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Qualitymanagementsystem–Businessmanagementsystemrequirementsforrailorganizations:ISO9001:2015andparticularrequirementsforapplicationintherailsectorISO/TS22163:2017•TheaimofthisTechnicalSpecificationwhichhasbeenpreparedbyUNIFE,theEuropeanRailIndustryAssociation,isthedevelopmentandcontinualimprovementofabusinessmanagementsystemtoensureproductqualityandsafetyintheglobalrailsector.由UNIFE（欧洲铁路工业协会）开发的本技术规范的目的是开发并持续改进运营管理体系以确保在全球铁路领域的产品质量和安全。ThecontentincludeISO9001:2015textandsupplementshasbeenoriginatedbytheUNIFE,IRISCertification™workinggroup.•WhenevertheISO9001:2015textinthisTechnicalSpecificationrefersto“qualitymanagementsystem”,thistermshallbeconsideredas“businessmanagementsystem”,notlimitedtoquality,sothatitencompassesallbusinessprocessesoftheorganization.Therefore,inthesupplementalrailsectorspecificrequirements,theterm“businessmanagementsystem”isusedoutsidetheboxedtext.本文内容包括ISO9001：2015的内容以及由UNIFEIRIS认证工作组开发的补充要求。当本技术规范中ISO9001：2015中提及“质量管理体系”时，这个术语应该理解为“运营管理体系”，不限于质量管理体系，因此其覆盖组织全部运营过程。因此，在铁路行业补充特定要求时，在方框外使用术语“运营管理体系”。•WheneverthisTechnicalSpecificationreferstoclausenumbers,itistobeunderstoodthatalltherequirementsunderthisclauseincludingsub-clausesaretobeconsidered.WheneverthisTechnicalSpecificationrefersto“safety”,thetermistobeunderstoodas“productsafety”,nottobeconfusedwith“occupationalsafety”.当本技术规范提及条款号，其可以理解为该条款下的所有要求包括子条款也要考虑。当本技术规范提及“安全”时，这个术语应理解为“产品安全”，不要与“职业安全”混淆。•WhenevertheISO9001:2015textinthisTechnicalSpecificationrefersto“qualitypolicy”or“qualityobjectives”thesetermsshallapplyto“safetypolicy”or“safetyobjectives”accordingly.当本技术规范中ISO9001：2015文中提及“质量方针”或“质量目标”，这些术语也适用于“安全方针”或“安全目标”。•WheneverthisTechnicalSpecificationrequiresdocumentedprocesses(e.g.calibrationandproduction),theseprocessescanbedefinedwithinasingledocumentedprocess(e.g.bothdefinedwithina“productionmanagement”process).当技术规范要求文件化过程时（例如：校准和生产），这些过程可以在一个文件中描述（例如：都描述中“生产管理”过程中。Tableofcontents目录Foreword前言0Introduction引言0.1General总则0.2Qualitymanagementprinciples质量管理原则0.3Processapproach过程方法0.3.1General总则0.3.2Plan-Do-Check-ActcyclePDCA循环0.3.3Risk-basedthinking基于风险的思维0.4Relationshipwithothermanagementsystemstandards与其他管理体系的关系1.1Scope–Supplemental范围-补充2Normativereferences引用标准3Termsanddefinitions术语和定义3.1Termsanddefinitionsfortherailsector铁路行业术语和定义3.2Abbreviations缩写4Contextoftheorganization组织的背景环境4.1Understandingtheorganizationanditscontext理解组织及其背景环境4.2Understandingtheneedsandexpectationsofinterestedparties理解相关方的需求和期望4.3Determiningthescopeofthequalitymanagementsystem确定质量管理体系的范围4.4Qualitymanagementsystemanditsprocesses质量管理体系及其过程4.4.14.4.24.4.3Qualitymanagementsystemanditsprocesses-Supplemental质量管理体系及其过程-补充5Leadership领导作用5.1Leadershipandcommitment领导作用和承诺5.1.1General总则5.1.2Customerfocus以顾客为关注焦点5.2Policy方针5.2.1Establishingthequalitypolicy建立质量方针5.2.2Communicatingthequalitypolicy沟通质量方针5.2.3Qualitypolicy–Supplemental质量方针补充5.2.4Safetypolicy安全方针5.3Organizationalroles,responsibilitiesandauthorities组织作用、职责和权限5.3.1Organizationalroles,responsibilitiesandauthorities–Supplemental组织作用、职责和权限-补充5.3.2Responsibilitiesandauthoritiesofprocessowners过程所有者的职责和权限6Planning策划6.1Actionstoaddressrisksandopportunities风险和机遇的应对措施6.1.16.1.26.1.3Actionstoaddressrisksandopportunities-Supplemental风险和机遇的应对措施-补充6.1.4Contingencyplanning应急计划6.2Qualityobjectivesandplanningtoachievethem质量目标及其实施的策划6.2.16.2.26.2.3Safetyobjectives安全目标6.3Planningofchanges变更的策划6.4Businessplanning经营计划7Support支持7.1Resources资源7.1.1General总则7.1.1.1General-Supplemental总则-补充7.1.2People人员7.1.3Infrastructure基础设施7.1.4Environmentfortheoperationofprocesses过程操作的环境7.1.5Monitoringandmeasuringresources监视和测量资源7.1.5.1General总则7.1.5.2Measurementtraceability测量的可追溯性7.1.5.3Monitoringandmeasuringresources-Supplemental监视和测量资源-补充7.1.6Organizationalknowledge组织的知识7.1.6.1Organizationalknowledge-Supplemental组织的知识-补充7.2Competence能力7.2.1Competence-Supplemental能力-补充7.3Awareness意识7.3.1Awareness-Supplemental意识-补充7.4Communication沟通7.5Documentedinformation形成文件的信息7.5.1General总则7.5.2Creatingandupdating编制和更新7.5.3Controlofdocumentedinformation文件化信息的控制7.5.4Controlofdocumentedinformation-Supplemental文件化信息的控制-补充8Operation运行8.1Operationalplanningandcontrol运行的策划和控制8.1.1Planningfortheoutsourcingortransferofprocesses过程外包和转包的策划8.1.2Tendermanagement投标管理8.1.3Projectmanagement项目管理8.1.3.1Projectintegrationmanagement项目整合管理8.1.3.2Projectscopemanagement项目范围管理8.1.3.3Projecttimemanagement项目时间管理8.1.3.4Projectcostmanagement项目成本管理8.1.3.5Projectqualitymanagement项目质量管理8.1.3.6Projecthumanresourcemanagement项目人力资源管理8.1.3.7Projectcommunicationsmanagement项目沟通管理8.1.3.8Projectriskandopportunitymanagement项目风险和机遇管理8.1.3.9Projectprocurementmanagement项目采购管理8.1.4Configurationmanagement技术状态管理8.1.5Changemanagement变更管理8.2Requirementsforproductsandservices产品和服务的要求8.2.1Customercommunication顾客沟通8.2.1.1Customercommunication-Supplemental顾客沟通-补充8.2.2Determiningtherequirementsrelatedtoproductsandservices产品和服务相关要求的确定8.2.2.1Determiningtherequirementsrelatedtoproductsandservices-Supplemental.产品和服务相关要求的确定-补充8.2.3Reviewofrequirementsrelatedtoproductsandservices产品和服务相关要求的评审8.2.4Changestorequi