RESTRICTED
WORLD TRADE G/TBT/W/38
9April 1997
ORGANIZATION(97-1494)
Committee onTechnical Barriers toTrade
THE RELATIONSHIP BETWEEN THE AGREEMENT ONTECHNICAL BARRIERS
TOTRADE AND RELEVANT ISO/IEC GUIDES
(Secretariat background paper)
1. Atitsmeeting of16October 1996(G/TBT/M/6), theCommittee onTechnical Barriers toTrade
agreed tosetupatechnical working group. Itismandated tostudy therelevant ISO/IEC Guides and
howtheymight contribute tofurthering theobjectives ofArticles 5and6oftheAgreement inorder
toassist theCommittee toconsider ifitwishes toadopt decisions andrecommendations regarding these
Guides.
2. TheTokyo Round TBTCommittee hasrecognized ISO/IEC Guides 25,39and43ontesting,
inspection andtype-approval andrecommended theiruse(Annex 1).However, thedecisions and
recommendations adopted bythisCommittee relate toobligations oftheTokyo Round TBTAgreement
andnottothose oftheWTO TBTAgreement. Since theentry intoforce ofthelatter Agreement,
theWTO TBTCommittee hasbeenlooking intothedecisions andrecommendations adopted bythe
Tokyo Round TBTCommittee withaviewtodeciding whether itisnecessary toadopt orupdate them.
Given thefactthattheUruguay Round negotiations expanded thecoverage anddisciplines regarding
conformity assessment procedures, andthatadditional ISO/IEC Guides havebeendeveloped since the
adoption ofthedecisions bytheTokyo Round TBTCommittee, itwasfeltthatatechnical working
group should beestablished tostudy therelevant ISO/IEC Guides. Ithelditsfirstmeeting on
13February 1997. TheWorking Group 'smandate covers acomplex andhighly technical areaofthe
TBTAgreement, andthereappear tobedifferences indelegations 'understanding oftheissues involved.
TheWorking Group hasthusrequested theSecretariat toprepare thisbasicbackground paper describing
theissues involved.
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I. INTRODUCTION
3. With increased globalization ofproduction andmarkets, conformity assessment isgaining
importance inassuring regulators andpurchasers thatforeign products fulfil therequirements of
(mandatory) domestic technical regulations or(voluntary) standards. However, trade problems may
ariseasaresult ofconformity assessment requirements, especially ifduplication ofprocedures are
required forproducts exported toseveral markets. Tofacilitate access, Article 5.1.2 ofthe
TBTAgreement provides that"conformity assessment procedures arenotprepared, adopted orapplied
withaviewtoorwiththeeffect ofcreating unnecessary obstacles tointernational trade. Thismeans,
interalia,thatconformity assessment procedures shallnotbemore strict orbeapplied more strictly
thanisnecessary togivetheimporting Member adequate confidence thatproducts conform withthe
applicable technical regulations orstandards ..."Article 6oftheAgreement encourages Members
toconclude agreements forthemutual recognition ofresults ofeachother'sconformity assessment
procedures (MRAs), recognizing thatprior consultations maybenecessary inorder toarrive ata
understanding regarding "adequate andenduring technical competence oftherelevant conformityG/TBT/W/38
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assessment bodies intheexporting Member, sothatconfidence inthecontinued reliability oftheir
conformity assessment results canexist; inthisregard, verified compliance, forinstance through
accreditation, withrelevant guides orrecommendation issued byinternational standardizing bodies
shallbetaken intoaccount asanindication ofadequate technical competence."1
4. Conformity assessments mayinvolve different procedures andemploy different methods and
mechanisms.2Compliance withtechnical requirements canbedemonstrated bymeans ofsuppliers '
declarations orbyasecond party'sorthirdparty'sassessment. These procedures mayimply various
degrees ofgovernment involvement. While some countries havecreated official bodies responsible
forascertaining compliance especially inhealth- andsafety-related areas, others havepassed laws
authorizing private organizations toverify compliance. Inthelatter case, thegovernment regulatory
authorities relyonthese organizations 'conformity assessment services.
5. Harmonization ofnational procedures andarrangements anduniform interpretation oftheir
results maysmooth thewayformutual recognition atnational andinternational levels. Inthiscontext,
Article 5.4oftheAgreement encourages Members touserelevant guides orrecommendations issued
byinternational standardizing bodies asabasis fortheirconformity assessment procedures, except
where ...such guides orrecommendations orrelevant parts areinappropriate fortheMembers
concerned."3Tofulfiltheirpurpose, conformity assessments needtobebased onmutual confidence -
between producers andbuyers, regulators andprivate assessment services, federal andlocalauthorities,
andbetween regulatory bodies participating inmutual recognition agreements (MRAs). Inturn,this
raises thequestion astohowconfidence canbeengendered andmaintained, andwhat criteria may
beusedtojudge thequality, competence andimpartiality ofadomestic and,asthecasemaybe,foreign
conformity assessment body.
II. ISO/IEC GUIDES DEVELOPED BYISO/CASCO
6. Since1980,theISOCouncilCommitteeonConformityAssessment(ISO/CASCO)hasdeveloped
guidesandotherpublicationsoncertificationandrelatedactivities.4Likeitspredecessor,ISO/CERTICO,
ISO/CASCOrespondstotheneedsofproducerstodemonstratethattheirproductsmeettherequirements
ofspecified standards orregulations. However, while recognizing theimportant roleofmanufacturer 's
declaration ofconformity through normal contacts withcustomers, "ISO Council resolutions have
emphasizedthepreparationofguidancedocumentsonthird-partycertificationandassessmentprocedures
inorder thatnational systems maybecompatible onewithanother soastofacilitate bilateral and
multilateral agreements."5
1Emphasis added byWTO Secretariat.
2Under Annex 1oftheTBT Agreement, conformity assessment procedures aredefined toinclude: "any
procedureused,directlyorindirectly,todeterminethatrelevantrequirementsintechnicalregulationsorstandards
arefulfilled.Conformityassessmentproceduresinclude,interalia,proceduresforsampling,testingandinspection;
evaluation, verification andassurance ofconformity; registration, accreditation andapproval aswellastheir
combinations."
3Emphasis added.
4AttheTBTCommittee meeting of1March 1996, arepresentative from ISO/CASCO gave apresentation
outlining thelatest developments inISO'swork relating torules andguides inconformity assessment activities
(G/TBT/M/4).
5ISO/IEC Guide 16-Code ofprinciples onthird party certification systems andrelated standards .G/TBT/W/38
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7. TheWTO/TBT Technical Working Group onISO/IEC Guides hasreceived eight ISO/IEC
guides forconsideration. Thefollowing section briefly describes theircontent.
Guide 22-General Criteria forSupplier 'sDeclaration ofConformity (1996)
8. TheGuide specifies theprocedures tobeusedwhen asupplier offers orisrequested todeclare,
thataproduct, process orservice conforms tospecific requirements laiddown innormative documents,
including standards. Therelevant declaration maybebased ontesting orassessment bythesupplier
(first-party assessment) orasecond orthirdparty.
Guide 25-General Requirements fortheCompetence ofCalibration andTesting Laboratories, third
edition (1990)
9. TheGuide wasdrawn upinresponse toarequest from ILAC (International Laboratory
Accreditation Cooperation). Itisdestined forusebycalibration andtesting laboratories thatareto
berecognized ascompetent byaccreditation, certification andother bodies tocarry outspecific
calibrations ortests. TheGuide provides thebasisforestablishing quality systems tofacilitate correct,
accurate andproper testing, andincludes therequirement tohavesufficient competent personnel,
measuring andtesting equipment aswellasthesuitable accommodation andenvironment. Laboratories
shall useappropriate methods andprocedures forcalibrations andtests, andmaintain proper
documentation andrecording systems.
Guide 39-General Requirements fortheAcceptance ofInspection Bodies (1988)
10. ThisGuide setsoutgeneral criteria forinspection bodies toensure theirtechnical competence,
impartiality, confidentiality, thoroughness, careful observation andaccurate reporting.
Guide 43-Development andOperation ofLaboratory Proficiency Testing (1984)
11. TheGuideisintendedforusebygovernmentalornon-governmentalbodies,suchasaccreditation
andcertification bodies, tovetthetechnical competence oftesting laboratories. Proficiency testing
istheuseofresults generated ininterlaboratory testcomparisons forthepurpose ofassessing the
technical competence ofparticipating testing laboratories. Itisoneofanumber ofmechanisms which
cancontribute totheestablishment ofmutual confidence between different testing laboratories.
Guide 58-Calibration andTesting Laboratory Accreditation Systems -General Requirements for
Operation andRecognition (1993)
12. Theobjective istoprovide guidance forthesetting upandoperation ofanaccreditation body
andtofacilitate MRAs ofaccreditation oflaboratories between suchbodies. Theintention istoensure
recognition atthenational orinternational leveloftheaccreditation granted andtheservices covered,
andofthecompetence andreliability oftheaccreditation bodies.G/TBT/W/38
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Guide 61-General Requirements forAssessment andAccreditation ofCertification/Registration Bodies
(1996)
13. TheGuide setsoutguidelines forabodywhich istoberecognized atnational orinternational
level ascompetent andreliable inassessing andaccrediting certification/registration bodies.6
Conformancewithitsrequirementswillpromoteequivalenceofnationalsystemsandfacilitateagreements
onmutual recognition ofaccreditation between suchbodies. TheGuide provides, inter alia, for
non-discrimination (i.e.,services accessible toallapplicants) andtheoperation ofquality management
system (i.e.formal documentation andarrangements, financial stability, sufficient qualified personnel,
policies andprocedures fortheresolution ofcomplaints) toensure confidentiality, objectivity or
impartiality oftheaccreditation bodies.
Guide 62-General Requirements forBodies Operating Assessment andCertification/Registration of
Quality Systems (1996)
14. ThisGuide intends toensure thatbodies assessing, certifying and/or registering quality systems
operate inaconsistent andreliable manner withaviewtofacilitating theiracceptance onanational
andinternational basis. TheGuide isdestined forusebybodies entrusted withrecognizing the
impartiality, competence andreliability ofcertification/registration bodies; itdoesnotextend tothe
certification ofproducts, processes orservices. Therelevant provisions (non-discrimination, etc.)are
similar tothose contained inGuide 61.
Guide 65-General Requirements forBodies Operating Product Certification Systems (1996)
15. TheGuide specifies general requirements forthird parties operating aproduct certification
system toberecognized ascompetent, consistent andreliable. Inturn,compliance mayfacilitate their
acceptanceonanationalandinternationalbasis.Generalprovisionsincludenon-discriminatorytreatment,
impartiality, technical competence, financial stability, transparency oftheevaluation andcertification
procedures, quality management systems, aswellasmaintaining documentation andreporting systems,
proceduresfortheresolutionofcomplaints,appealsanddisputes.Certifiedproductsmustbeperiodically
checked forthecontinued conformity withtherelevant standards.
III. HOW THE RELEVANT ISO/IEC GUIDES RELATE TOTHE TBTAGREEMENT
Harmonization
16. Withaviewtoreducingunnecessaryobstaclestotradethatmightresultfromnationaldifferences
inconformityassessmentproceduresandimprovingeconomicefficiency,theTBTAgreementencourages
Members toharmonize suchprocedures through theuseofinternational guides andparticipate inthe
preparation ofthese guides byinternational standardizing bodies (Preamble andArticles 5.4and5.5
oftheAgreement). ISO/IEC guides developed byinternational standardizing bodies aredeemed to
conform withandhavenocontradiction totheprinciples oftheAgreement. However, itisworth
noting that:
6Insome countries, bodies which verify conformity ofproducts, processes, services orsystems tospecified
standards arecalled "certification bodies", inother countries "registration bodies" or"assessment bodies" .G/TBT/W/38
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(i) while theAgreement encourages theuseofguides developed byinternational
standardizing bodies, itdoesnotmake reference toanyinternational standardizing body
norparticular guide;
(ii) Article 5callsfortheuseofinternational guides but,contrasting with Article 2.5,
doesnotprovidethatconformityassessmentproceduresinaccordancewithinternational
guides "shall berebuttably presumed nottocreate anunnecessary obstacle to
international trade"; and
(iii) while ISO/IEC Guides establish abasisfortheharmonization ofactivities orprocedures
ofconformity assessment bodies, Members using theGuides maystilldevelop their
ownnational procedures, requirements andsystems.
Mutual Recognition Agreements
17. Multiple testing, inspection andcertification requirements mayincrease business costs and
uncertainties forexporters andcreate unnecessary barriers totrade. Ideally, testing ofaproduct should
takeplace onlyinthecountry oforigin, withtheresults being accepted inallexport markets. Against
thisbackground,theTBTAgreementencouragesmutualrecognitionofconformityassessmentprocedures
bycentral government bodies. Article 6oftheAgreement callsonMembers toenterintonegotiations
formutual recognition agreements onconformity assessment andaccept theresults ofconformity
assessment procedures byother Members whenever possible, provided theyaresatisfied withthose
procedures andconsider thattheyofferanassurance ofconformity equivalent totheirownprocedures.
TheAgreement recognises thatprior consultations maybenecessary inorder toarrive atamutually
satisfactory understanding regarding thecompetence oftherelevant conformity assessment bodies.
Inthatconnection, relevant guides orrecommendations issued byinternational standardizing bodies
aretobetaken intoaccount asanindication ofadequate technical competence. Some oftheISO/IEC
guides havebeenprepared forthatpurpose. However, while establishing common ground tofacilitate
negotiation ofMRAs, theydonotcontain guidelines ormodules forMRAs.
International Conformity Assessment Systems
18. Article 9.1encourages Members toformulate andadopt international systems forconformity
assessment, andparticipate insuchsystems, where apositive assurance ofconformity withatechnical
regulation orstandard isrequired.7Infact,thework ofILAC andother international conformity
assessment systems hasbenefited from international guides, suchasISO/IEC Guide 25.TheGuide
hashelped topromote confidence incalibration andtesting laboratories, facilitate cooperation between
them andother bodies, andassist intheprocess ofexchanging information andexpertise.
Transparency
19. TransparencyandpredictabilityareamongthebasicprinciplesunderlyingallWTOAgreements.
Intheareaofconformity assessment, these principles callfortheuseofinternational guides bythe
competent bodies. Such guides helpsuppliers toanticipate andprepare intimefortherelevant
proceduresandrequirements(fees,processingperiods,documents).Commensuratewiththerequirements
ofArticle 5.2.2, some ISO/IEC Guides explicitly require conformity assessment bodies tomaintain
clearandprecisemanagementsystems,proceduresanddocumentation.Toensureimpartialandobjective
7Inthesame vein, thepreamble totheTBT Agreement states: "Members Recognizing theimportant
contribution thatinternational standards andconformity assessment systems canmake inthisregard byimproving
efficiency ofproduction andfacilitating theconduct ofinternational trade; Desiring therefore toencourage the
development ofsuch international standards andconformity assessment systems; ...".G/TBT/W/38
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assessments, several Guides seektoensure thatthebodies allow forthepossibility "toreview complaints
concerning theoperation ofaconformity assessment procedure andtotakecorrective action when a
complaint isjustified" (Article 5.2.8).
National Treatment
20. Article 5.1oftheAgreement provides thatconformity assessment procedures grant access to
products fromother Members under conditions "nolessfavourable thanthose accorded tosuppliers
oflikeproducts ofnational origin ...". Thecoverage ofthisnational-treatment obligation extends
tothetimeneededforthecompletionofconformityassessmentprocedures;confidentialityofinformation;
andanyfeesimposed (Articles 5.2.1, 5.2.4, 5.2.5). Some ISO/IEC Guides havesimilar provisions.
Procedures forAssessment ofConformity byOther Bodies
21. Under Articles 7,8and9oftheAgreement, Members arerequired to"take suchreasonable
measures asmay beavailable tothem" toensure compliance bylocal government bodies,
non-governmentalbodiesandinternationalandregionalsystemsforconformityassessmentwithArticles5
and6.Thisincludes theprovisions relating totheuseofinternational guides.
Supplier 'sDeclaration
22. Under theAgreement, conformity assessment procedures aredefined toinclude anyprocedures
used, directly orindirectly, todetermine thattherelevant requirements intechnical regulations or
standards arefulfilled. Pursuant toArticle 5.1.2, Members areobliged toensure thattheir"conformity
assessment procedures shallnotbemore strict orbeapplied more strictly thanisnecessary togive
theimportingMemberadequateconfidencethatproductsconformwiththeapplicabletechnicalregulations
orstandards, taking account oftherisksnon-conformity would create". Thus, ifMembers consider
supplier 'sdeclaration aslesstrade restrictive thanalternative approaches forconformity assessment,
ISO/IEC Guide 22-General Criteria forSupplier 'sDeclaration ofConformity -could betheguide
touseandaccepted.
Conformity Assessment Procedures forManagement Standards
23. ISO/IEC Guides 61and62provide international guidelines fortheoperation andaccreditation
ofquality system registration/certification bodies. ThetwoGuides serve asareference forthesetting
upofQuality System Assessment Recognition (QSAR) systems established byISOandIEC. TheGuides
relate toconformity assessment procedures formanagement standards, i.e.ISO9000 and
ISO14000, whose status under theAgreement isunder discussion intheCommittee.G/TBT/W/38
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ANNEX 1
Decision adopted bytheTokyo Round TBTCommittee concerning ISO/IEC Guides
(TBT/16/Rev.8)
TESTING, INSPECTION AND TYPE APPROVAL
UseofISO/IEC Guides:
Background andpurpose:
Initsdiscussion offurthering theobjectives ofArticle 5oftheAgreement, theCommittee
considered thefollowing Guides oftheInternational Organization forStandardization (ISO) andthe
International Electrotechnical Commission (IEC) asproviding animportant contribution tothe
establishment ofmutual confidence intesting andinspection activities between Parties:
ISO/IEC Guide 25-1990: "General Requirements fortheCompetence of
Calibration andTesting Laboratories";
ISO/IEC Guide 39-1988: "General Requirements fortheAcceptance of
Inspection Bodies";
ISO/IEC Guide 43-1984: "Development andOperation ofLaboratory
Proficiency Testing";
Accordingly, theCommittee adopted therecommendations stated below:
Recommendations:
(a) Anytesting andinspection activity developed within theterritories ofParties should
bebased ontheprinciples andrulespresented intheISO/IEC Guides 25,39and43.
(b) Parties should provide information onnational measures taken topromote the
implementation oftheprinciples andrulesinISO/IEC Guides 25,39and43asabasis
fortesting andinspection activities intheirterritories.G/TBT/W/38
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ANNEX 2
ListofGuides Currently Published under CASCO
- ISO/IEC Guide 2:1996 Standardization andrelated activities -General vocabulary
- ISO/IEC Guide 7:1994 Guidelines fordrafting ofstandards suitable foruseforconformity
assessment
- ISO/IEC Guide 22:1996 General criteria forsupplier 'sdeclaration ofconformity
- ISO/IEC Guide 23:1982 Methods ofindicating conformity withstandards forthird-party
certification systems
- ISO/IEC Guide 25:1990 General requirements forthecompetence ofcalibration andtesting
laboratories
- ISO/IEC Guide 27:1983 Guidelines forcorrective action tobetaken byacertification body
intheevent ofmisuse ofitsmark ofconformity
- ISO/IEC Guide 28:1982 General rulesforamodel third-party certification system forproducts
- ISO/IEC Guide 39:1988 General requirements fortheacceptance ofinspection bodies
- ISO/IEC Guide 42:1984 Guidelines forastep-by-step approach toaninternational certification
system
- ISO/IEC Guide 43:1984 Development andoperation oflaboratory proficiency testing
- ISO/IEC Guide 44:1985 General rulesforISOandIECinternational third-party certification
schemes forproducts
- ISO/IEC Guide 53:1988 Anapproach totheutilization ofasupplier 'squality system inthird-
party product certification
- ISO/IEC Guide 56:1989 Anapproach tothereview byacertification bodyofitsowninternal
quality system
- ISO/IEC Guide 57:1991 Guidelines forthepresentation ofinspection result
- ISO/IEC Guide 58:1993 Calibration andtesting laboratory accreditation systems -General
requirements foroperation andrecognition
- ISO/IEC Guide 60:1994 ISO/IEC Code ofgood practice forconformity assessment
- ISO/IEC Guide 61:1996 General requirements forassessment andaccreditation of
certification/registration bodies
- ISO/IEC Guide 62:1996 General requirements forbodies operating assessment and
certification/registration ofquality systems
- ISO/IECGuide65:1996Generalrequirementsforbodiesoperatingproductcertificationsystems