ISO TS 22163 标准.ppt

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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-clausesaretobeconsidered

5、.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“qualityo

6、bjectives”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.bothdefine

7、dwithina“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目目录Foreword 前言前言0 Introduction 引言引言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0.4Rel

8、ationshipwithothermanagementsystemstandards与其他管理体系的关系1.1 Scope Supplemental 范范围-补充充2 Normative references引用引用标准准3 Terms and definitions 术语和定和定义3.1 Terms and definitions for the rail sector铁路行路行业术语和定和定义3.2 Abbreviations 缩写写4 Context of the organization 组织的背景的背景环境境4.1Understandingtheorganizationandits

9、context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5 Leadership领导作用作用5.1Le

10、adershipandcommitment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 质量方量方针补充充5.2.4 Safety policy 安全方安全方针5.3Organizationalroles,responsibilitiesandauthorities组织作用、职责和权限5.3.1 Org

11、anizational roles,responsibilities and authorities Supplemental组织作用、作用、职责和和权限限-补充充5.3.2Responsibilitiesandauthoritiesofprocessowners过程所有者的职责和权限6 Planning策划策划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 风险和机遇的和机遇的应对措施措施-补充充6

12、.1.4 Contingency planning 应急急计划划6.2Qualityobjectivesandplanningtoachievethem质量目标及其实施的策划6.2.16.2.26.2.3 Safety objectives 安全目安全目标6.3Planningofchanges变更的策划6.4 Business planning 经营计划划7 Support 支持支持7.1Resources资源7.1.1General总则7.1.1.1 General-Supplemental 总则-补充充7.1.2People人员7.1.3Infrastructure基础设施7.1.4En

13、vironmentfortheoperationofprocesses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7.1.5.3 Monitoring and measuring resources-Supplemental 监视和和测量量资源源-补充充7.1.6Organizationalknowledge组织的知识7.1.6.1 Organizational knowledge-Supplemental 组织的知的知识-补充充7.

14、2Competence能力7.2.1 Competence-Supplemental 能力能力-补充充7.3Awareness意识7.3.1 Awareness-Supplemental 意意识-补充充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 文件化信息的控制文件化

15、信息的控制-补充充8 Operation 运行运行8.1Operationalplanningandcontrol运行的策划和控制8.1.1 Planning for the outsourcing or transfer of processes过程外包和程外包和转包的包的策划策划8.1.2 Tender management 投投标管理管理8.1.3 Project management 项目管理目管理8.1.3.1 Project integration management项目整合管理目整合管理8.1.3.2 Project scope management 项目范目范围管理管理8.1

16、.3.3 Project time management项目目时间管理管理8.1.3.4 Project cost management项目成本管理目成本管理8.1.3.5 Project quality management 项目目质量管理量管理8.1.3.6 Project human resource management项目人力目人力资源管理源管理8.1.3.7 Project communications management项目沟通管理目沟通管理8.1.3.8 Project risk and opportunity management 项目目风险和机遇管理和机遇管理8.1.3.

17、9 Project procurement management 项目采目采购管理管理8.1.4 Configuration management 技技术状状态管理管理8.1.5 Change management 变更管理更管理8.2Requirementsforproductsandservices产品和服务的要求8.2.1Customercommunication顾客沟通8.2.1.1 Customer communication-Supplemental 顾客沟通客沟通-补充充8.2.2Determiningtherequirementsrelatedtoproductsandserv

18、ices产品和服务相关要求的确定8.2.2.1 Determining the requirements related to products and services-Supplemental.产品和服品和服务相关要求的确定相关要求的确定-补充充8.2.3Reviewofrequirementsrelatedtoproductsandservices产品和服务相关要求的评审8.2.4Changestorequirementsforproductsandservices产品和服务相关要求的变更8.2.5 Requirements for products and services-Suppl

19、emental产品和服品和服务相关相关要求要求-补充充8.3Designanddevelopmentofproductsandservices产品和符合的设计和开发8.3.1General总则8.3.1.1 General-Supplemental 总则-补充充8.3.2Designanddevelopmentplanning设计和开发策划8.3.2.1 Design and development planning-Supplemental设计和开和开发策划策划-补充充8.3.3Designanddevelopmentinputs设计和开发的输入8.3.3.1 Design and deve

20、lopment inputs-Supplemental设计和开和开发的的输入入-补充充8.3.4Designanddevelopmentcontrols设计和开发的控制8.3.4.1 Design and development controls Supplemental设计和开和开发的控制的控制-补充充8.3.4.2 Design reviews设计评审8.3.4.3 Design verification设计验证8.3.4.4 Design validation设计确确认8.3.5Designanddevelopmentoutputs设计和开发的输出8.3.5.1 Design and d

21、evelopment outputs-Supplemental 设计和开和开发的的输出出-补充充8.3.6Designanddevelopmentchanges设计和开发的变更8.4Controlofexternallyprovidedprocesses,productsandservices外部提供的过程、产品和服务的控制8.4.1General总则508.4.1.1 General-Supplemental 总则-补充充8.4.2Typeandextentofcontrol控制的类型和程度8.4.2.1 External provided products,process or servi

22、ce approval of release 外外部提供的部提供的产品、品、过程或服程或服务放行的批准放行的批准8.4.2.2 External provided products,process or service verification after release 外部提供的外部提供的产品、品、过程或服程或服务放行后的放行后的验证 8.4.2.3 Monitoring of external provider performance,re-evaluation and ranking外部供方的外部供方的绩效效监视、再、再评估和估和评级8.4.3Informationforexterna

23、lproviders外部供方的信息8.4.3.1 Information for external providers-Supplemental 外部供方的信息外部供方的信息-补充充8.4.4 Supply chain management 供供应链管理管理8.5Productionandserviceprovision生产和服务的提供8.5.1Controlofproductionandserviceprovision生产和服务提供的控制8.5.1.1 Control of production and service provision-Supplemental 生生产和服和服务提供的控制

24、提供的控制-补充充8.5.1.2 Special processes 特殊特殊过程程8.5.1.3 Production equipment 生生产设备8.5.2Identificationandtraceability标识和可追溯性8.5.2.1 Identification and traceability Supplemental标识和可追溯性和可追溯性-补充充8.5.3Propertybelongingtocustomersorexternalproviders顾客或外部供方所有的财产8.5.3.1 Property belonging to customers or external

25、 providers-Supplemental 顾客或外部供方所有的客或外部供方所有的财产-补充充8.5.4Preservation防护8.5.4.1 Preservation-Supplemental 防防护-补充充8.5.5Post-deliveryactivities交付后活动8.5.5.1 Post-delivery activities-Supplemental 交付后活交付后活动-补充充8.5.6Controlofchanges变更控制8.5.7 Production scheduling 生生产计划划8.6Releaseofproductsandservices产品和服务的放行8

26、.6.1 Release of products and services-Supplemental 产品和服品和服务的放行的放行-补充充8.7Controlofnonconformingoutputs不合格输出的控制8.7.3 Control of nonconforming outputs-Supplemental 不合格不合格输出的控制出的控制-补充充8.8 RAMS/LCC8.9 First article inspection 首件首件检验8.10 Obsolescence management 废弃管理弃管理8.11 Innovation management 创新管理新管理9Pe

27、rformanceevaluation绩效评价9.1Monitoring,measurement,analysisandevaluation监视、测量、分析和评价9.1.1General总则9.1.1.1 General-Supplemental 总则-补充充9.1.2Customersatisfaction客户满意9.1.2.1 Customer satisfaction-Supplemental 客客户满意意-补充充9.1.3Analysisandevaluation分析和评价9.1.3.1Analysisandevaluation-Supplemental分析和评价9.2Internal

28、audit内部审核9.2.19.2.29.2.3 Internal audit-Supplemental 内部内部审核核-补充充9.2.3.1 Audit programme 审核核计划划9.2.3.2 Auditors management 审核核员管理管理9.3Managementreview管理评审9.3.1General总则9.3.1.1 General-Supplemental 总则-补充充9.3.2Managementreviewinputs管理评审-输入9.3.2.1 Management review inputs-Supplemental 管理管理评审输入入-补充充9.3.3

29、Managementreviewoutputs管理评审输出9.3.3.1 Management review outputs-Supplemental 管理管理评审输出出-补充充9.4 Process reviews 过程程评审10Improvement改进10.1General总则10.2Nonconformityandcorrectiveaction不符合及纠正措施10.2.110.2.210.2.3 Nonconformity and corrective action Supplemental 不符合及不符合及纠正措施正措施补充充10.3Continualimprovement持续改进

30、11Bibliography参考书目0Introduction引言0.1General总则ISO9001:2015,QualitymanagementsystemsRequirements质量管理体系-要求0.1 General总则The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable devel

31、opment initiatives.采用质量管理体系是组织的战略决策，可以帮助组织改进其整体绩效，并且为积极进行可持续发展提供可靠基础。The potential benefits to an organization of implementing a quality management system based on this International Standard are:基于本国际标准实施一个质量管理体系对组织的潜在益处是：a)the ability to consistently provide products and services that meet custome

32、r and applicable statutory and regulatory requirements;有能力持续提供满足顾客以及适用的法律法规要求的产品和服务；b)facilitating opportunities to enhance customer satisfaction;促进增强顾客满意的机会；c)addressing risks and opportunities associated with its context and objectives;应对与组织的背景和目标相关的风险和机遇；d)the ability to demonstrate conformity to

33、 specified quality management system requirements.有能力证实对规定的质量管理体系要求符合性。This International Standard can be used by internal and external parties.本标准可以用于于内部和外部。It is not the intent of this International Standard to imply the need for:以下需求不是本标准的目的：-uniformity in the structure of different quality manag

34、ement systems;不同质量管理体系结构的统一；-alignment of documentation to the clause structure of this International Standard;统一文件以对应本国际标准的条款结构-the use of the specific terminology of this International Standard within the organization.在组织内使用本国际标准中的特定术语。The quality management system requirements specified in this I

35、nternational Standard are complementary to requirements for products and services.在本国际标准中规定的质量管理体系要求是产品和服务要求的补充。This International Standard employs the process approach,which incorporates the Plan-Do-Check-Act(PDCA)cycle and risk-based thinking.本标准采用过程方法，结合PDCA循环和基于风险的思维。The process approach enables

36、 an organization to plan its processes and their interactions.过程方法使组织能够策划它的过程和过程之间的相互作用。The PDCA cycle enables an organization to ensure that its processes are adequately resourced and managed,and that opportunities for improvement are determined and acted on.PDCA循环使组织确保它的过程能够获得充分的资源并且得到充分管理，确定改进的机会

37、并实施。Risk-based thinking enables an organization to determine the factors that could cause itsprocesses and its quality management system to deviate from the planned results,to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise.基于风险的思维

38、使组织能够确定那些可能导致它的过程和质量管理体系偏离策划的结果的因素，通过预防控制来减少负面的影响，而且最大化的利用它们产生的机遇。Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment.To achieve this objective,the organization might find it necessary t

39、o adopt various forms of improvement in addition to correction and continual improvement,such as breakthrough change,innovation and re-organization.在日益动态和复杂的环境下，持续满足要求并确定未来的需求和期望，以应对挑战。为了达成这个目标，组织可能发现除了纠正和持续改进还有必要采用不同形式的改进，例如突破性改变，创新和重组。In this International Standard,the following verbal forms are u

40、sed:在本标准中，使用下列非谓语动词：-“shall”indicates a requirement;“应”表明一种要求-“should”indicates a recommendation;“应该”表明一种建议-“may”indicates a permission;“可”表明一种许可-“can”indicates a possibility or a capability.“可以”表明一种可能性或能力 Information marked as“NOTE”is for guidance in understanding or clarifying the associated requi

41、rement.注”是理解或澄清有关要求的指南。0.2 Quality management principles 质量管理原则This International Standard is based on the quality management principles described in ISO 9000.The descriptions include a statement of each principle,a rationale of why the principle is important for the organization,some examples of be

42、nefits associated with the principle and examples of typical actions to improve the organizations performance when applying the principle.本标准是建立在ISO 9000中所阐述的质量管理原则，阐述包括每项原则的概述，管理原则对组织的重要性的基本原理，和原则相关利益的一些例子，以及应用这些原则改进组织绩效的典型的实例。The quality management principles are:质量管理原则有：customer focus;以顾客为关注焦点 le

43、adership;领导作用 engagement of people;全员参与 process approach;过程方法 improvement;改进 evidence-based decision making;基于证据的决策 relationship management.关系管理0.3 Process approach过程方法0.3.1 General总则This International Standard promotes the adoption of a process approach when developing,implementing and improving th

44、e effectiveness of a quality management system,to enhance customer satisfaction by meeting customer requirements.Specific requirements considered essential to the adoption of a process approach are included in 4.4.本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。本标准4.4条款包含了着重考虑采用过程方法的特定要求。Understand

45、ing and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its intended results.This approach enables the organization to control the interrelationships and interdependencies among the processes of the system,so that the overall per

46、formance of the organization can be enhanced.将相互关联过程的作为系统进行理解并加以管理，有助于组织实现预期结果的有效性和效率。过程方法使组织能够管控系统中各个过程之间的相关联系和相关性，这样能够增强组织的整体绩效。The process approach involves the systematic definition and management of processes,and their interactions,so as to achieve the intended results in accordance with the qu

47、ality policy and strategic direction of the organization.过程方法包含了过程的系统的定义和管理以及过程间的相互作用，以达到与组织质量方针和战略方向一致的预期的结果。Management of the processes and the system as a whole can be achieved using the PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of opportunities and prevent

48、ing undesirable results.可以在全面关注旨在预防不良结果并利用机会的“基于风险的考虑”的基础上，应用“策划实施检查改进”（PDCA循环）的方法学实现对过程及系统作为一个整体进行管理。The application of the process approach in a quality management system enables:在质量管理体系中应用过程方法能够：a)understanding and consistency in meeting requirements;理解并持续满足要求；b)the consideration of processes in

49、terms of added value;从增值的角度考虑过程；c)the achievement of effective process performance;有效过程绩效的实现；d)improvement of processes based on evaluation of data and information.在数据和信息评价的基础上改进过程。Figure 1 gives a schematic representation of any process and shows the interaction of its elements.The monitoring and m

50、easuring check points,which are necessary for control,are specific to each process and will vary depending on the related risks.图1 给出了任意一个过程的图示，展示了各要素间的相互作用。监视和测量的检查要点对于控制是必要的，对于每个过程是特定的，并会根据相关的风险而不同0.3.2 Plan-Do-Check-Act cycle PDCA循环The PDCA cycle can be applied to all processes and to the quality