8 - 9 June 1999
WTO Symposium on conformity assessment procedures
Index:
The World Trade Organization
Centre William Rappard
Rue de Lausanne 154
Geneva back to top
Background
1. At the First Triennial Review held in November 1997, the Committee on Technical Barriers to Trade reviewed the implementation and operation of the TBT Agreement, including Articles 5-9 concerning 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 recognition 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; (iv) that relevant ISO/IEC Guides are useful in contributing to improved efficiency and to facilitating the conduct of international trade; and (v) 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 Agreement 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 to provide information on their experience in using relevant international guides and recommendations on conformity assessment and to 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 to conformity 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 of application. In the light of this exercise, the Committee will consider making recommendations aimed at ensuring that the procedures for the assessment of conformity avoids 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, including how these systems could contribute to solving the problems of multiple testing and certification/registration for traders and industries, in particular for small and medium size enterprises. This exercise will also address the extent to which international guides and recommendations contribute to the establishment of these systems, and the possible technical assistance needed for developing countries to develop operational conformity assessment procedures within the context of Articles 11.6, 11.7 and 12.5; and
(iv) Review the operation of Articles 6, 10.7 and other relevant provisions which contain disciplines with respect to recognition of the results of conformity assessment procedures. In this regard, Members are also invited, on a voluntary basis, to exchange information. The review will address the possible difficulties and problems associated with MRAs. In the light of this 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/W/63, 70, 72, 79, 81, 85 and 99).
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Objectives and coverage of the symposium
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 organize a WTO Symposium on Conformity Assessment Procedures to develop an improved understanding of the issues. This would provide an opportunity 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 Members) in the regulatory and private spheres, at the international, regional and national levels. The discussions will remain relevant to the work of the TBT Committee and on how conformity assessment procedures can facilitate and impede international trade, but it is for the TBT Committee to decide if and how account will be taken of the discussions.
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Programme of the symposium
6. The Symposium 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 listed above), and finishing with a factual report by the Chairman. 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 and debate 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 (Annex 1), whilst taking account of the elements described in document G/TBT/5 and the relevant provisions of the TBT Agreement.
Tuesday, 8 June 1999
9:00 Welcome
Mr.
Jan-Eirik Sørensen
Director, Trade and Environment Division
A. Introduction
I. The TBT Agreement
Relevant provisions to avoid unnecessary obstacles to international trade in cases where a positive assurance of conformity with a technical regulation or standard is required
9:10 Ms. Doaa
Abdel Motal
The WTO Secretariat
II. Examples of Procedures for Assessment of Conformity for Business Transactions in the Market Place
9:30 Ms.
Kanya Sinsakul
Thai Industrial Standards Institute, Thailand
9:40 Mr.
Roger Kestemont
Schneider Electric SA, France
9:50 Mr. Shri
S. K. Sharma
Bureau of Indian Standards, India
10:00 Mr.
Toshiyuki Kajiya
Matsushita Electric Industrial Co. Ltd., Japan
10:10 Mr.
Roberto Paiva
Ministerio de Economia, Chile
10:20 Dr. L.
H. Ng
Hong Kong, China
10:30 Mr. Ali
Ali El-Neggar
Authority for Standardization and Quality Control, Egypt
10:40 Mr. Joe
Gryn
Canadian Standards Association
10:50 Question and Answer
B. PANELS
SESSION I. Relevant International Guides and Recommendations on Conformity Assessment
Moderator: Mr.
Mohan Kumar
Chairman, Committee on Technical Barriers to Trade
Rapporteur: Mr. Hideo Shindo, Japan
Main Speakers:
11:30 The
preparation, adoption and application of relevant guides, standards or recommendations
prepared by international standardizing bodies
Mr. John Donaldson
Committee on Conformity Assessment of the International Organization for Standardization
(ISO/CASCO)
11:45 The
harmonization of national or regional legal metrology relevant to conformity assessment
procedures
Mr. Attila Szilvássy
International Organization of Legal Metrology (OIML)
Panelists:
Remarks on the use of relevant guides or recommendations issued by international standardizing bodies - Experiences of practitioners
12:00
Perspective of an international laboratory accreditation system
Ms. Belinda Collins
International Laboratory Accreditation Cooperation (ILAC)
12:10
Perspective of an international certification body accreditation system
Mr. Takashi Ohtsubo
International Accreditation Forum (IAF)
12:20
Perspective of a regional accreditation system
Mr. Xiao Jianhua
The Pacific Accreditation Cooperation (PAC)
12:30
Perspective of a testing laboratory
Mr. David Stanger
Laboratory Liaison Committee (ILAC)
12:40
Perspective of a certification body
Mr. Kiyoto Mitsui
Japan Quality Assurance Organization
12:50
Perspective of an inspection body
Société Générale de Surveillance S.A. (SGS)
13:00 Lunch
14:15 Questions and Panel Discussion
SESSION II. Various Types of Conformity Assessment Procedures and their Conditions of Application
Moderator: Mr. José Antonio Buencamino, Philippines
Rapporteur: Mr. Martin Loken, Canada
Main Speakers:
15:00
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
Mr. David White
European Commission
15:15 Third
party's evaluation of conformity and accreditation as a tool for demonstrating the
technical competence of conformity assessment bodies/auditors - a national experience
regarding quality system assessment
Mr. Juichi Nagano
Ministry of International Trade and Industry, Japan
15:30
Supplier's declaration of conformity - a national experience
Ms. Suzanne Troje
United States
Panelists:
15:45 Remarks
on third party's evaluation of conformity and accreditation as a tool for demonstrating
the technical competence of conformity assessment bodies - a sectorial experience
Mr. Shri S. K. Sharma
Bureau of Indian Standards, India
15:55 Remarks
on 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
Mr. Peter Clark
Standards Council of Canada
16:05 Remarks
on the use of supplier's declaration of conformity - a sectorial experience
Mr. John Wilson
Information Technology Industry Council, United States
16:15 Questions and Panel Discussion
SESSION III. Approaches with Respect to Recognition of the Results of Conformity Assessment Procedures
Moderator: Ms. Maria Nazareth Farani Azevedo, Brazil
Rapporteur: Mr. John Adank, New Zealand
Main Speakers:
17:00 The
different kinds/levels of mutual recognition agreements
Mr. Philippe Meyer
European Commission
17:15
Recognition of the Results of Foreign Conformity Assessments (Autonomous Recognition) -a
national experience
Mr. Heinz Hertig
Switzerland
Panelists:
17:30
Conclusion of mutual recognition agreements in the private sector - a practitioner's
perspective
Mr. Joe Bhatia
Underwriters Laboratories, United States
17:40
Negotiating and implementing mutual recognition agreements at the regulatory level between
governments - a national experience
Mr. William McCrum
Industry Canada
17:50
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
Dr. L.H. Ng
Hong Kong, China
18:00 Good
Laboratory Practice in the context of Mutual Acceptance of Data of the Assessment of
Chemicals
Mrs. Dian Turnheim
The Organization for Economic Co-operation and Development (OECD)
18:10 Mutual
recognition agreement - prospective from industries
Mr. Ingfried Becker
IBM, Germany
Wednesday, 9 June 1999
9:00 Questions and Panel Discussion
SESSION IV. Role of International and Regional Systems for Conformity Assessment
Moderator: Mr. Otto Genee, Netherlands
Rapporteur: Ms. Patricia Woo, Hong Kong, China
Main Speakers:
10:00
Existing international and regional systems for conformity assessment in metrology
Dr. Robert Kaarls
Le Bureau International des Poids et Mesures (BIPM)
10:15
Existing international and regional systems for conformity assessment in testing
laboratories
Ms. Belinda Collins
International Laboratory Accreditation Cooperation (ILAC)
10:30
Existing international and regional systems for conformity assessment in
certification/registration bodies
Dr. Takashi Ohtsubo
International Accreditation Forum (IAF)
10:45
Existing international and regional systems for conformity assessment in a specific sector
Mr. C. J. Johnston
IEC Conformity Assessment Board (IEC)
Panelists:
The experience of a regional/national accreditation system
11:00
Perspective of a national metrology body
Mr. Edward Nemeroff
National Conference of Standards Laboratories, United States
11:10
Perspective of regional accreditation systems for testing laboratories and
certification/registration bodies
Mr. John Gilmour
Asia Pacific Laboratory Accreditation Cooperation (APLAC)
11:20 Mr.
Reinaldo Balbino Figueiredo
Interamerican Accreditation Cooperation (IAAC)
11:30 Mr.
Beer Budoo
Southern African Development Community (SADC) Cooperation on Accreditation (SADCA)
11:40 Mr.
Lars Ettarp
European Co-operation for Accreditation (EA)
11:50 In a
specific sector
Dr. Christopher Elliot
Forest Stewardship Council (FSC)
12:00 Questions and Panel Discussion
13:00 End of day
Thursday, 10 June 1999
C. A Factual report of the symposium
10:00
Factual, Non-binding Summary Report of the Symposium
Mr. Mohan Kumar
Chairman (under his own responsibility), based on the reports of the rapporteurs
10:30 Close of the Conference
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Annex I
Questions for consideration
Session
I
Relevant International Guides and Recommendations on Conformity Assessment
1. Does the use of international guides and recommendations contribute to confidence in the procedures conducted by domestic bodies (both in relation to marketplace requirements and regulatory acceptance)? How does the use of these internationally agreed guides contribute to the acceptance of data and ultimately to 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, what 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 are 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 or advantages? What are the difficulties or impediments to their use? Is it worth it? How do the guides or recommendations relate to accreditation and enable test results/certifications to be accepted nationally and internationally?
6. What kind of technical assistance is needed for the conformity assessment bodies in developing countries which use 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 Procedures and their Conditions of Application Back
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What are the main conformity assessment approaches applied by Members at the national/regional level? (e.g., the certification procedures, accreditation systems, government involvement and the extent that the supplier's declaration is permitted.) Is there a lack of harmonized approaches/procedures? What is the cost and benefit associated with the approaches?
What are the views of practitioners and business on single/multiple national accreditation systems? What are the advantages and disadvantages of having limited number of accreditation systems or a variety of systems based on the professional speciality of accreditation field? How does this affect trade?
To what extent do government regulatory authorities rely on non-governmental conformity assessment bodies to carry out conformity assessments to demonstrate compliance with technical regulations (i.e., certain governments may recognize specific conformity assessment bodies under their national or 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?
How does the market create a demand for third party conformity assessment in the absence of government-driven requirements?
How are governments involved in the development of rules and implementation of conformity assessment systems? How do governments 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?
What are the conditions to use suppliers' self declaration? e.g., in what areas/sectors? Big enterprises/SME? What kind of protection is there for consumers? What are the liability laws? Relevant ISO/IEC Guide? Practitioner's experience? Are there different approaches/modules to use for the suppliers' self declaration? What might be the problems/advantages of using suppliers' self declaration? What are the difficulties to overcome? Can it be the sole means for certification? What is the relationship between third-party assessment and suppliers' declaration of conformity?
How can developing country Members build up their conformity assessment systems? What kind of technical assistance is needed?
What is the need for accreditation systems? Are these systems needed in small economies? What can testing results or certificates without accreditation bring to the global trading system? What is the way to assist bodies in developing countries in gaining recognition of their procedures to demonstrate their exports conformity?
How can governments ensure the implementation of Article 8 of the TBT Agreement by non-governmental conformity assessment bodies?
Session
III
Disciplines with Respect to Recognition of the Results of Conformity Assessment Procedures
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1. What is the situation of existing MRAs negotiations, and what does the future hold for MRAs?
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 results and/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 and 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?
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. What is the current information on the work of ISO/CASCO in developing guidelines on MRAs.
8. 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?
9. What is the degree of interest in the introduction of multilateral MRAs either at the regulatory level or at the agency level?
10. What are the views of practitioners and business on MRAs?
11. Can MRAs meet global challenges? What is needed in the future?
Session IV
Role of International and Regional Systems for Conformity Assessment
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1. How can governments obtain membership in a regional or international conformity assessment systems?
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 is the confidence in the results of conformity assessment ensured under these systems? 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 and 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 as well as 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. How do your domestic 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?
11. What kind of technical assistance can be provided to developing countries in joining the regional or international systems? What kind of assistance is 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 and/or advantages? What are the difficulties to overcome? Is it worth it?