WORLD TRADE
ORGANIZATIONG/TBT/W/217
30 June 2003
(03-3454)
Committee on Technical Barriers to Trade Original:  English
CONFORMITY ASSESSMENT:
A FRAMEWORK TO IMPROVE THE APPLICATION OF THE TBT AGREEMENT
Submission by the European Communities
I. INTRODUCTION
1. Conformity assessment plays a vital role in ensuring the fulfilment of public policy
objectives, such as protection of health and the environment.  It also provides confidence for users
that requirements applicable to products and systems have been met.  Such confidence, in turn,
directly contributes to the market acceptance of those products and systems.  However, conformityassessment can also act as a substantial burden on exporters and importers, especially for developing
countries, and particularly when a variety of procedures are applied in domestic and foreign markets
for similar products.
2. The TBT Agreement provides for rules for the preparation, adoption and application of
conformity assessment procedures by central and local government bodies, as well as by non-governmental bodies with a view to avoiding unnecessary obstacles to international trade.  It also
encourages Members to participate in international or regional systems of conformity assessment.
3. The TBT Agreement promotes the recognition of conformity assessment results conducted
outside the importing country as a way of reducing barriers to trade.  It emphasises that confidence in
the continued reliability of conformity assessment results is a prerequisite for such recognition.  The
Agreement says that verifiable compliance with re levant international guides or recommendations for
the operation of accreditation, testing, inspection and certification bodies is considered as anindication of adequate technical competence.
4. In the 2
nd Triennial Review, the TBT Committee noted the existence of different approaches
to facilitate acceptance of results of conformity assessment.  An indicative list of the different
approaches was elaborated.  The list contained the following approaches: mutual recognition
agreements for conformity assessment to specific regulations;  co-operative (voluntary) arrangements
between domestic and foreign conformity assessment bodies; the use of accreditation to qualify
conformity assessment bodies; government designation; unilateral recognition of results of foreign
conformity assessment; and manufacturer’s/supplier’s declarations.
5. In the 3rd Triennial Review, the EC would like to propose that the Third Triennial Review
examines conformity assessment issues in detail, with consideration being given to the development
of some form of guidance, if sufficient progress is made.  The EC welcomes the approach proposed
by Canada in G/TBT/W/196.  This paper usefully proposes that priority be given to three related
areas.  In the EC’s view these areas could be addressed as follows:
(a) To encourage greater adoption (and use) of international standards and guides by 
users of conformity assessment (e.g. manufacturers);
(b) To strengthen the global conformity assessment system;G/TBT/W/217
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(c) To ensure that the most appropriate level and type of conformity assessment is taken.
6. The EC believes that this framework can be used as a mechanism to help address relevant
conformity assessment issues.
7. In this contribution the EC addresses issues related to each of these points in turn.
II. INTERNATIONAL STANDARDS AND GUIDES
8. The EC has been a strong advocate for the application of ISO/IEC Guides and standards in
the domain of conformity assessment for many years now (for example, please refer to G/TBT/W/43
and 70).  Our views have not changed.  The IS O CASCO Standardisation Framework contains a
wealth of information related to the operation of accreditation, testing, inspection and certification
bodies, which if correctly applied, would promote a consistent application of the TBT Agreement, and
would facilitate mutual confidence between Members.
9. Since considerable changes have occurred in recent years in the development of the related
standards and guides, the EC proposes that ISO/IEC be invited to bring the Committee up to date on
issues such as concepts, terms and definitions for conformity assessment used by the ISO/IEC system.
This would allow Members to note possible differences with the TBT Agreement and facilitate a more
informed discussion to take place within the Committee.
III. GLOBAL CONFORMITY ASSESSMENT ISSUES
10. The further elaboration of ideas on this issue builds on the work already undertaken in the
second triennial review.  As a mechanism to deepen discussions on this issue, the Community
welcomes the submission by Japan (G/TBT/W/194), which proposes a policy framework for theacceptance of results of conformity assessment procedures.  We believe that this provides a good
basis for the development of new ideas.
11. As part of this discussion, we would like to focus in particular on the aspect of accreditation.
Where 3
rd party certification is used, the TBT Agreement (Article 6.1.1) highlights the use of
accreditation as a possible tool for Members to verify the technical competence of conformityassessment bodies in exporting countries.  In the ISO/IEC Guide 2 accreditation is defined as a
“procedure by which an authoritative body gives formal recognition that a body or person is
competent to carry out specific tasks”.  The EC considers that accreditation, when operated to
recognized international standards, offers a va luable mechanism to help promote the acceptance of
conformity assessment activities, thus potentially acting as a useful trade facilitation tool.  Regional
schemes for co-operation in the accreditation field may also offer significant benefits, in particular for
developing countries.  Furthermore, arrangements between national and regional accreditation bodiesand international accreditation bodies have raised the potential for accreditation to be used to this end.
International and regional accreditation schemes recognizing the voluntary accreditation programs of
their members as equivalent can help to reduce duplicative conformity assessment work and cost and
to enhance confidence between participating member s.  At international level, the work of the
International Laboratory Accreditation Co-opera tion (ILAC) and the International Accreditation
Forum (IAF) is particularly relevant.
12. In practice, accreditation implies that conformity assessment bodies (testing and calibration
laboratories, certification and inspection bodies) are re-assessed and re-audited at regular intervals by
an independent accreditation body to ensure that they meet the technical requirements defined in
international standards.  Accreditation ensures that conformity assessment bodies meet transparentand objective criteria of competence and impartiality.  This facilitates the acceptance of test reports
and certificates issued by accredited conformity assessment bodies.  In turn, this should reduceG/TBT/W/217
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barriers to trade due to duplicate testing and certification requirements.  It may be of particular benefit
to developing countries.
IV. LEVEL AND TYPE OF CONFORMITY ASSESSMENT
13. The EC considers that Members should always take into consideration the nature and level of
risks involved, as well as the specific characteristics of the sector before fixing the conformity
assessment procedure.  The goal should be to make the level of conformity assessment procedure
commensurate with the level of risk involved.  Also, for many product categories it is feasible, and
desirable, to allow alternative procedures, which will then allow the manufacturer to choose which
procedure, from the allowed alternatives, to use to demonstrate compliance with requirements of the
particular technical regulation.  Within the EC we have had considerable experience in applying these
goals.
14. We have also had a considerable experience in two fields that may be of interest to Members,
namely supplier’s declaration of conformity and the use of quality assurance techniques as possible
options for the assessment of conformity.
15. EC experience is that supplier's declaration of conformity can facilitate market access without
prejudice to the fulfilment of legitimate public policy objectives, when it is combined with effective
product liability laws, well developed market surveillance systems and penalties for false or
misleading declarations.  The EC proposes that Members continue to exchange experience with
regard to the use of supplier's declaration of conformity.  The EC have tabled a separate paper dealing
with this aspect.
16. Concerning the use of quality assurance techniques, the EC New Approach system allows the
use of production quality assurance, in accordance with ISO 9002, also product quality assurance in
accordance with ISO 9003 and full quality assurance in accordance with ISO 9001.  The use of the
quality assurance techniques as conformity assessment procedures has proved to be successful in the
EC.
V. FUTURE WORK
17. The EC considers that there is considerable opportunity to improve the application of the
TBT Agreement in the domain of conformity assessment.
18. The work towards the comparison of practices in the development of conformity assessment
procedures schemes in WTO Members could start with a discussion on the general principles for the
application of conformity assessment procedures with the possible goal of the development of
guidance and good practice on conformity assessment.  The application of these principles will
facilitate the use of mechanisms for the acceptance of results of conformity assessment.
19. In order to ensure that developing countries can benefit from the possibilities of a well
established conformity assessment system, WTO Members should further consider assistance to help
developing countries to develop their own conform ity assessment system and/or to comply with the
conformity assessment requirements in export countries.
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