups in order to focus on specific
tasks or to provide a draft standard.
Beyond this, some sectors (e.g. construction, energy management…) also have Sector Fora.
Sector Fora coordinate the activities in one sector and provide advice to the CEN BT and
Technical Committees on related issues.
The three decision layers at technical level
What kinds of documents are developed by CEN?
Documents developed by Technical and Project Committees
In addition to European Standards (ENs), CEN Technical and Project Committees can also draft
Technical Specifications (TS) and Technical Reports (TR). All these documents are voluntary in
application.
European Standards (EN) guarantee the commitment of National Standardization Bodies
(NSBs) to adopt them as identical national standards and withdraw any conflicting national
standards. The development of an EN includes a public commenting period (enquiry) followed by
an approval by weighted vote by CEN members. There is an agreement between CEN National
Members not to publish national standards on the same subject as a European standard. This
comes into effect as soon as work on an EN is started at the European level. This agreement is
known as ‘standstill’1.
Technical Specifications (TS) can be produced when there is no immediate need or not enough
consensus for ENs, or where technology is not mature enough and the subject matter is still
under technical development. CEN National Members announce the existence of the TSs in the
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same way as for the ENs and shall make them available but they are not obliged to adopt them
as national standards or to withdraw any conflicting national standards.
Technical Reports (TR) are documents containing informative material such as data from a
survey, description of the state of the art on a particular subject, information on work in other
organisations, etc., which are not suitable to be published as an EN or TS.
The following table lists the main characteristics and gives a comparison between the different
documents that can be developed by Technical or Project Committees.
Standstill
Public Enquiry
Approval
TS
TR
Yes
No
No
Yes (5 months)
No
No
CEN National members by
weighted vote
Withdrawal of
national conflicting
standards
Review
EN
Yes
Review at intervals of not more
than 5 years, starting from the
date of availability of the EN.
CEN National Members by
weighted vote
CEN National Members
by simple majority vote
No
Review after 3 years.
Review at intervals ofnot more
than 3 years, starting from the
date of availability of the TS.
No
Recommended to
review regularly.
No lifetime limit
1
Standstill is an agreement between CEN National Members not to take any action, either during the preparation of a
European Standard or after its approval, which could endanger the progress of work at European level. More
specifically CEN National Members are not to publish a new and/or to revise a national standard on the same subject
which is not completely in line with the EN.
CEN Workshop agreements
A CEN Workshop agreement (CWA) is a document developed in a CEN Workshop and not in a
Technical or Project Committee. CEN Workshops are open to direct participation of any
interested party; participation is not based on national delegations as in the case of Technical and
Project Committees (see below). Workshop participants can also come from outside Europe.
The CWA was first introduced in CEN to meet the needs of the fast-evolving information and
communications technology sector for rapid elaboration of consensus documents at European
level, but it is now available to all of the CEN sectors.
CEN Workshop agreements are approved by the CEN workshop participants. CWAs do not have
the status of a European Standard and as a consequence CEN national members do not have to
adopt them as national standards and conflicting national standards or specifications may
continue to exist.
Further information:
™ Types of documents developed by CEN (http://www.cen.eu/CEN/PRODUCTS)
4
How standards are produced
Who writes a standard?
Standards are not drafted by Standards Bodies but by experts in the specific field covered by the
standard. It is the role of the Standards Bodies to facilitate this process. The drafting of standards
is undertaken in CEN Technical Committees (TC) or Project Committees (PC). Experts
participate in the TC/PC via the National Standardization Body in their country and could come
from trade associations (industry), professional institutions, government, consumer bodies,
academia, education bodies, customers, certification bodies, etc.
CEN Members send a delegation (normally not exceeding 3 people) to represent the common
national position with the aim of reaching a consensus on a standard at European level. CEN
Members ensure that the delegation convey a national point of view that takes account of all
interests affected by the work.
The Secretariat of a TC/PC is assigned to a CEN member. The Secretary provides management
support associated with the running of the TC and, in particular, he/she arranges meetings,
ensures that documents for the meetings (e.g. calling notices, agendas, etc.) are distributed on
time, records the main decisions of the committee and prepares and distributes reports of the
meetings.
The Chair of a TC/PC provides overall leadership and conducts meetings in an impartial manner,
guiding the meeting in order to reach balanced and prompt decisions while ensuring that all
points of view are heard and considered.
A TC can create working groups to carry out a specific task, for example, to provide the TC with a
draft standard.
CEN Associates can participate in a TC/PC as observers, who can give their views and
comments on documents but they do not have voting rights. European associations have the
possibility to ask for liaison with a specific TC/PC and, once granted, participate as observers.
Moreover, there are possibilities for representatives of bodies or companies from countries
outside the CEN membership to participate in the CEN work under well-defined conditions.
5
Participation in European Technical and Project Committees
The first task of a newly created TC is to adopt a Business Plan. The main objective of the
Business Plan is to provide a concise and up-to-date overview for interested stakeholders of
important business, technological, environmental and social trends in the field addressed by the
work of the CEN committee. In addition, the Business Plan also establishes the priorities and
work plan of the Technical Committee.
PCs do not normally need to elaborate a full Business Plan but they shall establish and agree on
a work programme, which will need to be formally approved by the CEN Technical Board.
Further information:
™ Responsibilities and functioning of a Technical Committee (www.cen.eu/go/tcs)
™ Responsibilities and functioning of a Project Committee (www.cen.eu/go/projectcommittee)
™ Liaison with a Technical or Project Committee (www.cen.eu/go/tclo)
™ Technical Committee Business Plan (www.cen.eu/go/tcbp)
™ Participation of experts from countries outside of the CEN membership
(www.cen.eu/go/participation)
Contact:
European organisations interested
federations@cencenelec.eu.
in
having
a
liaison
with
a
TC/PC
can
contact
6
What are the different steps in the development of a standard?
Once a proposal for new work has been accepted, it is allocated to a Technical or Project
Committee (TC/PC). If no existing TC/PC is competent on the subject, a new one is created.
CEN documents are developed according to strict rules to ensure that they reflect the values of
openness, transparency and consensus. The specific steps will vary slightly depending on
whether the document to be developed is to become a European Standard or a Technical
Specification/Technical Report.
European Standard (EN)
The TC/PC will elaborate a draft standard. To allow rapid progress in drafting, a smaller group of
experts (working group) shall be created in the case of a TC.
Once the draft is ready, a public consultation (enquiry) will take place. This is a key stage in the
process of ensuring transparency and acceptability of the standard.
The comments received during the public consultation will then be examined by the TC/PC and
the draft will be amended in line with the decisions made by the TC/PC. A report of this process
will be drafted and will include justification for comments not accepted. The final draft, once
modified, is submitted to a formal vote. This is a weighted vote of all national standardization
bodies that are member of CEN. 1
Development of a European Standard (EN)
NATIONAL
IMPLEMENTATION
Technical Specification (TS) and Technical Report (TR)
The TC/PC will develop a draft technical specification or technical report. To allow rapid progress
in drafting, a smaller group of experts (working group) shall be created in the case of a TC.
Once the draft is ready the TC/PC will approve the TS or TR, by weighted vote in the case of TS,
or by simple majority vote of the CEN national members in the case of a TR. The draft can be
1
If it is reasonable to suppose that a document is acceptable at European level then it can be submitted to the Unique
Acceptance Procedure (UAP) which combines the CEN enquiry and the formal vote.
7
voted on in a meeting - in this case all relevant documents have to be circulated at least three
months in advance - or by correspondence.
Development of a Technical Specification (TS) or a Technical Report (TR)
Further information:
™ Enquiry process ( www.cen.eu/go/enquiry)
™ Formal vote of a European Standard (EN) (www.cen.eu/go/formalvote )
™ Weights allocated to CEN members in the case of weighted vote
(www.cen.eu/go/WeightedVote)
™ Development of Technical Specifications (www.cen.eu/go/specs)
™ Development of Technical reports (www.cen.eu/go/tech_reports)
How long does it take to develop a standard?
In order to develop standards within acceptable timeframes according to market needs and, at
the same time, to guarantee sufficient time for consultation and consensus building, European
Standards (ENs) are developed in a maximum timeframe of 3 years. In the case of Technical
Specifications (TSs) and Technical Reports (TRs), the maximum timeframe is 21,5 months. This
time starts to run once the Technical or Project Committee or the Technical Board has taken the
decision of registering the new work item.
The graphics below show in detail the time allocated for every step in the development of ENs,
TSs and TRs.
8
Timeframe for the development of European Standards (EN)
9
Timeframe for the development of Technical Specifications/Technical Reports
(TS/TR)
What to do if it is not possible to stick to the established timeframe?
Registered work items that fail to comply with the established timescale are automatically deleted
from the CEN work programme. To avoid this, in the case of registered work items, the TC/PC
has the possibility to request a 9-month extension of the timeframe, called a 'tolerance'.
In some specific cases, for example when there are no available reference documents and the
drafting work will have to start from scratch, there is a need for research before starting to draft
the standard or resources are limited within the TC, there is the possibility to register a
preliminary work item. In the case of preliminary work items, the TC/PC can start the initial
development of a draft without the three-year timeframe having started. Once the draft is ready or
the TC/PC is sure that it will be able to finish the draft within the established timeframe, it
transfers the work item to its active work programme. The three-year timeframe will start to run
from the moment at which the preliminary work item has been transferred into the active work
programme of the TC/PC.
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Does CEN co-operate with other standards organisations?
European level
CEN is committed to ensuring a coherent set of European standards and specifications. To this
effect, cooperation between the European Standardization Organisations (ESOs) is essential.
CEN has a cooperation agreement with the other two recognized ESOs: CENELEC, which
develops standards in the electro-technical field, and ETSI, which develops standards in the field
of telecommunications.
The aim of this agreement is to co-ordinate the work of the three organisations. The agreement
foresees that technical bodies (Technical or Project Committees or working groups) of any of the
organisations may set up a liaison with another technical body. The technical body in liaison
would be able to participate in the meetings of the TC/PC and receive documents but without
voting right.
In addition, there is also a possibility to establish joint working groups or TCs when there are
cross-cutting issues affecting the areas of two or the three organisations. For example, in the
area of Energy management there are several joint CEN and CENELEC technical bodies.
International level
CEN aims at adopting and developing European standards that are consistent with international
standards and globally relevant. Within this context, CEN has concluded a cooperation
agreement with its counterpart at international level, the International Organization for
Standardization (ISO). This agreement is known as the Vienna Agreement. Its aim is to
coordinate the standardization work between the European and international level and to
optimise the use of available resources and expertise for the benefit of stakeholders in both
organisations.
The agreement foresees several types of cooperation between ISO and CEN. Cooperation can
take place by exchanging correspondence between ISO and CEN Technical or Project
Committees, by representation at meetings or by adopting the same text as both ISO and
European Standard. In relation to the adoption of the same text as an ISO and European
Standard, there are various possibilities:
™ Adoption by CEN of an available ISO standard
™ Adoption by ISO of an available European Standard
™ Elaboration of a common standard under the lead of one organisation and with a parallel
ISO/CEN approval procedure.
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Elaboration of standards in parallel under the Vienna Agreement
Further information:
™ Vienna agreement, guidelines on its application and frequently asked questions on this topic
(www.cen.eu/go/va)
12
Drafting standards
How are standards written?
It is the purpose of a European Standard to set out clear and unambiguous provisions which
facilitate trade and communication. To this end, a European Standard needs to be as detailed
as necessary within the limits of its scope, take full account of current technology and science,
be prepared with user and consumer acceptance in mind and be comprehensible to qualified
users who have not been directly involved in its drafting.
Many sources may be used for the drafting of a standard, including national standards,
research papers, etc. In the case of sources protected by copyright, if a person brings a
significant contribution for inclusion in a standard for which the copyright belongs to someone
else, he must declare that fact so that CEN can obtain permission to use it.
In addition, the drafting of standards entails the consideration of well established rules which
are all defined in Part 3 of the CEN/CENELEC Internal Regulations. These rules relate to
many aspects such as the clause structuring, the terminology to be used, figures and their
related keys, etc. Whilst these rules appear to be restrictive, in practice, they impart clarity and
precision that is unlikely to be achieved in any other way. For example, it is highly beneficial to
differentiate requirements (those things that have to be done to ensure compliance with the
standard) from material that is provided by way of guidance and support. In this respect, there
are a series of verbal forms that have to be used when drafting a standard:
™ SHALL is used to express a requirement of a standard. If compliance with the standard is
claimed, compliance with all the expressions with shall is required.
Example:
“The transit time of a postal item shall be measured in units of days and expressed as
(J + n) days.”
“All assignments shall be documented.”
™ SHOULD is used to express recommendations
Example:
“Care should be taken after preparation to prevent the contamination. If contamination
occurs […]”
™ MAY in a standard indicates that the standard is giving permission
Example:
“One connection may have many channels.”
™ CAN describes a possibility
Example:
“This product can be subjected to external climatic conditions.”
Further information:
™ Part three of the CEN/CENELEC Internal Regulations (www.cen.eu/go/IR3)
™ Copyright (www.cen.eu/go/Copyright )
13
What is the typical structure of a standard?
As a minimum, a standard shall include the following elements:
™ A title;
™ A foreword;
™ The scope defining the subject, and the area to which the standard applies, areas
excluded, kind of document (specification, test method, guidelines…);
™ The main provisions of the standard (the recommendations, measurement method,
requirements…).
In addition to these sections a standard can also, if necessary, include:
™ An introduction, explaining, for example, what the reason for developing a standard is
and why it is helpful;
™ Normative references, which are references to other documents (mainly European, ISO,
IEC or other standards) which are indispensable for the application of the standard. The
number of normative references shall be limited to the minimum needed and the
referenced documents shall be available when the standard is published.
™ Terms and definitions giving definitions necessary for the understanding of the terms that
are used in the standard.
™ Annexes, which can be:
• Normative, which are an integral part of the standard
• Informative, which contain additional information/examples to better understand the
standard, but are not indispensable for the application of the standard.
The normative or informative character of an annex shall be specified.
™ Bibliography
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Example: Structure of EN 15038 ‘Translation services – Service requirements’
How can environmental and other aspects be integrated into
standards?
Products and services may affect the environment. By considering environmental aspects in
European Standards, standardization can make a positive contribution to sustainable
development.
In 1999, CEN created the Environmental helpdesk (EHD) as a service to assist CEN Technical
Committees to address environmental issues in order to integrate these aspects in European
Standards.
15
The EHD has made available an environmental framework, which is a toolbox for standard
writers and includes information, training, examples and guidance on how to consider
environmental aspects in European Standards.
CEN has also produced a series of guides to help standards writers take into account a series
of aspects such as the environment, safety or the needs of persons with disabilities when
drafting standards.
Further information:
™ Web site of the Environmental Helpdesk (www.cen.eu/CEN/services/ehd)
™ CEN Guide 4: Guide for addressing environmental issues in product standards
(www.cen.eu/go/guide4 )
™ CEN/CENELEC Guide 6: Guidelines for standards developers to address the needs of
older persons and persons with disabilities (www.cen.eu/go/guide6 )
™ CEN/CENELEC Guide 14: Child safety guidance for its inclusion in standards
(www.cen.eu/go/guide14 )
™ CEN/CENELEC Guide 11: Product information relevant to consumers - Guidelines for
standard developers (www.cen.eu/go/guide11)
16