G/TBT/54  
 
19 March  2024 
(24-2418) Page: 1/10 
Committee on Technical Barriers to Trade    
 
 
GUIDELINES ON CONFORMITY ASSESSMENT PROCEDURES  
NON-PRESCRIPTIVE PRACTICAL GUIDELINES TO SUPPORT REGULATORS IN THE CHOICE 
AND DESIGN OF  APPROPRIATE AND PROPORTIONATE  
CONFORMITY ASSESSMENT PROCEDURES  
DECISION  
Adopted at the meeting of 13-15 March 2024  
_______________  
 
 
The WTO Agreement on Technical Barriers to Trade (TBT Agreement) recognizes that WTO Members 
may require a positive assurance of conformity with technical regulations or standards to fulfil their 
legitimate objectives, su ch as the protection of human health or safety,  or the  environment ; and 
national security  requirements . Building on previous decisions and recommendations, including in 
the Eighth and Ninth Triennial Reviews, the TBT Committee  agreed to develop non -prescri ptive 
practical guidelines to support regulators in the choice and design of appropriate and proportionate 
conformity assessment procedures .1 
 
 
 
 
1   GENERAL CONSIDERATIONS  ................................ ................................ ......................  2 
2   ELEMENTS  ................................ ................................ ................................ ..................  2 
2.1   Considerations related to risk  ................................ ................................ .....................  2 
2.2   Market surveillance  ................................ ................................ ................................ ... 4 
2.3   International standards, guides or recommendations  ................................ .....................  5 
2.4   Confidence  ................................ ................................ ................................ ..............  6 
2.5   Acceptance of results  ................................ ................................ ................................  7 
2.6   Transparency and consultation  ................................ ................................ ...................  8 
2.7   Domestic coordination  ................................ ................................ ...............................  8 
2.8   Development dimension  ................................ ................................ ............................  9 
2.9   Flexibility and agility in the face of uncertainty  ................................ ..............................  9 
3   ANNEX 1: TYPES OF CONFORMITY ASSESSMENT  ................................ ......................  10 
4   ANNEX 2: INDEX OF REFERENCE MATERIAL  ................................ .............................  10 
  
 
1 G/TBT/41 , para. 4.17.b  (Eighth) and G/TBT/46 , para. 4.18.a (Ninth).  G/TBT/54  
 
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  1  GENERAL CONSIDERATIONS  
1.1.  Regulators' have a fundamental responsibility to ensure that technical regulations are not more 
trade restrictive than necessary to fulfil the Members' legitimate objectives, such as the protection 
of human health or safety,  or the  environment ; and nationa l security  requirements . Recognizing 
this, the TBT Agreement additionally requires that procedures used to demonstrate conformity with 
such technical regulations , or standards , do not create unnecessary barriers to trade.   
1.2.  The present guidelines are meant to provide key guidance principles and best practices  to 
support regulators in the choice and design of appropriate and proportionate conformity assessment 
procedures to ensure that conformity assessment procedures are not prepared, adopted or applied 
with a view to or with the effect of creating unnecessary obstacles to international trade. In assessing 
whether conformity assessment procedures are "appropriate and proportionate" in the context of 
these guidelines, Members should reference the provisions of  the TBT Agreement relevant to 
conformity assessment procedures in Articles 5 -9, Article 5.1.2 in particular.  
1.3.  These guidance principles and best practices should also serve as trade -facilitating tools, 
enhance trust between different regulatory systems and  contribute to facilitating the acceptance of 
results of conformity assessment. As such, the guidelines should foster trust -building across different 
regulatory frameworks. The following general considerations apply:  
a. Non-prescriptive . The guidelines contai n practical recommendations that are 
non-prescriptive and voluntary. The guidelines are non -binding.  
b. Neutral.  The guidelines do not give preference to any specific approach. They are 
intended to be neutral and structured in a way that will enable regulator s across the WTO 
Membership to understand and use them.  
c. Flexible . The guidelines are intended to provide flexibility for regulators and policymakers 
to innovate and select the conformity assessment procedure(s) most aligned with their 
particular needs, ci rcumstances, and regulatory objectives.  
d. Complementary . The guidelines do not duplicate but seek to complement existing work 
and guidance at the national, regional and international levels.  
1.4.  These guidelines may complement regulatory impact analyses, risk assessments, or other 
methodologies used by Members prior to the preparation of technical regulations or conformity 
assessment procedures.   
1.5.  Nothing in these guideline s should be construed to  add to or detract from the rights and 
obligations of WTO Members under the TBT Agreement or any other WTO agreement .  
1.6.  These guidelines may be reviewed and updated by Members as appropriate . 
2  ELEMENTS  
2.1.  There are a range of possible e lements that may support regulat ors in the choice and design 
of appropriate and proportionate conformity assessment procedures . The following elements are 
neither exhaustive nor mutually exclusive . They may not necessarily carry the same weight for all 
Members . Regulators may select the procedure s that are most closely aligned with their specific local 
needs  and circumstances . 
2.1  Considerations related to risk  
Product  
2.2.  It is important to identify the product to which the conformity assessment procedure(s) will 
apply, as well as the  specified requirements to be assessed (as set out in applicable technical 
regulations or standards and based on product requirements in terms of performance rather than 
design or descriptive characteristics whenever appropriate). In selecting appropriate conformity 
assessment procedures, factors to consider may include: the complexity of the product and its G/TBT/54  
 
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  technology; the production method (e.g. mass production based on a "specimen" or small series 
production); the complexity and transparency of the suppl y chain ; the intended use, user, and 
lifetime of a product; as well as the technical competencies and infrastructures of the particular 
sector or industry  as they relate to regulatory compliance. Regulators may also consider, for 
instance, the level of ris k the specific product poses to a consumer in the event of a safety incident 
or the quality record of a given product and the level of confidence between consumers and 
producers. In addition, regulators may consider the infrastructure of market surveillanc e available 
for the product (see paragraphs 2.9, 2.32, 2.33 and 2.35). 
Nature and degree o f risk  
2.3.  The choice and design of conformity assessment procedures should be appropriate and provide 
adequate confidence in relation to the nature and degree of the risk involved in the product(s) or 
their related processes and production methods, and/or sector(s) at hand (see paragraph 2.2) and 
the level of safety or protection of other relevant public interest(s).  The conformity assessment 
development process is about appropriately identifying , analysing, evaluating,  and managing risk in 
an efficient, effective ma nner while facilitating trade in line with international obligations.  A risk 
assessment2 may usefully include the identification, analysis, and evaluation of the particular risk(s) , 
including  by making full use of risk management methodologies  and technol ogies. A regulator may 
also use methodologies such as regulatory impact analyses to define the best evidence -based 
regulatory solution to mitigate risk. A regulator may usefully determine its needed level of confidence 
that an objective(s) has/have been ac hieved, considering the type and degree of risks associated 
with non -conformity (and their respective consequences) and the expected costs of demonstrating 
conformity (e.g. for producers, suppliers, consumers, and the regulator).  A range of risks may be 
considered, including in relation to: protection of human health or safety , animal or plant life or 
health , or the  environment; consumer protection and the prevention of deceptive practices; and, 
national security  requirements .  
2.4.  In assessing  tradeoffs involved in managing risks , the local context should also be considered . 
The circumstances , experiences  and capacities  of each Member , and the allocation of public 
resources  may differ from Member to Member . Developing and least-developed  countries may face 
particular constraints in managing risks . What is perceived as high risk in one market may not 
necessarily be seen i n the same way in another.  However, an assessment of risks is not the only 
factor that Members may take into account in their decisions on conformity assessment.  
Evidence  
2.5.  The choice  and design  of conformity assessment procedures should be evidence -based. 
Whenever possible, risk assessment should follow clear processes and be based on a scientific 
approach, including the use of criteria set out in relevant international standards, guides, or 
recommendations. This risk assessment should enable regulators to ascertain, based on the  current 
available  technical or scientific evidence, whether the risk and/or its magnitude is acceptable or not. 
Regulators may also rely on best current  available evidenc e3 and experience  from relevant  and 
recognized  scientific bodies, specialised agencies , research by academic institutions,  or other 
independent scientific expertise.  Following the design of the conformity assessment procedures, an 
evidence -based validatio n of the procedures should be undertaken to evaluate if stated objectives 
are achieved. The validation process should involve relevant stakeholders.  
Level of confidence  
2.6.  The regulator's  needed level of confidence  may also inform  the type of conformity assessment 
procedure s (e.g. first-party for low risk , third-party for high risk , or an appropriate selection of 
conformity assessment types for moderate risk4), and the impartiality and independence for bodies  
performing those activities (s ee section  2.4). For product categories that, based on a risk 
assessment, present risks for public interest that are generally considered to be low, the use of first -
party conformity assessment is a preferred option.  While all types of conformity assessment 
 
2 Risk assessment may include associated regulatory impact assessment (RIA) analysis, as part of good 
regulatory practice.  
3 This means peer reviewed, can be cited, and is accessible  and verified information . 
4 For a more detailed description of the types of conformity assessment , see the Annex 1 to this 
document. Annex 2 contains an index of reference material.  G/TBT/54  
 
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  procedures may  be rigorous, regulators may have different requirements for their level of confidence 
in those conducting that procedure  and the integrity of the process used . The greater the risk  and 
needed level of confidence , the more stringent a conformity assessment  procedure may generally 
be, with greater oversight (by regulators ) and independence  (of conformity assessment bodies ). 
Notwithstanding, r egulators should avoid creating unnecessary barriers to trade , including by 
assessing the risks  and concerns  associated with non -conformity and the costs associated with 
demonstrating conformity .  
Traceability and transparency in supply chains  
2.7.  The choice and design of conformity assessment procedures should, where appropriate, explore  
opportunities presented by new technologies to promote supply chain transparency  and traceability . 
Promoting transparency and  traceability through  access to conformity assessment data will enhance 
regulator and consumer confidence in the marketplace, improving supply chain resilienc e. The 
increasing complexity of digital and transnational supply chains also present new challenges  which 
should be considered . These  includ e protection of intellectual property , the need for other data 
protection , the impact on  MSMEs , as well as  opportuni ties for the traceability and verification of 
conformity assessment data.  
Regular review of conformity assessment  procedures  
2.8.  The choice of the conformity assessment procedures should not be seen as permanent. It 
should benefit from regular review as the elements that influenced the original choice of conformity 
assessment procedure may change over time. Regular review of relevant measures and procedures 
based on developments in technology, improvements in data availability, the market, evolving 
capabiliti es of Members, and outcomes of market surveillance should be taken into account.  
2.2  Market surveillance  
Members ' capacities  
2.9.  The choice and design of conformity assessment procedure s is linked to Members' capacities  
and approaches to market surveillance , including the formal and informal roles of the private sector, 
law enforcement system s, consumer protection legislation and product liability, and other relevant 
legal and administrative frameworks . In this context, r egulators may need to strike an appropriate 
balance between pre - and post -market control.   
Risk-based : including sampling and testing  
2.10.  As it may not be possible or desirable to check all products placed on the market, market 
surveillance systems  or approaches  should be risk-based . Regulat ors or other bodies  may assess 
possible risks posed by the objects of conformity assessment and take targeted post-market 
measures , including sampling and testing . A risk -based approach may take into account factors , 
such as possible  dangers  and non -compli ance associated with the products and, where available, 
data on their occurrence on the market, activities and operations under the control of economic 
operators (including manufacturers, importers, distributers, sellers) , their past record of non-
compliance, consumer complaints and other information that might indicate non -compliance.  
2.11.  Regulators or other bodies performing m arket surveillance carry out sampling and testing  
based on possible risks posed  by the products being assessed . Such activi ties require adequate 
resources and prioritisation, targeting based on sound data and evidence, as well as regular 
evaluation of results. Collecting and analysing information on product accidents , or on products 
withdrawn from the market,  also helps in rev iewing and improving performance of the conformity 
assessment system.  G/TBT/54  
 
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  Authorities  
2.12.  The power s of regulatory  and of market surveillance  authorities may impact their choice and 
design of conformity assessment procedures. These powers should be well-defined an d be exercised 
in a way that ensures procedural fairness . They may include the right , within their territories,  to:  
i. conduct inspection, whether announced or unannounced, sampling and verification of 
goods;  
ii. request information (documents or data) related to compliance;  
iii. enter into any premises, lands or means  of transportation related to producers ; 
iv. adopt  measures that are not applied more strictly than necessary when products 
present a risk or do not comply , including requiring  preventive and correc tive action ; 
product recall , when there is a high probability that accidents or safety problems may 
occur with a product ; and,  
v. impose  sanction mechanisms, such as the ability to impose penalties.  
Strategic planning  
2.13.  Strategic planning is key to ensuring the  effectiveness of market surveillance and supervision  
of conformity assessment . A market surveillance strategy can help provide ongoing confidence in  
manufacturers' operating under first -party  conformity assessment and in  the results of conformity 
assessment bodies  operating under third-party conformity assessment . Strategies should take into 
account not only short -term risks but also medium - to long -term developments of the market  and 
sector , including the development of new technologies . For examp le, in the context of the rapid 
development of e -commerce, public authorities in charge of market controls may need to rely on 
new types of interventions, such as requesting conformance records for review from  relevant 
economic operators. Depending on the production method (e.g. mass production based on a 
"specimen" or small series production) differing approach es to market surveillance  may be required . 
2.14.  Constant risk monitoring and foresight should be promoted and encouraged such that 
emerging risks can be identified as early as possible . In this exercise, dialogue with the various 
interested parties , including the private sector,  is crucial.  
Transparency  and independence  
2.15.  It is important to maintain transparency in the development of draft technical regulati ons, as 
well as in the designation and role of the authorities responsible for their enforcement , whether in 
specific geographic areas , or for specific products or sectors. Other public policies, such as disclosure 
of information on market surveillance, pr oduct accidents or publication of recalls, can help promote 
and support compliance.  
2.16.  Regulators should ensure the independence of market surveillance functions from conformity 
assessment functions with a view to avoiding conflicts of interest.   
2.3  International standards , guides  or recommendations  
2.17.  Harmonization with international standards, guides or recommendations facilitates global 
trade and reduces costs for industries , including by avoiding duplicative conformity assessment 
procedures  as well as technical barriers to trade . Pursuant to  Article 5.4 of the TBT Agreement, 
Members shall use relevant guides or recommendations issued by international standardizing bodies. 
For example, Members may make use of conformity assessment  standards, such as  the ISO 
Committee on Conformity Assessment ("CASCO") toolbox . Nevertheless, regulators are not limited 
in their choice of international standards , guides,  or recommendations for conformity assessment.  G/TBT/54  
 
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  2.4  Confidence  
2.18.  Confidence in conformity assessment bodies can facilitate trade by contributing to the 
acceptance of results of conformity assessment. Confidence can be established in different ways 
depending on whether first -, second - or third -party conformity assessment is chosen. The use of 
international  standards, guides, or recommendations helps to establish confidence in the technical 
competence, impartiality, independence, and consistent operation of conformity assessment bodies 
carrying out conformity assessment activities. Amongst others,  accreditat ion (ISO/IEC 17011) and 
peer assessment (ISO/IEC 17040) are recommended approaches that can be used to confirm that 
conformity assessment is undertaken in accordance with relevant international standards (e.g. 
ISO/IEC 17025 (testing), 17020 (inspection), 1 7021-1 (management systems certification), 17029 
(validation and verification) and 17065 (product or process certification)).5 Regulators may specify 
additional programme requirements (e.g. minimum competency requirements, administrative 
procedures) to en sure conformity assessment activities are undertaken consistently to address 
specific public policy and regulatory objectives.  
Impartiality   
2.19.  In order for conformity assessment bodies to perform their activities, it is important to ensure 
they are impartial and free from bias of manufacturers, importers and other interested parties, 
including their clients.6 Conformity assessment bodies should identify potential and actual conflicts 
of interests and establish strategies to minimize them. Conformity  assessment bodies and their 
personnel should be free from any commercial, financial, or other pressure that might influence their 
judgment. The structure of the conformity assessment body, its policies, and procedures, should 
also safeguard its impartiali ty, especially if the body has activities other than those of assessing 
conformity. Where subcontractors are used to perform testing, inspections or other conformity 
assessment activities, these should meet the same requirements that the contracting confor mity 
assessment body itself should meet in order to perform the sub -contracted activities.  
Oversight  
2.20.  Establishing an adequate level of oversight is important. This should include, for example, 
ways for handling complaints (e.g. a stakeholder indicating tha t program requirements are not being 
met) and appeals (e.g. a stakeholder disagreeing with a decision of a conformity assessment body). 
The complaint process is useful for discovering non -conformities and provides information for 
programme improvement.  
Information  
2.21.  Regulators should ensure the protection of confidential information and data for conformity 
assessment purposes and avoid unnecessary information burdens for applicants , so that information 
provided to conformity assessment bodies is limited to th at which is required solely for the purpose 
of assessing conformity and determining fees.  
Openness  
2.22.  Where appropriate, conformity assessment approaches should foster openness by recognizing 
all conformity assessment body applicants that can fulfil the requi rements for qualification or 
recognition.   
Digital technologies  
2.23.  Digital technologies and solutions can help improve the transparency of conformity 
assessment procedures and enhance supply chain integrity. For example, they may support the 
 
5 "Indicative List", G/TBT/1/Rev.15 , Annex 1.  
6 For example, a gover nment -designated body can establish whether a laboratory is adequately 
impartial when it determines conformity with ISO/IEC 17025. In addition, if Manufacturer's/Supplier's 
Declaration of Conformity (SDoC)  is supported by testing undertaken by in -house bodies belonging to the 
supplier's organisation, such supplier should, as far as possible, establish conditions that guarantee the 
independence of the activities of in -house testing bodies.  G/TBT/54  
 
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  acceptance and re cognition of conformity assessment results, by providing real -time access to 
conformity data, and facilitating post -market activities.  
2.5  Acceptance of results  
"Indicative list " 
2.24.  The TBT Committee provided a range of approaches that governments might choose to  apply 
across different sectors to ease the burdens associated with duplicative testing and certification (the 
Indicative List of Approaches to Facilitate Acceptance of the Results of Conformity Assessment, the 
"Indicative List").7 This includes the consideration that certification undertaken by Members is 
consistent with Article 5 of the TBT Agreement and the Indicative List.  
Accreditation  
2.25.  Accreditation, when operated according to relevant international standards, guides and 
recomm endations, promotes confidence in the technical competence of conformity assessment 
bodies. Using (or taking account of) international treaties, agreements or arrangements involving 
cooperation among accreditation bodies can usefully contribute to reinforc ing the acceptance of 
conformity assessment results. Multilateral recognition arrangements, such as the International 
Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) can 
play an important role in supporting wider  the acceptance of conformity assessment results around 
the world.  
2.26.  Conformity assessment procedures may include the acceptance of conformity assessment 
results ( e.g., certificates of conformity, laboratory tests or inspection reports) performed by 
conform ity assessment bodies recognized by  signatories to international accreditation fora.  
Arrangements  
2.27.  Arrangements between domestic and foreign conformity assessment bodies, such as the 
IECEE CB Scheme8, can also help facilitate acceptance of results. Conform ity assessment bodies are 
encouraged to join relevant functioning international agreements or arrangements for harmonisation 
and/or facilitation of acceptance of conformity assessment results.  For the purposes of establishing 
new mutual recognition agreeme nts and arrangements, or equivalence agreements, some of the 
minimum elements to be considered include: Objective; Scope (including the standards and 
technical regulations covered); Competent authorities; Cooperation modalities; Procedures that 
guarantee c ompliance with the MRA / MRA compliance verification system; Duration; Consultations; 
Contact points.  
Other approaches  
2.28.  The Indicative List identifies other approaches to facilitate the acceptance of conformity 
assessment results, including MRAs for conformity assessment to specific regulations, government 
designation, unilateral recognition of results of conformity assessment, and 
Manufacturer's/Supplier's Declaration of Conformity (SDoC) .9 Regulatory cooperation  can also 
facilitate accepta nce of conformity assessment results , such as through joint or shared inspections . 
Whenever possible, economic operators  should  be offered alternative procedures to demonstrate 
compliance, and the possibility of carrying out the conformity assessment proce dure in more than 
one step, provided these meet a regulator's needed level of confidence.  
 
7 See G/TBT/1/Rev.15 , Annex 1.  
8 IEC System for Conformity Assessment  Schemes  for Electrotechnical Equipment and Components 
(IECEE) Certification Body (CB)  Scheme.  
9 See G/TBT/1/Rev.15 , Annex 1.  G/TBT/54  
 
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  Reliance  on the work of other regulators  
2.29.  Regulators may also consider opportunities to rely on the work of other trusted regulators in 
areas such as inspection, eval uation, and market surveillance, in order to make the best use of 
available resources.  
2.6  Transparency  and consultation  
2.30.  For a chosen conformity assessment procedure  to be effective and achieve the desired policy 
objectives, its content need s to be communicated to relevant stakeholders  and opportunities for 
consultations  provided . This entails providing clear and transparent information about specified 
requirements . Criteria and procedures for the appointment or recognition of conformity asses sment 
bodies to perform specified conformity assessment activities should be made public, informed to 
relevant  stakeholders  and undergo a transparent selection or recognition process. Regulators should 
consider input from  relevant  stakeholders when proposi ng and establishing conformity assessment 
procedures. M eaningful consultation with relevant  stakeholders , parties  and trading partners on 
proposed and existing conformity assessment procedures  helps ensure that the procedures are fit 
for purpose and adapte d to the level of risk identified.  Timely notification to the WTO according to 
existing disciplines of the TBT Agreement , as well as reference to the collected decisions and 
recommendations by the TBT Committee , is vital . Transparency , including publicatio n of draft 
conformity assessment procedures for comment,  in the design, development, operation , and 
evaluation  of conformity assessment procedures fosters greater acceptance and understanding of 
governmental decisions and contributes  to effective policy. M embers' TBT national notification 
authorities and enquiry points play a crucial role in providing transparency  to relevant stakeholders, 
including WTO Members. Transparency also involves providing - and making publicly available - 
information about the bod ies that regulators have designated to perform conformity assessment, 
including on the scope of activities of each body. Transparency should also be ensured in relation to 
the fees imposed for conformity assessment performed by government bodies , as well as information 
relating to market surveillance and recall program . 
2.31.  It is important to participate in formal and informal information -sharing between regulators 
across WTO Members to promote transparency, the sharing of best practices, and understanding in 
the choice and design  of conformity assessment procedures. Information -sharing of this nature can 
reduce unnecessary technical barriers to trade and promote international trade by fostering trust 
and supporting foreign acceptance of conformity assessment results.  
2.7  Domestic  coordination  
Mechanisms  
2.32.  Coordination between relevant government agencies, national quality infrastructure (NQI) 
institutions (metrology, standardization, conformity assessm ent, and accreditation), customs 
authorities, the private sector and other relevant stakeholders  can help avoid unnecessary 
duplication of conformity assessment and leverage existing domestic, regional, and international 
efforts, both public and private. S uch coordination can help ensure that the requirements proposed 
by regulators are appropriate and practical, with respect to the Member's NQI as well as international 
conformity assessment practices, systems, schemes, and capacity. Members may consider for ming 
a committee of representatives from each government agency to serve as a forum for information 
exchange and discussion of best practices for conformity assessment, and to facilitate compliance 
with international obligations. This can include (but shou ld not be limited to) advisory, consultative 
or review (including peer review) meetings, committees, or panels. If one agency has overall 
responsibility for conformity assessment activity or policy, that agency would be a logical focal point 
for such coord ination.  
NQI supports coordination  
2.33.  It is important to liaise with the NQI institutions early in the regulatory development process 
to help achieve effective regulatory outcomes. Consultation with NQI institutions can also identify 
gaps in capacity which m ight limit the effectiveness of conformity assessment procedures. A 
responsive, coordinated, technically competent and efficient NQI is an important support for 
regulators in the choice and design of conformity assessment processes. The NQI should be G/TBT/54  
 
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  devel oped as a fully integrated system, rather than treating each part in isolation. A quality policy 
can help ensure the overall arrangements and interactions of quality infrastructure institutions and 
improve overall coordination of the NQI.  Regulators should  be informed of the obligations contained 
in the TBT  Agreement.  
2.8  Development dimension  
Considering the needs of developing country Members  
2.34.  The needs and difficulties encountered by developing country M embers in implementing 
conformity assessment procedures should be fully considered , including with respect to variations in 
the level of development of their NQI . For example, if economic operators in developing or least 
developed Members (LDCs) have limitations in fulfilling certain conformity proce dures, regulators 
may seek to accommodate these limitations while still taking into account the risk associated with 
the product . Consistent  with Article 11  of the TBT Agreement , Members with financial, human and 
technological resources shall, if requested , provide advice and grant technical assistance and 
capacity building on mutually agreed terms to assist in the development of conformity assessment 
activities and enable participation in international and regional systems for conformity assessment, 
includ ing in the area of NQI.  
Evaluation  of adequate NQI  
2.35.  WTO Members have differing economies, industry bases, systems  for quality infrastructure , 
and regulatory frameworks. Some Members may be constrained by insufficient capacity in 
establishing and managing co nformity assessment systems, including oversight of conformity 
assessment bodies and market surveillance activities ; or by other  specific challenges, such as 
fundamental technological or infrastructural problems. Such difficulties may also create barriers to 
developing country Members' exports. In such cases, Members should consider how other Members' 
technical assistance can help overcome such constraints, while looking to draw upon international 
best practices in conformity assessment that both facilitate  trade and provide regulator confidence. 
Regulators are an important element of any NQI system and should  be supported to  play an active 
role in furthering its development.  Regulators should assess the adequacy of national quality 
infrastructure and design conformity assessment procedures and market surveillance that facilitate 
trade, to support the implementation of the TBT Agreement.  
2.9  Flexibility and agility in the face of uncertainty  
2.36.  Broader challenges and uncertainty  in an increa singly complex global environment and rapidly 
changing technological, societal, geopolitical and economic trends are unavoidable. To adequately 
account for new risks and challenges , foreseen and unforeseen events, as well as emergencies (such 
as the COVID -19 pandemic) , regulators and policymakers need to  work closely together , and with 
private sector and subject matter experts, to ensure that conformity assessment systems and 
approaches are adaptive, responsive, and remain relevant. Continuous dialogue with  various experts 
and interested parties is a particularly important element. To effectively respond to new challenges 
and benefit from new technologies, regulators are encouraged to use digital or electronic means to 
enhance the quality of conformity asses sment procedures. The elements  listed above may be 
reconsidered or given different weight by regulators in the context of crises . 
_______________  G/TBT/54  
 
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  3  ANNEX  1: TYPES OF CONFORMITY ASSESSMENT  
3.1.  Annex 1.3 to the TBT Agreement defines "conformity assessment procedure" as:  
Any procedure used, directly or indirectly, to determine that relevant 
requirements in technical regulations or standards are fulfilled.  
Explanatory note  
Conformity assessment procedures include, inter alia, procedures for 
samplin g, testing and inspection; evaluation, verification and assurance of 
conformity; registration, accreditation and approval as well as their 
combinations.  
3.2.  Three types of conformity assessment can be differentiated according to who controls or directs 
the rel evant procedures or activities, and who reviews, decides, and attests that that fulfilment of 
specified requirements has (or has not) been demonstrated.1 
a. First-party conformity assessment is performed by the person or organization that 
provides or that is  the object2 of conformity assessment. For example, such activities are 
performed by providers, designers or owners of the object, investors in the object, and 
advertisers or promoters of the object.3 First-party conformity assessment – for example, 
SDoC  – is generally used for low -risk products or sectors.  
b. Second -party conformity assessment is performed by a person or organization that has a 
user interest in the object of conformity assessment. Persons or organizations performing 
second -party conformity assessment activities include, for example, purchasers or users 
of products, or potential customers seeking to rely on a supplier's management system, 
or organizations representing those interests (e.g. consumer advocacy organizations).4 
c. Third-party confo rmity assessment is performed by a person or organization that is 
independent of the provider of the object of conformity assessment and has no user 
interest in the object.5 Third-party conformity assessment – for example, accredited 
testing, inspection, certification or verification and validation – is generally used for high -
risk products or sectors.  
3.3.  Both first - and third -party conformity assessment are widely used in regulator conformity 
assessment schemes .6 They offer differing levels of confidence a nd require appropriate frameworks 
in place to support their reliable use.  
4  ANNEX 2: INDEX OF REFERENCE MATERIAL  
• ISO Policy Committee on Conformity Assessment (ISO/CASCO), Conformity Assessment 
Tools to Support Public Policy, at https://casco.iso.org/conformity -assessment.html .  
__________  
 
1 Adapted from ISO/IEC 17000:2020(en) Conformity assessment — Vocabu lary and general principles  
2 The object of conformity assessment can include a product, process, service, system, installation, 
project, data, design, material, claim, person, body or organization, or any combination thereof ( Adapted from 
ISO/IEC 17000:20 20(en) Conformity assessment — Vocabulary and general principles, para. 4.2).  
3 Adapted from ISO/IEC 17000:2020(en) Conformity assessment — Vocabulary and general principles, 
para. 4.3.  
4 Adapted from ISO/IEC 17000:2020(en) Conformity assessment — Vocabulary and general principles, 
para. 4.4.  
5 Adapted from ISO/IEC 17000:2020(en) Conformity assessment — Vocabulary and general principles, 
para. 4.5.  
6 A conformity assessment scheme is the construction of the conformity assessment activities, roles, 
and the types of organizations performing each role. The scheme also includes the set of requirements, 
specifications, standards, and methods for determining conformity. A conformity assessment scheme can be 
operated at an international, regional, national,  sub-national, or industry sector level.