RESTRICTED
WORLD TRADE G/TBT/W/43/Add.2
19September 1997
ORGANIZATION(97-3769)
Committee onTechnical Barriers toTrade
PRACTICAL EXPERIENCE OFINDIVIDUAL GOVERNMENTS
AND INTERNATIONAL ORGANIZATIONS INUSING
INTERNATIONAL GUIDES ONCONFORMITY
ASSESSMENT
Note bytheSecretariat
Addendum
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 contains information received from thedelegation ofthePhilippines.
_______________
In1991, inaneffort toprepare forregionalization andinternationalization inthefields of
standardization andconformity assessment, thePhilippines adopted anumber ofENstandards as
Philippine National Standards through itsNational Standards BodyandWTO/TBT Notification Enquiry
Point, theBureau ofProduct Standards (BPS). These standards areEN45001, 45002, 45003, 45011,
45012 and45014. Recognizing thatforthePhilippines tobeabletoenter intoMutual Recognition
Arrangements withother countries andtobeaccepted asaparticipant inregional/international fora,
organizations andassociations suchastheAsiaPacific Economic Cooperation (APEC), theInternational
Accreditation Forum (IAF), andtheInternational Laboratory Accreditation (ILAC), conformity
assessment procedures must conform withinternationally accepted practices.
WiththeissuanceofISO/IECGuidesin1993,EN45001and45003werewithdrawnandreplaced
byISO/IEC Guides 25:1990 and58:1993, respectively, andISO/IEC Guides 61:1996 and62:1996
were lateradopted asPhilippine National Standards. Recently, draftISO/IEC Guide 25:1996 was
circulated forcomments toconcerned sectors inthePhilippines andsubsequently received nationwide
acceptance duetothefactthatsome difficulties intheinterpretation andimplementation ofsome of
theelements intheoldISO/IEC Guide 25arenowaddressed inthenewdraftguide, inparticular with
respecttothealignmentoftherequirementsoftheISO9000(QualityManagementSystem)withISO/IEC
Guide 25elements.
TheBPSoperates athirdparty certification known asthePSCertification Marking Scheme
where amanufacturer, afterrigid factory andproduct assessment byBPS, isgranted thelicense to
usethePSQuality Mark onitsproduct foritscapability toconsistently manufacture inaccordance
withaspecific Philippine National Standard (PNS). Thescheme usesISOGuide 65:1996 foritsG/TBT/W/43/Add.2
Page2
operation. Forthethird party assessment declaration ofconformity, BPSusesISO/IEC Guide 22.
(Presently, firstparty andsecond party declarations arenotencouraged asBPShasyettodevelop a
system toevaluate conformity incases where there isaneedtodoso.)Partofthescheme isthe
utilizationofqualityassessorswhopasstherequirementsoftheNationalRegistrationSchemeforQuality
ofAssessors (NRSQA) patterned aftertheISO10011-Part 2andtheIATCA Guidelines.
In1992, theISO9000 Certification scheme waslaunched byBPStospurbusiness growth
andprovide greater assistance toFilipino manufacturers andexporters inupgrading theirquality systems
tomeet global market requirements. PNS1512/EN 45012 were thenusedtooperate thescheme.
TheENwassubsequently replaced byISO/IEC Guide 62in1996.
InJune1995, BPSbecame anaccreditation bodyforISO9000certifying bodies andEN45010
wasusedintheaccreditation scheme. In1996, ISO/IEC Guide 61wasadopted asPNS1602:1996
andthisreplaced EN45010. Likewise, assessors arenowevaluated andreevaluated using theISO
10011-Parts 1to3,andIATCA Guidelines.
IntheuseofISO/IEC Guides 61and62,difficulties intheinterpretation andimplementation
ofthestandards havebeenencountered. Asadeveloping country, theexperience ofPhilippine auditors
intheaccreditation process cannot compare withthatofdeveloped countries. Forone,thelackof
formal training forourassessors haveresulted indifficulties indetermining theextent oftheaudit.
Furthermore, issues related tocompetence, conflict ofinterest (asthere isthinlinedividing training
andconsultancy), impartiality andcontrol ofsubcontractors (i.e., subcontracted auditors/trainers),
particularly those involved inconsultancy/training activities, areoften raised. Asaresult, confidence
needs tobebuiltamong auditors. Asfarastheoperation offoreign certification bodies inthePhilippines
isconcerned, BPShasdifficulties indetermining theareaofcompetence ofthese certification bodies.
Togainnationalandinternationalrecognitionfortestingcompetenceanddisciplinedcommitment
toquality management, theBPSLaboratory Accreditation Scheme (BPSLAS) wasestablished in1995.
ISO/IEC Guide 25:1990 wasusedinassessing applicants forlaboratory accreditation (which was
subsequently adopted asPNS1600 in1993). Initsoperation oftheBPSLAS, BPSfollows ISO/IEC
Guide 58(PNS 1601:1993). Assessors arealsoevaluated following theISOandIATCA Guidelines.G/TBT/W/43/Add.2
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ANNEX
1. ISO/IECGuidesAdoptedbyBPSasPhilippineNationalStandardsinitsConformityAssessment
Activities:
ISO/IEC Guide 25:1990 General Requirements fortheCompetence ofCalibration and
(PNS 1600: 1993) Testing Laboratories
ISO/IEC Guide 58:1993 Calibration andTesting Laboratory Accreditation System
(PNS 1601: 1993) General Requirements forOperation andRecognition
ISO/IEC Guide 61:1996 General Requirements forAssessment andAccreditation of
(PNS 1602: 1996) Certification/Registration Bodies
ISO/IEC Guide 62:1996 General Requirements forBodies Operating Assessment and
(PNS 1603: 1996) Certification /Registration ofQuality System
ISO10011-1: 1990 Guidelines forAuditing Quality Systems
(PNS 1100-1: 1992) Part1-Auditing
ISO10011-2: 1990 Guidelines forAuditing Quality Systems
(PNS 1100-2: 1992) Part2-Qualification Criteria forQuality Systems Auditors
ISO10011-3: 1990 Guidelines forAuditing Quality Systems
(PNS 1100-3: 1992) Part3-Management ofAudit Programmes
Note: Ofthe8ISO/IEC Guides identified byWTO, only 4have been adopted asPNS.
2. ISO/IEC Guides Being Used asReference inConformity Assessment Activities:
ISO/IEC Guide 65:1996 General Requirements forBodies Operating Product Certification
System
ISO/IEC Guide 22:1996 General Criteria forSuppliers Declaration ofConformity
Note: These guides areintheprocess ofbeing formally adopted asPNS.
3. ISO/IEC Guides Notadopted orUsed asReference:
ISO/IEC Guide 39 General Requirements fortheAcceptance ofInspection Bodies
ISO/IEC Guide 43 Development andOperation ofProficiency Testing
Note: Theregistration ofinspection bodies andthedevelopment andoperation ofproficiency testing arenot
being done byBPS atthemoment, butthese Guides may beadopted astheneed arises.