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1/34Qualitymanagementsystems—RequirementsISO9001:2015(E)Introduction........1Scope....2Normativereferences.....3Termsanddefinitions.......4Contextoftheorganization.....4.1Understandingtheorganizationanditscontext.4.2Understandingtheneedsandexpectationsofinterestedparties4.3Determiningthescopeofthequalitymanagementsystem....4.4Qualitymanagementsystemanditsprocesses..5Leadership.........5.1Leadershipandcommitment..5.1.1General........5.1.2Customerfocus...........5.2Policy........5.2.1Establishingthequalitypolicy......5.2.2Communicatingthequalitypolicy......5.3Organizationalroles,responsibilitiesandauthorities6Planning........6.1Actionstoaddressrisksandopportunities........6.2Qualityobjectivesandplanningtoachievethem..6.3Planningofchanges...........7Support............7.1Resources....7.1.1General....7.1.2People...7.1.3Infrastructure.......7.1.4Environmentfortheoperationofprocesses.7.1.5Monitoringandmeasuringresources..7.1.6Organizationalknowledge......7.2Competence....7.3Awareness...7.4Communication.....7.5Documentedinformation.............7.5.1General......7.5.2Creatingandupdating...........7.5.3Controlofdocumentedinformation质量管理体系要求GB/T19001—201X/ISO9001:2015代替GB/T19001—2008(ISO9001:2015，IDT)引言1范围2规范性引用文件3术语和定义4组织环境4.1理解组织及其环境4.2理解相关方的需求和期望4.3确定质量管理体系的范围4.4质量管理体系及其过程5领导作用5.1领导作用和承诺5.1.1总则5.1.2以顾客为关注焦点5.2方针5.2.1制定质量方针5.2.2沟通质量方针5.3组织内的角色、职责和权限6策划6.1应对风险和机遇的措施6.2质量目标及其实现的策划6.3变更的策划7支持7.1资源7.1.1总则7.1.2人员7.1.3基础设施7.1.4过程运行环境7.1.5监视和测量资源7.1.6组织的知识7.2能力7.3意识7.4沟通7.5成文信息7.5.1总则7.5.2创建和更新7.5.3成文信息的控制2/348Operation.....8.1Operationalplanningandcontrol...........8.2Requirementsforproductsandservices....8.2.1Customercommunication.....8.2.2Determiningtherequirementsforproductsandservices....8.2.3Reviewoftherequirementsforproductsandservices..8.2.4Changestorequirementsforproductsandservices......8.3Designanddevelopmentofproductsandservices....8.3.1General......8.3.2Designanddevelopmentplanning...8.3.3Designanddevelopmentinputs....8.3.4Designanddevelopmentcontrols.......8.3.5Designanddevelopmentoutputs........8.3.6Designanddevelopmentchanges....8.4Controlofexternallyprovidedprocesses,productsandservices..8.4.1General......8.4.2Typeandextentofcontrol.......8.4.3Informationforexternalproviders.............8.5Productionandserviceprovision.....8.5.1Controlofproductionandserviceprovision...8.5.2Identificationandtraceability.......8.5.3Propertybelongingtocustomersorexternalproviders8.5.4Preservation......8.5.5Post-deliveryactivities........8.5.6Controlofchanges..................8.6Releaseofproductsandservices...8.7Controlofnonconformingoutputs......9Performanceevaluation....9.1Monitoring,measurement,analysisandevaluation....9.1.1General..9.1.2Customersatisfaction..9.1.3Analysisandevaluation.....9.2Internalaudit.......9.3Managementreview..9.3.1General......9.3.2Managementreviewinputs.9.3.3Managementreviewoutputs......10Improvement.......10.1General........10.2Nonconformityandcorrectiveaction.....10.3Continualimprovement.....AnnexA(informative)Clarificationofnewstructure,terminologyandconcepts..AnnexB(informative)OtherInternationalStandardsonqualitymanagementandqualitymanagementsystemsdevelopedbyISO/TC176..Bibliography.....8运行8.1运行策划和控制8.2产品和服务的要求8.2.1顾客沟通8.2.2产品和服务要求的确定8.2.3产品和服务要求的评审8.2.4产品和服务要求的更改8.3产品和服务的设计和开发8.3.1总则8.3.2设计和开发策划8.3.3设计和开发输入8.3.4设计和开发控制8.3.5设计和开发输出8.3.6设计和开发更改8.4外部提供的过程、产品和服务的控制8.4.1总则8.4.2控制类型和程度8.4.3提供给外部供方的信息8.5生产和服务提供8.5.1生产和服务提供的控制8.5.2标识和可追溯性8.5.3顾客或外部供方的财产8.5.4防护8.5.5交付后的活动8.5.6更改控制8.6产品和服务的放行8.7不合格输出的控制9绩效评价9.1监视、测量、分析和评价9.1.1总则9.1.2顾客满意9.1.3分析与评价9.2内部审核9.3管理评审9.3.1总则9.3.2管理评审输入9.3.3管理评审输出10改进10.1总则10.2不合格和纠正措施10.3持续改进附录A（资料性附录）新结构、术语和概念说明附录B（资料性附录）SAC/TC151制定的其他质量管理和质量管理体系标准参考文献3/34Introduction0.1GeneralTheadoptionofaqualitymanagementsystemisastrategicdecisionforanorganizationthatcanhelptoimproveitsoverallperformanceandprovideasoundbasisforsustainabledevelopmentinitiatives.ThepotentialbenefitstoanorganizationofimplementingaqualitymanagementsystembasedonthisInternationalStandardare:a)theabilitytoconsistentlyprovideproductsandservicesthatmeetcustomerandapplicablestatutoryandregulatoryrequirements;b)facilitatingopportunitiestoenhancecustomersatisfaction;c)addressingrisksandopportunitiesassociatedwithitscontextandobjectives;d)theabilitytodemonstrateconformitytospecifiedqualitymanagementsystemrequirements.ThisInternationalStandardcanbeusedbyinternalandexternalparties.ItisnottheintentofthisInternationalStandardtoimplytheneedfor:—uniformityinthestructureofdifferentqualitymanagementsystems;—alignmentofdocumentationtotheclausestructureofthisInternationalStandard;—theuseofthespecificterminologyofthisInternationalStandardwithintheorganization.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproductsandservices.ThisInternationalStandardemploystheprocessapproach,whichincorporatesthePlan-Do-Check-Act(PDCA)cycleandrisk-basedthinking.Theprocessapproachenablesanorganizationtoplanitsprocessesandtheirinteractions.ThePDCAcycleenablesanorganizationtoensurethatitspr