RESTRICTED  WORLD TRADE  
ORGANIZATION  G/TBT/M/33/Add.1 
21 October 2004 
 (04-4475) 
Committee on Technical Barriers to Trade  
  
REPORT OF THE SPECIAL MEETING OF THE TBT COMMITTEE DEDICATED TO  
CONFORMITY ASSESSMENT PROCEDURES HELD ON 29 JUNE 2004 
 
Chairperson:  Mr. Juan Antonio Dorantes Sánchez (Mexico)
 
 
Addendum to the Minutes of the Meeting of 1 July 2004  
 
Note by the Secretariat1 
  1. A Special Meeting of the TBT Committee Dedicated to Conformity Assessment Procedures 
(hereafter "Special Meeting") was held on 29 June 2 004.  The purpose of this Special Meeting was to 
advance the Committee's Work Program in the area  of conformity assessment, bearing in mind the 
recommendations made at the Third Triennial Revi ew of the TBT Committee.  The agenda of the 
Special Meeting covered three points: (i) exchange  of information on Members' experiences with 
Supplier's Declaration of Conformity (SDoC); (ii) information on the operation of accreditation fora; 
and (iii) other issues related to  conformity assessment procedures.
2   
 
 
I. EXCHANGE OF INFORMATION ON MEMB ERS' EXPERIENCES WITH SUPPLIER'S 
DECLARATION OF CONFORMITY (SDOC) ............................................................................................... .2 
A. BRAZIL ............................................................................................................................... ........................2  
B. CHINESE TAIPEI ............................................................................................................................... ...........3  
C. THE EUROPEAN COMMUNITIES ..................................................................................................................6  
D. OTHER INFORMATION ON SDOC ................................................................................................................9  
II. INFORMATION ON THE OPERATIO N OF ACCREDITATION FORA ....................................10  
A. THE INTERNATIONAL LABORATORY ACCREDITATION CO-OPERATION (ILAC);  INTERNATIONAL 
ACCREDITATION FORUM (IAF);  AND THE EUROPEAN CO-OPERATION FOR ACCREDITATION (EA)...................10  
B. ISO/IEC  STANDARDS FOR ACCREDITATION .............................................................................................18  
III. OTHER ISSUES RELATED TO CONFORMITY ASSESSMENT.................................................25  
A. JORDAN ............................................................................................................................... .....................25  
B. EUROPEAN COMMUNITIES ........................................................................................................................25  
C. BUREAU INTERNATIONAL DES POIDS ET MESURES (BIPM) .....................................................................29  
D. IEC  SYSTEM FOR CONFORMITY TESTING AND CERTIFICATION OF ELECTRICAL EQUIPMENT ...................35  
E. ORGANIZATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) .......................................41  
F. INTERNATIONAL ORGANIZATION OF LEGAL METROLOGY (OIML)..........................................................42  
G. INFORMATION ON ITA  FROM THE SECRETARIAT ......................................................................................46  
 
 
 
                                                      
1 This document has been prepared under the Secretariat's ow n responsibility and is without prejudice to the positions of 
Members or to their rights or obligations under the WTO. 
2 Job(04)/91 references all documents dealing with conformi ty assessment circulated in  the TBT Committee since 1995. G/TBT/M/33/Add.1 
Page 2  
 
I. EXCHANGE OF INFORMATION ON MEMBERS' EXPERIENCES WITH 
SUPPLIER'S DECLARATION OF CONFORMITY (SDOC) 
2. The Chairman recalled that the TBT Committee ha d previously held initial discussions on the 
issue of SDoC and that there had been a number of submissions from Members relevant to SDoC 
going back as far as 1998.
3    The Third Triennial Review, r ecognized the benefits of the SDoC 
approach for the assurance of conformity when used in appropriate circumstances.  The purpose of the 
current meeting was to start a more in-depth di scussion of SDoC in the Committee ahead of the 
planned workshop in March 2005.   
A. BRAZIL  
1. Statement 
3. The representative of Brazil  presented his country's experience with SDoC (circulated in 
G/TBT/W/240).  He also proposed to present, in deta il, the use of SDoC in the case of disposable 
lighters as a case study in the workshop on SDoC to be held in March 2005.  
2. Discussion 
4. The representative of India  asked whether Brazil, in its system of conformity assessment, 
utilized SDoC only in relation to mandatory tec hnical regulations, or whether SDoC was also 
employed in the case of voluntary standards.  
5. The representative of Brazil  confirmed that CONMETRO had adopted a decision to apply 
SDoC only to technical regulations; it was not applied to voluntary standards. 
6. The representative of Canada  was interested to hear more detail on the methodology used for 
risk assessment (paragraph 8 of G/TBT/W/240).   
7. The representative of Brazil  replied that its methodology for risk assessment was based on 
software which had been specially developed for risk assessment and that took into account various 
factors, including environmental, social and econom ic factors concerning the particular product.   
8. The representative of Canada  was also interested to h ear more about the "mark of 
conformity".  Was such a mark granted through a process of third party certification, or SDoC?  Was 
this the mark of the accreditation body, or was it a mark provided by a regulator?  Moreover, with 
respect to non-conformance of bodies that were lic ensed to apply the mark, what procedures were 
followed to ensure that the licen see met all the requirements?   Similarly the representative from 
Colombia  asked whether under its SDoC scheme, Braz il had provided for surveillance procedures 
after marketing.  Moreover, did the scheme cont emplate any sanctions for the non-compliance with 
the "conformity mark".   
9. The representative of Brazil  confirmed that two separate product marks were required for 
SDoC:  one granted by INMETRO, and the other mark displaying the regulation.  Regarding the 
question from Colombia, Brazil did conduct market surveillance.  If a product was found to be non-
conforming it would be removed from the market. 
10. The representative of the European Communities  noted that the way SDoC had been applied 
so far in Brazil, part of the procedure included t esting the product.   While the European Communities 
shared this type of application of SDoC in some  areas, in other areas the supplier's declaration was 
completely left in the hands of the manufacturer  and no test with an accredited or authorized 
                                                      
3 The various submissions on SDoC are listed in JOB(04)/70 (cir culated on 10 June 2004).  This document also contains key 
points made in the TBT Committee, since 1995, specifically on SDoC.   G/TBT/M/33/Add.1 
 Page 3 
 
 
laboratory was necessary.  Did Brazil have any plans to give the responsibility entirely to the 
manufacturer, without any intervention of a laboratory?  The representative of Egypt  had a similar 
question (paragraph 14 of G/TBT/W/240). 
11. The representative of Brazil  clarified that the existing procedure did not make testing 
requirements for SDoC mandatory in all cases. Testing was only required in situa tions when and if the 
National Council for Metrology, Standardization an d Industrial Quality (CONMETRO) considered it 
necessary. 
12. The representatives from Mexico  and China  sought clarifications from Brazil on how it 
evaluated whether a product presented a "mild risk" (paragraph 11 of G/TBT/W/240).  How were 
such risks evaluated?   
13. The representative of Brazil  said that the risk assessment methodology used was based on 
special software which took into account the co sts and benefits, as well as the economic, social, 
environmental factors and the level of commerc ial confidence that could be achieved through 
implementing SDoC programs. 
14. The representative of Egypt  asked what proportion of the SDoC programmes adopted in 
Brazil applied to imported products versus domestically produced.  He referred, in particular, to the 
case of disposable lighters (paragraph 16 of G/TBT/W/240). 
15. Taking the example of disposable lighters, the representative of Brazil  said that 70 per cent of 
the products were domestically produced and the remaining 30 per cent were imported.  
16. The representative of China  sought a clarification from Brazil in relation to the definition of 
an accredited laboratory (paragraph 9 of G/TBT/W/ 240).  Was this for a laboratory accredited in 
Brazil or did Brazil accept laboratories accredited elsewhere in accordance with the ISO standard?  
17. The representative of Brazil  clarified that the requirement that testing laboratories be 
accredited was equally applicable to both Brazilian a nd foreign manufacturers.  It was however a pre-
requisite that all such laboratories be accredited by the ILAC. 
18. The representative from Malaysia  asked whether Brazil considered SDoC a viable alternative 
for a wide range of products (paragraph 12 of G/ TBT/W/240)?  In taking the decision to use SDoC as 
an option, had the Brazilian authoriti es evaluated the costs and benefits? 
19. The Brazilian  representative replied that the cauti ous approach adopted by her country's 
authorities, based on risk assessment, had led to the use of SDoC on only three products.  She 
reiterated that costs-benefits were used as a factor when taking a decision on whether SDoC was to be used or not. 
B. C
HINESE TAIPEI  
1. Statement4 
20. The representative of Chinese Taipei  recalled that SDoC was a new conformity assessment 
procedure for its domestic manufactures, consumers and government officers.  Batch inspection had 
been the only conformity assessment procedure used over the previous forty years. Recognized as the 
least-onerous approach to providing assurance of conformity, SDoC was introduced into the 
regulatory system in January 2002.  Reviews of the effectiveness of the new system were carried out 
in August 2002 and December 2003, respectively.   The experiences with SDoC faced by Chinese 
                                                      
4 Two previous papers submitted by Chinese Taipei on SDoC  have been circulated in G/TBT/W/195 (12 March 2003) and 
G/TBT/W/195/Add.1 (16 March 2004). G/TBT/M/33/Add.1 
Page 4  
 
Taipei was discussed in four parts: (i) the planning  stage; (ii) the implementation stage; (iii) the 
evaluation stage; and (iv) future action. 
21. In respect of the planning stage, certain acti ons had to be taken to get SDoC included as a 
conformity assessment procedure in the regulator y system. This involved making revisions to 
applicable laws or regulations, providing adequate education to ke y players - including government 
officers, industry and consumers - as well as improving the enforcement mechanism. 
22. The legislative framework was refined first in 1997 and again in 2001 to provide a legal basis 
for implementing SDoC.  Under the new framework, provisions relating to market surveillance were 
strengthened and the penalties for violations were  increased in order to deter manufacturers from 
exploiting the new procedure or attempting to market non-compliant products. The penalties that 
could be imposed for violations were currently twen ty times higher than those allowed in the original 
regulation. For example, the minimum fine for vi olations involving false or incorrect labelling was 
now approximately US$ 2,900 compared to the US$ 140 stipulated previously. 
23. Regarding the implementation stage, the SDoC  system was implemented in January 2002, 
with 19 items of electronic products selected as the fi rst group to be covered by the new procedure. 
The product list consisted mainly of parts or access ories of IT equipment and this particular group 
was selected because of its relativ ely low risk to public safety. While successful implementation of 
the new system could not be guaranteed, the selecti on was made with due consideration for the fact 
that the finished products remained subject to pre-market controls and that the protection of 
consumers would thus still be maintained. 
24. The SDoC procedure, as applied to the 19 products selected required the supplier or 
manufacturer to be registered, the product to be tested by laboratories recognized by the regulator and 
a declaration to be made by the supplier or manufacturer that the product met the technical 
requirements.  A product had to be labelled with an inspection mark, which differentiated it (by the 
presence of the letter "D"), from those using ot her conformity assessment procedures.  The 
registration or identification number given by the regulator to the supplier or manufacturer needed 
also to be shown on the product, so that the pers on responsible for that particular product in the 
market surveillance programs could be identified, if necessary. 
25. In respect of the evaluation stage,  in order to evaluate the eff ectiveness of the SDoC system in 
the market-place, specially desi gned market surveillance programs were applied to the selected 
products.  These had two parts, appearance checki ng and sample testing. Appearance checking was 
used to monitor whether the insp ection mark was affixed to the pr oducts.  Sample testing involved 
purchasing products from the open market and testing to verify whether they were consistent with the 
information contained in the related conformity decl aration and technical report.  The first review of 
the system was carried out in August 2002, coveri ng the appearance checking phase only.  The second 
was in December 2003 and covered both parts of the surveillance program. 
26. The first review found a non-compliance rate of 30 per cent, the most likely reason being that 
the supplier or manufacturer was unfamiliar with the requirements. To correct  this, specific measures 
were taken to increase manufacturers' awareness of the SDoC requirements and to remind them of the penalties that could be incurred th rough violations. Exchangeable pow er supply, a key component that 
affected the electromagnetic compatibility performan ce of a computer, was the product selected as the 
subject of the second review.  This time, the rates of non-compliance were found to be 0.5 per cent in 
the appearance check and 48 per cent in the sampl e testing.  The appearance checks showed 
satisfactory results in comparison with those c onducted in 2002, where the non-compliance rate was 
30 per cent, and the Chinese Taipei authorities were pleased with the apparent effectiveness of the 
programmes designed to raise manufacturers' awareness of the new system.  The high rate of non-
conformity found in sample testing, however, rais ed serious concerns about the effectiveness of the 
SDoC system to meet legitimate objectives, partic ularly when non-conformity could no longer be  G/TBT/M/33/Add.1 
 Page 5 
 
 
attributed to lack of awareness, as confirmed by the appearance check results . Measures, such as the 
imposition of penalties and follow-up checks on th e corrective action taken by the supplier or 
manufacturer, were being taken to correct  such a high rate of non-conformity. 
27. In respect of future action, and in view of the evaluation results, discussions were taking place 
on making changes to the procedure, to perhaps include the registration of products and the 
enforcement of market surveillance skills. In a ddition, the current year's market surveillance 
programme for the SDoC system was being extende d in scope to include other products such as 
electronic calculating machines, hard disc devices, soft disc devices, main boards of computers and add-on cards.  Final results were expected at the end of 2004, and Chinese Taipei would be pleased to 
share them with any interested Members. 
28. While the experience Chinese Taipei had had from implementing SDoC might not seem very 
positive at the current stage, it was certainly not discouraged from using the system.  Considering all the benefits that SDoC could bring to facilitati ng trade, Chinese Taipei was pleased to have the 
opportunity of sharing its detailed findings with WTO Members in the hope that this empirical case 
study would contribute to the discussion at the SDoC Workshop to be held in 2005.  It was necessary 
to explore all the different aspects in order to eventually arrive at a successful and effective system 
that did not compromise the protection of consumers.   
29. The representative of Chinese Taipei stressed th at the experiences reported were based on its 
own particular industrial structure, which consiste d mainly of small and medium-sized enterprises.  
She was interested in hearing from other Member s that had successfully implemented SDoC and who 
would also be willing to share their empirical experi ences, especially in terms of any regulatory action 
they had been taken to resolve problems along the way. 
2. Discussion 
30. The representative of Australia
 asked, in respect of Chinese Taipei's product testing 
mechanisms, if simple product tests administered by laboratories would be acceptable to the regulator or did such laboratories have to be accredited.  In other words, was the regulator free to chose any 
laboratory, accredited or not?  Also, had any consider ation been given to the use of pre-sale testing to 
ensure that there would not be any failur es once the product was released on the market. 
31. The representative from Chinese Taipei
 clarified that for laboratories conducting SDoC tests 
to be recognized by its regulators, in addition to  compliance with ISO/IEC Guide 17025, laboratories 
needed to comply with specific standards for the testing of electronic products. If a laboratory was 
interested in becoming a designated laboratory fo r the purposes of the SDoC scheme, they could 
apply to the Bureau of Standards, Metrology and Inspection for recognition.  After such a request, 
assessment personnel would be sent.  Furthermore,  there was a procedure in place through which 
laboratories which had already received accreditation under existing internatio nal standards, could 
have part of this assessment waived. 
32. The representative of Brazil  asked how one could explain th e high level of non-conformity 
found in the sample testing and what measures were being taken to address this problem.   
33. The representative of Chinese Taipei  said that her authorities were still in the process of 
interviewing the non-conforming manufacturers and would impose a fine if they found that a manufacturer participating in the scheme had intenti onally avoided testing its products before placing 
them on the market.  Such a fine for non- compliance could extend up to NTD 1 million. 
34. The representative from Egypt
 asked how registration requirements would apply to foreign 
suppliers.  G/TBT/M/33/Add.1 
Page 6  
 
35. The representative of Chinese Taipei
 clarified that, for foreign suppliers, registration was 
done by a local representative within Chinese Taipei . This local representative issued a registration 
number that was then communicated to the foreign supplier of the product so that it could be marked upon that product.   
C. T
HE EUROPEAN COMMUNITIES  
1. Statement 
36. The representative of the European Communities  referred to an earlier EC submission on 
Suppliers Declaration of Conformity (G/TBT/W/218, 30 June 2003) in respect of the EC's own experience on SDoC. He noted that while SDoC was sometimes referred to as "manufacturer’s declaration of conformity" or "self-declaration of conformity", the underlying concept of the terms 
was the same.  The supplier was the party that supp lied the product and this could be a manufacturer, 
a distributor or an importer of the product.  
37. The EC's experience in the use of SDoC had been within the framework of New Approach 
Directives, which consisted of re gulations covering a wide range of industrial products, such as: 
electrical equipment, machinery, toys, medical de vices, personal protective equipment, recreational 
crafts, radio and telecommunication equipment a nd equipment for use in potentially explosive 
atmospheres. The Directives set down the essentia l public interest requirements for families of 
products (dealing with safety, health and enviro nmental protection), the relevant conformity 
assessment procedures tailored to the specific risks inherent to the product family, and the "CE" 
marking to be affixed on products by the ma nufacturer before placing them on the market. 
Irrespective of which conformity assessment system was used, the product was marked with the CE 
mark.  This mark reflected conformance with all mandatory requirements. As such, the product 
marking did not distinguish between SD oC and third party certification.  
38. Before deciding to apply SDoC, several elements needed to be taken into consideration.  In 
particular, issues such as the appropriateness of SDoC in view of the nature of the risks involved, the 
economic infrastructures of the given sector (e.g . existence or non-existence of certification 
laboratories) and the production system. SDoC was the preferred option for product categories 
presenting risks that were generally considered to be  low. However, the risk factor was not the only 
factor for deciding whether SDoC should be used fo r a particular category of products. Several other 
factors, such as: the number of existing voluntary marking schemes for a product;  the types of production methods used for the manufacture of the product; the kinds of certification schemes 
available; and, the maturity of the standardizati on mechanism in a particular product sector were all 
taken into account. Therefore, it was possible that  SDoC was used as a method of conformity 
assessment even in product categories which were otherwise viewed as medium or high risk, such as electrical products. 
39. Regarding standards, the use of SDoC was mo stly linked to the application of harmonized 
European standards that were elaborated by the European st andardization bodies CEN, CENELEC 
and ETSI, following a mandate by the European Commission.  These contained technical 
specifications for the fulfilment of the relevant essential requirements.  The standardization process 
offered the possibility to transpose standards and base them on international standards from ISO, IEC 
and ITU-T as they became available.  However, the use of harmonized European standards remained 
voluntary and manufacturers were free to choose any t echnical solution to comply with the relevant 
essential requirements.   
40. Regarding the obligations on suppliers, the representative of the European Communities 
noted that for all products intended to be placed on the market, the supplier had to ensure that they 
satisfied the relevant legal requirements.  Applyi ng the declaration of conformity (DoC) imposed the 
obligation upon the supplier to take care of the re quirements of documentation and declaration.  The  G/TBT/M/33/Add.1 
 Page 7 
 
 
supplier had to establish a technical file cont aining the documentation that covered design, 
manufacture and operational aspects of the product re flecting the results of an appropriate risk 
assessment and, if applicable, the test results obt ained from a competent laboratory.  The supplier had 
to also draw up and keep together with the file a copy of the DoC.  The supplier had to keep it for a 
period ending at least 10 years after the last pr oduct had been manufactured and had to make it 
available to the relevant national authorities for inspection purposes. The supplier took full 
responsibility for placing the product on the market and had to take all measures necessary in order 
that the manufacturing process ensured compliance of the manufactured products with the technical 
documentation and with the relevant  legal requirements. For some categories of higher-risk products 
covered by New Approach Directives, an add itional step was required, which involved the 
intervention of a third-party certification body.  This  allowed for an examination of a product sample, 
and tests being made prior to the product bein g certified and being allowed to be placed on the 
market. 
41. Regarding market surveillance and product liab ility laws, according to the EC experience, 
SDoC could facilitate market access without prej udice to the fulfilment of legitimate public policy 
objectives, when it was combined with well devel oped market surveillance systems and effective 
product liability laws.  Market surveillance was an essential tool for the enforcement of any 
legislation – and in particular for goods that we re placed on the market following SDoC.  Market 
surveillance involved monitoring products to ensu re they complied with legislation and taking 
remedial action when products did not comply.  It  also included penalties for false or misleading 
declarations.  In the European Communities th is was the responsibility of national authorities 
specially nominated or established by the Member Stat es.  To help ensure the fulfilment of legitimate 
public policy objectives, the lesser the involvement of a third party during the conformity assessment 
before the product was placed on the market, the great er the need for efficien t market surveillance. 
42. In conclusion, the EC representative stressed th at the EC experience was that the introduction 
of SDoC coupled with ex-post market surveillance and effective product liability laws worked well in 
certain specific sectors and had not created problem s with regard to the fulfilment of the legitimate 
public policy objectives pursued. Moreover the use of SDoC also facilitated imports from third 
countries and could be considered to help deve loping countries fully benefit from the opportunities 
offered by the world trading system.  While the use of SDoC implied certain costs for administrations, 
in particular higher costs for market surveillance,  it tended to imply lower costs for industry and 
importers, resulting in cheaper products for consumers and possibly, in the long run, higher level of 
competitiveness and job creation.  An appropriate bala nce needed to be struck, taking into account the 
imperative objectives of protecting health, safety and the environment, and the constraints on the 
resources of administrations. 
2. Discussion 
43. The representative of Egypt  sought clarification on liability related issues in the EC 
submission, in particular with respect to pena lties being imposed upon suppliers for non-conformity. 
Under what conditions would a supplier be given a "second chance" in the event that it was found to 
be non-conforming on one given occasion?  
44. The representative of the European Communities  replied that the EC Directive, which dealt 
with product liability for non-conformance, was transpo sed to the laws of each Member State, so that 
the penalty for the faulty product would vary from Stat e to State within the EU.  In other words, the 
actual application of the provisions of the Directiv e was dependant on the Member States themselves.  
45. The representative of Egypt  also asked what areas had entailed the most difficulties in 
effectively implementing SDoC.   G/TBT/M/33/Add.1 
Page 8  
 
46. The representative of the European Communities
 replied that the areas of difficulty were 
basically in relation to two categories of products in which it was found, through market surveillance, 
that there was a high degree of non-conformance, na mely:  electronic goods and toys.  The problem 
was particularly bad in the case of toys.  In  the European Communities Toys Directive, two 
procedures were used, one of which was SDoC.  This  procedure only operated if there were existing 
EC standards in that area. If there were no standard s for the particular product category, then it went 
to a type approval. In this case, quite a few inst ances of faulty products had been discovered which 
was a sensitive issue given the nature of the product.  As soon as a fault was detected, the "safeguard 
clause" was used and if the problem was detected in  one Member State, then all Member States were 
immediately informed and steps were taken to with draw the product from all markets and a system to 
investigate was set up. 
47. The representative of the United States  noted that the US approach to SDoC was not guided 
by the risk analysis approach followed by the EC, e.g. motor vehicles in the United States used SDoC 
despite the high risk category of products that it fall s into. It was pointed out that the infrastructure 
existing in the market sector was an import consider ation to be kept in mind when deciding whether 
or not a product should be subject to SDoC. 
48. The representative of India  referred to the section of the EC submission dealing with the 
possible intervention of a third party certification bod y.  He asked whether there was a risk threshold 
beyond which third party certifica tion would be triggered?  
49. The representative from th e European Communities  clarified that in most cases of SDoC, 
third party certification was not required.  Howeve r, in some cases, such as in the case of telecom 
equipment using radio frequencies, tests would be requ ired to be carried out to test the frequency used 
by such equipment. This would strictly speaking not amount to third party certification; these were 
simply additional tests which were required to be  carried out to complement the details already 
contained in the "technical file".   
50. The representative of Canada  expressed interest in the EC's post market surveillance 
mechanism and the procedure used by EC Member States for tracking faulty products.  She asked if 
the EC representative could elaborate on how these mechanisms worked and clarify whether there 
were any standardized procedures used by EC  Member States while addressing these issues.  
51. The representative of th e European Communities  pointed out that the peculiarity of the EC 
system meant that Member States were respons ible for market surveillance and there was no 
harmonized system of conducting market surveill ance. Member States approached the issue 
differently, for example some Member States had a more centralized system of tackling market 
surveillance whereas others dealt with it through local governments.  Despite the differences of the 
approaches and the procedures used by Member St ates in dealing with market surveillance, the 
European Communities was making an effort along w ith its Member States th rough initiatives such as 
a "joint visit programs".  These initiatives could, in  the future, lead to the application of common 
criteria for market surveillance fo r all Member States to follow. 
52. The representative of China  sought clarification from the EC representative as to whether the 
"notified bodies" where manufacturers needed to have  their products tested, could be located outside 
the European Communities if they were accredited in accordance with intern ational standards.   
53. The representative of th e European Communities clarified that if pure SDoC was used, there 
would be no need for the involvement of any notified body, and the only requirement that needed to 
be fulfilled was the maintenance of the technical f ile.  However, in some cases where certificates had 
to be issued by "notified bodies", the EC regulati ons required such "notified bodies" to be notified 
within the territory of the Eur opean Communities itself.  However,  the EC representative pointed out 
that it was possible for laboratories located outsi de the European Communities to enter into sub- G/TBT/M/33/Add.1 
 Page 9 
 
 
contracting arrangements with notified bodies within  the European Communities, which would assist 
in accessing the EC market. 
54. The representative of Chinese Taipei  asked what had prompted the European Communities to 
reconsider the effectiveness of various SDoC schemes which had been employed?  
55. The representative of the European Communities  replied that while no formal study to 
measure the effectiveness of various schemes had be en conducted, there was a continuing analysis of 
how these schemes were working in various sectors. Th is process of analysis involved consultations 
with experts and ensured a constant feedback on the effectiveness of measures taken. The EC 
representative gave the examples of the medical devices sector and the telecom sector in the EU, where industry and consumer views were taken into account and legi slative changes made according 
to the feedback. 
56. The representative from Malaysia
 wished to know whether th e European Communities had 
conducted an evaluation of the alternatives to SDoC, and the costs to be incurred in its 
implementation.  
57. The representative of the European Communities  stated that all new proposals for legislation 
went though a process of rigorous impact assessmen t, wherein costs of implementation, benefits, 
available alternatives, and appropriate procedures we re all assessed before introduction. The European 
Communities believed that impact assessment would play an important role in all its future 
legislation. 
D. OTHER INFORMATION ON SDOC 
1. New Zealand 
58. The representative of New Zealand  underlined her country's support for the adoption of the 
SDoC approach to products that did not pose a high risk to health, safety and the environment.  She simultaneously recognized that this did not mean th at to adopt SDoC the product needed to present 
absolutely no risk.   New Zealand had judged it safe to apply SDoC to electrical safety equipment, for example, where there could be some intrinsic risk to health and safety.  She pointed out that SDoC 
was appropriate for a wide range of products becau se it reduced the cost of compliance significantly 
for the exporter;  it was used extensively by export ers in New Zealand.  Exporters, particularly small 
and medium scaled enterprises (SMEs), who had not had to obtain pre-market approvals in New 
Zealand had found this approach less difficult do ma nage.  There were a number of advantages to 
SDoC, including:  the reduction in compliance cost s; decrease in administrative costs for regulators 
which allowed them to spend greater resources on post market surveillance which they found more 
effective; the placing of legal liability squarely on th e supplier; and, the encouragement to industry to 
self-regulate. 
2. Australia 
59. The representative from Australia
 pointed out that his country had had a system of accepting 
manufacturers' declarations of conformity si nce the 1950s for many products, including some 
products which were considered high risk. Austra lia's system was based on the notion of the 
demonstration of technical competence by the ma nufacturer at the pre-sale stage. This was an 
accreditation based system, largely based on the application of the ISO/IEC 17025 for laboratory testing.  This had proven to be very effective in Australia;  there had been very few serious problems 
in Australia as a result of inadequate quality or  compliance of manufactured products – the problem 
was often with specification, not with compliance to the specification.  Australia accepted all 
imported products on the same basis.  This meant that a product which was tested in a system based 
on accreditation for testing and certification was acceptab le in Australia.  As had been mentioned by G/TBT/M/33/Add.1 
Page 10  
 
Brazil, Australia also effectivel y recognized foreign laboratories if they were accredited to conduct 
the appropriate tests by a signatory of the ILAC arrangement. 
3. ISO 
60. The representative of the ISO
 noted that reference had been made to the ISO/IEC Guide 22 on 
the subject of SDoC.  As was evident from the di scussion, there were various interpretations on how 
to apply SDoC.  This was why there had been a decision in the ISO to move from a "guide" to a 
"standard".  He informed Members that this ne w standard, ISO 17050, was at its final stage of 
development and was scheduled to be voted upon.  It would hopefully be published by the end of 
2004 and used by regulators and market players to clarify the concept of SDoC. 
II. INFORMATION ON THE OPERATION OF ACCREDITATION FORA 
61. The Chairman  recalled that the Committee had, in the Third Triennial Review highlighted the 
importance of accreditation as a mechanism whic h could promote confidence when used in 
accordance with international st andards. The Committee, in an effort to improve Members 
implementation of Articles 5-9 of the TBT Agreemen t and to improve the understanding of Member's 
own conformity assessment systems, had invited indi vidual Members and Observers to introduce their 
own experiences in this area of conformity assessment.   
A. THE INTERNATIONAL LABORATORY ACCREDITATION CO-OPERATION (ILAC);  
INTERNATIONAL ACCREDITATION FORUM (IAF);  AND THE EUROPEAN CO-OPERATION FOR 
ACCREDITATION (EA) 
1. Statement 
62. The representative of the ILAC, IAF and the EA5 began by noting that one way of describing 
accreditation was as third party assessment at th e second level of control (in the sense that 
accreditation bodies controlled conformity assessment  bodies).   Accreditation operated in the 
voluntary and mandatory fields for calibration, t esting, inspection and certification (Figure 1).  
Accreditation bodies needed to be independent, im partial, transparent and open.  Accreditation 
facilitated international recognition based on MLAs / MRAs (Multilateral Agreements or Multilateral 
Arrangements).  These were the ulti mate products that organizations of accreditation bodies were 
aiming at in order to facilitate this rec ognition and thus avoiding multiple assessments.  
                                                      
5 Mr. Daniel Pierre, Chief Executive of th e Comité Français d'Acréditation (COFRAC).  G/TBT/M/33/Add.1 
 Page 11 
 
 
Figure 1 
Accreditation
2nd and last level of control in the conformity assessment 
chain
Operates in the voluntary and in the mandatory fields for:
•calibration
•testing
•inspection
•certification (products, personnels, systems)
Independant and impartial
Transparent and open
International recognition through MLA’s. 
 
63. It was noted that the ILAC  was a legal entity under the Dutch Law and a non-profit 
organization.   The membership of ILAC was as follows: 
(a) 45 Full Members (signatories to the Arrangement) representing 36 economies; 
(b) 15 Associates representing 14 economies; 
(c) 22 Affiliates representing 18 economies; 
(d) 4 Regional Cooperation Bodies; and, 
(e) 19 Stakeholders. 
64. The European Co-operation for Accreditation (EA)  was one of the member regions of ILAC 
representing European Accreditation bodies (Figure 2) .  A second big region was the Asia Pacific 
Region, APLAC (Asia Pacific Laboratory Accredita tion Cooperation).  Other regions included the 
IAAC (Inter-America Accreditation Co operation)  and SADCA (the Cooperation Body for South 
Africa).     
Figure 2 
Israël South-Africa Brazil Australia, Canada,
Hong-Kong China,Peopole’s 
Republic of China, 
Indonesia, India, 
Japan,
Republic of Korea, 
Malaysia,
New Zealand,
Singapore,
Chinese Tapei,
Thailand, USA, 
Vietnam.Austria, Belgium,
Czech Republic,
Denmark, Finland,
France, Germany,Ireland, Italy,
Netherlands,
Norway, Slovak
Republic,
Slovenia, Spain, 
Sweden, 
Switzerland, United Kingdom.Unaffiliated SADCA IAAC APLAC EA
Full Members (MRA Signatories)
 
 G/TBT/M/33/Add.1 
Page 12  
 
65. In respect of the organizational structure of ILAC (Figure 3), it was noted that the Joint 
Development Support Committee was dedicated to he lp accreditation bodies in developing countries 
in order to enable them to join the status of ILAC MRA Signatories. 
Figure 3 
Organisation Structure
Accreditation
Policy
CommitteeTechnical 
Accreditation 
Issues 
CommitteePublic Affairs
CommitteeLaboratory
CommitteeJoint 
Development 
Support 
CommitteeFinance & 
Audit 
CommitteeSecretariatArrangements 
Management 
Committee
General 
AssemblyArrangement 
Council
Executive 
Committee
 
 
 
66. The IAF could be described as a sister organization to the ILAC; it was a legal entity under 
the US law and had similar membership and organi zational structure as the ILAC (Figures 4 and 5).  
With respect to Members, there were: 
(a) 41 Accreditation Body Members (of which 32 MLA signatories); 
(b) 15 Associates (stakeholders);  
(c) 4 Regional Groups; and, 
(d) 2 Special Recognition Interest Liaison Groups (ISO, QUEST). 
67.   The Asia Pacific region was represente d in the IAF through the PAC (Pacific Asia 
Cooperation). For the time being, the IAF had established its Multilatera l Recognition Agreement 
only in the field of quality systems certification. The intention of the IAF was to extend the scope of 
this MLA to product certification and  environmenta l management system certification in the near 
future.  With respect to inspection, the two organi zations (ILAC and IAF) had decided to cooperate in 
order to establish equivalent multilatera l agreements in the field of insp ection.  This had, however, not 
yet been established.  G/TBT/M/33/Add.1 
 Page 13 
 
 
Figure 4 
USA South Africa Brazil
MexicoCanada,
China,India,
Indonesia,
Japan,
Korea,
Malaysia,
New Zealand,
Philippines,
Singapore,
Thailand.Austria, Belgium,
Czech Republic,
Denmark, Finland,
France, Germany,
Ireland, Italy,Netherlands,Norway, Slovak
Republic, Spain, Sweden,
Switzerland, 
United Kingdom.Unaffiliated SADCA IAAC PAC EAMLA Signatories
 
 
Figure 5 
Organisation Structure
Secretary
MLA Committee Technical Committee Development Support
CommitteeExecutive Committee
(includes Directors)Board of DirectorsIAF Members
 
 
 68. The European Co-operation for Accreditation (the "EA") , was a legal entity under Dutch 
Law.  It was noted that the difference between th e EA membership structure compared to the ILAC 
and IAF, was that the stakeholders were not Member s of EA, but constituted the EA Advisory Board.  
There were: 
(a) 39 Full Members (of which 31 signatories to the MLA); 
(b) 3 Associate members; and, 
(c) 12 Contracts of cooperation. 
69. All the categories of stakeholders were on the A dvisory Board.  This Advisory Board, which 
had been established five years ago, permitted the stakeholders at the European level to give 
accreditation bodies (Members of EA) their views.   The MLA Committee of the EA was in charge of 
managing the MLA.  There existed also a number of Technical Committees (Figure 6).  
 G/TBT/M/33/Add.1 
Page 14  
 
Figure 6 
EA
ADVISORY BOARDGENERAL ASSEMBLY 
OF ACCREDITORS
Secretariat
EXECUTIVE 
COMMITTEE
Publications,
Promotion&legal
Affairs CommitteeCertification
CommitteeInspection
CommitteeLaboratory
Committee
WG
WG
WGWG
WGWGWG
WGWGMLA
CommitteeOrganisation Structure
 
 
70. Regarding the EA MLA Signatories, it was explai ned that the EA MLA covered all the fields 
of accreditation (testing, calibration, inspection, product certification, quality system certification, 
environmental management system certification,  product certification, personnel certification).  
However, the establishment of the Multilateral Re cognition Agreement was done as a step-by-step 
process, which meant that while some of the EA  Members had been recognized as competent and 
impartial to deliver accreditation in all fields, others had not yet reached that level of recognition.   
Figure 7 showed the various levels of rec ognition achieved by the EA MLA signatories. 
 
Figure 7 
wwwwww ..europeaneuropean --accreditationaccreditation ..orgorg
MLA SIGNATORIES
June 2004EA
European cooperation for Accreditation
Non signatories
Environnemental
management
Systems certification Calibration ; testing ; 
products certificationCalibration; testingCalibration; testing; products
and quality systems certification
Associate membersCalibration; testing; products 
quality systems and 
personnel certificationCalibration; testing; products, 
quality systems andpersonnel certification; inspection
Calibration; testing, 
inspectionTesting ; products certification 
and quality systems certification
 
 
 
71. The representative of ILAC, IAF and EC noted that the ILAC (laboratories) and IAF 
(certification bodies) operated world-wide and that the EA was an example of a regional co-operation 
accreditation body, operating only in Europe.  It w as important to underline that none of these 
organizations provided themselves any accreditation.  Only their Members provided accreditation, and 
therefore, it was important to stress the role of these organizations as organizations of  accreditation 
bodies.  Their main tasks were:   G/TBT/M/33/Add.1 
 Page 15 
 
 
(a) harmonization of accreditation practices between members (establishing guidance);  
(b) establishing a multilateral recognition agreem ent / arrangement (peer evaluations); 
(c) promoting accreditation as a tool for facilitating trade; and, 
(d) helping developing countries to set  up their own accreditation schemes. 
72. Regarding the work of accreditation bodies  themselves, it was explained that these worked 
more or less in the same way as conformity assessm ent bodies.  The first step was the receipt of a 
request for accreditation.  Second, an assessment of  the applicant was undertaken.  This assessment 
was, in essence, an audit with  an assessment team composed of a quality assessor and technical 
experts.  The third step was the decision made on the basis of the assessment report.  After the 
decision was taken the applicant bodies were granted accreditation, and this accreditation was 
monitored.  This meant that there would be surv eillance visits and accreditation was renewed after a 
certain period.  He noted that the future ISO Standard 17011 would give more guidance on how to 
harmonize the surveillance and reassessment periods.   
73. It was stressed that there was a need to ha rmonize accreditation practices even when these 
relied on international standards established by ISO (ISO established international standards used by 
accredited bodies, but also by the accreditation bodies themselves).  All actors relied on the use of the 
international standards. However, these standards need ed to be clarified or needed some precision in 
their application so as to ensure that one accreditati on was equivalent to another.  This was the first 
main role of organizations  of accreditation bodies.   
74. The second one was to establish the Multilateral Recognition Agreements.  These were based 
on peer evaluations.  All accreditation bodies that we re accepted as signatories to an MRA (or MLA) 
had been evaluated by their peers.  An exam ple of this was the assessment of COFRAC ( Comité 
Français d'Acréditation ) by an EA team.  In this case, COFRAC  was audited for one full week by six 
peer evaluators from several countries of Europe.  Th is worked in the same way at the international 
level.  ILAC and IAF relied on their regional cooperation bodies (for example, EA in Europe, APLAC 
or PAC in the Asia Pacific) in this respect.  Only those accreditation bodi es that had been peer 
evaluated could be signatories to the MLAs.  These peer  evaluations were conducted every four years.   
 
Figure 8 
Facilitating trade
(nationally and internationally)
Reducing the need for multiple assessments « one stop 
testing, one stop certification »
Traceability of measurements to SI Units
Recognition by Industry
Recognition by Regulators: MOUs between EA/European 
Commission, EA/EFTA
Cooperation with standardization: MOU between 
ILAC/IAF/ISO signed in march 2004
¾cooperation in technical work
¾complaint exchange procedure
 
 
75. The third main task of ILAC, IAF and EA was to promote accreditation as a tool for 
facilitating trade (Figure 8).  Trade facilitation was meant both from a national and international G/TBT/M/33/Add.1 
Page 16  
 
perspective.  The role of accreditation was to reduce the need for multiple assessments, this was 
sometimes referred to as "one-stop testing, one-stop certification".  If there was confidence in a test or 
in a certificate because it had been covered by an acc reditation body, then there should be no need to 
repeat that test, or check the certificate.  More over, accreditation in the field of laboratories also 
provided confidence in the traceability of  measurements to SI units.   
76. Industry, as the main stakeholder in accreditation bodies, was involved in accreditation 
bodies' work, and, therefore, recognized accreditation as important to establish confidence.  The issues 
were the same with respect to regulators.  It was important that regulators had confidence in the work 
done by accredited bodies (MoUs between the EA and the European Commission existed, for 
example).  Accreditation in itself was not so important.  What was important was the conformity 
assessment activities done under the control of accreditation and the confidence in these activities. 
77. ILAC and IAF also cooperated with standa rd-setting bodies and there existed an MoU 
between ILAC, IAF and ISO which was signed in Ma rch 2004.  This MoU was designed to facilitate 
cooperation in technical work and to exchange view s on the complaints received.  The purpose of this 
was to avoid, for example, deficient ISO 9000 certification or accreditation, which could happen 
despite surveillance.   
 
Figure 9 
Joint ILAC/IAF  Committee
¾identify needs (trainings, translations,…)
¾Organize seminars
Money allocated in 2004:
¾ILAC budget = 10 000 $
¾IAF budget = 20 250 $
Countries already helped: Argentina, Nicaragua, Peru, 
Trinidad and Tobago, Chili, Guatemala, Panama, 
Colombia, Costa RicaHelping developing countries
 
 
78. In respect of assistance given to developing countries to set up their own accreditation 
schemes  (Figure 9), there existed a joint IL AC/IAF Committee which addressed this goal and 
identified the needs of new and developing accreditati on bodies.  This work dealt mainly with the 
training of assessors and translations of documents.  The joint ILAC/IAF Committee organized 
seminars in order to provide information to newl y established bodies.  ILAC and IAF had allocated 
some money from their budgets which was drawn from the fees which came from each Member (Figure 9).  It was also noted that there was an important cooperation between ILAC, IAF and UNIDO (for the time being through separate Mo Us between UNIDO and ILAC and IAF).  The 
objective of this co-operation was to develop accred itation bodies.  At the European level, the EA 
coordinated projects financed by the European Un ion, such as the PHARE project for Central and 
Eastern European countries, and MEDA wh ich was for the Mediterranean area. 
79. The representative of ILAC, IAF and the EA stated that a global approach to conformity 
assessment based on accreditation, carried out by IAF and ILAC MLA or MRA signatories offered  G/TBT/M/33/Add.1 
 Page 17 
 
 
the best means to reduce and eliminate conformity  assessment-related trade barriers and, therefore, 
facilitated trade. 
2. Discussion 
80. The representative of the United States  wished to know more about the ILAC requirement 
regarding the need for accreditation bodies to be "inde pendent".  What did it mean for an accreditation 
body to be independent?  Second, the United States also asked for some details on the issue of ILAC 
Membership.  She understood that there were 45 Full Members which were signatories to the 
arrangement.  But there were also "19 stakeholders " and "4 Regional Co-operation bodies" (paragraph 
63, above).  What were the differenc es?  Also, was it possible for several countries to join together, so 
as to pool resources, and  establish one accreditation programme that would service a combined 
market?  And if so, could such an organizati on be  a signatory under the ILAC procedures? 
81. Regarding the independence of accreditation bo dies, the representative of ILAC, IAF and EA  
replied that international standards required accredita tion bodies to be independent and impartial. The 
forthcoming publication of the ISO/IEC Guide 17011 would clarify exactly what was meant by the 
independence and impartiality of an accreditation body .  For the time being there was the ISO Guide 
58 for the accreditation of laboratories; Guide 61 for accreditation of certification; and Guide 17010 
for accreditation of inspection.  All of these dealt with what constituted "independence".  But, he 
noted, nobody was ever fully independent;  some accreditation bodies, for example, were linked to 
their governments, or to their National Measurement  Institutes (NMIs).  What was important was the 
independence and impartiality of the decision  of accreditation itself.   Finally, it was confirmed that an 
accreditation body established commonly between severa l countries could become a signatory to the 
ILAC or the IAF MLAs. 
82. In respect of how ILAC/IAF were dealing with specific programmes, the representative of 
ILAC, IAF and EA  noted that it happened sometimes that a sector of the economy wished to establish 
its own scheme for standardization, accreditation and certification (examples existed for organic food 
producing or sustainable forest operating). The difficulty in those cases came from the structure of the 
schemes which were not independe nt and/or impartial and could be competing with nationally 
recognized accreditation bodies.  For the time being, th ere were still discussions on this issue in both 
ILAC and IAF, but they could not be offered memb ership as their goal was not to enter in to a 
multilateral recognition arrangement. Another goa l was to avoid double accreditation for some 
conformity assessment bodies in certain countries. 
83. Regarding the status of the stakeholders in ILAC and IAF, the representative of ILAC, IAF 
and EA  presented the different categories: direct stak eholders (organizations of laboratories or 
certification bodies), indirect stakeholders such as industry associations (such as ISCA), end-consumers associations and regulators.  With respec t to getting the participation of regulators, this 
was easier at the national level and not so difficult at the regional level (the EA had, for example, 
close links with the European Commission).  Howeve r, it was difficult at the global level.  It was 
perhaps a good sign that the ILAC and IAF could speak at the WTO;  this kind of co-operation was 
necessary. 
84. The representative from Chinese Taipei
 asked, first, if there were any studies that had been 
undertaken by ILAC or IAF with respect to how thei r test results or certifi cation results (coming from 
accreditation schemes recognized by ILAC and IAF) ha d been recognized by regulators?  Second, she 
sought some clarification and elaboration on th e content of the MoUs between the European 
Commission and EA.  Moreover, regarding the MLA or MRA between various accreditation bodies 
within ILAC and IAF, how did this agreement work ?  Did this mean that the results of accredited 
laboratories, or certification bodies, were accepted by other accreditation bodies?  How did the recognition work in terms of the acceptance of test r esults, or certification results?  Third, were there G/TBT/M/33/Add.1 
Page 18  
 
studies showing how the MRA in ILAC (or MLA for IAF)  affected the use by regulators of the results 
of the accreditation? 
85. The representative of ILAC, IAF and EA
 confirmed, in respect of first question, that studies 
had been undertaken for ILAC two years ago and that  another survey was under way.  He stated that 
the situation in each country was different dependi ng on the relation – or links – between national 
accreditation bodies and their governments.  In some  cases there was a good recognition by regulators 
of accreditation.  Regarding the MoU between the European Commission and EA, it was noted that it 
had resulted in the provision of technical help thro ugh the EA to some EC Member States to set up 
accreditation bodies. Moreover the European Commissi on was represented in the EA Advisory Board 
(Figure 9).  More specifically on the content of the ILAC or IAF or EA MRAs, it was noted that each 
signatory to an MRA recognized, at the same level of confidence, any accreditation granted by 
another signatory. This meant that a test repor t covered by an accreditation granted by an MRA 
signatory was considered at the same level of confidence as in another country where there was 
another MRA signatory.  To get the recognition of the results themselves the two laboratories needed 
to be using the same test standard. 
86. The representative of Egypt  sought a clarification from ILAC/IAF relating to the procedures 
through which a member was granted accreditation.  It was his understandings that the first procedural 
step for the granting of accreditation was the receipt of a request.   What was the type of request made, its content, and what was the time frame involved for assessing such a request? This was of 
importance to African countries. 
87. The representative of ILAC, IAF and EA
 noted that the procedure was rather simple:  the 
applicant needed to contact its accreditation body requesting accreditation for the scope of conformity 
assessment.  The first step in the process was to defi ne the scope:  was it testing, or calibration, or 
both?   And what kind of testing or calibration di d it constitute?  This wa s done jointly between the 
applicant and the accreditation body.  The second step  was the assessment.  The assessment team was 
constituted depending on the scope wh ich determined the choice of technical expert, and the size of 
the team.  Finally the assessment report was studied and the decision taken on its basis. The full 
process needed at least several months, depending also on the responsiveness of the applicant. 
B. ISO/IEC  STANDARDS FOR ACCREDITATION  
1. Statement 
88. The representative of the ISO6 began by stressing that ISO was not an accreditor.  The ISO's 
role was to set the framework, the overall rules, pr ocedures, requirements for all types of conformity 
assessment, one of which was accreditation.  The so called ISO/CASCO "toolbox" covered all these 
various aspects of conformity assessment (Figure 10).  With one exception (out of 23) all the 
documents were ISO/IEC Intern ational Standards or Guides.7  The "CASCO" (the conformity 
assessment committee) developed these documents that  subsequently were voted on by the Members 
of ISO.  These were also voted on and approved sep arately by the IEC National Committees.  In other 
words, CASCO was run under the ISO Central Secr etariat, but produced documents that were 
approved by both ISO and IEC Members.   
                                                      
6 Mr. Graeme Drake, Head of Conformity Assessment at the ISO Central Secretariat.  
7 The only exception is ISO Guide 27:1983, Gu idelines for corrective action to be take n by a certification body  in the event of 
misuse of its mark of conformity.  G/TBT/M/33/Add.1 
 Page 19 
 
 
Figure 10 
3
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28ISO/IEC tool box for
conformity assessment
A tool box covering all aspects of definition, 
implementation, evaluation, recognition and use of 
conformity assessment (calibration, testing, certification, 
inspection, accreditation)
Through the ISO Committee on conformity assessment
(CASCO), ISO and the IEC provide a neutral platform 
for the establishment of internationally recognised CA 
procedures, covering 1st, 2ndand 3rdparty assessments
These International Standards and Guides fall into the ‘international standards’ referred to in the WTO TBT 
agreement
 
 
 
Figure 11 
4
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28Accreditation :
Determining and moni toring  competence
Once requirements for products, systems or personnel are 
established, there is often a demand, whether from public 
authorities or from the market, for some form of attestation of 
conformity
The purpose of accreditation bodies is to provide a process to 
determine and monitor the competence of conformity assessment operators (laboratories, certification 
bodies/registrars, inspection bodies). It facilitates acceptance of 
results, i.a. through Multilateral Agreements (MLAs) between 
accreditation bodies based on peer assessment
The ISO/IEC toolbox provides the International Standards and 
Guides that set out fundamental requirements for the 
accreditation process, accreditation bodies, accredited activities, 
as well as guidance on peer assesment and mutual recognition. 
 
 
 
89. Accreditation was one means  of establishing the competence of people and organizations that 
in the market place held themselves out to be good conformity assessment operators.  Accreditation 
established that the product certifiers, the testers, the laboratories, etc., were competent, and that they 
had the right skills in order to provide the servi ces they claimed to be able to provide.   
 G/TBT/M/33/Add.1 
Page 20  
 
Figure 12 
5
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28ISO’s partnership with the international 
accreditation community
ISO does not undertake accreditation or other conformity 
assessment activities
IAF-ILAC-ISO Memorandum of Understanding (MoU) signed in 
March 2004:
reaffirms ISO/IEC Standards and Guides as the prime vehicle for setting international requirements for accreditation and 
accredited conformity assessment activities;
IAF and ILAC may establish guidance statements to ensure 
consistent application by accreditors, without adding requirements; and 
Organizes the collaboration on the development and updating of standards, as well as for the handling of complaints
 
 
90. Regarding the relationship between ISO, IAF a nd ILAC, and EA (Figure 12).  It was noted 
that with the exception of ISO, these bodies were e ither international or regional  associations of 
accreditors.  ISO set the rules for how accreditation could be done, but did not involve  itself in 
actually doing accreditation.  The MoU with IAF and ILAC separated out the functions of each 
organization.  Basically it reaffirmed a number of  understandings that had evolved over the past 20 
years.  That ISO/IEC standards and guides were  the prime source of rules, procedures, and 
requirements for how things must be done in a ge neric way.  The IAF and ILAC, on the other hand, 
developed guidance documents on ho w accreditors should apply, in a consistent manner (and without 
adding additional requirements), the more generic texts of the ISO.  
91. The other main component of the MoU with IAF and ILAC was a commitment to share 
complaints about how the system was working.  Ho wever, while the IAF, ILAC and ISO had agreed 
to share complaints of a generic or structural nature to examine whether there was anything wrong 
with the system or the standard, or the guidance provided, they would not address other more 
business-oriented complaints that were not of a gene ric, structural nature or motivated by commercial 
self-interest. 
 
Figure 13 
6
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28ISO/IEC 17011
ISO/IEC 17011, Conformity assessment - General requirements 
for accreditation bodies accrediting conformity assessment bodies
Will replace:
ISO/IEC Guide 58:1993, Calibration and testing 
laboratory accreditation systems -- General 
requirements for operation and recognition 
ISO/IEC Guide 61:1996, General requirements for 
assessment and accreditation of 
certification/registration bodies
ISO/IEC TR 17010:1998, General requirements for bodies 
providing accreditation of inspection bodies
  G/TBT/M/33/Add.1 
 Page 21 
 
 
  92. The representative of the ISO noted that th ere was a new international standard on 
accreditation that had been approved in 2004.  The final vote on this document, ISO/IEC 17011, had 
been completed in May and had received over 92 per cent approval from the voting Members of ISO 
and IEC.  For an international standard, this w as high.  ISO/IEC 17011 would replace the current suite 
of documents which accreditation bodies used for th eir daily operations; these would probably be 
withdrawn at the end of 2004 (listed in the Figure 13).   Once published, ISO/IEC 17011 would 
contain the future requirements on accreditation.  Th e full scope of the standard was covered by the 
following points: 
(a) scope; 
(b) normative references; 
(c) terms and definitions; 
(d) accreditation body; 
(e) management; 
(f) human resources; 
(g) accreditation process; and, 
(h) responsibilities of the accreditation body and the conformity assessment body. 
93. In essence, the new international standard set out what an accreditation body was supposed to 
do, or not supposed to do.  It set out how accr editation bodies should manage themselves:  what 
human resources they should have; what the generi cally approved process for accreditation was.  At 
the end, the standard defined and separated out va rious responsibilities.  Finally, it set out what an 
accreditation  body was responsible for and what th e responsibilities of a conformity assessment body, 
accredited by an accreditation body, were.   
Figure 14 
8
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28
inclusion of ‘impartiality’
prohibition on directly undertaking other conformity assessment 
services or consultancy;
bodies related to the accreditation body may do this but must 
have:
different top management
different people
no influence
distinctly different name, logos and symbols
deliberate identification and management of relationships that have the potential for a conflict of interest;ISO/IEC 17011 contd.
 
 
94. The new standard had underscored, very clear ly, the need for accreditation bodies to show 
and demonstrate that they were impartial.  This c oncept was not quite the same  as 'independence'.  Yet 
impartiality had been generated as a requirement in the new standard in a number of ways.  
Effectively, accreditation bodies that wished to hold themselves out in the market place as meeting the 
requirements of the international standard 17011 in  the future could not, themselves, undertake any 
form of conformity assessment activity that they  would otherwise be accrediting.  It was this 
separation of responsibility which was important:  one could not have accreditation bodies accrediting G/TBT/M/33/Add.1 
Page 22  
 
in a particular field of conformity assessment and, at the same time, have another unit within that same body which actually operated in their field of conformity assessment.  These two had to be 
separate.   
95. This posed quite a lot of problems for some of  the current accreditation bodies in the world.  
This was particularly so for those accreditation b odies which were part of their own government.  
Applying ISO/IEC 17011, in theory, meant that the accr editation part needed to be sucked out of the 
government and set up as a separate entity.  For many developing countries, but also for many 
developed countries, this was probl ematic and sometimes politically unacceptable; it might not either 
be the most efficient method of operation for a particular market.   
96. As a result, it had been recognized (third bullet point Figure 14), that it was possible to have 
bodies related to the accreditation body, that did pr ovide conformity assessment services, but through 
having: different top management; different staff; no influence on the accreditation decision; and distinctly different names and logos.  Taking th ese points into account, it was believed that the 
impartiality and the separation was enough to make sure that through this standard, accreditation 
remained isolated or independent so that it c ould then be impartial when it undertook accreditation 
activities.  To underscore the above stated, there was now also a requirement in the standard that made 
it the accreditation body's own responsibility to analy se all its relationships, an d to manage conflicts 
of interest, if they existed.  This was something that other  accreditation bodies could contest.   
Figure 15 
10
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28ISO/IEC 17011 implications
May require some government and accreditation bodies to 
restructure their accreditation functions and related legislation
Better defines the operational framework that needs to be in place for accreditation and the international acceptance of conformity assessment results that are based on mutually recognised accreditation
There will need to be a transition period for IAF and ILAC 
members to allow structures to be adjusted where necessary -
this is being discussed between IAF, ILAC and ISO (expected date of publication of ISO/IEC 17011: end of 2004)
 
 
 
97. The ISO/IEC Standard 17011 was, in some se nses, a ground breaking document.  It would 
require questions to be raised about the placeme nt of the accreditation activity within a country:  
whether it was inside or outside government, and how separation and impartiality was ensured.  This 
would also be the future basis for the accreditation members of the IAF and ILAC.   
98. In terms of implementation, there would have to be some form of transition period.  The 
current accreditation bodies set up around the world were based on the three previous guides (Figure 13) and there would be a need for time for those sy stems to adjust to the requirements of the new 
standard.  In some countries, these were already in pl ace while in other countries this was not the case.  
Although no transition date had been set yet, this was likely to be done when ILAC, IAF, and ISO met 
at the highest level in Cape Twon, South Africa in October 2004.  G/TBT/M/33/Add.1 
 Page 23 
 
 
Figure 16 
9
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28ISO/IEC 17011 in context
17025
Labs
Guide 60
Good
PracticeGuide 68
MRAs17000
Definitions17040
Peer
Assessment17011
Accreditation17021
MS Cert17050
SDoC
Guide 43
Prof. Test
LabsGuide 67
Product
CertGuide 28
Product
CertGuide 65
Product
Cert17020
Inspection
 
 
 99. In relation to Figure 16, accreditation bodies that met 17011 accreditation (centre of the slide) 
could accredit the top level (laboratories, produc t certifiers inspection and management systems 
certification).   The whole conformity assessment system was based on ISO/IEC Guide 60 on Good Practice, which would be published in 2004 along with ISO/IEC 17000 on Vocabulary and general 
principles for conformity assessment.  ISO/IE C Guide 68 was about Mutual Recognition of 
Conformity Assessment results (MLAs, MRAs, et c) and had been published in 2002.  This has 
previously been reported the WTO TBT Committee.
8 
 
Figure 17 
10
 WTO TBT Committee Special Meeting on Conformity Assessment Procedures, June 2004CASCO Comms/047
2004-06-28ISO/IEC 17011 implications
May require some government and accreditation bodies to 
restructure their accreditation functions and related legislation
Better defines the operational framework that needs to be in place for accreditation and the international acceptance of conformity assessment results that are based on mutually recognised accreditation
There will need to be a transition period for IAF and ILAC 
members to allow structures to be adjusted where necessary -
this is being discussed between IAF, ILAC and ISO (expected date of publication of ISO/IEC 17011: end of 2004)
 
 
100. In respect of developing countries and confor mity assessment work, one of the criticisms 
which had been levelled at ISO, or in particular  the Committee on Conformity Assessment, was that 
there was not enough developing count ry input.  Much had happened how ever, over the last five years 
to ensure developing country participation.  The current Chairman of CASCO was from a developing country (Mr. Mario O. Wittner from Argentina).  Moreover, in CASCO, there were approximately 
                                                     
 
8 G/TBT/W/73/Add.1. G/TBT/M/33/Add.1 
Page 24  
 
100 countries with voting rights and half of these we re developing countries.  There had been a big 
push to ensure that Membership in CASCO was not limited to North America, Europe and Australasia.  This had led to the present situ ation where the dynamic in terms of the Members 
participating – writing comments and having th eir views understood – was more balanced. 
101. Moreover, the ISO was currently in the mids t of a two-year programme which involved 
regional workshops in developing c ountries on conformity assessment.
 9  One of these had been 
completed in Brazil in May 2004 for the Americas  region, and the next one would take place in 
December, in India for the South Asia region. 
2. Discussion 
102. The representative of the European Communities  asked, in respect of the MoU between ISO, 
ILAC and the IAF, whether ILAC and IAF coopera ted in such a way that their guidelines were 
identical; or did they develop guidelines independently?   
103. The representative of ISO  said that the IAF and the ILAC would, on this particular subject 
(the one standard for accreditation) begin a process of writing what guidance was necessary in a joint 
group as of October 2004.  There was still, however , discussion with respect to how much guidance 
would be required as there was a significant amount of  detail in the international standard as it stood. 
Nevertheless, in relation to other conformity assessment standards, there could be specifics for 
laboratories, which ILAC would want to include, and,  likewise, more detail in respect of certification 
bodies which IAF might want to address. 
104. The representative of Egypt  suggested that the ISO conduct a workshop on conformity 
assessment in Africa. 
105. The representative of Canada  asked how the development of an ISO standard or guide on 
conformity assessment differed from that of an ISO standard for a product.  Also, what was the kind 
of status that international standards for conform ity assessment had compared to those of standards 
for products?  
106. The representative of ISO  noted that the ISO was not the only international body that could 
offer globally relevant standards;  this was evident in some sectors in particular.  However, in the area 
of conformity assessment, the international standa rds and guides set by ISO/CASCO fully met the 
definition of international standards under the TBT Agreement.  The process to develop such 
standards was set out in the ISO/IEC directives.  T hose who could participate in this work were all 
member countries of IEC or ISO.  Moreover, a set of liaison bodies existed with any particular committee.  In CASCO's case, there were 10 form al liaison bodies which included ILAC and IAF.  
These liaison bodies did not only consist of accreditors, but also of representatives of the certification 
bodies and the laboratories who were actually accred ited.  In sum, the CASCO documents resulted 
from a good degree of representation from all interested parties. 
107. The representative of Australia
 asked, in respect of impartiality, whether there was a move to 
suggest that governments should separate themsel ves altogether from accreditation activities.   
108. The representative of ISO  clarified that this was not the case.  There was no "master plan" that 
suggested that accreditation bodies could not be part of governments.  Nevertheless, the accreditation 
function  had to be able to demonstrate that it was impar tial.  To do this some countries had chosen to 
separate out the accreditation bodies from their governments thereby placing it under another operational framework.  Others, howev er – and legitimately so – had ke pt it as part of the government 
(or even brought it inside government), but this wa s done together with the appropriate checks and 
                                                     
 
9 Further information on conformity assess ment can be found at http://www.iso.org/.  G/TBT/M/33/Add.1 
 Page 25 
 
 
balances so as to be able to demonstrate that the services provided by the accreditation body remained 
impartial.  
III. OTHER ISSUES RELATED TO CONFORMITY ASSESSMENT 
A. JORDAN  
1. Statement 
109. The statement made by the representative of Jordan  was circulated in G/TBT/W/241.10   
2. Discussion 
110. The United States  noted that Jordan seemed to be moving towards conforming to the new 
ISO/IEC Standard on accreditation and developing its  independence.  She asked about the rationale 
behind the choice the four groups of products for DAMAN certification: toys, electrical and electronic 
appliances, safety equipment, vehicles and tyres and food products on a voluntary basis.  Had there 
been some study or evidence of problem s that had underpinned this choice? 
111.  The representative of Jordan  stated that the products we re chosen because Jordanian 
authorities did not have the capability or testing in frastructure to verify the conformity of the 
compliance of these products to the technical regulati ons.  Hence, to ensure protection of health and 
safety of Jordanian people, these products were subjected to mandatory testing. 
112. The representative of Malaysia  referred to the section on insp ection and market surveillance 
and asked whether the inspection of factories was also undertaken at overseas producers exporting to 
Jordan.  Second, in respect of the risk based sy stem, was it intended to be an alternative to the 
DAMAN Program? 
113. The representative of Jordan  responded that Jordan was only interested in products that 
entered the Jordanian market.  Hence, it was only th e Jordanian factories that were subjected to the 
local visits.  In respect of the second question, she noted that the risk based system could become an 
alternative to the DAMAN program in the future, if  it was developed to include all the factors that 
should be considered when developing a system. 
B. EUROPEAN COMMUNITIES  
1. Statement 
114. The representative of the European Communities11 began by stressing that the European 
Union was a community of different countries.  Whil e the overall approach was to form an internal 
market with free movement of goods between th ese countries, the individual EC Member States had 
all started out with individual certification schemes , different technical regulations and conformity 
assessment procedures.   
115. For conformity assessment, two main instruments were used:  (i) mutual recognition in the 
sense that if a product was approved in one country , then other countries of the Community were 
obliged to recognise the conformity assessment resu lts and allow the product to circulate freely, 
(ii) technical harmonization which entailed the estab lishment of European Directives, which basically 
harmonized or approximated the laws of the Members States.  
                                                      
10 Mrs. Rab'ah Al-Ajarmeh, Head of DAMAN Unit at the Jordanian Institution for Standards and Metrology. 
11 Mr. Brian Jenkinson, Deputy Head of Unit, Director ate General for Enterprise, European Commission. G/TBT/M/33/Add.1 
Page 26  
 
116. With respect to pre-market assessment, th e representative of the European Communities 
referred to the "New and Global Approach".  These policies, which were complementary to each other, and developed in the mid to late 1980's, were designed to cover wide fields of products or risks 
with one piece of legislation and to impose gene ric essential requirements that would not become 
obsolete and that limited government intervention to what was essential.   
Figure 18 
TBT Committee - Special Meeting on Conformity Assessment7CONFORMITY ASSESSMENT -
KEY ELEMENTS
1 Modules
2 Notified bodies
3 Quality assurance
4 Technical file
5 EC declaration of conformity
6 CE marking
=> free movement of goods in Single Market
 
 
 117. In respect of the Global Approach, which was relevant to conformity assessment, the 
fundamental point was that the manufacturer (or hi s authorised representative in the case of imported 
goods) was responsible for conformity.  There was an effort to limit the number of different types of 
conformity assessment procedures to a reasonably sma ll range (these were referred to as "modules" in 
the Global Approach).  In most cases, the manufactur er was aided by a Notified Body (a certification 
body – or conformity assessment body) and there was an element of choice in that the manufacturer 
could chose any Notified Body.   
118. The key elements of the Global Approach were se t out in Figure 18.  It established eight basic 
modules to cover different situations (Figure 19).  Each sectoral Directive specified which modules 
could be used.  In some cases, it was just a single module or mayb e two modules used in combination 
with each other.  In other directives, there wa s a choice.  Sometimes, the choice was not for the 
manufacturer to make; this depended on the type of product and the risk associated.  Nevertheless, in 
general terms, every directive specified whic h modules applied.  These covered the design and 
production phases and most modules required the use of notified bodies.   Module A was the supplier's declaration of conformity (SDoC).   
  G/TBT/M/33/Add.1 
 Page 27 
 
 
Figure 19 
TBT Committee - Special Meeting on Conformity Assessment9…the basic Modules
A Internal control of production (design&production)
B EC type examination (design) (notified body)
C Conformity to type (production)
D Production quality assurance (prod.) (notified body)
E Product quality assurance (production) (notified body) 
F Product verification (production) (notified body)
G Unit verification (design&production) (notified body)
H Full quality assurance (design&prod.) (notified body)
 
 
119. Figure 20 showed that SDoC covered both the design phase and the production phase 
(because the technical file associat ed with SDoC covered both these aspects).  Some other modules, 
such as type examination, only related to the design phase and the production phase was covered by a 
second module.  Module G and H also covered both phases. 
Figure 20 
TBT Committee - Special Meeting on Conformity Assessment10
The Modules
Self-declaration
Total Quality
AssuranceType Examination
 
 
120. In the EU there were about 1300 certificati on bodies.  These were independent third party 
bodies, notified by the Member States whose res ponsibility it was to ensure their continuing 
competence.  There was a system in place where by the Notified Bodies met regularly to discuss 
problems of mutual interest.  Hence, whilst there was cooperation, on the other hand, there was also 
competition, in that a manufacturer could go to the Notified Body of his choice.   The designation 
process for the Notified Bodies themselves was s upported by accreditation, although, in the EC 
system, this was not mandatory.  The EN 45000 Series of Standards was used and these were usually identical to the ISO guides and standards.   
121. Three of the modules referred to quality assura nce.  These were all optional – there was no 
obligation to always use quality assurance modules  and what the ISO 9000 offered was only one 
solution, and it was not mandatory. G/TBT/M/33/Add.1 
Page 28  
 
122. In the context of SDoC, it was the responsibility of the manufacturer to prepare 
documentation related to the product to demonstrate th at the product complied with the requirements.  
This was done through the "technical fi le" which was basically a set of documents that had to be made 
available to the authorities and the Notified Bodies upon request. 
123. The EC Declaration of Conformity was drawn up and signed by the manufacturer.  It was a 
commitment to declare that the product conformed to the requirements defined in each Directive.  
This included items such as the product, informa tion on the manufacturer, applicable Directives and 
standards. 
124. Another part of the conformity assessment proce dure was that the products be marked with a 
CE Mark.  Such marking meant that the product me t all the legal requirement s and that it could be 
placed on the market.  This was not a mark or origin or quality.  It was simply a mark that indicated 
that the equipment complied with the legal re quirements for it to be placed on the market. 
125. Post-market control ensured that market surv eillance guaranteed equal protection for citizens 
and a level playing field for enterprises.  The objec tive within the EU was to achieve a uniform, high 
level of enforcement of internal market legislation.   In the EU this was a national responsibility and it 
was carried out by government officials in the mark et place.  The way in which this was carried out 
could vary.  This was not a disadvantage in that if different countries applied slightly different 
procedures for market surveillance, there was a bette r chance of a product being found to be in non-
conformity.
12   
2. Discussion 
126. The representative of the United States  noted that the EC approach allowed for competition 
amongst Notified Bodies, but, according to her unde rstanding, there was no ability for a body located 
outside of the European Union to become a Notified B ody;  this was an internal EU matter – in other 
words, the competition did not extend beyond the European Union.   
127. The representative of th e European Communities  confirmed the US understanding.  The 
Directives required that the Notified Bodies had to exis t in one of the territories of the Member States.  
In a union of 25 countries, it was difficult to imagine how the “community” could manage to assess 
the competence of a body outside the EU territories.  However, this was an issue that was raised 
regularly and was therefore on the agenda, and the EU would be looking into what steps, if any, could 
be taken. 
128. The representative of the United States  recalled a point had been made to the effect that the 
ISO 9000 Standard was not mandatory; it was but one option.  What were the other options and how 
did suppliers demonstrate that they had other credible quality assurance approaches?  The US 
understanding was that this was done on a case- by- case basis with the Notified Bodies and that there 
was no centralized body informing suppliers of opti ons (such as through the provision of a list of 
other available options).  
129. The representative of the European Communities  noted that the US question referred to 
quality systems in use (the different quality proced ures within the 8 modules).  The answer to this 
question was rather similar to the choice that the manufacturer had to demonstrate compliance with the essential requirements. If the manufacturer used European Standards, there was a "presumption of 
conformity" that the essential requirements in th e directives had been me t (because the European 
Standards covered the essential requirements).  There was a similar concept for the application of the 
quality system standards.  Normally, a manufacturer would seek certification from the Notified Body 
                                                     
 
12 More information on the New Approach and the Global A pproach (11 EU languages) can be found at: Internet 
(http//europa.eu.int/comm/enterprise/newapproach/index.htm).  G/TBT/M/33/Add.1 
 Page 29 
 
 
of the quality system in place based on the interna tional standard, but there was no obligation for him 
to do so.  Hence this was similar to the notion of "presumption of conformity".  
130. The representative of Brazil  asked what criteria were used to demand accreditation for 
Notified Bodies.  
131. The representative of the European Communities  clarified that the designation of the 
conformity assessment bodies in Europe was a Member State responsibility and the use of 
accreditation was not mandatory.  Nevertheless, in most Member States accreditation was used – but, 
again, it was the national responsibility of a Member  State to take the appropriate measures necessary 
to ensure that the criteria for the designation of  a Notified Body were met (and accreditation was one 
way of doing this).  There was, in addition, an  on-going discussion on the ro le of accreditation within 
the EU. 
132. The representative of China  asked whether the New and Global Approach also applied to the 
10 new Members of the EU.  
133. The representative of th e European Communities  noted that the accession process of the 10 
new Member States had taken several years and that  all new Members States had had to transpose the 
existing stock of Community law.  Therefore, as of 1 May 2004, the rules on the New and the Global 
Approach applied to both old and new Member States. 
134. The representative of India  asked where the issue of recognition through mutual recognition 
agreements (MRAs) fit in the overall appr oach of the EU on conformity assessment.  
135. The European Communities  noted that mutual recognition agreements (MRAs) with countries 
outside of the EU, were based on the fact that th e technical regulations in place and the way that 
bodies were notified in both parties were differen t:  the MRA was not a tool which attempted to 
determine equivalence or harmonize.  An MRA rec ognized the competence of each party.  In this 
sense, when the EU negotiated MRAs with count ries outside Europe, the EC explained how the 
designation of Notified Bodies worked in the EU.  Ho wever, in any event, to operate under the terms 
of the MRA, bodies had to be designated specifically  with the knowledge that they could approve 
products against a third country legislation.  In principle these agreements, which had gone through a 
stage of negotiation and implementation, were now , by and large, operational and were working. 
C. BUREAU INTERNATIONAL DES POIDS ET MESURES (BIPM)13 
1. Statement 
136. The representative of the BIPM14 noted that the BIPM had a very strong link with conformity 
assessment because, in essence, the BIPM covered th e measurements that were necessary to show 
traceability to international standards so as to be able to comply and show conformity in a confident 
way.  It was important to note that metrology,  accreditation and standardization represented three 
groups of activities that were one consistent and cohe rent whole.  All countries, of whatever stage in 
development, needed to have some aspect of each of those elements in place.   
 
                                                      
13 International Bureau for Precision in Measurement. 
14 Professor Andrew Wallard, Director, BIPM. G/TBT/M/33/Add.1 
Page 30  
 
Figure 21 
METRE CONVENTION
• An intergovernmental treaty which, inter alia, established the 
BIPM as the centre for coordination of world measurement
• Affirmed international support for the International System of 
Units - the SI - and its extension
• Covers, generally, the voluntary  sector
• 51 full Member States
• 16 Associates of the General Conference of Weights and 
measures
The International Bureau for Precision in Measurement 
 
137. Established in 1875, the BIPM operated under the second oldest inter-governmental treaty in 
the world (only the International Telecommunicati ons Union preceded it).  The BIPM was set up by 
governments at a diplomatic conference to coordina te measurement worldwide.  The heart of that 
Declaration, the Meter Convention (Figure 21), was th e International System of Units.  In general the 
BIPM covered what was referred to as the voluntary  sector whereas the OIML dealt primarily with 
measurement which was part of legislation but th ere was a very close partnership between the two 
organizations.   
138. There were 51 Full Member States of the BI PM, some of which were developing countries 
and 16 Associates.  The "Associate" group was specifically set up to cover developing countries and groups of  developing countries (this was relevant to  the US delegation's question at the end of 
paragraph 80, above and pa ragraph 146, below).   
 
Figure 22 
BIPM’s MISSION
“THE ROLE OF THE BIPM IS WORLDWIDE 
UNFORMITY OF MEASUREMENT.”
“It achieves this through providing the necessary 
scientific and technical basis for such uniformity 
and by collaborating with other institutions and 
organisations that have related missions.”
General Conference on Weights and Measures, 2003.
The International Bureau for Precision in Measurement 
 
139. The BIPM mission statement was worldwide uniformity of measurement (Figure 22).  This 
could not be done by the BIPM alone.  The BIPM was a small organization and it was inevitable that 
there was a need for partnerships, MoUs, and other types of close relationships with specialist bodies  G/TBT/M/33/Add.1 
 Page 31 
 
 
in their own areas.  So, whilst the BIPM had MoUs  with ILAC and the WHO, it was essential that 
there were also partnerships with organizations  like the Food and Agriculture Organization (FAO), 
with ISO, IEC, ITU and specialised technical bodi es in a number of areas.  This was particularly 
important as the BIPM moved from traditional activities in physics and engineering to cover areas like 
food and chemistry.   
Figure 23 
TRACEABILITY: THE HEART OF OUR BUSINESS
METROLOGICAL TRACEABILITY:
“The property of a measurement result relating the result to a 
stated metrological reference through an unbroken chain of 
calibrations or comparisons each contributing to the stated 
uncertainty ”
DRAFT Vocabulary of International Metrology: 2004 revision
National Metrology Institutes provide the top level standards at a 
national level: all measurements should be traceable to them
in order to establish confidence worldwide.
The International Bureau for Precision in Measurement  
 
140. The representative of the BIPM stressed that th e International System of Units was at the 
heart of the BIPM's work.  It had provided the international system of units in physics and engineering for over 125 years.  Although still lively and meeti ng new challenges, the huge growth area was now 
in the area of chemistry, medicine, food and envi ronmental measurements.  While it was not always 
easy to achieve traceable measurement worldwide to  unique and agreed measurement standards in 
these areas, it was the best way of achieving technical  confidence.  Hence, fo r the BIPM, the concept 
of traceability was the selling point; metrological tr aceability was the process of tracing the result of a 
measurement through unbroken chains of comparisons or  calibrations (Figure 23).  In most cases, and 
in most countries, there would be a national body wh ich provided the top level standards at whatever 
level of accuracy was appropriate to what was n eeded in the countries. Ideally, in each country all 
measurements would be traceable to these national standards.  
 G/TBT/M/33/Add.1 
Page 32  
 
Figure 24 
•In 1999 the CIPM developed 
an MRA between NMIs to 
address  technical barriers 
to trade caused by lack of
traceability and 
equivalence. 
Complying with the MRA 
means that an NMI’s
calibration certificates are 
acceptable world-wide with a 
validated accuracy.
The International Bureau for Precision in Measurement  
 
141. The work of the BIPM was to coordinate the international measurement system.  A 
measurement made by an industrial company needed to be traceable to the standards which were held 
in that particular country. Here the work of ILAC and ISO/IEC 17025 was important in giving 
confidence in the traceability of measurements made in accredited laboratories to national standards. 
However, if the top level standard s were not equivalent to similar standards held in other countries, 
then the whole system that a country might be tryi ng to put in place could be weakened, because there 
would be no confidence that the top level measurement standards were equivalent.  
142. However, if ILAC provided the confidence of traceability to national standards for accredited 
laboratories, how did national metrology institutes pr ove technical competence and equivalence? This 
was the role of the BIPM.  Up until a few years a go, there had been no formal system in place for 
doing that.  To respond to that challenge, the CIPM (International Committee for Weights and 
Measures) produced, in 1999, a mutual recognition arrangement (CIPM - MRA) that was aimed at providing technical confidence at that highest level (F igure 24).  It was very much driven by the needs 
of regulators and accreditors, as technical barriers to trade could be caused by lack of equivalence of 
national measurement standards.  The bottom line was that the signatories to the CIPM - MRA 
accepted each others calibration certifications worldwide. 
  G/TBT/M/33/Add.1 
 Page 33 
 
 
Figure 25 
GOALS OF THE CIPM MRA
• To provide confidence in the measurement capabilities of 
NMI, particularly for accreditors and regulators
• To provide a technically sound basis for the international 
recognition of the realisation of the SI by NMIs , new and old, 
large and small, experienced and in developing countries
• the technical underpinning for agreements that can be used to 
accept measurements related to trade
•t o  reduce TBTs caused by lack of traceability and equivalence
• to complement the ILAC Arrangement
The International Bureau for Precision in Measurement
 
 
143. The goal was to provide international confid ence in traceable measurement, and in what 
national laboratories said they could achieve in their measurement processes.  The CIPM - MRA 
provided a technically sound basis for the intern ational recognition of the activities of national 
metrology institutes from all countries and so help ed reduce unnecessary technical barriers to trade 
caused by the lack of traceability and equivalence.   
Figure 26 
“EQUIVALENCE STATEMENT”
“This certificate has been issued under the 
provisions of the MRA drawn up by the CIPM. All 
participating institutes recognise the validity of each 
other’s calibration and measurement certificates for 
the quantities and ranges specified in Appendix C of 
the MRA (for details see http//www.bipm.org)”
6th Joint Committee of the Regional Metrology Organisations and 
the BIPM : March 2001
The International Bureau for Precision in Measurement 
 
144. To be part of the CIPM's Mutual Recogn ition Arrangement, a national laboratory had to 
(i) have its calibration and measurement capabilities (CMCs) validated by others based on objective 
evidence (peer assessment);  (ii) take part in ke y comparisons that gave technical confidence in the 
day-to-day measurements at the NMIs (Natio nal Metrology Institutes) worldwide; and to 
(iii) implement a quality/management system (which  was essentially based on ISO/IEC 17025).  This 
was applicable to countries at any stage of devel opment.  Whilst this might appear a complicated 
system, it had the benefit of enabling countries to  relate the measurement s made, say, in Chinese 
Taipei, to those in Brazil, Egypt, Germany or Keny a, for example, through the BIPM's international 
framework.  In  addition, an NMI which complie d with this arrangement could put, on their 
calibration certificates, a statement like the one set out in Figure 26.   G/TBT/M/33/Add.1 
Page 34  
 
145. The BIPM also maintained a database of fu lly reviewed and inte rnationally accepted NMI 
measurement capabilities, including any differences between National Standards (18000 validated and 
peer reviewed entries).  This was the only database of NMI calibration services that assured 
traceability to the SI units and quantities.  As a result, a degree of competition had been created 
between National Metrology Institutes services in th at an accredited laboratory or other user could go 
to any national institute which was a signatory to  the CIPM MRA and ask for a measurement to be 
made.  That measurement would be accepted worldwide.   
146. With respect to developing countries, it was str essed that the MRA applied to all countries.  
The status of "Associate of the General Confer ence on Weights and Measures" had been created 
within the Metre Convention to deal with developing countries (currently, he noted, there were 16 
such members).  Economic groupings were eligible and the BIPM had a strong regional organization 
within which Regional Metrology Organisations arra nged for the participation for many developing 
countries. 
147. On the issue of how regulators used the results, it was stressed that more and more regulations 
required accurate measurement.  Regulators first need ed to be confident that measurements made in 
ISO/IEC 17025 accredited laboratories were traceable to National Standards at an NMI.  The CIPM 
MRA then provided  the evidence that Regulators n eeded to have confidence that the standards at 
NMIs were equivalent. Hence, there was no need to specify that measurements were traceable to any 
given NMI.   
148. The representative of the BIPM gave an exampl e that related to the In Vitro Diagnostic 
Devices Directive of the EU.  This Directiv e was about traceability of values to reference 
measurement procedures, and materials of a higher or der, but the Directive itself did not specify what 
was meant by that.  The BIPM was asked to step in a nd the  result was:  (i) a data base of agreed and 
validated higher order reference materials for use by the industry and which was likely to be accepted 
by the European Commission;  (ii) a common data  base of reference methods, validated and agreed 
against objective criteria; (iii) a set of reference laboratories that could perform the measurements and 
that had an appropriate quality system. This w as underpinned through a series of comparisons which 
were designed to validate technical capabilities a nd which resulted in a framework which could be 
used in organic and biological reference materials and measurements, and in food.
15  
Figure 27 
SUMMARY
• The CIPM MRA provides a framework of validated and accepted 
measurement capabilities whatever the level of national activity
• It complements the ILAC and OIML Arrangements• It covers engineering, chemistry, medicine, food and SPS
•ACCREDITED LABORATORIES ASSURE TRACEABILITY
•THE MRA STATEMENT ASSURES EQUIVALENCE
•BOTH ASSURE ACCEPTANCE WORLDWIDE
The Framework supports trade and is being adopted by users in 
industry, accreditation and regulation
The International Bureau for Precision in Measurement
 
 
                                                      
15 More information on the BIPM can be obtained from www.bipm.org.  G/TBT/M/33/Add.1 
 Page 35 
 
 
2. Discussion 
149. The representative of Canada  asked the representative from the BIPM whether he could 
provide any examples of where there had been pr oblems with measurement and how these may have 
impeded trade.  
150. In response, the representative of the BIPM  noted that one example was a discussion between 
Canada and Germany on the whiteness  of paper the origin of which was the fact that the standards 
that were held by Canada differed by those wh ich were held by Germany.  By making the 
comparisons the dispute had been resolved, and, th e Canadian industry had sav ed about $40 million in 
doing so.  There were other examples, for instance with  respect to the level of pollutants in fish that 
had come from certain African countries, and there we re levels of contaminan ts in chicken carcasses 
which were traded between Southern America and the EU, where, again, the testing methods differed.  
Without going into further detail, he stressed that there were a number of well-documented case-
studies that showed that a lack of equivalence of  national standards at the top level could cause 
problems. This was especially likely when the industrial need for accurate  measurement was very 
close to the levels of accuracy which NMIs could provide. 
D. IEC  SYSTEM FOR CONFORMITY TESTING AND CERTIFICATION OF ELECTRICAL EQUIPMENT  
1. Statement 
151. The representative of the IEC16 noted that the IEC was founded in 1906 to promote 
international co-operation on all questions of st andardization in the field of electrotechnology 
(electrotechnology being anything with electricity running through it).  The IEC also promoted co-operation in areas related to standardization, incl uding with respect to conformity assessment.   
Figure 28 
4
IEC Family
Member National Committees
51 Full Members with full voting rights
11 Associate Members with limited voting rights
Affiliate Country Programme
68 participating countries
Launched 3 years ago
IEC Standards and how to use IEC conformity 
assessment schemes
IEC “Family” stands at 130
 
 
152. Regarding the "IEC family" set out in Figure 28,  the representative of the IEC noted that the 
difference between an Associate Member and a Fu ll Member was essentially one of voting rights on 
technical work (Associate Memb ers had limited voting rights).  The IEC's Affiliate Country 
Programme had been organized as a direct respon se to a call from the TBT Committee to increase the 
participation of developing countries in the standard -setting work of organizations such as the IEC.  
This Programme had been launched in 2001 and ther e were currently 68 participating countries.  
                                                      
16 Mr. Jonathan Buck, Head of Communications, IEC Central Office, Geneva. G/TBT/M/33/Add.1 
Page 36  
 
Essentially, it provided guidance on the selection of  appropriate standards and focus of relevant 
technical work in developing countries.   
 
Figure 29 
5
Conformity Assessment
1stparty, the seller: supplier’s declaration of 
conformity
2ndparty, the buyer: purchaser does his/her own 
testing
3rdparty, neither seller nor buyer: independent testing
 
 
153. With respect to the basics on conformity assess ment, there were three different types of 
schemes (Figure 29).  He would only focus on the schemes of the IEC which dealt with third party (i.e. independent) testing, although the IEC did provide  international standards in the other two areas.  
Reiterating the point that conformity assessment schemes could make a contribution to facilitating 
trade, it was noted that there was a growing emph asis on world markets and, in response to market 
needs, global conformity assessment ensured that time was saved and costs were cut – also at the global level.  The key issue was:  increasing confidence  in products and services.  
154. The IEC had three conformity assessment schem es which all fell under a Management Body 
known as the Conformity Assessment Board.  Thes e were the IECEE, the IECQ-CECC (dealt with 
quality conformity of electronic components in the non-regulated areas) and the IECEx (dealt with 
electrical equipment for operation in explosive atmos pheres, heavily regulated).  All of the schemes, 
including the IECEE, had common objectives.  These could be summarized as: (i) flexible national 
representation from both government and private sector;  (ii) open to members and non-members; and, (iii) the use of the principle of Peer Assessment.  Regarding the latter, Figure 30 compared 
multilateral Peer Assessment with the alternative of concluding a series of bilateral agreements.    G/TBT/M/33/Add.1 
 Page 37 
 
 
Figure 30 
9
Principle of peer assessment
Bilateral recognition
H
A
B
C
DEFG H
A
B
C
DEFG
IEC SCHEMEPeer assessment
Multilateral
n(n-1)/2 relations
1,260 audits
630 agreementsn relations
36 audits
1 agreementExample
N=36
 
 
155. The schemes were all based on IEC internati onal standards.  Nevertheless, while they 
encouraged the harmonization to these standards, they accommodated national differences.  The IEC 
schemes were product-focused, not system-focused.   The schemes endeavoured to eliminate the 
multiple testing of products (except where there was a need to test for national differences) and they 
covered regulated as well as non-regulated areas.   
 
Figure 31 
11
IEC and Conformity Assessment
IEC COUNCIL
National Committees
IECEECOUNCIL BOARD
CONFORMITY ASSESSMENT
BOARD
Management of CertificationEXECUTIVE COMMITTEE
(IEC Officers)
STANDARDIZATION MANAGEMENT 
BOARD
Management of International 
Consensus Standards Work
IECEx
IECQ-CECC
 
 
 156. The functioning of the schemes was illustrated in Figure 31.  Basically, on the top, the 
governing body within the IEC was the IEC Council.   The Standardization Management Body looked 
after the technical development of the standard s and, underneath that, there were 175 Technical 
Committees, and about 15,000 experts around the world writing the international standards.  On the 
right-hand side, there was the Conformity Assessment  Board, which oversaw the running of the three 
schemes.   
157. It was noted that the IECEE Scheme was a multilateral certification system based on 
international standards.  It dealt with the safety
 of electrical and electronic products and its aim was to G/TBT/M/33/Add.1 
Page 38  
 
facilitated trade by promoting harm onization of national standards with  international standards.  It 
was managed by the Certification Management  Committee which reported to the Conformity 
Assessment Board.  The Scheme was also known as the "CB Scheme" which stood for Certification 
Bodies Scheme.  Within the Scheme there was a "Member Body" (or the National Certification Body 
– which could either be recognizing or recognizing and issuing), the Testing Laboratories, the Test 
Certification (which was the proof the product confor med to the IEC Standard), and, finally, there was 
a Test Report, which was the report of the test, give n to the National Certification Body in order to 
issue the certificate. The Membership of the CB Sche me was set out in Figure 32 and  Figure 33 listed 
the full range of subject matters  covered by the Scheme.   
 
Figure 32 
14
IECEE Statistics
43 Member countries
54 National Certification Bodies
129 Testing Laboratories
34 117 testing certificates issued in 2003
CB-Full Certification Scheme: Manufacturers can 
reduce steps required to obtain certification at 
national level
 
 
Figure 33 
15
IECEE Scheme Coverage:
IT and office equipment
Electronics, entertainment
Electrical equipment for 
medical use
Installation accessories 
and connection devices
Safety transformers and 
similar equipment
Lighting
Switches for appliances 
and automatic controls for 
electrical household 
appliancesPortable tools
Photovoltaics
Household and similar equipment
Measuring instruments
Low voltage, high power 
switching equipment
Installation protective 
equipment
Capacitors as components
Batteries
Cables and Cords
 
 
158. How did this work?  The manufacturer of equipment wishing to export that equipment to a 
country would send the equipment for testing to obtai n a certificate.  The laboratory would test the 
equipment for conformity to the relevant IEC Inte rnational Standards.  A CB Test Report would be 
issued and sent to the NCB which would, subsequently , issue a certificate (CB Test Certificate).  Then 
the manufacturer who wished to export the equipm ent would send the CB Test Certificate to the  G/TBT/M/33/Add.1 
 Page 39 
 
 
National Certification Bodies (NCBs) in other count ries.  The NCBs in those countries (Issuing and 
Recognizing) would issue the certificates without testing the equipment as they would recognize  that 
testing and assessment had already been done.  Next, according to the status of the NCB, the manufacturer would be able to affix other countries'  national marks of conformity to its equipment 
and export this equipment to those countries (and/or receive a Test Certificate proving that they could 
enter that market).  This saved both time a nd money, reducing overall manufacturing costs. 
 
Figure 34 
18
Test Certificates issued
 
 
159. In terms of the evolution of the Test Certif icates under the Scheme, Figure 34 showed the 
number of certificates that had been issued sin ce 1994; these were now close to the 34,000.  The 
lighter bar (to the right) showed the level of r ecognition by other national certification bodies (NCBs), 
in other words, other certificates being is sued as a result of that recognition.  
160. The IEC had an on-line system of registration of  all the certificates.  There were currently 
45,000 certificates registered since 2002.  This syst em gave the end-user full access to information on 
which certificates had been issued, where and by whom .  It allowed all parties involved in the process 
to have immediate verification of the Test Certif icates.  More information was available on the web-
site itself.17   
161. What were the potential advantages of the Sche me?  For the consumer, the Scheme offered 
confidence in compliance of imported products.  A regular concern voiced in WTO workshops the 
IEC had participated in was th e issue of "dumping" of poor qu ality goods.  Developing countries 
wanted to use a scheme, such as the CB Scheme, in  order to prevent the dumping of low quality goods 
on their territories.  The Scheme also prevented "hid ing" behind false origins (e.g. built in one place 
but trans-shipped through another).   Moreover, the Scheme opened up  the widest range of acceptable 
products to consumers.  With respect to the benefits  of the Scheme for the industry, the whole idea of 
the Scheme was about reducing manufacturing costs – it eliminated the need for repeated testing 
around the world.  This could also mean that market s opened faster as the delays connected to testing 
would be reduced.  For government, the potential adva ntage was that there was confidence that the 
imported goods were in compliance.  Moreover, the Sc heme offered an assurance of neutrality in that 
there would be no favoured supplier countries.  In  this sense, the CB Scheme offered the assurance 
that the issuer of the certificate did indeed confor m to Article 6.1.1 of the TBT Agreement, regarding 
the phrase on "adequate and enduring technical competence".   
                                                      
17 www.iecee.org. G/TBT/M/33/Add.1 
Page 40  
 
 
Figure 35 
23
WARNING!!!
Do not put the “cart before the horse”
Standards are used as reference points for conformity 
assessment
A country needs standards before its can truly benefit 
from conformity assessment
 
 
162. One of the problems the IEC had encountered w ith the Affiliate Country Programme, was that 
the countries tended to ask for information on th e conformity assessment schemes without really 
looking first at the need for national standards.  As underscored in Figure 35, there was a need for 
having an infrastructure in place at the national level relating to the standards  required that best met a 
given country's particular needs. Standards pr ovided the reference point for the conformity 
assessment.  In other words, a country  needed to establish its standards before  it could truly benefit 
from the conformity assessment schemes. 
163. The IEC Schemes were global in nature.  The IEC endeavoured to provide the one-stop shop 
with the relevant international standards in its core competency area, as well as the relevant 
conformity assessment schemes.  The IEC believed that the principle of Peer Assessment was proving to be a viable model and was, in practice, wo rking well.  The Schemes themselves were open to 
Members and Non-Members of the IEC.  The CB Scheme was a particularly good example.  Over the 
last ten years, the growth of the recognition of the Scheme – and the level of interest from all 
countries – had been remarkable. The IEC had tried to adopt a "building block approach" to encourage and help countries to estab lish their needs, first in terms of the standards, and then to 
identify which was the appropriate use of the conf ormity assessment scheme that best met the national 
needs and resources.  
2. Discussion 
164. The representative of Chinese Taipei
 asked whether there was an interface between the CB 
Scheme and the MRA operated by ILAC, or the MLA operated by the IAF.  Was there an interface in the recognition of test reports or test certificates?  Also, it had been mentioned that the Schemes were 
open to non-members and the representative of Chinese Taipei wished to have some further 
elaboration on this point.  
165. The representative of the IEC
 noted that an active relationship already existed between 
IECEE and ILAC. The two bodies were collaborating on joint assessments, sharing common sets of 
documents, in addition to regular  meetings under the auspices of the IEC Conformity Assessment 
Board and the ILAC Technical Panel.  The IEC EE and ILAC had established a Joint Working Group 
entitled "Uniform understanding of ISO/IEC 17025" . In addition, the IECEE was currently 
considering signing a Memorandum of Understanding between ILAC members and IEC Schemes 
(essentially IECEE) members. The IECEE had also initiated preliminary discussions with the IAF  G/TBT/M/33/Add.1 
 Page 41 
 
 
with a view to achieving similar objectives and pro cedures as those in place with ILAC.  Regarding 
membership, it was noted that it was the IEC National Committee that designated the national 
certification body in their country. In terms of the application, non-members could simply apply to the IEC secretariat in Geneva requesting participation in the IEC Scheme and th e IEC membership would 
consider that application.
18   
166. The representative of the United States  wished for some more elaboration on the point that a 
country needed standards before it could truly be nefit from conformity assessment.  At a practical 
level what did this mean and what would the IEC advice be to a particular country? 
167. The representative of the IEC  stressed that the IEC was trying, through the IEC Affiliate 
Country Program, to demystify the world of electrot echnical standards.  It had to be recognized that 
developing countries did not need full and comprehensive access and use of all 4,500 IEC 
international standards.  What the IEC was trying to do  was to work with participants to try to identify 
what were the areas of domestic interests and releva nce to that country, both with respect to its 
domestic industry as well for the potential of importing electrical goods.  
168. The representative of Switzerland  asked what the exact requirements were for certification 
bodies to become a "national certification body".  Was it so that smaller or medium sized certification 
bodies were unlikely to meet the criteria under the IEC CB scheme?  In other words, how could it be 
avoided that the IEC CB Scheme became a "club" for larger certification bodies?  
169. The representative of the IEC  clarified that the terms of operation of the Scheme clearly stated 
that every country was permitted to participate at wh atever level it wished. The level of benefits and 
the level of membership was determined according to  the national needs of each country. In terms of 
the management of the Scheme, there was a C onformity Assessment Board which oversaw the 
functioning of the CMC running the CB Scheme so as to ensure that there was fair representation and 
that all applications and enquiries to the Sche me were handled in an appropriate manner.  
E. ORGANIZATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) 
170. The representative of the OECD19 noted that in its successive reviews of the operation of the 
TBT Agreement, the TBT Committee had in the past noted concerns with respect to the restrictive 
effect on trade of diverse and often multiple conf ormity assessment procedure and requirements. As 
part of its ongoing work, the OECD was currently i nvolved in the identification and analysis of the 
nature of non-tariff measures which had a potentia lly negative impact on market access, and could 
potentially cause difficulty to traders.  In this re gard, the OECD had launched a study which looked in 
particular at how conformity assessment procedures could facilitate trade on one hand, but could also 
cause some difficulties on the other. This work woul d involve some conceptual analysis, such as the 
identification of the players who operate in the fi eld, and the costs and benefits which conformity 
assessment procedures entailed.  It needed to be kept in mind, however, that conformity assessment 
procedures was "a big whole" whose parts could be quiet drivers, interrelated and each of which could 
individually benefit or hamper trade. The OECD  would be looking at under what circumstances 
conformity assessment requirements can facilitate trade or create barriers.  
171. Regarding the policy context, it needed to be kept in mind that conformity assessment 
procedures could provide substantia l benefits for manufacturers, consumers, government regulators 
and for trade in general. The primary aim of the procedures was to prove wh ether products were safe 
and fit for use and consumption, or not so. This system therefore supported the role of regulators 
                                                      
18 This response was provided in writing by the IEC after the me eting.  More detailed informa tion can be found in the Basic 
Rules IECEE 01 and Rules of Procedure IECEE 02, availa ble from http://www.iecee.org/cb scheme/pdf/IECEE01.pdf and  
http://www.iecee.org/cbscheme/pdf /IECEE02.pdf, respectively. 
19 Ms. Barbara Fliess, Principal Admini strator of the Trade Directorate. G/TBT/M/33/Add.1 
Page 42  
 
responsible for protecting health, safety, environm ent etc.  Conformity assessment procedures had a 
legitimate role to play in the overall context of regulatory regimes.  
172. The OECD study would also consider the negative effects of conformity assessment 
procedures systems;  these entailed costs to produc ers, importers, governments and society overall.  
There needed to be a cost-benefit analysis of each such system. And while conformity assessment was 
part of the normal costs of doing business, and n ecessary in both domestic and international trade, it 
could also present significant costs for traders that could arise in three ways:  it could raise costs 
directly to business, it could delay market entry, and it could raise transaction cost, thereby reducing 
competition and retarding the development of economi es.  Duplicative testing was one example that 
could lead to all three of these cost outcomes. 
173. It was noted that the data on costs of compliance and the different effects on market access 
that conformity assessment procedures presented in  different countries, was scarce.  Hence, the 
OECD's work would be a systematic effort to gath er available data and perhaps even generate new 
data in this regard.  The OECD would review WTO material, including submissions and discussions 
in the TBT Committee.  From this review of WT O material, the OECD study aimed at producing a 
shortlist of key concerns and issues of importance to  trade which would guide the subsequent part of 
OECD analysis which would, in turn, consist of conducting several case studies to document and illustrate the ways in which specific conformity assessment requirements impacted on trade, and the 
experiences with the tools which were available for action.  
174. In addition, the OECD work would seek to dete rmine the extent of cross-border conformity 
assessment activity today.  It would seek to answer the question of whether conformity assessment 
activity was getting easier or more difficult. It would also examine whether conformity assessment 
barriers were the subject of significant concerns to bu sinesses that engaged in trade.  Given the lack of 
data, OECD would consider collec ting data through a survey instrument, possibly by involving a 
sample of conformity assessment bodies, and the OE CD would also conduct focused interviews with 
other stakeholders who were closely affected by conformity assessment requirements, such as 
manufacturers and exporters.  
175. The OECD hoped that the study would provide useful background to the discussions in the 
TBT Committee.  It could contribute greater spec ificity on information on national experiences that 
were being dealt with in the TBT Committee's wo rk programme.  The study could also benefit 
developed and developing  countries which were in the process of developing or improving their 
existing conformity assessment infrastructure, progr ammes or policies. The OECD expected that the 
first report of the results of this research would be available at the end of 20 05.  The OECD would be 
pleased to share this with the TBT Committee. 
F. I
NTERNATIONAL ORGANIZATION OF LEGAL METROLOGY (OIML) 
1. Statement 
176. The representative of the OIML20 noted that the OIML was a Paris-based inter-governmental 
treaty organization, which had been founded in 1955 and signed, originally, by 24 countries.  When 
the Metre Convention (previously addressed by the BIPM, Figure 21, above) was established, it had been thought that this organisation would be able  to solve all metrology problems.  However, 
participants discussed a number of practical problem s within an International Conference on Practical 
Metrology, and it was decided to establish the OIML as a separate organization to look at these practical problems pertaining to the regulated u se of measurements and measuring instruments. 
                                                     
 
20 Mr. Ian Dunmill, Assistan t Director of the OIML.  G/TBT/M/33/Add.1 
 Page 43 
 
 
177. Currently there were 59 Member States of th e OIML and 50 Corresponding Members.  The 
main difference between the two categories was one of voting rights (Figure 36, see also paragraph 191, below). 
Figure 36 
2What is the OIML ?What is the OIML ?
Inter-governmental treaty organisation
Treaty signed by 24 countries in 1955
Currently has 59Member States …
… and 50Corresponding Members
Headquarters in Paris (the BIML)
 
 
178. In distinguishing between the work of the OIML  and that of the BIPM, the representative of 
the OIML referred to the definition of "legal metrol ogy" and stressed that the key issue was that legal 
metrology was where governments became concerned with measure ment, and this was where the 
OIML had a role to play whereas the BIPM was concerned with the primary metrological standards: 
“Legal metrology comprises all activities for which legal requirements are prescribed 
on measurement, units of measurement, measuring instruments and methods of measurement, these activities being perform ed by or on behalf of governmental 
authorities , in order to ensure an appropriate level of credibility of measurement 
results in the national regulatory environment. Legal metrology is not a specific 
discipline of metrology, it makes use of scientific metrology to get appropriate 
references and traceability, and it may a pply to any quantity addressed by 
metrology.” [emphasis added] 
(Draft Revision of OIML D 1 Law on metrology ) 
179. In addition to the traditional areas of competence on weights and measures, a number of other 
fields now fell under the scope of legal metrology.  In this sense there had b een considerable change 
in the scope of legal metrology which had originally  been focused almost exclusively on weights and 
measures in the marketplace.  Today, legal metrol ogy was applied to areas such as health and safety 
(for example, medical measuring instruments, equipm ent used to analyse samples taken in a medical 
context, or radiation dose meters);   protection of workers in the environment from noise, vibration and 
radiation;  measurements in the environmental pollu tion field (pollution of the earth, water and soil); 
and in the field of law enforcement (speed  detectors and alcohol breath meters). 
180. The OIML aimed at eliminating barriers to trade caused by metrology.  It did this by 
harmonizing laws and regulations used in its Member States in the areas of measurement, pre-
packages and measuring instruments.   Pre-pack ages, which had not been one of the original 
considerations of the OIML, had become an impor tant area for developing countries, where a large 
percentage of their exports were pre-packaged agricultural products destined for industrialized 
countries.  In attempting to harmonize these laws, the organization produced "International G/TBT/M/33/Add.1 
Page 44  
 
Recommendations", which were a form of interna tional standard.  There were currently over a 
hundred of these, covering all the different ranges of  measuring instruments.  These were intended to 
be model technical regulations that were deve loped by technical committees throughout all the 
Member States of the organization.  They set out metrological requirements for the accuracy of the instrument, and technical requirements, where these were necessary.   The OIML also produced 
standard test procedures and standard test reports, so that the same tests were applied in different 
countries. 
181. The OIML Certificate System fo r Measuring Instruments  was set up in 1991.  A certificate 
issued under this scheme stated that a particul ar measuring instrument complied with all the 
requirements of the appropriate International R ecommendation.  There was a supporting test report 
which gave all the details of the type approval tests which were conducted to gain that certificate.  The 
OIML certificates were registered at the headquart ers of the OIML against a fee paid by the issuing 
authority, and the certificate Issuing Authority us ually passed that fee on to the company that was 
receiving the test certificate.  This was a comple tely voluntary system; there was no obligation for any 
other Member State of the organization to accept that certificate. 
182. This voluntary recognition had enabled devel oping countries to have a "ready-built" type 
approval system.  Many developing countries accepted these certificates, even though they had neither any metrological infrastructure nor testing facilities themselves, to give a guarantee of the level of quality and accuracy of measuring instruments whic h they accepted to put on their domestic market.  
They would then require some kind of policing infrast ructure, in order to ensure that the instruments 
on the market actually were the same ones. 
 
Figure 37 
7OIML Certificates by categoryOIML Certificates by category
Non automatic weighing instruments
Load cells
Automatic catchweighing instruments
Fuel dispensers
Automatic gravimetric filling instruments
Diaphragm gas meters
Automatic level gauges
Continuous totalizing weighing instruments
Others
 
 
183. About a third of all the certificates which had been  issued were for load cells (large dark area 
in Figure 37), which were a module of weighing inst ruments.  The other large sector (light-coloured) 
was for non-automatic weighing instruments (the ki nd of instrument commonly found in a grocer's 
store or supermarket, or a vehicle weighbridge).  In  other words, around two-thirds of the certificates 
which had been issued were for parts of, or w hole, weighing instruments.  Hence, although the 
System covered a large number of different categories of instruments, the vast majority of certificates which had been issued were for weighing instruments. 
184. Although the system had worked well, and in practice there was a very wide recognition of 
the certificates amongst OIML Member States, it was d ecided that something else needed to be done.   G/TBT/M/33/Add.1 
 Page 45 
 
 
With the objective of addressing the issue of acce ptance of the certificates, in 2003, the OIML 
established a Mutual Acceptance Arrangement (MAA ), which was a framework for the acceptance of 
certificates amongst Member States of the OIML.  Issuing authorities in Member States would sign 
Declarations of Mutual Confidence (DoMC), of which there would be one for each category of 
instruments (one for non-automatic weighing instrume nts, another for petrol pumps, etc.).  No one 
country had to sign up to all of them, so the gr oups of countries could be completely different, 
according to the category of instrument concerned.  Nevertheless, the participants that signed these 
agreements agreed to accept and use test repor ts which were issued under the agreement in the 
production of their national type approvals,  and not to repeat all the testing. 
185. The representative of the OIML stressed that it was important to note the fact that DoMCs 
were engagements between the Issuing Authorities w ithin countries;  it was not the State that was 
engaging itself.  There was still need for a type approval process in each country.  This system only 
intended to harmonize the use of the test reports;  it was not an acceptance of a certificate.  In other 
words, because the OIML had no legal basis for i ssuing an international type approval, individual 
Member States would still have to issue type approval certificates of their own.  Confidence was built-
in either by accreditation (by signatories of the ILAC MRA) or by peer assessment – either approach 
was based on ISO 17025. 
186. For each DoMC, a Committee on Participation Revi ew (CPR) would be set up, consisting of 
representatives of those countries wishing to particip ate to consider whether they were all at the 
appropriate level to be accepted internationally amongst themselves.  The OIML secretariat would 
participate in the CPRs to ensure that there wa s a consistent approach taken between different 
categories of instruments.  For example, wh en a DoMC was signed for non-automatic weighing 
instruments, there would be a transition period wher e participants in that particular DoMC would 
issue all their OIML certificates ba sed on that DoMC, but non-participants in the DoMC would still 
be able to issue OIML certificates under the old OIML Certificate System.  After that transition 
period, those who were not participating in the DoMC would be stopped from issuing OIML 
certificates.  It was noted that the arrangements for th is had yet to be finalized.  Moreover, this was a 
fee-based system, where it is proposed that the I ssuing Authorities would be paying a fixed annual fee 
(€1200) to participate in each DoMC that they choose to participate in.  It is also proposed that there 
will be an additional fee for registration of each ce rtificate issued under that DoMC (€150).  The first 
two DoMCs would be for load cells and for non-auto matic weighing instruments.   The first stages for 
setting these up (establishment of the CPRs and preparation for the signing of the DoMCs), would 
take place in the beginning of 2005,  following the recruitment of a new member of staff at the BIML 
to take responsibility for this.21 
2. Discussion 
187. The representative of the United States  enquired whether the concept of Declaration of 
Mutual Confidence was different from the concept of  mutual recognition agreements / arrangements 
(MRAs)? 
188. The representative of the OIML  replied that there was no significant difference between the 
two terms and that it was basically a group of countries, or a group of Issuing Authorities in those countries, who got together to decide whether the te st results produced within those countries were all 
acceptable to each other. The intention was to ensure  that the countries were confident with their own 
results of measurement. 
189. The representative of Canada
 asked what the procedure was for becoming a Member of the 
OIML? 
                                                      
21 More information is available at:  www.oiml.org. G/TBT/M/33/Add.1 
Page 46  
 
190. The representative of the OIML
 replied that there were two categories of membership 
according to the Convention which set up the organi zation:  "Members States" and "Corresponding 
Members".  The Corresponding Members had a higher proportion of developing countries than were 
included in Member States. There were slight ly different requirements for each category of 
membership.  In order to become a Member State, th e country needed to be a signatory to the original 
treaty;  this was a longer process (and of a more political nature).  To qualify as a Corresponding 
Member, it was sufficient that the h ead of the national authority responsible for legal metrology sent a 
letter to the OIML requesting membership and furn ished an undertaking to continue to pay the 
subscription, which was around a €1000 per year (for Corresponding Members).  The minimum subscription for a Member State was around €12000. 
191. Contributions from Member States were divided into classes as a function of population, with 
some derogation given to those countries with a la rge population but low GDP.  In practice, the OIML 
encouraged the participation of developing countries in the activ ities of the OIML.  Corresponding 
Members could participate practically in all the mee tings and work of the organization.  They could 
participate in all the technical work, providing comme nts which would be taken into consideration by 
Technical Committees.  However, Corresponding Members were not eligible to vote on the 
acceptance of documents produced by the Tech nical Committees.  Moreover, to encourage 
developing countries to make use of OIML publications , it was the intention of the OIML to make all 
its publications available free of charge to both Members States and non-members as from the 
beginning of 2005. 
G. I
NFORMATION ON ITA  FROM THE SECRETARIAT  
192. The Chairman  drew the Committee's attention to some  other work in the WTO relevant to 
conformity assessment.   He noted that it was his understanding that the Committee of Participants on the Expansion of Trade in Information Technology Products had decided to proceed by formulating 
"Guidelines" in the specific area of  EMC/EMI (E lectro-Magnetic Compatibility / Electro-Magnetic 
Interference) relating to conformity assessment pr ocedures.  He invited a representative of the 
Secretariat to brief the Committee on this work 
1. Statement  
193. The representative of the Secretariat
 noted that the Committee of Participants on the 
Expansion of Trade in Information Technolog y Products was a plurilateral group, currently 
representing some 63 WTO Members.  Pursuant to paragraph 3 of the Annex of the Ministerial 
Declaration on Trade and Information Technology Pr oducts, this Committee had been encouraged to 
examine and consult on non-tariff barriers in IT produc ts (tariffs were minimal in this area and being 
reduced or eliminated).   
194. In November 2000, the Committee had launche d a "Non-tariff Measures Work Programme", 
wherby it would identify NTMs that were impediment s to IT trade.  There were three components to 
this work:  first the identification of NTMs that were impediments to IT trade;  second, the 
examination of their impact on trade in IT products ; and third, give formal consideration to the 
outcome of these two first phases. 
195. During the first phase (identification of NTMs ), 26 non-tariff measures had been notified by 
ITA participants.  The vast majority of these were in the area of conformity assessment / testing and certification (nine particular notifications), and th e second largest incidence of NTMs was in the area 
of standards and regulatory envi ronment (eight notifications).
22  
                                                      
22 Document G/IT/SPEC/Q2/11/Rev.1 compiles th is information on the NTBs identified.    G/TBT/M/33/Add.1 
 Page 47 
 
 
196. As a practical way to proceed, one particular NT B was chosen for a so-called "pilot project".  
This was the EMC/EMI (electromagnetic compatibility/e lectromagnetic interference).  As a first step, 
the Committee conducted a survey to get an idea of the different regulatory environments or regimes 
of ITA members.  Following this, in 2003, a workshop was held specifically on EMC/EMI.  At this workshop it was determined that while there was a large degree of harmony with respect to the 
standards, the problem was more one of conformity assessment procedures.
23    
197. A paper on so-called "Best Practices for EMC/EMI-Related Conformity Assessment 
Procedures for IT Products", which highlighted ma ny of the points from our workshop, took the 
matter to the next step (G/IT/24).  At the last meeting of the Committee (June 2004), the Committee agreed to move forward and proceed by formula ting "guidelines" for EMC/EMI-related conformity 
assessment procedures.   
 
__________ 
                                                     
 
23 An overview of the survey responses is contained in documen t G/IT/SPEC/Q4/19/Rev.2.  More information on the workshop 
is contained in document G/IT/23 and the WTO web site compiles all the presentations made at the workshop.