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1、Quality management system Business management system requirements for rail organizations:ISO 9001:2015 and particular requirements for application in the rail sectorISO/TS22163:2017TheaimofthisTechnicalSpecificationwhichhasbeenpreparedbyUNIFE,theEuropeanRailIndustryAssociation,isthedevelopmentandcon
2、tinualimprovementofabusinessmanagementsystemtoensureproductqualityandsafetyintheglobalrailsector.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,IRISCertificationworkinggroup.WhenevertheISO9001:2015textinthisTechn
3、icalSpecificationrefersto“qualitymanagementsystem”,thistermshallbeconsideredas“businessmanagementsystem”,notlimitedtoquality,sothatitencompassesallbusinessprocessesoftheorganization.Therefore,inthesupplementalrailsectorspecificrequirements,theterm“businessmanagementsystem”isusedoutsidetheboxedtext.本
4、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-clausesaretobeconside
5、red.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“q
6、ualityobjectives”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.bot
7、hdefinedwithina“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。Table of contents目录Foreword 前言0 Introduction 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0.4R
8、elationshipwithothermanagementsystemstandards与其他管理体系的关系1.1 Scope Supplemental 范围-补充2 Normative references引用标准3 Terms and definitions 术语和定义3.1 Terms and definitions for the rail sector铁路行业术语和定义3.2 Abbreviations 缩写4 Context of the organization 组织的背景环境4.1Understandingtheorganizationanditscontext理解组织及其背
9、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5 Leadership领导作用5.1Leadershipandcommi
10、tment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5.2.3 Quality policy Supplemental 质量方针补充5.2.4 Safety policy 安全方针5.3Organizationalroles,responsibilitiesandauthorities组织作用、职责和权限5.3.1 Organizational roles, res
11、ponsibilities and authorities 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6 Planning策划6.1Actionstoaddressrisksandopportunities风险和机遇的应对措施6.1.16.1.26.1.3 Actions to address risks and opportunities - Supplemental 风险和机遇的应对措施-补充6.1.4 Contingency planning 应急计划6.2Q
12、ualityobjectivesandplanningtoachievethem质量目标及其实施的策划6.2.16.2.26.2.3 Safety objectives 安全目标6.3Planningofchanges变更的策划6.4 Business planning 经营计划7 Support 支持7.1Resources资源7.1.1General总则7.1.1.1 General - 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
13、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7.1.5.3 Monitoring and measuring resources - Supplemental 监视和测量资源-补充7.1.6Organizationalknowledge组织的知识7.1.6.1 Organizational knowledge - Supplemental 组织的知识-补充7.2Competence能力7.2.1 Competence - Supplemental
14、 能力-补充7.3Awareness意识7.3.1 Awareness - 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7.5.4 Control of documented information - Supplemental 文件化信息的控制-补充8 Operation 运行8.1Operationalplanningandcont
15、rol运行的策划和控制8.1.1 Planning for the outsourcing or transfer of processes过程外包和转包的策划8.1.2 Tender management 投标管理8.1.3 Project management 项目管理8.1.3.1 Project integration management项目整合管理8.1.3.2 Project scope management 项目范围管理8.1.3.3 Project time management项目时间管理8.1.3.4 Project cost management项目成本管理8.1.3.
16、5 Project quality management 项目质量管理8.1.3.6 Project human resource management项目人力资源管理8.1.3.7 Project communications management项目沟通管理8.1.3.8 Project risk and opportunity management 项目风险和机遇管理8.1.3.9 Project procurement management 项目采购管理8.1.4 Configuration management 技术状态管理8.1.5 Change management 变更管理8.2Requirementsforproductsandservices产品和服务的要求8.2.1Customercommunication顾客沟通8.2.1.1 Customer communication - Supplemental 顾客沟通-补充8.2.2Determiningtherequirementsrelatedtoproductsandservices产品和服务相关要求的确定8.2
