GeneralrequirementsforthecompetenceoftestingandcalibrationlaboratoriesExigencesgénéralesconcernantlacompétencedeslaboratoiresd'étalonnagesetd'essaisINTERNATIONALSTANDARDISO/IEC17025Thirdedition2017-11ReferencenumberISO/IEC17025:2017(E)©ISO/IEC2017InternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---ii©ISO/IEC2017–AllrightsreservedCOPYRIGHTPROTECTEDDOCUMENT©ISO/IEC2017,PublishedinSwitzerlandAllrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCh.deBlandonnet8•CP401CH-1214Vernier,Geneva,SwitzerlandTel.+41227490111Fax+41227490947copyright@iso.orgwww.iso.orgISO/IEC17025:2017(E)InternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---ISO/IEC17025:2017(E)Foreword..........................................................................................................................................................................................................................................vIntroduction................................................................................................................................................................................................................................vi1Scope.................................................................................................................................................................................................................................12Normativereferences......................................................................................................................................................................................13 Terms and definitions.....................................................................................................................................................................................14Generalrequirements.....................................................................................................................................................................................34.1Impartiality................................................................................................................................................................................................34.2Confidentiality.........................................................................................................................................................................................35Structuralrequirements..............................................................................................................................................................................46Resourcerequirements.................................................................................................................................................................................56.1General...........................................................................................................................................................................................................56.2Personnel.....................................................................................................................................................................................................56.3Facilitiesandenvironmentalconditions..........................................................................................................................66.4Equipment...................................................................................................................................................................................................66.5Metrologicaltraceability.................................................................................................................................................................86.6Externallyprovidedproductsandservices....................................................................................................................87Processrequirements.....................................................................................................................................................................................97.1Reviewofrequests,tendersandcontracts.....................................................................................................................97.2Selection,verificationandvalidationofmethods..................................................................................................107.2.1Selectionandverificationofmethods........................................................................................................107.2.2Validationofmethods...............................................................................................................................................117.3Sampling....................................................................................................................................................................................................127.4Handlingoftestorcalibrationitems................................................................................................................................127.5Technicalrecords...............................................................................................................................................................................137.6Evaluationofmeasurementuncertainty.......................................................................................................................137.7Ensuringthevalidityofresults..............................................................................................................................................137.8Reportingofresults.........................................................................................................................................................................147.8.1General...................................................................................................................................................................................147.8.2Commonrequirementsforreports(test,calibrationorsampling)..................................157.8.3Specificrequirementsfortestreports.......................................................................................................157.8.4Specificrequirementsforcalibrationcertificates............................................................................167.8.5Reportingsampling–specificrequirements........................................................................................167.8.6Reportingstatementsofconformity............................................................................................................177.8.7Reportingopinionsandinterpretations...................................................................................................177.8.8Amendmentstoreports..........................................................................................................................................177.9Complaints...............................................................................................................................................................................................177.10Nonconformingwork.....................................................................................................................................................................187.11Controlofdataandinformationmanagement.........................................................................................................198Managementsystemrequirements...............................................................................................................................................198.1Options........................................................................................................................................................................................................198.1.1General...................................................................................................................................................................................198.1.2OptionA................................................................................................................................................................................208.1.3OptionB................................................................................................................................................................................208.2Managementsystemdocumentation(OptionA)...................................................................................................208.3Controlofmanagementsystemdocuments(OptionA)...................................................................................208.4Controlofrecords(OptionA)..................................................................................................................................................218.5Actionstoaddressrisksandopportunities(OptionA)....................................................................................218.6Improvement(OptionA).............................................................................................................................................................228.7Correctiveactions(OptionA)..................................................................................................................................................228.8Internalaudits(OptionA)..........................................................................................................................................................238.9Managementreviews(OptionA).........................................................................................................................................23©ISO/IEC2017–AllrightsreservediiiContentsPageInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---ISO/IEC17025:2017(E)AnnexA(informative)Metrologicaltraceability..................................................................................................................................25AnnexB(informative)Managementsystemoptions.......................................................................................................................27Bibliography.............................................................................................................................................................................................................................29iv©ISO/IEC2017–AllrightsreservedInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---ISO/IEC17025:2017(E)ForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.Inthefieldofconformityassessment,ISOandtheInternationalElectrotechnicalCommission(IEC)developjointISO/IECdocumentsunderthemanagementoftheISOCommitteeonConformityassessment(ISO/CASCO).TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seewww.iso.org/directives).Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(seewww.iso.org/patents).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationonthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO'sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:www.iso.org/iso/foreword.html.ThisdocumentwaspreparedbytheISOCommitteeonConformityAssessment(CASCO)andcirculatedforvotingtothenationalbodiesofbothISOandIEC,andwasapprovedbybothorganizations.Thisthirdeditioncancelsandreplacesthesecondedition(ISO/IEC17025:2005),whichhasbeentechnicallyrevised.Themainchangescomparedtothepreviouseditionareasfollows:—therisk-basedthinkingappliedinthiseditionhasenabledsomereductioninprescriptiverequirementsandtheirreplacementbyperformance-basedrequirements;—thereisgreaterflexibilitythaninthepreviouseditionintherequirementsforprocesses,procedures,documentedinformationandorganizationalresponsibilities;—adefinitionof“laboratory”hasbeenadded(see3.6).©ISO/IEC2017–AllrightsreservedvInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---ISO/IEC17025:2017(E)IntroductionThisdocumenthasbeendevelopedwiththeobjectiveofpromotingconfidenceintheoperationoflaboratories.Thisdocumentcontainsrequirementsforlaboratoriestoenablethemtodemonstratetheyoperatecompetently,andareabletogeneratevalidresults.LaboratoriesthatconformtothisdocumentwillalsooperategenerallyinaccordancewiththeprinciplesofISO9001.Thisdocumentrequiresthelaboratorytoplanandimplementactionstoaddressrisksandopportunities.Addressingbothrisksandopportunitiesestablishesabasisforincreasingtheeffectivenessofthemanagementsystem,achievingimprovedresultsandpreventingnegativeeffects.Thelaboratoryisresponsiblefordecidingwhichrisksandopportunitiesneedtobeaddressed.Theuseofthisdocumentwillfacilitatecooperationbetweenlaboratoriesandotherbodies,andassistintheexchangeofinformationandexperience,andintheharmonizationofstandardsandprocedures.Theacceptanceofresultsbetweencountriesisfacilitatediflaboratoriesconformtothisdocument.Inthisdocument,thefollowingverbalformsareused:—“shall”indicatesarequirement;—“should”indicatesarecommendation;—“may”indicatesapermission;—“can”indicatesapossibilityoracapability.FurtherdetailscanbefoundintheISO/IECDirectives,Part2.Forthepurposesofresearch,usersareencouragedtosharetheirviewsonthisdocumentandtheirprioritiesforchangestofutureeditions.Clickonthelinkbelowtotakepartintheonlinesurvey:17025_ed3_usersurveyvi©ISO/IEC2017–AllrightsreservedInternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories1ScopeThisdocumentspecifiesthegeneralrequirementsforthecompetence,impartialityandconsistentoperationoflaboratories.Thisdocumentisapplicabletoallorganizationsperforminglaboratoryactivities,regardlessofthenumberofpersonnel.Laboratorycustomers,regulatoryauthorities,organizationsandschemesusingpeer-assessment,accreditationbodies,andothersusethisdocumentinconfirmingorrecognizingthecompetenceoflaboratories.2NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO/IECGuide99,Internationalvocabularyofmetrology—Basicandgeneralconceptsandassociatedterms(VIM)1)ISO/IEC17000,Conformityassessment—Vocabularyandgeneralprinciples3 Terms and definitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO/IECGuide99andISO/IEC17000andthefollowingapply.ISOandIECmaintainterminologicaldatabasesforuseinstandardizationatthefollowingaddresses:—ISOOnlinebrowsingplatform:availableathttps://www.iso.org/obp—IECElectropedia:availableathttp://www.electropedia.org/3.1impartialitypresenceofobjectivityNote1toentry:Objectivitymeansthatconflictsofinterestdonotexist,orareresolvedsoasnottoadverselyinfluencesubsequentactivitiesofthelaboratory(3.6).Note2toentry:Othertermsthatareusefulinconveyingtheelementofimpartialityinclude“freedomfromconflictofinterests”,“freedomfrombias”,“lackofprejudice”,“neutrality”,“fairness”,“open-mindedness”,“even-handedness”,“detachment”,“balance”.[SOURCE:ISO/IEC17021-1:2015,3.2,modified—Thewords“thecertificationbody”havebeenreplacedby“thelaboratory”inNote1toentry,andtheword“independence”hasbeendeletedfromthelistinNote2toentry.]1)AlsoknownasJCGM200.INTERNATIONALSTANDARDISO/IEC17025:2017(E)©ISO/IEC2017–Allrightsreserved1InternationalOrganizationforStandardizationProvidedbyIHSMarkitunderlicensewithvariousNationalStandardsBodiesLicensee=ShenzhenInstituteofStandardsandTechnology9972181NotforResale,2018/1/2503:25:03NoreproductionornetworkingpermittedwithoutlicensefromIHS--`,,``,,,,,`,`,,```,`,`,`-`-``,```,,,`---ISO/IEC17025:2017(E)3.2complaintexpressionofdissatisfactionbyanypersonororganizationtoalaboratory(3.6),relatingtotheactivitiesorresultsofthatlaboratory,wherearesponseisexpected[SOURCE:ISO/IEC17000:2004,6.5,modified—Thewords“otherthanappeal”havebeendeleted,andthewords“aconformityassessmentbodyoraccreditationbody,relatingtotheactivitiesofthatbody”havebeenreplacedby“alaboratory,relatingtotheactivitiesorresultsofthatlaboratory”.]3.3interlaboratorycomparisonorganization,performanceandevaluationofmeasurementsortestsonthesameorsimilaritemsbytwoormorelaboratoriesinaccordancewithpredeterminedconditions[SOURCE:ISO/IEC17043:2010,3.4]3.4intralaboratorycomparisonorganization,performanceandevaluationofmeasurementsortestsonthesameorsimilaritemswithinthesamelaboratory(3.6)inaccordancewithpredeterminedconditions3.5proficiency testingevaluationofparticipantperformanceagainstpre-establishedcriteriabymeansofinterlaboratorycomparisons(3.3)[SOURCE:ISO/IEC17043:2010,3.7,modified—Notestoentryhavebeendeleted.]3.6laboratorybodythatperformsoneormoreofthefollowingactivities:—testing;—calibration;—sampling,associatedwithsubsequenttestingorcalibrationNote1toentry:Int
本文档为【实验室认可规则英文版ISO IEC 17025：2017】，请使用软件OFFICE或WPS软件打开。作品中的文字与图均可以修改和编辑，
图片更改请在作品中右键图片并更换，文字修改请直接点击文字进行修改，也可以新增和删除文档中的内容。
该文档来自用户分享，如有侵权行为请发邮件ishare@vip.sina.com联系网站客服，我们会及时删除。
[版权声明] 本站所有资料为用户分享产生，若发现您的权利被侵害，请联系客服邮件isharekefu@iask.cn，我们尽快处理。
本作品所展示的图片、画像、字体、音乐的版权可能需版权方额外授权，请谨慎使用。
网站提供的党政主题相关内容(国旗、国徽、党徽..)目的在于配合国家政策宣传，仅限个人学习分享使用，禁止用于任何广告和商用目的。
浙公网安备 33021202002483