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FINALDRAFTINTERNATIONALSTANDARDISO/IECFDIS17025ISO/CASCOSecretariat:ISOVotingbeginon:2017-08-14Votingterminateson:2017-10-09Generalrequirementsforthecompetenceoftestingandcalibrationlaboratories检测和校准实验室能力的通用要求翻译及认可交流联系方式Tel.:18657856588(微信同号)ReferencenumberISO/IECFDIS17025:2017(E)ThisdraftissubmittedtoaparallelvoteinISOandinIEC.ISO/CENPARALLELPROCESSINGISOIEC17025:2017检测和校准实验室能力的通用要求页码PageI/ⅡForeword前言ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.Inthefieldofconformityassessment,ISOandtheInternationalElectrotechnicalCommission(IEC)developjointISO/IECdocumentsunderthemanagementoftheISOCommitteeonConformityassessment(ISO/CASCO).ISO(国际标准化组织)是一个世界性的国家标准机构联合会(ISO成员机构)。国际标准的编制工作通常是通过ISO技术委员会进行的。各成员机构对设立技术委员会的主题感兴趣，有权代表该委员会。国际组织、政府和非政府组织以及ISO，也参与了这项工作。在符合性评估领域，ISO和国际电工委员会(IEC)在符合性评估委员会(ISO/CASCO)的管理下制定了ISO/IEC联合文件。TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Part1.InparticularthedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see).在ISO/IEC指示第1部分中描述了用于开发本文件的程序和用于进一步维护的程序。特别需要注意的是不同类型的ISO文件需要不同的审批标准。本文件是根据ISO/IEC指令，第2部分(见指令)的编辑规则起草的.Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.DetailsofanypatentrightsidentifiedduringthedevelopmentofthedocumentwillbeintheIntroductionand/orontheISOlistofpatentdeclarationsreceived(see).提请注意本文件的某些内容可能是专利权的主题。ISO不应负责识别任何或所有这些专利权。在本文件的开发过程中所确定的任何专利权的细节，将在所收到的专利声明的ISO列表中介绍(见专利).Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.本文件所使用的任何商业名称都是为方便用户而提供的信息，不构成背书。Foranexplanationonthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISO’sadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT)seethefollowingURL:对于标准的自愿性质说明，ISO特定术语的含义与符合性评估有关的表达，以及ISO在贸易技术壁垒中遵守世界贸易组织(WTO)原则的信息，请参阅以下网址:(CASCO)andcirculatedforvotingtothenationalbodiesofbothISOandIEC,andwasapprovedbybothorganizations.该文件由ISO评定委员会(CASCO)编写，并分发给ISO和IEC的国家机构投票，并得到两个组织的批准。Themainchangescomparedtothepreviouseditionareasfollows:—therisk-basedthinkingappliedinthiseditionhasenabledsomereductioninprescriptiverequirementsandtheirreplacementbyperformance-basedrequirements;—thereisgreaterflexibilitythaninthepreviouseditionintherequirementsforprocesses,procedures,documentedinformationandorganizationalresponsibilities;—adefinitionof“laboratory”hasbeenadded(see3.6).与上一版相比，主要变化如下:——本版所采用的基于风险的思想，使一些规定性的需求减少，并以基于业绩的要求取代它们;——在过程、程序、成文信息和组织责任方面，比以前的版本有更大的灵活性;——增加了“实验室”的定义(见3.6)。ISOIEC17025:2017检测和校准实验室能力的通用要求页码PageII/ⅡIntroduction引言Thisdocumenthasbeendevelopedwiththeobjectiveofpromotingconfidenceintheoperationoflaboratories.Thisdocumentcontainsrequirementsforlaboratoriestoenablethemtodemonstratetheyoperatecompetently,andareabletogeneratevalidresults.LaboratoriesthatconformtothisdocumentwillalsooperategenerallyinaccordancewiththeprinciplesofISO9001.制定本标准的目的是增强对实验室运作的信任。本标准包含了实验室能够证明其运作能力，并且能够产生出有效结果的要求。符合本标准的实验室通常也是依据ISO9001的原则来运作的。Thisdocumentrequiresthelaboratorytoplanandimplementactionstoaddressrisksandopportunities.Addressingbothrisksandopportunitiesestablishesabasisforincreasingtheeffectivenessofthemanagementsystem,achievingimprovedresultsandpreventingnegativeeffects.Thelaboratoryisresponsiblefordecidingwhichrisksandopportunitiesneedtobeaddressed.本标准要求实验室计划并采取措施应对风险和机遇。同时应对风险和机遇是提升管理体系有效性、取得改进效果、以及预防负面效应的基础。实验室有责任确定要应对哪些风险和机遇。Theuseofthisdocumentwillfacilitatecooperationbetweenlaboratoriesandotherbodies,andassistintheexchangeofinformationandexperience,andintheharmonizationofstandardsandprocedures.Theacceptanceofresultsbetweencountriesisfacilitatediflaboratoriesconformtothisdocument.使用本标准将促进实验室与其他机构的合作，有助于相互间信息和经验的交流，也有助于标准和程序的协调统一。如果实验室符合本标准，将促进结果的国际互认。Inthisdocument,thefollowingverbalformsareused:—“shall”indicatesarequirement;—“should”indicatesarecommendation;—“may”indicatesapermission;—“can”indicatesapossibilityoracapability.FurtherdetailscanbefoundintheISO/IECDirectives,Part2.在本标准中，使用了以下动词形式：——“应”表示要求；——“应当”表示建议；——“可”表示可以；——“能”表示可能或能力。ISO/IEC工作导则第2部分中对这些动词做了更详细的说明。ISOIEC17025:2017检测和校准实验室能力的通用要求页码Page1/35ISOIEC17025:2017GeneralrequirementsforthecompetenceoftestingandcalibrationlaboratoriesISOIEC17025:2017检测和校准实验室能力的通用要求1SCOPE1范围Thisdocum