   
  
G/TBT/GEN/323  
 
28 March 2022 
(22-2560) Page: 1/6 
Committee on Technical Barriers to Trade    
 
THEMATIC SESSION ON CONFORMITY ASSESSMENT PROCEDURES  
(ACCREDITATION)  
8 MARCH 2022, 10:00 -13:00  
Moderator's Report1 
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At the Ninth Triennial Review, Members agreed to continue to hold thematic sessions in conjunction 
with its regular meetings during 2022 to 2024, with a view to further deepening the Committee's 
exchange of experiences on specific topics. On this basis, the Committee agreed to hold a thematic 
session on conformity assessment procedures with a focus on accreditation.2 Information about the 
speakers, presentations, and related materials are available on the WTO website.3 
 
1  GUIDING QUESTIONS  
• How can accreditation and related policies of Members be advanced to further reduce 
barriers to trade in goods? How can the ILAC and IAF, and cooperation between accreditation 
systems, be leveraged to avoid such barriers?  
• How has accreditation landscape changed in the past 25 years since the TBT Agreement was 
drafted, and is there a need for further Committee guidance on accreditation considering 
this? 
• How can accreditation (and accreditation policies) help permit participation of CABs located 
in the territories of other Members in their CAPs on a national treatment basis, in light of 
multiple approac hes to support a trusted accreditation regime?  
 
2  INTERVENTIONS  
2.1.  Mr. Fei Yang4 (China) explained how accreditation facilitates export of mask s and other 
epidemic prevention products. After the outbreak of COVID -19, there was fast-growing demand for 
China -manufactured anti -epidemic products including facemasks, protective gloves, protective suits 
and other personal protective equipment. However, standards and conformity assessment 
procedures for those products , he noted,  are n ot harmonized across countries and referred, as an 
example, to differences between the standard s of China and the European Union for facemasks. In 
particular, he noted that EU regulations require facemasks for medical use and personal protection 
to be cert ified by notified bodies and that Chinese manufacturers encountered difficulties in satisfying 
these requirements.  
2.2.  Mr Fei Yang  further explained that the European Commission issued Commission 
Recommendation (EU) 2020/403 of 13 March 2020 on conformity ass essment and market 
surveillance procedures within the context of COVID -19, allowing EU member States to grant access 
to Chinese facemasks manufactured and tested according to Chinese standards as long as testing 
laboratories  are accredited by the China Nat ional Accreditation Service for Conformity Assessment 
(CNAS). In response to these developments, CNAS cooperated with European Accreditation (EA) and 
 
1 Mr. Hélio Silva (Brazil). This Report is provided on the Moderator's own responsibility.  
2 G/TBT/46 . 
3 https://www.wto.org/english/tratop_e/tbt_e/tbtts_e/tbtts080322am_e.htm  
4 Director of international cooperation division, China National Accreditation Services for Conformity 
Assessment (CNAS).  G/TBT/GEN/323  
 
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  published the list of accredited testing laboratories for facemasks and other personal protective 
products  that helped EU authorities to gain confidence in CNAS accreditation. CNAS  had received 
more than 500 enquires asking to confirm authenticity of test reports and CNAS assigned dedicated 
staff to provide timely responses to all enquiries. This case study, h e said, demonstrates that 
accreditation plays a critical role in reducing barriers to trade and facilitating cross -border trade in 
goods.  
2.3.  Mr. Reinaldo Figueiredo5 (United States) presented an overview on the global acceptance of 
conformity assessment resu lts and ISO/CASCO work in this respect. He noted that CASCO is a 
committee in ISO that develops conformity assessment standards , guides and recommendations  
(these are known as the ISO/CASCO toolbox). He said that regulators and the private sector, when 
using the ISO/CASCO toolbox, assure the market that statements of conformity in relation to 
products, processes or services are well grounded. He also noted that the ISO/CASCO toolbox is 
widely used by conformity assessment bodies and had proven to be support ive in designing 
conformity assessment procedures. Mr. Figueiredo specifically referred to 
ISO/IEC  Guide  60:2004(en) Conformity assessment  — Code of good practice  which is currently 
being revised . He noted that CASCO has a policy for developing standards ( e.g. "common elements", 
neutrality principles) and explained the two layers of consensus in CASCO: national  (national mirror 
committees) and international. Based on the above, he said that CASCO as a global network can 
contribute to reducing technical barr iers to trade.  
2.4.  Ms Stacy Cho6 (United States) provided an overview of a new, voluntary conformity 
assessment program for medical devices called the Accreditation Scheme for Conformity Assessment 
(ASCA)  Pilot Program . The aim of the ASCA , she said,  is to enhance the FDA's confidence in test 
methods and results, promote a least burdensome approach to the development and review of 
medical devices and support international harmonization. It seeks to decrease the burden of 
individual premarket submission an d ensure that patients have timely and continued access to safe, 
effective, and high  quality medical devices. She noted that the FDA, when establishing this program, 
uses existing international standards whenever possible (e.g. ISO/IEC 17011, ISO/IEC 17025 ). 
2.5.  Ms Cho provided an  overview of how the ASCA program works: (i) the FDA grants  ASCA 
recognition  to qualified accreditation bodies; (ii) testing laboratories who want to be part of the 
program obtain an assessment from an ASCA recognized accreditation bod y and then obtain ASCA 
accreditation from the FDA; (iii) medical device manufacturers select ASCA accredited testing 
laborator ies; (iv) ASCA accredited testing laboratories conduct testing and provide relevant 
information to the manufacturers; (v) the manu facturers include their declaration of conformity and 
ASCA summary test report in their premarket submission to the FDA; and (vi) the FDA conducts a 
review of the submission per the ASCA guidance documents.  
2.6.  Ms Elisabeth George7 (United States) highlighte d the value of conformity assessment from 
the perspective of the medical device industry. She noted that Philips is an active member of many 
standard -developing organizations (including ISO, IEC, CTA, AAMI, NEMA, ASTM). She said that 
Philips  embraces the u se of international standards that support the company in getting the products 
into the market in a timely fashion. She then explained some particularities of medical device 
industry, and, in this context, emphasised the need to get life -saving technologie s to the patients 
as soon as possible by removing technical barriers to trade, focusing on good regulatory practices, 
and leveraging standards and conformity assessment. In this respect, Phillips supports the work of 
the Inter -American Coalition for Regula tory Convergence for the Medical Technology Sector. 
Regulatory misalignment impacts the time to market and potentially access to key innovations. In 
seeking authorization in the US and EU markets, Philips will submit the same test data and 
certifications, but must go through two different review processes ; this increases the  burden. In this 
respect, she called for further efforts to advance the work on an IMDRF Medical Device Single Review 
Program (MDSRP). In other markets like Brazil, China or Japan, conformity assessment produces 
were not globally aligned, and variations be tween regulators in terms of structure, resources and 
standards recognition leads to different requirements for retesting, re -certification and additional 
labelling. Ms George emphasized the benefits of manufacturers being able to test once, and submit 
 
5 Chair, International Organization for Standardization, Commi ttee on Conformity Assessment (CASCO) 
(ISO).  
6 Senior Policy Analyst, Standards and Conformity Assessment Program, Center for Devices and 
Radiological Health, U.S. Food and Drug Administration.  
7 Head of Global Regulations & Standards, Phillips.  G/TBT/GEN/323  
 
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  the same data to all jurisdictions, which supports a more rapid access to market s giving all patients 
globally the same care.  
2.7.  Ms. Gillian Kelleher8 (United States) stressed  the value of accreditation in the work of the 
Global Food Safety Initiative (GFSI). The GFSI  brings together 37 retailers and manufacturers to 
oversee food safety standards for consumers and plays a unique role in enhancing food safety 
management systems around the world. The GFSI focuses on three strategic objectives: (i) 
benchmarking an d harmonization; (ii) capability building; and (iii) public -private collaboration. She 
explained that the GFSI does not provide food safety certification but rather recognizes certification 
programs that meet the GFSI benchmarking requirements , including  that certification bodies must 
be accredited against ISO/IEC 17065 or ISO/IEC 17021 , and must be assessed by accreditation 
bodies that are IAF members and signatories to IAF MLA. She said that these requirements provide 
a proven framework of check s and bala nces that improves the rigor and consistency of the audit of 
the certification process. Accreditation plays a key role in advancing food safety around the world 
and builds trust and confidence among food industry stakeholders.  
2.8.  Mr. Sugeng Raharjo9 (Indone sia) provided an overview of accreditation policy in Indonesia 
in supporting the acceptance of export products. Starting in the 2000s, accreditation in Indonesia 
began to improve product quality and facilitate trade. The National Accreditation Body of Indonesia 
is the only national accreditation body in Indonesia. To ensure global recognition and acceptance of 
conformity assessment results, it became a signatory to, among others, the IAF and ILAC.  Mr 
Raharjo elaborated on Indonesia's timber legality verification system , implemented in 2002 in light 
of the illegal timber trade problem in Indonesia which  had made it difficult for Indonesian wood 
products to access international markets. However, t his tool had not been effe ctive in assuring 
trading partners that Indonesian timber was not produced illegally. The situation changed only after 
the conclusion of the Indonesia -EU Voluntary Partnership Agreement  to improve forest governance 
and promote trade in legal timber from In donesia to the EU  in 2014 (that became effective as of 
2016). This scheme helped to enhance confidence and increase export value of Indonesian wood 
products. This case study, he said, demonstrates that in some cases accreditation schemes are not 
enough in supporting the acceptance of export products , and there is also a need for concluding 
mutual recognition agreements.  
2.9.  Mr. Emanuele Riva10 (European Union) emphasized  the importance of having data that 
demonstrate s the value of accreditation  to economies an d societies . In this respect,  the IAF launched 
the working group on sustainability that will be open for different stakeholders. He referred to an 
Italian study (June 2019 –May 2020) on the impact of the quality infrastructure ( QI) that 
demonstrated that QI: (i) provides benefits for the economy; (ii) constitutes an investment for the 
economy (e.g. higher productivity of certified manufacturing exporting companies); and (iii) has an 
impact on sustainability (e.g. less injury due to  the adoption of a certified management system; 
million tons of CO2 equivalent saved due to certifications in the energy and environmental fields).  
To better understand trends in certification and sustainability, he mentioned the IAF CertSearch 
database of  accredited certifications. He reported that  the IAF was in the process of merging with 
the ILAC to arrive to one organization and align from a technical point of view.  
2.10.  Mr. Andreas Steinhorst11 (European Union) discussed the role of accreditation in the E U 
single market for goods and international trade. He explained that the European co -operation for 
Accreditation ( EA) is an association that comprises 49 national accreditation bodies and is recognized 
by the European Commission as the European accreditati on infrastructure. He explained that two 
decades ago the European accreditation landscape had been fragmented, and, as a result, 
conformity assessment bodies needed to obtain several accreditations. In 2008, the European 
Commission reached consensus to est ablish a common accreditation framework. He then explained 
key principles of accreditation  from the EU perspective : (i) accreditation is the last level of control 
in conformity assessment process; (ii) accreditation serves public interest; (iii) national a ccreditation 
bodies act as public authorities; (iv) accreditation is not -for-profit activity; (v) there must be no 
duplication in the work of conformity assessment and accreditation bodies; (vi) there must be only 
 
8 CEO & President Kelleher Consultants LLC.  
9 Director of Harmonization System and Accreditation, National Standardization Agency of Indonesia.  
10 Accredia Vice General Manager and IAF Chair (IAF).  
11 Executive Secretary of EA (European co -operation for Accreditat ion). G/TBT/GEN/323  
 
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  one national accreditation body; and (vii)  accreditation bodies shall be evaluated by the EA. He also 
highlighted the crucial role of international standards (the ISO/CASCO toolbox) in this context.  
2.11.  He explained how the  accreditation framework is used in free trade agreements. For example,  
CETA contains a TBT Chapter which refers to the CETA protocol on the mutual acceptance of the 
results of conformity. This protocol  establishes a framework for mutual recognition of acc reditation 
and conformity assessment bodies for the covered sectors (e.g. electronic goods, machinery, toys). 
This framework will allow EU companies in selected product categories to have their products tested 
and certified for the Canadian market in the E U, as well as Canadian companies to have their 
products tested and certified for the EU market in Canada.  
2.12.  Mr. Mpho Phaloane12 (South Africa) presented South African 's National Accreditation 
System (SANAS) and the acceptance of conformity assessment results. He said that SANAS is the 
sole accreditation body for the South Africa  established in terms of "Accreditation for Conformity 
Assessment, Calibration and Good regula tory Practice Act, Act No. 19 of 2006 ". SANAS is 
internationally recognized as signatory to the ILAC/IAF/AFRAC MRAs, and a monitoring authority for 
the OECD GLP compliance. He underlined the  common aim of the IAF and ILAC to support conformity 
assessment s chemes which reduce risk for businesses, regulators and consumers by ensuring that 
accredited services can be relied upon. He said that although ILAC/IAF  MRA/MLA is broadly accepted 
in the voluntary domain, there is still work to be done to adopt a system in terms of the regulatory 
domain. In this context, he referred to the TBT Committee's  Indicative List of Approaches to Facilitate 
the Acceptance of the Results of  Conformity Assessment. All the listed approaches  require a level of 
assurance of the compete nce of the conformity assessment bodies so that conformity assessment 
results can be trusted , and accreditation plays an important role in this respect . In order to overcome 
barriers related to differing conformity assessment procedures, WTO Members should  use the 
existing global structures of ILAC and IAF for the mutual acceptance of conformity assessment 
results.  
2.13.  Ms. Lana Marashdeh13 (Jordan) described the role of accreditation in the implementation of 
the Sustainable Development Goals (SDGs). Although CO VID-19 slowed countries' progress in 
achieving the SDGs and widened the gap between developing and developed countries, accreditation 
still has a vital role in achieving SDGs. In particular, accreditation provides technical foundations 
that are critical to  the functioning of developed and developing societies, helps producers to achieve 
greater acceptance of products , and provides consumers with a greater confidence in products. The 
positive impact of accreditation is clearly aligned with the SDGs pillars. She referred to the Jordanian 
decision to exempt  accredited  energy efficient products from taxes as an example of how to use 
accreditation for both  reduc ing technical barriers to trade and achiev ing SDGs.  
2.14.  Mr. Paul A. Moliski14 (United States) presented on accreditation from the perspective of a 
conformity assessment body (Intertek). Intertek strives  to use internationally harmonized standards 
to test products once, certify them and have them accepted globally. He noted that accr editation is 
Intertek's licen ce to do business, especially for providing access to international markets. In this 
context, he explained that individual requirements in certain countries or regions slow business and 
trade and there are some processes that r equire duplicative accreditations.  In this respect, he 
mentioned the need for multiple accreditations for the 6 laboratories operated by Intertek in the EU 
market. In particular, he noted that ILAC  and IAF systems do not always recognize differences in 
national or regional requirements and regulations. There was a need for additional flexibility with 
respect to national implementation of ILAC and IAF resolutions and mandatory documents  in light 
of these differences. Another issue he highlighted is that the relationships between the conformity 
assessment and accreditation bodies do not always constitute a fruitful partnership, and called for  
more productive collaboration with accreditation bodies.  
3  DISCUSSION  
3.1.  The discussion  was focused on the following issues : (i) how accreditation can be used to further 
reduce technical barriers to trade; (ii) how cooperation between accreditation systems can be 
 
12 Executive (Accreditation) at the South African National Accreditation System.  
13 Director of the Jordan Accreditation System (JAS -AU).  
14 Global Vice President of Accreditation, Intertek.  G/TBT/GEN/323  
 
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  leveraged to avoid technical barriers to trade; and (iii) lesson s learned during  the COVID -19 
pandemic.  
3.2.  With respe ct to the first two issues, participants emphasized the key role of the ILAC and IAF 
framework for recognition of conformity assessment results and overcoming technical barriers to 
trade. Active cooperation among national accreditation bodies of ILAC and I AF framework was vital 
to build mutual confidence and trust. However, some challenges with the IAF and ILAC platforms 
were mentioned . The growth of private conformity assessment schemes was overshadowing the 
established system under ILAC and IAF and create d confusion. With respect to medical devices, 
national deviations and additional regulatory requirements limited the potential benefits of ILAC and 
IAF, such that in some markets a product could immediately be placed on the market, while in 
others, this can take two to three years . The lack of flexibility on national implementation of  ILAC 
and IAF directives had been costly for accreditation and certification bodies in certain countries. 
However, it was pointed out that 90% of countries have a simila r accreditation system, with one 
national accreditation body per country.  
3.3.  Participants stressed the importance of : (i) building productive relationships between 
accreditation bodies and local regulators; (ii) concluding mutual recognition agreements for bu ilding 
further confidence in conformity assessment procedures of trading partners; and (iii) stakeholders' 
engagement for greater collaboration among accreditation bodies.  
3.4.  With respect to the COVID -19 pandemic,  there was discussion of how accreditation bo dies in 
developed and developing Members pivoted to remote assessment, which was not precluded under  
the ISO/CASCO toolbox.  COVID -19 accelerated innovations in accreditation, and led to  rethinking 
the methods , breadth of expert participation  and frequency of assessments (e.g. audits can occur 
more frequently with remote tools). In some cases, there was a need to change or provide 
interpretations of  standards  to provide the necessary flexibility  (e.g. certain standards specify one 
audit per year) , but such i nterpretations should in any event be in line with the ISO/CASCO toolbox . 
The potential to use remote assessment and digital tools varied across types of procedures (e.g. 
certification or inspection) . Accreditation bodies need to establish strong relations hips with 
regulators  to help facilitate trade . 
4  COMMENT BY  THE MODERATOR  
4.1.  We heard many useful national and sector case studies on how accreditation systems can help 
reduce technical barriers to trade, and how cooperation between accreditation systems can he lp in 
that regard. International standards, guides and recommendations of the ISO/IEC CASCO are the 
foundation for accreditation and, thus, are integral for facilitating acceptance of conformity 
assessment results.  
4.2.  We talked about how accreditation facili tates mutual recognition of conformity assessment 
results and, therefore, has trade -facilitating effects. In this context, the IAF and ILAC are widely 
recognized platforms for promoting recognition and acceptance of test results through cooperation 
among a ccreditation bodies. The importance of mutual recognition agreements for building further 
confidence in conformity assessment procedures of trading partners was repeatedly highlighted. 
However, some challenges with the IAF and ILAC platforms were mentioned , such as how to handle 
national deviations, and the need to provide flexibility in the implementation of resolutions and in 
relation to mandatory documents that may not be appropriate for all countries or regions. We 
discussed the use of accreditation fra mework in FTAs. For example, CETA contains a TBT Chapter 
and a protocol on the mutual acceptance of the results of conformity. This protocol establishes a 
framework for mutual recognition of accreditation and conformity assessment bodies for the covered 
sectors.  
4.3.  Our discussion highlighted the importance of stakeholders' engagement for greater 
collaboration among accreditation bodies, including with regulators and the private sector. Medical 
devices were highlighted as a sector where accreditation holds gre at potential to facilitate trade and 
reduce barriers. One example demonstrated how regulators can trust and rely on accredited testing 
laboratories to perform pre -market testing of medical devices. Given the need to get lifesaving 
medical technologies to p atients as quickly as possible, there was a suggestion for further 
cooperation between medical device regulators to facilitate registration procedures.  G/TBT/GEN/323  
 
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  4.4.  Accreditation was a tool for supporting implementation of the SDGs, and we heard an example 
of how it ha d helped to promote the use of energy efficient products. We also heard about the value 
of accreditation in facilitating global trade in safe food. The growth of private conformity assessment 
schemes was creating confusion and tended to duplicate governmen t schemes.  
4.5.  We discussed the impact of the COVID -19 pandemic on the global accreditation system. In this 
context, accreditation has been essential for accelerating trade in medical goods. Cooperation 
between accreditation bodies and regulators allowed quali ty and safety assured personal protective 
equipment to move quickly across borders to fill supply gaps. Accreditation bodies worldwide turned 
to remote assessment to ensure continuity of their work while still ensuring rigor and confidence in 
product quali ty. The use of hybrid or remote assessment formats was expected to continue after the 
pandemic, although in -person visits would still be an integral component of the process.  
__________  