ISO-IEC17025(英文版）

VLAC-VR101FifthEdition1GeneralrequirementsfortheLaboratoryAccreditation(ISO/IEC17025Version)Dateofissue:December19,2002VoluntaryEMCLaboratoryAccreditationCenter,Inc.(VLAC)ThisdocumentiscopyrightedundertheCopyrightAct.Unauthorizedreproduction,transcription,oranyotherunauthorizedduplicationofthisdocumentinwholeorinpart,withtheexceptionofreproductionforprivateuse,mayconstituteaninfringementofthecopyrightandotherrightsVLAC-VR101FifthEdition2ContentsIntroduction1.Scope2.Normativereferences3.Termsanddefinitions4.Managementrequirements5.TechnicalrequirementsAnnexA:Cross-referencesbetweenthisguideandISO9001/2AnnexB:GuidelinesforestablishingapplicationsforspecificfieldsBibliographyVLAC-VR101FifthEdition3GeneralrequirementsfortheLaboratoryAccreditationIntroductionThesegeneralrequirements(hereinafterreferredtoasthisstandard)setforthrequirementsapplicabletoqualitycontrolsystemsandtestequipmentthatatestinglaboratorymustpossesswhenapplyingforlaboratoryaccreditationfromtheVoluntaryEMCLaboratoryAccreditationCenter,Inc.(hereinafterreferredtoasthisCenter).TheserequirementsarebasedonISO/IEC17025,“Generalrequirementsforthecompetenceofcalibrationandtestinglaboratories.”However,theitemsandprovisionsoftheaforesaiddocumentthatapplytocalibrationbodiesandanalysisbodiesshallnotapplyhereunder,sincetheaccreditationworkperformedbythisCentertargetslaboratoriesinvolvedinthefieldofEMC.Specifically:a)ItemsmarkedCalibrationBodyshallnotapply.b)Ofthedescriptionofcalibrationmethods,thoseitemstobeperformedbycalibrationbodiesshallnotapply.c)Descriptionsofsamplingshallnotapply.Note:Thesamplingdescribedinsaiddocumentappliesprimarilytoanalysislaboratories.TheresponsibilitiesandcontrolpertainingtoproductqualityareoutsidethescopeofcompetencyofEMClaboratories.d)Descriptionsofreferencematerialsshallnotapply.Note:Theseareintendedforanalysislaboratories.Sincecalibrationbodiesandcalibrationsconductedbyprivateconcernswereexcludedfromthescopeofthisdocument,thecorrespondingitemswerestruckthroughtoindicatetheirdeletion.However,whenalaboratoryperformsinternalcalibrationsofitsowntestequipment,itmustcomplywiththecorrespondingitempart.Tofacilitateverificationofcorrespondencewiththelatterdocument,theitemsinthisstandardarenumberedinthesamemannerasitemsunderISO/IEC17025.1.Scope1.1ThisInternationalStandardspecifiesthegeneralrequirementsforthecompetencetocarryouttestsand/orcalibrations,includingsampling.Itcoverstestingandcalibrationperformedusingstandardmethods,non-standardmethods,andlaboratory-developedmethods.1.2ThisInternationalStandardisapplicabletoallorganizationsperformingtestsand/orcalibrations.Theseinclude,forexample,first-,second-andthird-partylaboratories,andlaboratorieswheretestingand/orcalibrationformspartofinspectionandproductcertification.ThisInternationalStandardisapplicabletoalllaboratoriesregardlessofthenumberofpersonnelortheextentofthescopeoftestingand/orcalibrationactivities.WhenalaboratorydoesnotundertakeoneormoreoftheactivitiescoveredbythisInternationalStandard,suchassamplingandthedesign/developmentofnewmethods,therequirementsofthoseclausesdonotapply.1.3Thenotesgivenprovideclarificationofthetext,examplesandguidance.TheydonotcontainrequirementsanddonotformanintegralpartofthisInternationalStandard.VLAC-VR101FifthEdition41.4ThisInternationalStandardisforusebylaboratoriesindevelopingtheirquality,administrativeandtechnicalsystemsthatgoverntheiroperations.Laboratoryclients,regulatoryauthoritiesandaccreditationbodiesmayalsouseitinconfirmingorrecognizingthecompetenceoflaboratories.1.5CompliancewithregulatoryandsafetyrequirementsontheoperationoflaboratoriesisnotcoveredbythisInternationalStandard.1.6IftestingandcalibrationlaboratoriescomplywiththerequirementsofthisInternationalStandardtheywilloperateaqualitysystemfortheirtestingandcalibrationactivitiesthatalsomeetstherequirementsofISO9001whentheyengageinthedesign/developmentofnewmethods,and/ordeveloptestprogrammescombiningstandardandnon-standardtestandcalibrationmethods,andISO9002whentheyonlyusestandardmethods.AnnexAprovidesnominalcross-referencesbetweenthisInternationalStandardandISO9001andISO9002.ISO/IEC17025coversseveraltechnicalcompetencerequirementsthatarenotcoveredbyISO9001andISO9002.NOTE1:ItmightbenecessarytoexplainorinterpretcertainrequirementsinthisInternationalStandardtoensurethattherequirementsareappliedinaconsistentmanner.Guidanceforestablishingapplicationsforspecificfields,especiallyforaccreditationbodies(seeISO/IECGuide58:1993,4.1.3)isgiveninannexB.NOTE2:Ifalaboratorywishesaccreditationforpartorallofitstestingandcalibrationactivities,itshouldselectanaccreditationbodythatoperatesinaccordancewithISO/IECGuide58.2NormativereferencesThefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionsofthenormativedocumentsind