ISO9001-2015-FDIS版-中英文双语版

FINALDRAFTISO/TC176/SC2Secretariat:BSIVotingbeginson:2015­07­09Votingterminateson:2015­09­09RECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT,WITHTHEIRCOMMENTS,NOTIFICATIONOFANYRELEVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.INADDITIONTOTHEIREVALUATIONASBEINGACCEPTABLEFORINDUSTRIAL,TECHNOLOGICAL,COMMERCIALANDUSERPURPOSES,DRAFTINTERNATIONALSTANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHELIGHTOFTHEIRPOTENTIALTOBECOMESTANDARDSTOWHICHREFERENCEMAYBEMADEINNATIONALREGULATIONS.INTERNATIONALISO/FDISSTANDARD9001Qualitymanagementsystems—RequirementsSystèmesdemanagementdelaqualité—ExigencesPleaseseetheadministrativenotesonpageiiiISO/FDIS9001:2015(E)ii©ISO2015–AllrightsreservedISO/CENPARALLELPROCESSINGThisfinaldrafthasbeendevelopedwithintheInternationalOrganizationforStandardization(ISO),andprocessedundertheISO-leadmodeofcollaborationasdefinedintheViennaAgreement.Thefinaldraftwasestablishedonthebasisofcommentsreceivedduringaparallelenquiryonthedraft.ThisfinaldraftisherebysubmittedtotheISOmemberbodiesandtotheCENmemberbodiesforaparalleltwo-monthapprovalvoteinISOandformalvoteinCEN.Positivevotesshallnotbeaccompaniedbycomments.Negativevotesshallbeaccompaniedbytherelevanttechnicalreasons.COPYRIGHTPROTECTEDDOCUMENT©ISO2015,PublishedinSwitzerlandAllrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO’smemberbodyinthecountryoftherequester.ISOcopyrightofficeCh.deBlandonnet8•CP401CH-1214Vernier,Geneva,[e-mail]:2015(E)©ISO2015–AllrightsreservediiiContents目次Foreword前言0Introduction引言0.1General总则0.2Qualitymanagementprinciples质量管理原则0.3Processapproach过程方法0.4Relationshipwithothermanagementsystemstandards与其他管理体系标准的关系1Scope范围2Normativereferences规范性引用文件3Termsanddefinitions术语和定义4Contextoftheorganization组织情境4.1Understandingtheorganizationanditscontext理解组织及其情境4.2Understandingtheneedsandexpectationsofinterestedparties理解相关方的需求和期望4.3Determiningthescopeofthequalitymanagementsystem确定质量管理体系范围4.4Qualitymanagementsystemanditsprocesses质量管理体系及其过程5Leadership领导力5.1Leadershipandcommitment领导力和承诺5.1.1General总则5.1.2Customerfocus以顾客为关注焦点5.2Qualitypolicy质量方针5.2.2Developingthequalitypolicy制定质量方针5.2.2Communicatingthequalitypolicy沟通质量方针5.3Organizationalroles,responsibilitiesandauthorities组织的角色、职责和权限ISO/FDIS9001:2015(E)iv©ISO2015–Allrightsreserved6Planningforthequalitymanagementsystem质量管理体系策划6.1Actionstoaddressrisksandopportunities应对风险和机会的措施6.2Qualityobjectivesandplanningtoachievethem质量目标和实现计划6.3Planningofchanges变更的策划7Support支持7.1Resources资源7.1.1General总则7.1.2People人员7.1.3Infrastructure基础设施.7.1.4Environmentfortheoperationofprocesses过程运行环境7.1.5Monitoringandmeasuringresources监视和测量资源7.1.6Organizationalknowledge组织知识7.2Competence能力7.3Awareness意识7.4Communication沟通7.5Documentedinformation文件化信息7.5.1General总则7.5.2Creatingandupdating编制和更新7.5.3Controlofdocumentedinformation文件化信息的控制8Operation运行8.1Operationalplanningandcontrol运行的策划和控制8.2Determinationofrequirementsforproductsandservices产品和服务要求的确定8.2.1Customercommunication顾客沟通8.2.2Determinationofrequirementsrelatedtoproductsandservices与产品和服务有关的要求的确定8.2.3Reviewofrequirementsrelatedtoproductsandservices与产品和服务有关的要求的评审8.2.4Changetorequirementsforproductsandservices产品和服务要求的变更ISO/FDIS9001:2015(E)©ISO2015–Allrightsreservedv8.3Designanddevelopmentofproductsandservices产品和服务的设计和开发8.3.1General总则8.3.2Designanddevelopmentplanning设计和开发的策划8.3.3DesignanddevelopmentInputs设计和开发的输入8.3.4Designanddevelopmentcontrols设计和开发的控制8.3.5Designanddevelopmentoutputs设计和开发的输出8.3.6Designanddevelopmentchanges设计和开发的更改8.4Controlofexternallyprovidedprocesses,productsandservices外部提供的过程、产品和服务的控制8.4.1General总则8.4.2Typeandextentofcontrol控制类型和程度8.4.3Informationforexternalproviders外部供方信息8.5Productionandserviceprovision生产和服务提供8.5.1Controlofproductionandserviceprovision生产和服务提供的控制8.5.2Identificationandtraceability标识和可追溯性8.5.3Propertybelongingtocustomersorexternalproviders顾客或外部供方的财产8.5.4Preservation防护8.5.5Post-deliveryactivities交付后活动8.5.6Controlofchanges变更的控制8.6Releaseofproductsandservices产品和服务的放行8.7Controlofnonconformingprocessoutputs不合格输出的控制9Performanceevaluation绩效评价9.1Monitoring,measurement,analysisandevaluation监视、测量、分析和评价9.1.1General总则9.1.2Customersatisfaction顾客满意9.1.3Analysisandevaluation分析和评价9.2Internalaudit内部审核ISO/FDIS9001:2015(E)vi©ISO2015–Allrightsreserved9.3Managementreview管理评审9.3.1General总则9.3.2Managementreviewinput管理评审输入9.3.3Managementreviewoutput管理评审输出10Improvement改进10.1General总则10.2Nonconformityandcorrectiveaction不合格和纠正措施10.3Continualimprovement持续改进AnnexA(informative)Clarificationofnewstructure,terminologyandconcepts附录A（资料性附录）新结构、术语和概念说明AnnexB(informative)OtherInternationalStandardsonqualitymanagementandqualitymanagementsystemsdevelopedbyISO/TC176附录B（资料性附录）ISO/TC176开发的其他有关质量管理和质量管理体系的国际标准Bibliography参考文献ISO/FDIS9001:2015(E)©ISO2015–Allrightsreser