RESTRICTED
WORLD TRADE G/TBT/W/43
13June1997
ORGANIZATION(97-2430)
Committee onTechnical Barriers toTrade
PRACTICAL EXPERIENCE OFINDIVIDUAL GOVERNMENTS
AND INTERNATIONAL ORGANIZATIONS INUSING
INTERNATIONAL GUIDES ONCONFORMITY
ASSESSMENT
Note bytheSecretariat
Atthefirstmeeting oftheTechnical Working Group onISO/IEC Guides Relating toArticles 5
and6oftheAgreement, theSecretariat wasrequested tocompile inapaper thepractical experience
ofindividual governments andinternational organizations inusing ISO/IEC Guides, aswellasother
guides andrecommendations issued byinternational standardizing bodies.
Thispaper compiles relevant information received fromMembers andconformity assessment
bodies.G/TBT/W/43
Page2
CONTENTS
Page
I. Experience oftheEuropean Union intheuseoftheISO/IEC Guides
onConformity Assessment -Submission bytheEuropean Commission 3
II. UseofISO/IEC Guides byInternational Laboratory Accreditation
Cooperation (ILAC) Members -Information received from ILAC 8
III. AnOverview ofInternational Conformity Assessment Systems
-Information received from theSwedish board forAccreditation
andConformity Assessment 10G/TBT/W/43
Page3
I. EXPERIENCE OFTHE EUROPEAN UNION INTHE USEOFTHE ISO/IEC GUIDES
ONCONFORMITY ASSESSMENT
Transposition oftheGuides atEuropean level
1. TheISO/IEC Guides form thebasis oftheEN45000 series ofstandards. Attached isatable
indicating which ISO/IEC Guides correspond towhich EN45000 standards. Atpresent, theGuides
andtheENsarenotidentical butcanbesaidtobeequivalent toeachother. TheGuides thathavebeen
recently revised anddeveloped byISO/CASCO havebeensubmitted tothenational members ofCEN
andCENELEC forpublic enquiry orvoteasthecasemaybe.
2. ISO/IECGuides61,62and65havebeensubmittedforformalvoteasprEN45010,prEN45012
andprEN 45011 respectively, withadeadline of27May1997.
3. ISO/IEC Guides 2and22havebeensubmitted forUnique Acceptance Procedure (UAP) as
prEN 45020 andprEN 45014 respectively withadeadline of1November 1997.
4. Therevised draftofISO/IEC Guide 25hasbeensubmitted forenquiry asprEN 45001.
5. Ifthevotes andenquiries onthese Guides aresuccessful theywillnotonlybetransposed as
European standards butalsoasnational standards intheEUandEFTA countries.
Community policy andlegislation inthefieldofconformity assessment
6. Thefollowing actslaydown thebasicrulesgoverning theCommunity ’sconformity assessment
system:
- Council Resolution of7May1985onanewapproach totechnical harmonization andstandards
(85/C 136/01).
- Commission Communication totheCouncil submitted bytheCommission on15June1989
-Aglobal approach tocertification andtesting -quality measures forindustrial products (COM
(89)209final).
- Council Resolution of21December 1989onaglobal approach toconformity assessment (90/C
10)
- Council Decision of22July1993 concerning themodules forthevarious phases ofthe
conformity assessment procedures andtherulesfortheaffixing anduseoftheCEconformity
marking, which areintended tobeusedinthetechnical harmonization directives (93/465/EEC).
7. TheCouncil hasinitsDecision 93/465/EEC recognized that:
“Notifiedbodieswhichcanprovetheirconformitywithharmonisedstandards(EN45000series),
bysubmitting anaccreditation certificate orother documentary evidence, arepresumed to
conform totherequirements ofthedirectives. ”
8. Thismeans thattheEN45000 standards (andevencorresponding ISO/IEC Guides) arenot
mandatory buthave been given aprivileged position withregard todemonstrating thetechnical
competence ofNotified Bodies, i.e.those bodies thatcarry outtheconformity assessment procedures
intheCommunity’sNewApproachdirectives.TheMemberStatesoftheEUhavecommittedthemselves
toindicate which EN45000 standard hasbeenusedfortheassessment ofthebodytheyarenotifying.G/TBT/W/43
Page4
9. Atthemoment, theCommission istogether withtheMembers States attempting toclarify a
number ofissues suchasthelinkbetween themodules oftheGlobal Approach andtheEN45000
standards andthepossible needofadditional orcomplementary criteria inorder tobridge theEN45000
standards andtherequirements onNotified Bodies inthedirectives. TheCommission alsotogether
withtheMember States drafting apolicy ontheroleofaccreditation inrelation totheCommunity ’s
policy inthefieldofconformity assessment.
10. Theexperience oftheCommission isthattheEN45000 standards andaccreditation are
increasingly being usedbytheEUMember States asabasis fortheassessment ofthetechnical
competence ofthebodies seeking notification. InoneMember State, thenational accreditation body
hasevenbeenempowered bythegovernment tonotify theNotified Bodies.
11. TheCommissioniswithintheframeworkofthePRAQIIIprogrammegivingtechnicalassistance
tothecentral andeastern European countries withwhich theCommunity hasEurope Agreements.
Specific projects havebeensetupinthefields ofstandardisation, metrology, accreditation andtesting
andcertification. Theaimistoaidthereceiving countries tosetupthenecessary, legal, administrative
andtechnical infrastructures inorder tooperate standards andconformity assessment systems along
theprinciples applied inwestern Europe.G/TBT/W/43
Page5
CONFORMITY ASSESSMENT STANDARDS -ISO/IEC GUIDES AND
EUROPEAN STANDARDS
(TheISO/IEC Guides andENsindicated below donotalways correspond toeachother exactly)
ISO/IEC Guides ENstandards
General Guide 2:1996 Standardization
andrelated activities -
General vocabularyEN45020:1993 General
terms andtheirdefinitions
concerning standardization
andrelated activities
Guide 26:1981 Justification
ofproposals for
establishment ofstandards
Guide 7:1994 Guidelines for
drafting ofstandards suitable
forconformity assessment
Guide 60:1994 Code ofgood
practice forconformity
assessment
Schemes Guide 42:1984 Guidelines for
astep-by-step approach toan
international certification
system
Guide 44:1985 General rules
forISOandIECinternational
third-part certification
schemes forproducts
Laboratories Guide 25:1990 General
requirements forthe
competence ofcalibration and
testing laboratoriesEN45001:1989 General
criteria fortheoperation of
testing laboratories
Guide 38:1983 General
requirements forthe
acceptance oftesting
laboratoriesEN45002:1989 General
requirements fortesting
laboratories
Guide 58:1993 Calibration
andtesting laboratory
accreditation systems -
General requirements for
operation andrecognitionEN45003:1995 Calibration
andtesting laboratory
accreditation system -
General requirements for
operation andrecognitionG/TBT/W/43
Page6
ISO/IEC Guides ENstandards
Laboratories (cont'd) Guide 43-1:1996 Proficiency
testing byinterlaboratory
comparison -Part1:
Development andoperation
ofproficiency testing
schemes
Guide 43-2:1996 Proficiency
testing byinterlaboratory
comparison -Part2:
Selection anduseof
proficiency testing schemes
bylaboratory accreditation
bodies
Guide45:Guidelines forthe
presentation oftestresults
Guide 49:Guidelines forthe
development ofaquality
manual fortesting
laboratories
Certification bodies Guide 28:1982 General rules
foramodel thirdparty
system forproducts
Guide 61:1996 General
requirements forassessment
andaccreditation of
certification/ registration
bodiesprEN 45010:1995 General
requirements forassessment
andaccreditation of
certification/registration
bodies
Guide 40:1983 General
requirements forthe
acceptance ofcertification
bodiesEN45011:1989 General
criteria forcertification
bodies operating product
certification (+Guide 28)
Guide 65:1996 General
requirements forbodies
operating product
certification systemsprEN 45011:1995 General
requirements forbodies
operating product
certification systems
Guide 48:1986 Guidelines for
third-party assessment and
registration ofasuppliers
Quality systemEN45012:1989 General
requirements forcertification
bodies operating quality
system certification
(+Guide 40)G/TBT/W/43
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ISO/IEC Guides ENstandards
Certification bodies (cont'd) Guide 62:1996 General
requirements forbodies
operating assessment and
certification/ registration of
quality systemsprEN 45012:1995 General
requirements forbodies
operating assessment and
certification/registration of
quality systems
Guide 40 EN45013:1989 General
criteria forcertification
bodies operating certification
ofpersonnel
Guide 23:1982 Methods of
indicating conformity with
standards forthirdparty
certification schemes
Guide 27:1983 Guidelines for
thecorrective action tobe
taken byacertification body
intheevent ofmisuse ofits
conformity mark
Guide 53:1988 Anapproach
totheutilization ofa
supplier 'squality system in
thirdparty product
certification
Guide 56:1989 Anapproach
tothereview bya
certification body ofitsown
internal quality system
Inspection bodies Guide 39:1988 General
requirements forthe
acceptance ofinspection
bodiesEN45004:1995 General
criteria fortheoperation of
various types ofbodies
performing inspection
Guide 57:1991 Guidelines for
thepresentation ofinspection
results
Supplier 'sdeclaration Guide 22:1996 General
criteria forsupplier 's
declaration ofconformityEN45014:1989 General
criteria forsuppliers 's
declaration ofconformityG/TBT/W/43
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II. USEOFISO/IEC GUIDES BYINTERNATIONAL LABORATORY ACCREDITATION
COOPERATION (ILAC) MEMBERS -INFORMATION RECEIVED FROM ILAC
1. Interms oftheoverall conformity assessment activities ofILAC members, thefollowing Guides
aresuggested tobeofimmediate relevance:
(a) ISO/IEC Guide 2:1996 Standardization andrelated activities -General vocabulary
(b) ISO/IEC Guide 25:1990 General requirements forthecompetence ofcalibration and
testing laboratories
(c) ISO/IEC Guide 39:1988 General requirements fortheacceptance ofinspection
bodies
(d) ISO/IEC Guide 43:1997 Proficiency testing byinterlaboratory comparisons -
Part1:Development andoperation ofproficiency testing
schemes;
Part2:Selection anduseofproficiency testing schemes by
laboratory accreditation bodies
(e) ISO/IEC Guide 58:1993 Calibration andtesting laboratory accreditation systems -
General requirements foroperation andrecognition
2. Thepreparatory work forGuides 25,43 and58wasundertaken byvarious working groups
ofILAC before being processed intoISO/IEC Guides. ILAC members continue toplayaleading role
inthelatest revisions ofGuides 25and43.(ILAC members chairtheCASCO Working Groups revising
boththese Guides).
3. ISO/IEC Guide 39hasbeenincluded inthelistbecause ILAC hasextended itsscope ofinterest
tocover accreditation ofinspection bodies. Many ILAC members nowundertake, orplantoundertake,
thisadditional accreditation activity.
4. ApartfromtheaboveGuides,therearetwootherISO-sponsoredpublicationswhicharebecoming
widely adopted byILAC members, namely:
(a) Guide totheExpression ofUncertainty inMeasurement:1993, issued byBIPM; IEC; IFCC;
ISO; IUPAC; IUPAP; OIML.
(b) International vocabulary ofbasic andgeneral terms usedinmetrology:1993 issued byBIPM;
IEC; IFCC; ISO; IUPAC; IUPAP; OIML.
5. Additionally, thereisasubset oftheILAC membership (including representatives oftheUSA,
Japan andAustralia) which areoperating, ordeveloping, anadditional conformity assessment activity
tosupport theirlaboratory accreditation activities. Thishasresulted inestablishment ofanewwork
programme within ILAC todevelop appropriate criteria. Thisnewareaisaccreditation ofproducers
ofcertified reference materials ,andtheISOGuides ofrelevance infuture development ofaccreditation
criteria are:G/TBT/W/43
Page9
(a) ISOGuide 34:1996 Quality system guidelines fortheproduction ofreference
materials
(b) ISOGuide 30:1992 Termsanddefinitionsusedinconnectionwithreferencematerials
(c) ISOGuide 31:1981 Contents ofcertificates ofreference materials
(d) ISOGuide 35:1989 Certification ofreference materials -
General andstatistical principles
Guides 31,34and35areallcurrently being revised within ISO/REMCO.
Current status ofMajor Guides
(a) ISO/IEC Guide 2
AttheISO/CASCO plenary meeting heldinSydney lastweek, itwasresolved thatISObe
asked toconsider thepossibility ofsplitting thisGuide intotwoseparate parts -onedealing
withstandardization issues -theother dealing withconformity assessment terminology. ISO
would alsoconsider whether itshould bepublished asaStandard rather thanaGuide.
(b) ISO/IEC Guide 25
The1990edition ofISO/IEC Guide 25iscurrently under revision withatarget forcompletion
during 1998. Some consideration willalsobegiven toconversion ofGuide 25intoan
International Standard.
(c) ISO/IEC Guide 39
ISO/CASCO hasagreed torevise theexisting Guide 39andtopursue thepossible fast-track
adoption ofEN45004 asitsreplacement. Many non-European bodies arealready using
EN45004 inpreference totheexisting Guide 39.
(d) ISO/IEC Guide 43
The1984edition ofISO/IEC Guide 43istoogeneral tobeofpractical usetoILAC members
andhasnowbeenrevised forpublication (within thenextfewweeks) asatwo-part Guide.
(e) ISO/IEC Guide 58
There iscurrently noformal ISOproposal torevise ISO/IEC Guide 58,butthere issome
investigation taking place within CEN andCASCO onthepossibility ofcombining all
accreditationactivities(includingaccreditationoflaboratories,qualitysystemcertificationbodies
andproduct certification bodies) intoasingle generic Guide. Some ILAC members might
beconcerned atthispossibility, ifthespecial consideration needed forjudgement ofcompetence
oflaboratory accreditation bodies arelostordilute inageneric accreditation Guide. There
isalready concern thatGuide 58doesnotprovide sufficient detail onuseofproficiency testing
byaccreditation bodies oranyreference atalltotheneedforcredible accreditation programmes
tobesupported byaccess toawell-structured, national measurement system.G/TBT/W/43
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UseofISO/IEC Guides byILAC members
6. Atpresent, ILAC itself doesnotspecify theuseofanyStandards orGuides, butencourages
theadoption ofharmonized criteria andpractices amongst itsmembership. Naturally, thisinvolves
recommendations toadopt suitable ISO/IEC Guides suchasISO/IEC Guide 25:1990 andISO/IEC
Guide 58:1993. [NosuchILAC recommendation hasbeenmade onISO/IEC Guide 39duetoanumber
ofperceived deficiencies inthisdocument]. Presumably, thenewly revised ISO/IEC Guide 43will
alsoberecommended foradoption amongst ILAC members.
7. IfILAC infuture becomes involved inestablishment orcoordination ofmultilateral mutual
recognition agreements, thenitwould certainly specify appropriate ISO/IEC Guides orotheracceptable
documents, including those itsownworking groups generate.
8. Inpractice, almost alloftheILAC members would currently beusing ISO/IEC Guide 25:1990
asthebasic criteria foraccreditation oflaboratories. Many ILAC members, however, havefound
itnecessary tosupplement thisgeneric criteria document withtechnology-specific additional criteria.
9. Interms ofadoption ofISO/IEC Guide 58(oritsENequivalent), thisisessential forthose
accreditationbodieswishingtoenterintomultilateralmutualrecognitionagreements(MRAs)established
bytheEuropean cooperation forAccreditation ofLaboratories (EAL) ornowbeing established by
theAsia Pacific Laboratory Accreditation Cooperation (APLAC). Theformal procedures for
establishment ofEALandAPLAC multilateral MRAs dospecify compliance withISO/IEC Guides 25
and58(ortheirENequivalents). Therelevant procedures ofEAL andAPLAC are:
(a) APLAC-MRAC1 (1996): Establishment and Maintaining Mutual Recognition
Agreements; and
(b) EAL-P1 (1996): Establishing andMaintaining Mutual Recognition Agreements
between Laboratory Accreditation Bodies
10. ILAC itself hasalsopublished ILAC-G1 (1994) Guidelines forEstablishment andReview of
MutualRecognitionAgreements.TheILACGuidelinesalsospecifycompliancewithISO/IECGuides25
and58.
_______________
III. ANOVERVIEW OFINTERNATIONAL CONFORMITY ASSESSMENT SYSTEMS -
INFORMATION RECEIVED FROM THE SWEDISH BOARD FOR ACCREDITATION
AND CONFORMITY ASSESSMENT (SWEDAC)
Theattached booklet hasbeenreceived from SWEDAC andattheEuropean Community 's
request isbeing circulated toMembers.