99-1241WTO COMMITTEE ON TECHNICAL BARRIERS TO TRADE
DRAFT PROGRAMME OF INFORMATION SESSION ON CONFORMITY ASSESSMENT
At its Informal Meeting on 22 January 1999, the Committee agreed to organize an
Information Session on Conformity Assessment in June 1999.  The Secretariat was requested to
prepare a draft programme of this Session for the consideration of the Committee at its next meeting
to be held on 30-31 March 1999.  This draft has been prepared in response to the request, taking intoaccount the discussions held at the last Informal Meeting and suggestions made by interested
delegations.99-1241RESTRICTEDWORLD TRADE
ORGANIZATIONG/TBT/SPEC/12
29 March 1999
(99-1241)
Committee on Technical Barriers to Trade
DRAFT
INFORMATION SESSION ON CONFORMITY ASSESSMENT PROCEDURES
8-9 JUNE 1999
BACKGROUND
1.  At the First Triennial Review held November 1997, the Committee on Technical Barriers to
Trade reviewed the implementation and operation of the TBT Agreement, including Articles 5-9concerning conformity assessment procedures (G/TBT/5).  The Committee reiterated the importance
of the implementation of these provisions to avoid unnecessary obstacles to international trade.
2. The Committee noted, among other things:  (i ) the growing concern with respect to the
restrictive effect on trade of multiple testing and conformity assessment procedures;  (ii) that therecognition of results of conformity assessment could be achieved through different procedures and
approaches that might have different trade impacts;  (iii) the emerging interest in concluding mutual
recognition agreements (MRAs), and the possible difficulties and problems associated with MRAs;
and (iv) that relevant ISO/IEC Guides are useful in contributing to improved efficiency and to
facilitating the conduct of international trade, and that difficulties are still faced by certain countries
concerning the practical implementation of a number of Guides.
3. In order to further the objectives of the Agr eement and with a view to making recommendations
to remove any unnecessary duplication of conformity assessment, the Committee agreed, among other
things to:
(i) Pursue further discussions  on ISO/IEC Guides.  Members are invited, on a voluntary
basis, to continue providing information on their experience in using relevant
international guides and recommendations on conformity assessment, and the extent to
which these guides and recommendations have served as a basis for the recognition of
conformity assessment procedures adopted by bodies in their territories and in regional
and international conformity assessment systems, or as a harmonized approach toconformity assessment.  In the light of this exercise, the Committee will consider ways
and means for better implementation of Articles 5 and 6;
(ii) Invite Members, on a voluntary basis, to  exchange information on their experience in
the various types of conformity assessment procedures and their conditions ofapplication.  In the light of this exercise, the Committee will consider making
recommendations aimed at ensuring that pr ocedures for the assessment of conformity
avoid the creation of unnecessary obstacles to international trade;
(iii) Review the role of regional and international systems for conformity assessment as
covered by Article 9 and how these systems could contribute to solving the problems of
multiple testing and certification/registration for traders and industries, including inG/TBT/SPEC/12
Page 2
particular small and medium size enterprises.  This exercise will also address the extent
to which international guides and recomme ndations contribute to the establishment of
these systems, and the possible technical a ssistance needed for developing countries to
develop operational conformity assessmen t procedures within the context of
Articles 11.6, 11.7 and 12.5;  and
(iv) Review the operation of Articles 6, 10.7 a nd other relevant prov isions which contain
disciplines with respect to recognition of  the results of conformity assessment
procedures.  In this regard, Members are invited, on a voluntary basis, to exchange
information.  The review will also address the possible difficulties and problems
associated with MRAs.  In the light of th is exercise, the Committee may consider the
usefulness of drafting guidelines, inter alia for MRAs.
4. Since the First Triennial Review, relevant papers have been prepared concerning this subject-
matter (G/TBT/63, 70, 72, 79, 81, 85 and 99).
OBJECTIVES AND COVERAGE OF THE INFORMATION SESSION
5. With a view to carrying out the above-mentioned elements of the Work Programme of the
First Triennial Review, as well as items G (Technical Assistance) and H (Special and Differential
Treatment) as they relate to conformity assessment procedures, the Committee agreed to hold an
Information Session to develop an improved understanding of the issues.  This would provide anopportunity to exchange experiences on the parties involved (i.e., business, testing laboratory,
inspection and certification/registration bodies, accreditation bodies and metrology bodies), and the
different approaches and requirements used for the assessment of conformity (i.e., for specific sectors,
standards and in the territories of individual Member s) in the regulatory and private spheres, at the
international, regional and national levels.
PLANNING OF THE MEETING
6. The Information Session will be divided into three parts, starting with an Introductory Session
to present the relevant provisions of the Agreement and examples of conformity assessment
procedures for business transactions in the market-place, followed by Panel Sessions based on the
four items agreed by the Committee for its Work Programme at the First Triennial Review (as listedabove), and finishing with brief reports from rapporteur of the Panels.
A. INTRODUCTORY SESSIONS
I. The TBT Agreement
The provisions to avoid unnecessary obstacles to international trade in cases where a positive
assurance of conformity with a technical regulation or standard is required.
(The Secretariat)
II. Examples of Procedures for Assessment of Conformity for Business Transactions in the
Market Place
(Speakers from business communities, reflecting the procedures for business transaction of
multi-international enterprises, SMEs and different sectors in different countries/regions)
Questions and Answers
B. PANELSG/TBT/SPEC/12
Page 3
There will be four different panels.1  In each panel, the main speakers will introduce the issues
and provide factual information to enrich the Committee's understanding on the issues.  This
will be followed by short remarks by panelists (i.e., stakeholders in the business community,
regulatory officials and conformity assessment bodies) leading to an exchange of views anddebate amongst the speakers, panelists and participants.  In order to focus the remarks that
will be made, well defined questions will be provided to the panelists in advance (Annex 1).
Each presentation will not last more than 10-15 minutes to allow for questions and answers
and panel discussions, whilst taking account of the elements described in document G/TBT/5
and the relevant provisions of the TBT Agreement.  The discussions will remain relevant to
the work of the TBT Committee and on how conformity assessment procedures can facilitate
and impede international trade.
SESSION I. Relevant International Guides and Recommendations on Conformity
Assessment
Moderator:
Rapporteur:Main Speakers:
- Presentation 1:
The preparation, adoption and application of relevant guides/standards or recommendations
prepared by international standardizing bodies
(Representative from ISO/CASCO)
- Presentation 2:
The harmonization of national or regional legal metrology relevant to conformity assessment
procedures
(Representative from OIML)
Panelists:
- Remarks 1:
The use of relevant guides or recommendations issued by international standardizing bodies –
experience of a practitioner
(Representative from an international laboratory accreditation system)
[ILAC]
                                                     
1 Moderators and rapporteur are relevant experts nominated serving on their own individual capacity.G/TBT/SPEC/12
Page 4
- Remarks 2:
The use of relevant guides or recommendations issued by international standardizing bodies –
experience of a practitioner
(Representative from an international accreditation system for certification bodies)
[IAF]
- Remarks 3:
The use of relevant guides or recommendations issued by international standardizing bodies –
experience of a practitioner
(Representative from a regional (certification/laboratory) accreditation system)
- Remarks 4:
The use of relevant guides or recommendations issued by international standardizing bodies –
experience of a practitioner
(Representatives from a testing laboratory)
- Remarks 5:
The use of relevant guides or recommendations issued by international standardizing bodies –
experience of a practitioner
(Representative from a certification body)
- Remarks 6:
The use of relevant guides or recommendations issued by international standardizing bodies –
experience of a practitioner
(Representative from an inspection body)
Questions and Answers
Panel Discussion
SESSION II. Various Types of Conformity Assessment Procedures and their Conditions of
Application
Moderator:Rapporteur:
Main Speakers:
- Presentation 1:G/TBT/SPEC/12
Page 5
Third party's evaluation of conformity and accreditation as a tool to demonstrate the technical
competence of conformity assessment bodies – a national experience on assessing product
conformity
(Representative from a Member)
- Presentation 2:
Third party's evaluation of conformity and accreditation as a tool for demonstrating the
technical competence of conformity assessment bodies/auditors – national experience
regarding quality system assessment
(Representative from a Member)
- Presentation 3:
Supplier's declaration of conformity – a national experience(Representative from a Member)
- Presentation 4:
Recognition of the Results of Foreign Conformity Assessments (Autonomous Recognition) –
a national experience
(Representative from a Member)
Panelists:
- Remarks 1:
The use of supplier's declaration of conformity – a sectorial experience(Representative from the business communities/regulatory authorities)
- Remarks 2:
Third party's evaluation of conformity and accreditation as a tool for demonstrating the
technical competence of conformity assessment bodies – a sectorial experience
(Representative from the business communities/regulatory authorities)
- Remarks 3:
Third party's evaluation of conformity and accreditation as a tool for demonstrating the
technical competence of conformity assessment bodies/auditors – an experience with quality
system assessment
(Representative from the business communities/certification bodies)
Questions and Answers
Panel DiscussionG/TBT/SPEC/12
Page 6
SESSION III. Approaches with Respect to Recognition of the Results of Conformity
Assessment Procedures
Moderator:
Rapporteur:
Main Speakers:
- Presentation 1:
The different kinds/levels of mutual recognition agreements(Representative from Members)
- Presentation 2:
Recognition of the Results of Foreign Conformity Assessments (Autonomous Recognition) –
a national practitioner's experience
(Representative from Members)
Panelists:
- Remarks 1:
Conclusion of mutual recognition agreements in the private sector – a practitioner's
perspective
(Representative from a national conformity assessment body)
- Remarks 2:
Negotiating and implementing mutual recognition agreements at the regulatory level between
governments – a national experience
(Representative from a Member)
- Remarks 3:
Recognizing the equivalence of qualifications of foreign conformity assessment bodies, a
precondition for the autonomous recognition of the results of foreign conformity assessment –
the experience of a national accreditation body
(Representative from a national body involved)
- Remarks 4:
Mutual recognition arrangement in specific sectors[Representative from OECD - Good Laborator y Practice/Good Manufacturing Practice/Good
Clinical Practice]
- Remarks 5:G/TBT/SPEC/12
Page 7
Mutual recognition agreement – prospective from industries
[Transatlantic Dialogue]
Questions and Answers
Panel Discussions
SESSION IV. Role of International and Regi onal Systems for Conformity Assessment
Moderator:
Rapporteur:Main Speakers:
- Presentation 1:
Existing international and regional systems for conformity assessment in the area of
metrology
(Representative from BIPM)
- Presentation 2:
Existing international and regional systems for conformity assessment in the area of testing
laboratory
(Representative from ILAC)
- Presentation 3:
Existing international and regional systems for conformity assessment in the area of
certification/registration bodies
(Representative from IAF)
- Presentation 4:
Existing international and regional systems for conformity assessment in the area of a specific
sector
[Representative from IEC on IECEE CB Scheme and IECQ, IEC Quality Assessment System
for Electronic Components]G/TBT/SPEC/12
Page 8
Panelists:
- Remarks 1:
The experience of a regional/national accreditation system in the area of metrology(Representative from a regional/national)
- Remarks 2:
The experience of a regional accreditation system of testing laboratory
(Representative from a regional body)
- Remarks 3:
The experience of a regional accreditation system of certification/registration bodies(Representative from a regional body)
- Remarks 4:
The experience of a regional accreditation system covering both testing laboratories and
certification bodies
(Representative from a regional body)
- Remarks 5:
The experience of an international accreditation system of a specific sector[Representative from Forest Stewardship Council (FSL) or International Seed Testing
Association (ISTA)]
Questions and Answers
Panel DiscussionC. BRIEF REPORTS FROM RAPPORTEUR
[The Reports from rapporteur will be presented to the Committee at its Informal Meeting to
be held the following day for its information and/or consideration.]G/TBT/SPEC/12
Page 9
ANNEX I
QUESTIONS FOR PANELISTS' REMARKS
SESSION I
Relevant International Guides and Reco mmendations on Conformity Assessment
1. Does the use of international guides and recommendations contribute to confidence in the
procedures conducted by bodies domestically (both in relation to marketplace requirements and
regulatory acceptance)?  How does the use of these internationally agreed guides contribute to theacceptance of data and ultimately recognition of product conformity to standards and technical
regulations in the marketplace or by regulatory officials?
2. To what extent are procedures of conformity assessment bodies based on international
guides/recommendations?  Do bodies develop some additional standards independently?  If
international guides/recommendations are not used, wh at criteria, procedures and/or practices are
applied?
3. What mechanisms or activities are in place to ensure the harmonized interpretation and
application of ISO/IEC Guides?  If there is none, what would be needed?
4. What is the current status of the ISO/CASCO project to convert certain international guides to
international standards?
5. Practitioner's experience on using ISO/IEC Guides and other relevant international
guides/recommendation on conformity assessment procedures:  What are the incentives to develop
and use these guides?  Are there any problems/advantages?  What are the difficulties or impediments
to their use?  Is it worth it?  How does the guides/recommendations relate to accreditation and
enabling test results/certifications to be accepted nationally and internationally.
6. What kinds of technical assistance are needed for the conformity assessment bodies in
developing countries using international standards/guides?
7. Can the existing international guides/recommendations on conformity assessment procedures
meet the global challenges/needs?  What is needed in the future?
SESSION II
Various Types of Conformity Assessment Proc edures and their Conditions of Application
1. What are the main different conformity assessment approaches in Members at the
national/regional level?  (e.g., the certification procedures, accreditation systems, government
involvement and to the extent supplier's declaration is permitted.)  Is there a lack of harmonized
approaches/procedures?  What is the cost/benefit associated with the various approaches?
2. What are the views of practitioners and business on single/multiple national accreditation
systems?  What is the advantage and disadvantage of having limited number of accreditation systems
or a variety of systems based on the professional speciality of accreditation field?  And how does it
affect trade?
3. To what extent do government regulatory authorities rely on non-governmental conformity
assessment bodies to carry out conformity assessments to demonstrate compliance with technicalG/TBT/SPEC/12
Page 10
regulations (i.e., certain governments may recognize specific conformity assessment bodies under
their national/regional accreditation systems)?  Do the systems permit the participation of conformity
assessment bodies located in the territories of other members on a non-discriminatory basis, as
foreseen in Article 6.4 of the Agreement?
4. How does the market create a demand for third party conformity assessment in the absence of
government-driven requirements?
5. How are governments involved in conformity assessment systems in the context of the
development of rules and implementation of such sy stems, and to ensure confidence of the results of
conformity assessment under such systems?  How do governments perceive peer to peer assessment
between competing certification bodies as a measure to demonstrate competence in relation to work
under legislation?
6. Are there tools to ensure the confidence in the accreditation systems of each Member and in
the MRAs reached among them under international and/or regional conformity assessment systems?
7. What are the conditions to use suppliers' self declaration?  e.g., in what areas/sectors?  Big
enterprises/SME?  What kind of protection for cons umers?  Liability laws?  Relevant ISO/IEC Guide?
Practitioner's experience?  Are there different approaches/modules to use supplies' declaration?  What
might be the problems/advantages of using suppliers' self declaration?  What are the difficulties toovercome?  Can it be the sole means for certification?  What is the relationship between third-party
assessment and suppliers' declaration of conformity?
8. How can developing countries Members build up their conformity assessment systems, what
is needed?  What kind of technical assistance?
9. What is the need for accreditation systems?  Are accreditation systems needed in small
economies?  What can testing results or certificates without accreditation bring in the global trading
system?  What is the way to assist bodies in deve loping countries in gaining recognition of their
procedures to demonstrate their exports conformity?
10. How can government ensure the implementation of Article 8 of the TBT Agreement by
conformity assessment procedures by non-governmental bodies.
SESSION III
Disciplines with Respect to Recognition of the Results of Conformity Assessment Procedures
1. What is the situation of existing MRAs negotiations, and what will be the future situation?
2. To what extent do MRAs between governments in the regulated area use international or
regional conformity assessment arrangements to meet the requirements for acceptance of test resultsand/or certification?
3. What are the differences between the government-to-government MRAs and "mras" between
voluntary conformity assessment bodies?  Do the voluntary agreements imply acceptance by
regulators?
4. What are the existing/common confidence building measures used in negotiating agency
level/private sectors MRAs?  To what extent is the technical competence (in addition to the quality
systems of the conformity assessment bodies involved) covered during assessment by accreditation
bodies, and during evaluation of accreditation bodies?G/TBT/SPEC/12
Page 11
5. What is the system required for each government to rely on the results of peer evaluation
under the MRAs among the accreditation bodies?
6. Will membership of national accreditation bodies in international or regional mutual
recognition arrangements ultimately replace the need for government-to-government MRAs for
acceptance of the results of conformity assessment?
7. Information on ISO/CASCO work in developing guidelines on MRAs.
8. What is the degree of interest in the introducti on of multilateral MRAs either at the regulatory
level or at the agency level?
9. What are the views of practitioners and business on MRAs?
10. Can MRAs meet global challenges?  What is needed in the future?
SESSION IV
Role of International and Regional Systems for Conformity Assessment
1. How to obtain the membership of a regional/international conformity assessment system?
2. Can all WTO Members become members of international conformity assessment systems?  If
so, how?  What is the fee involved?  Are the exiting systems too costly?
3. Membership criteria:  What are the procedures to ensure neutrality and independence of the
system?  What disciplines are these systems based on and how the confidence of the results of
conformity assessment under the systems are ensured? What are the decision-making procedures to
ensure balance of interest among various regions and stakeholders?
4. How is peer assessment of member bodies carried out?  Are there procedures to ensure
transparency of the implementation of rules?  Are there surveillance mechanisms in place?
5. How do international conformity assessment systems demonstrate that test results issued by
or certificates granted by accreditation bodies in different economies are technically equivalent?
6. What is the extent of cooperation and coordination, formal and informal between international
and regional conformity assessment systems, and among different regional/international systems?What are the mechanisms in place to facilitate coordination?  Do they have problems coordinating and
cooperating?  How can this be improved?
7. How do these systems cooperate with international standardizing bodies and other
international organizations and WTO Member governments?
8. How do these systems relate to the requirement of certifications on quality/environmental
management system (i .e., ISO 9000 and ISO 14000)?
9. To what extent does the portability of test results and (recognition testing agencies) between
different organizations facilitate trade?
10. Ask the speakers/panelists for their self evaluation on the extent their systems contribute to
overcome trade barriers quantitatively.  Can international conformity assessment systems/
arrangements meet global challenges?  What changes are needed for the system and what will be the
future development?G/TBT/SPEC/12
Page 12
11. What kind of technical assistance can be provided to developing countries in joining the
regional/international systems?  What kinds of assistance are needed for the conformity assessment
activities in LDC?  What are the problems?
12. Do the systems take into account the market needs/its members needs/LDCs needs?
13. Practitioner's experience with the systems:  Are there problems/advantages?  What are the
difficulties to overcome?  Is it worth it?
__________