WORLD TRADE
G/TBT/GEN/78
15 December 2008
ORGANIZATION
(08-6126)
Committee on Technical Barriers to Trade
Original: English
UPDATE ON ISO AND CONFORMITY ASSESSMENT
The following information was provided by ISO at the TBT Committee meeting of
5-6 November 2008.
_______________
I.
INTRODUCTION
1.
ISO, in cooperation with IEC, is the recognized provider of consensus based International
Standards and Guides relating to conformity assessment. As a strategic orientation ISO does not get
involved directly in assessing compliance to its standards and is neutral towards first, second and third
party intervention.
2.
CASCO is ISO’s Policy Development Committee on conformity assessment under which
these documents are developed. CASCO's current membership consists in 107 ISO members,
including 76 Participating (P) members and 31 Observer (O) members. In addition to IEC, CASCO
maintains category A liaison with 15 other international organizations (see list at Annex 1).
3.
II.
At its Plenary Meeting in October 2008, CASCO addressed the following issues:
(a)
Revision of ISO/IEC 17020, General criteria for the operation of various types of
bodies performing inspection;
(b)
Revision of ISO/IEC 17024, General requirements for bodies operating certification
of person;
(c)
A resolution on market surveillance requesting ISO/CASCO to investigate future
activities for ISO/CASCO in the area of market surveillance in relation to the
CASCO standards and guides;
(d)
A joint ISO-IAF action plan on monitoring and improving the effectiveness of
accredited management system certification;
(e)
Updating of the CASCO Road Map which sets out the sequencing of future
systematic reviews and revisions of the CASCO documents for the next decade.
MARKET SURVEILLANCE
4.
CASCO held a market surveillance workshop in October 2008 to assist CASCO with
identification of future possible activities related to market surveillance. The workshop had three
sessions addressing regulators/ governmental bodies, conformity assessment activities and lastly
consumers and industry. The aims of the workshop were to:
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5.
III.
(a)
Identify good market surveillance practices at the national level;
(b)
Raise awareness and capacity to use the CASCO toolbox in market surveillance
activities;
(c)
To investigate market surveillance activities related to the oversight processes for
conformity assessment activities;
(d)
To identify actions when a product does not comply.
CASCO, following the workshop, will now develop an action plan to address:
(a)
How to facilitate rapid sharing of information on market surveillance;
(b)
Possible future ISO publications on good market surveillance practice;
(c)
Market surveillance in the area of services;
(d)
Promotion of existing ISO/IEC standards for conformity assessment.
ONGOING TECHNICAL WORK
6.
Other CASCO development projects are being progressed by their respective working groups.
These projects include the development of the following documents:
IV.
(a)
ISO/IEC 17021 Part 2 Conformity assessment – Requirements for third-party
certification auditing of management systems;
(b)
ISO/IEC 17007 Conformity Assessment – Guidelines for drafting normative
documents suitable for use for conformity assessment;
(c)
ISO/IEC 17043 General Requirements for proficiency testing;
(d)
ISO/IEC 17065 Conformity assessment – requirements for bodies providing
certification of product (including services) and processes.
PROMOTION OF THE CASCO 'TOOL BOX' AND WORKSHOPS
7.
Over the course of 2007-2008, the Chair and Secretary of CASCO have participated in
numerous events to promote the CASCO toolbox and highlight the importance of implementing
recognised conformity assessment practices. This is essential to address technical barriers to trade,
reduce the cost of conformity assessment procedures and ensure greater confidence in the trade of
goods and services.
8.
ISO/CASCO chaired a session at the annual Global Harmonization Task Force (GHTF –
Medical Devices) meeting held in Washington (USA) in October 2007.
9.
In 2007, two ISO regional workshops on conformity assessment for sustainable development
and trade were organized; the first in South Africa in May and the second in Tunisia in November. On
12-13 June 2008 a similar ISO workshop was held in Kiev (Ukraine).
10.
ISO has compiled a collection of three CD's (for sale) that contain all relevant standards and
guides for conformity assessment. The CD's are:
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(a)
International Standards and Guides relevant to an Accreditation Body
(b)
International Standards and Guides relevant to a Laboratory and/or Inspection Body
(c)
International Standards and Guides relevant to Certification and/or Inspection Body
(published in 2007)
11.
The 2008 March edition of the ISO magazine ISO Focus, focused on conformity assessment,
gives an update on developments within CASCO and the implementation of ISO standards in this
area.
12.
ISO jointly with UNIDO have recently issued a promotional document Fast Forward which
takes an entry level perspective aimed at interested parties who are tasked with the establishment,
upgrading and management of a National Standards Body in a developing country. It is intended to
issue in 2009 a complementary stand-alone publication specifically on good conformity assessment
practices.
13.
An updated list of CASCO guides and standards, published and under way, is contained in
Annex 2.
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ANNEX 1
LIST OF ORGANIZATIONS IN LIAISON WITH CASCO
BIPM:
CEOC:
CAC:
EOQ:
Eurolab:
IAF:
IFAN:
IFIA:
IIOC:
ILAC:
IPC:
QNet:
ITU-T:
OIML:
UILI:
Bureau International des Poids et Mesures
International Confederation of Inspection and Certification Organisations
Codex Alimentarius Commission
European Organisation for Quality
The European Federation of National Associations of Measurement, Testing
International Accreditation Forum
International Federation of Standards Users
International Federation of Inspection Agencies
Independent International Organisation for Certification
International Laboratory Accreditation Cooperation
International Personnel Certification Association
International Certification Network
International Telecommunication Union, Standardization Bureau
International Organization for Legal Metrology
International Union of Independent Laboratories
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ANNEX 2
LIST OF PUBLISHED CASCO GUIDES AND STANDARDS BY FIELD OF APPLICATION
(UPDATED AT 1 NOVEMBER 2008)
Vocabulary,
principles and
common elements of
conformity
assessment
ISO/IEC 17000: 2004 ISO
PAS 17001: 2005 ISO PAS
17002: 2004 ISO PAS
17003: 2004 ISO PAS
17004: 2005 ISO PAS
17005: 2008
Conformity assessment - Vocabulary and
general principles Conformity assessment Impartiality - Principles and requirements
Conformity assessment - Confidentiality Principles and requirements Conformity
assessment - Complaints and appeals Principles and requirements Conformity
assessment - Disclosure of information Principles and requirements Conformity
assessment - Use of management systems Principles and requirements
Product certification
ISO/IEC Guide 23: 1982
Reconfirmed in 2003
ISO/IEC Guide 28: 2004
ISO/IEC Guide 53: 2005
ISO/IEC Guide 65: 1996
ISO/IEC Guide 67: 2004
Code of good
practice for
conformity
assessment
Mutual Recognition
Arrangements
(MRAs)
Accreditation
ISO/IEC Guide 60: 2004
Methods of indicating conformity with
standards for third-party certification
systems Conformity assessment - Guidance
on a third-party certification system for
products Conformity assessment Guidance on the use of an organization's
quality management system in product
certification General requirements for
bodies operating product certification
systems Conformity assessment Fundamentals of product certification
Conformity assessment - Code of good
practice
Inspection
ISO/IEC 17020: 1998
Reconfirmed in 2002
ISO/IEC 17021:2006
System certification
Certification of
persons
ISO/IEC Guide 68: 2002
ISO/IEC 17011: 2004
ISO/IEC 17024: 2003
Arrangements for the recognition and
acceptance of conformity assessment
results
Conformity assessment - General
requirements for accreditation bodies
accrediting conformity assessment bodies
General criteria for the operation of various
types of bodies performing inspection
Conformity assessment - General
requirements for bodies providing audit and
certification of management systems
Conformity assessment - General
requirements for bodies operating
certification of persons
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Testing/calibration
ISO/IEC 17025: 2005
ISO/IEC Guide 43-1: 1997
ISO/IEC Guide 43-2: 1997
Marks of conformity
ISO Guide 27: 1983
Reconfirmed in 2003
ISO/IEC 17030: 2003
Peer assessment
ISO/IEC 17040: 2005
Supplier's
Declaration of
Conformity (SDoC)
ISO/IEC 17050-1: 2004
ISO/IEC 17050-2: 2004
General requirements for the competence of
testing and calibration laboratories
Proficiency testing by inter-laboratory
comparisons – Part 1: Development and
operation of proficiency testing schemes
Proficiency testing by inter-laboratory
comparisons – Part 2: Selection and use of
proficiency testing schemes by laboratory
accreditation bodies
Guidelines for corrective action to be taken
by a certification body in the event of
misuse of its mark of conformity
Conformity assessment - General
requirements for third-party marks of
conformity
Conformity assessment - General
requirements for peer assessment of
conformity assessment bodies and
accreditation bodies
Conformity assessment - Supplier's
declaration of conformity - Part 1: General
requirements
Conformity assessment - Supplier's
declaration of conformity - Part 2:
Supporting documentation
LIST OF CASCO PROJECTS UNDER WAY (UPDATED AT 1 NOVEMBER 2008)
Writing
specifications for use
in conformity
assessment
Inspection
ISO/IEC 17007 [CASCO WG 27]
Revision of ISO/IEC Guide 7:1994
DIS launched on 2008-06-20.
Auditing competence
ISO/IEC 17021 Part 2 [CASCO WG
21] CD closed on 2008-07-12. CD2
planned end November.
Certification of
persons
ISO/IEC 17024 [CASCO WG 30]
Revision of ISO/IEC 17024:2003 1st
WG meeting planned in Q1 2009
ISO/IEC 17020 [CASCO WG 31]
Revision of ISO/IEC 17020:1998 1st
WG meeting planned in Q1 2009.
Conformity assessment –
Guidelines for drafting normative
documents suitable for use for
conformity assessment
Conformity assessment –
Requirements for the operation
of bodies performing inspection
Conformity assessment –
Requirements for third party
certification auditing of
management systems
Conformity assessment –
General requirements for bodies
operating certifications of
persons
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Proficiency testing
ISO/IEC 17043 [CASCO WG 28]
Revision of ISO/IEC Guide 43:1997
CD closed on 2008-06-14. DIS
planned mid-November.
Conformity assessment –
General requirements for
proficiency testing
Product certification
ISO/IEC 17065 [CASCO WG 29]
Revision of ISO/IEC Guide 65:1996
Working Draft in progress.
Conformity assessment –
Requirements for certification
bodies certifying products
(including services) and
processes
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