ISOTS22163标准培训

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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.

17、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8.2.2.1 Determining the requirements related to products and services -Supplemental. 产品和服务相关要求的确定-补充8.2

18、.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 - Supplemental产品和服务相关要求-补充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8.

19、3.2Designanddevelopmentplanning设计和开发策划8.3.2.1 Design and development planning - Supplemental设计和开发策划-补充8.3.3Designanddevelopmentinputs设计和开发的输入8.3.3.1 Design and development inputs - Supplemental设计和开发的输入-补充8.3.4Designanddevelopmentcontrols设计和开发的控制8.3.4.1 Design and development controls Supplemental设计和

20、开发的控制-补充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设计确认8.3.5Designanddevelopmentoutputs设计和开发的输出8.3.5.1 Design and development outputs - Supplemental 设计和开发的输出-补充8.3.6Designanddevelopmentchanges设计和开发的变更8.4Controlofexternallyprovidedprocesses,productsandservices外部

21、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8.4.2Typeandextentofcontrol控制的类型和程度8.4.2.1 External provided products, process or service approval of release 外部提供的产品、过程或服务放行的批准8.4.2.2 External provided products, process or service verification after release 外部提供的产品、过程或服务放行后的验证 8.4.

22、2.3 Monitoring of external provider performance, re-evaluation and ranking外部供方的绩效监视、再评估和评级8.4.3Informationforexternalproviders外部供方的信息8.4.3.1 Information for external providers - Supplemental 外部供方的信息-补充8.4.4 Supply chain management 供应链管理8.5Productionandserviceprovision生产和服务的提供8.5.1Controlofproduction

23、andserviceprovision生产和服务提供的控制8.5.1.1 Control of production and service provision - Supplemental 生产和服务提供的控制-补充8.5.1.2 Special processes 特殊过程8.5.1.3 Production equipment 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-补充8.5.3Propertybelongingtoc

24、ustomersorexternalproviders顾客或外部供方所有的财产8.5.3.1 Property belonging to customers or external providers - Supplemental 顾客或外部供方所有的财产-补充8.5.4Preservation防护8.5.4.1 Preservation - Supplemental 防护-补充8.5.5Post-deliveryactivities交付后活动8.5.5.1 Post-delivery activities - Supplemental 交付后活动-补充8.5.6Controlofchange

25、s变更控制8.5.7 Production scheduling 生产计划8.6Releaseofproductsandservices产品和服务的放行8.6.1 Release of products and services - Supplemental 产品和服务的放行-补充8.7Controlofnonconformingoutputs不合格输出的控制8.7.3 Control of nonconforming outputs - Supplemental 不合格输出的控制-补充8.8 RAMS / LCC8.9 First article inspection 首件检验8.10 Ob

26、solescence management 废弃管理8.11 Innovation management 创新管理9Performanceevaluation绩效评价9.1Monitoring,measurement,analysisandevaluation监视、测量、分析和评价9.1.1General总则9.1.1.1 General - Supplemental 总则-补充9.1.2Customersatisfaction客户满意9.1.2.1 Customer satisfaction - Supplemental 客户满意-补充9.1.3Analysisandevaluation分析

27、和评价9.1.3.1Analysisandevaluation-Supplemental分析和评价9.2Internalaudit内部审核9.2.19.2.29.2.3 Internal audit - Supplemental 内部审核-补充9.2.3.1 Audit programme 审核计划9.2.3.2 Auditors management 审核员管理9.3Managementreview管理评审9.3.1General总则9.3.1.1 General - Supplemental 总则-补充9.3.2Managementreviewinputs管理评审-输入9.3.2.1 Ma

28、nagement review inputs - Supplemental 管理评审输入-补充9.3.3Managementreviewoutputs管理评审输出9.3.3.1 Management review outputs - Supplemental 管理评审输出-补充9.4 Process reviews 过程评审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 Supplement

29、al 不符合及纠正措施补充10.3Continualimprovement持续改进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 pr

30、ovide a sound basis for sustainable development 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 pro

31、vide products and services that meet customer 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

32、的风险和机遇；d) the ability to demonstrate conformity to 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：-

33、uniformity in the structure of different quality management 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

34、 quality management system requirements specified in this International 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

35、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 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 a

36、re 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 e

37、ffects and to make maximum use of opportunities as they arise. 基于风险的思维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 environmen

38、t. To achieve this objective, the organization might find it necessary to 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

39、突破性改变，创新和重组。In this International Standard, the following verbal forms are used: 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 I

40、nformation marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. 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 eac

41、h principle, a rationale of why the principle is important for the organization, some examples of benefits 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

42、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 leadership; 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 I

43、nternational Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements. Specific requirements considered essential to the adoption of a process a

44、pproach 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。Understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its intended results. This approach enables the organizati

45、on to control the interrelationships and interdependencies among the processes of the system, so that the overall performance 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 defini

46、tion and management of processes, and their interactions, so as to achieve the intended results in accordance with the quality 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 achieve

47、d using the PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of opportunities and preventing 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 ena

48、bles: 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 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

49、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 measuring 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

50、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 management system as a whole. 总的来说，PDCA循环可以适用于整个质量管理体系及其所有的过程。Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle. 图2 阐述了条款4至10

51、如何通过PDCA循环集合在一起。The PDCA cycle can be briefly described as follows: PDCA循环可简述如下 Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers requirements and the organizations policies, and identify and address risks and opp

52、ortunities; P策划：根据顾客的要求和组织的方针，以及识别和确定的风险和机遇，建立体系及其过程的目标，以及为了达成结果所需的资源； Do: implement what was planned; D实施：策划的实施； Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;

53、 C检查：根据方针、目标、要求和策划的活动，对过程及其产生的产品和服务进行监视和（适用时）测量，并报告结果； Act: take actions to improve performance, as necessary. A改进：必要时，采取措施，以改进绩效。 过程方法鼓励采用过程方法过程方法过程过程：通过使用资源和管理,将输入转化为输出的活动。过程方法过程方法：组织内诸过程的系统的应用，连同这些过程的识别和相互作用及管理。在开发、实施及改进质量管理体系的有效性时 通过满足顾客要求来增强顾客满意 过程方法为了有效地实施，需要：识别并管理众多关联的活动描述质量管理体系各过程的间的关系确保顾客的要

54、求被准确地输入在各过程中应用PDCA循环(Plan策划、Do实施、Check检查、Act处置)Plan计划计划Do实施实施Check检查检查Act处置处置“P-D-C-A 循环循环”过程单元 过程活动过程活动+各各种资源种资源输入输入输入输入输出输出输出输出控制控制控制控制( (例如操作程序例如操作程序例如操作程序例如操作程序) ) 0.2 过程方法过程方法基本的过程模式管理管理活动活动“促促进进者者”顾客顾客输入输入顾客顾客滿意滿意期望的期望的输出输出过程过程单元单元 培訓过程输入：- 學员- 導師- 培訓設施输出：- 學员管理層期望特性： 概念改变、澄清、理解、沟通、興趣轉化过程过程方法范

55、例过程方法范例过程单元 - 了解交互关系过程过程单元单元A过程过程单元单元D过程过程单元单元B过程过程单元单元C输入输入输入输入输出输出输出输出控制控制控制控制0.2 过程方法过程方法顾客顾客顾客导向顾客导向顾客导向过程过程过程输入输入输出输出管理过程支持过程顾客顾客过程的分类任何与组织及其顾客的接口直接相关的过程，包括来自于顾客的输入以及面向顾客的输出过程：输入：顾客要求输出：顾客满意与实现顾客满意关系重大的过程每一个联结都是对过程模式的有效运用顾客导向过程顾客导向过程(Customer Oriented Process)组织可能的顾客导向过程清单组织可能的顾客导向过程清单Market An

56、alysis / Customer Requirements市场分析/顾客要求Bid/Tender 投标Order/Request 订单/要求Product and Process Design 产品和过程设计Product and Process Verification/Validation产品和过程验证/确认Product Manufacturing 产品生产Delivery 交付Payment 支付Warranty/Service 担保/服务Post Sales/Customer Feedback 销售/顾客反馈每个关键过程都会有一个或多个支持过程来补充支持过程一般都有内部顾客和供方支

57、持过程举例：培训文件控制支持过程支持过程(Supporting Processes)可以是支持过程一般是对组织或其质量体系进行管理的过程管理过程举例：业务计划管理评审管理过程管理过程(Management Processes)存在过程所有者 (管理者)过程已经被确定需要时，将过程文件化已建立过程之间的联系过程被监测、分析及改进必须测量过程以确定其有效性应根据预先确定的目标来进行测量对数据进行分析以改进过程适当时，保存记录过程的关键因素人策划生产前期确認參照 A設備可用于交付1信息什么是过程管理?人策划生产前期确認參照 A設備可用于交付1信息目标目标目标目标目标目标目标目标什么是过程管理?人策划

58、生产前期确認參照 A設備可用于交付1信息目标目标目标目标目标目标目标目标行动行动行动行动什么是过程管理? 过程过程所有者所有者输入输出特性目标(绩效&满意度)过程测量和监察过程的识別“乌龟图”由由谁谁进行进行?(能力能力/技能技能/资格资格)过程名称过程名称过程步骤流程图过程步骤流程图输出输出(我们将交付什么我们将交付什么?)输入输入(我们将收到什么我们将收到什么?)使用什么方式使用什么方式?(材料材料/设备设备/装置装置)如何作如何作?(方法方法/指导书指导书/程序程序/技术技术)关键准则是什么关键准则是什么?(测量测量/评估评估/绩效绩效/指标指标)Support and linkage

59、process输出 B输入 A输出 C输出 D输出 C输入 B输出 A输入 D输出 E输入 EPDCA反饋反饋过程过程 A管理支持过程过程 B管理支持过程过程 C管理支持过程过程 E管理支持过程过程 D管理支持 PDCA PDCA PDCA输出 F输入 F內部顾客內部顾客內部顾客內部顾客过程过程 C管理支持 PDCA PDCA PDCA各过程如何相互作用？0.3.3 Risk-based thinking基于风险的考虑Risk-based thinking is essential for achieving an effective quality management system. 基于

60、风险的考虑是组织实现一个有效的质量管理体系必不可少的。The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example基于风险的考虑这一概念也已经隐含在本标准之前的版本，包括如 Carrying out preventive action to eliminate potential nonconformities, analyzing any nonconformities that do occur,

61、and taking action to prevent recurrence that is appropriate for the effects of the nonconformity. 实施预防措施来消除潜在的不符合，分析发生的任何不符合，并采取同不符合的影响相适应的措施避免再次发生。To conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities. A

62、ddressing both risks and opportunities establishes a basis for increasing the effectiveness of the quality management system, achieving improved results and preventing negative effects. 为符合本标准的要求，组织需策划和实施应对风险和机遇的措施。同时应对风险和机遇为增强质量管理体系的有效性，达成改进的结果和预防负面影响建立了基础。Opportunities can arise as a result of a s

63、ituation favorable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk

64、 is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities. 机遇可以因一种有利情况的出现来达成预期的结果，例如：一些允许组织吸引顾客，开发新产品和服务，减少浪费或提高生产效率的情形。应对机遇的措施也可以包括相关

65、风险的考虑。风险是一种不确定性和这些可以有正面或负面影响的不确定性的结果。由风险引起的正面的偏离可以提供机遇，但并不是所有的风险的正面影响都会产生机遇。 0.4 Relationship with other management system standards与其他管理体系标准的关系This International Standard applies the framework developed by ISO to improve alignment among its International Standards for management systems (see Clause

66、 A.1). 本标准适用于ISO开发的框架，从而在管理体系的国际标准中改进其一致性。（见条款A.1) This International Standard enables an organization to use the process approach, coupled with the PDCA cycle and risk-based thinking, to align or integrate its quality management system with the requirements of other management system standards. 本标准

67、使组织采用过程方法，并与PDCA循环和基于风险的考虑相结合，从而使组织的质量管理体系与其他管理体系标准的要求一致或整合。This International Standard relates to ISO 9000 and ISO 9004 as follows: 本标准与ISO 9000 和 ISO 9004 的关联如下： ISO 9000 Quality management systems Fundamentals and vocabulary provides essential background for the proper understanding and implement

68、ation of this International Standard; ISO 9000 质量管理体系基础和术语 为合适的理解和实施本标准提供了重要的背景。 ISO 9004 Managing for the sustained success of an organization A quality management approach provides guidance for organizations that choose to progress beyond the requirements of this International Standard. ISO 9004 组

69、织持续成功的管理 一种质量管理方法为组织超越本标准要求追求进步提供了指南。Annex B provides details of other International Standards on quality management and quality management systems that have been developed by ISO/TC 176. 附件B提供了ISO/TC 176已经开发的关于质量管理和质量管理体系的其他国际标准的细节This International Standard does not include requirements specific t

70、o other management systems, such as those for environmental management, occupational health and safety management, or financial management. 本标准不包括其他管理体系的特定要求，例如环境管理，职业健康安全管理或财务管理。 Sector-specific quality management system standards based on the requirements of this International Standard have been d

71、eveloped for a number of sectors. Some of these standards specify additional quality management system requirements, while others are limited to providing guidance to the application of this International Standard within the particular sector. 许多领域已经建立了基于本标准要求的特定领域的质量管理体系标准。这些标准中的一些规定了附加的质量管理体系要求，而另

72、一些仅限于为本标准在特定领域的应用提供指南。 A matrix showing the correlation between the clauses of this edition of this International Standard and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access web site at: www.iso.org/tc176/sc02/public.本版标准和先前版本(ISO 9001:2008) 之间的联系作了一个矩阵模型，可以在ISO

73、/TC 176/SC 2 的公开网站 www.iso.org/tc176/sc02/public 上找到。Quality management system-requirements质量管理体系-要求1 scope范围This International Standard specifies requirements for a quality management system when an organization: 本标准为有下列需求的组织规定了质量管理体系要求a) needs to demonstrate its ability to consistently provide pro

74、ducts and services that meet customer and applicable statutory and regulatory requirements, and需要证实其具有稳定地提供满足顾客要求和适用法律法规要求的产品和服务的能力；b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conform

75、ity to customer and applicable statutory and regulatory requirements. 通过体系的有效应用，包括体系持续改进的过程，以及保证符合顾客和 适用的法律法规要求，旨在增强顾客满意All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services

76、it provides. 本标准规定的要求是通用的，意在适用于各种类型、不同规模和提供不同产品和服务的组织。 NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer. 注1：在本标准中，术语“产品”或“服务”仅适用于：预期提供给顾客或顾客所要求的产品和服务。 NOTE 2 Statutory and regulatory requirements can

77、be expressed as legal requirements. 注2：法律法规要求可称作为法定要求1.1ScopeSupplemental范围-补充ThisTechnicalSpecificationdefinesqualitymanagementsystemrequirementsintherailsector(RQMS)本技术规范确定了铁路工业的质量管理体系要求（RQMS）tobeappliedthroughoutthewholesupplychainofrailwayindustrialrelatedproductsforthedesign&development,manufac

78、turingandmaintenanceactivities(excludingoperationsandservicesofrailtransports)应用于铁路工业整个供应链相关产品的设计开发、制造和维护保养活动（不包括铁路运输的服务和运行）thatprovidescontinualimprovement,emphasizingdefectpreventionanddefectreductioninthesupplychain在整个供应链进行持续改进、强调防错和减少浪费toenhanceandsustainproductquality,includingitssafetyaspects.

79、强化和持续稳定的保证产品质量，包括产品安全方面。NOTEThisTechnicalSpecificationallowsorganizationstohavethesameflexibilitywhendeterminingtheboundariesandapplicabilityofthequalitymanagementsystemasdescribedinclause4.3ofISO9001:2015.注：在确定ISO9001：2015第4.3条要求的质量管理体系边界和应用时，本技术规范允许组织有相同的弹性。2 Normative references引用文件The following

80、documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. 下列文件中的条款，整体或部分通过本标准的引

81、用而成为本标准的条款。凡是注日期的引用文件，只有引用版本适用，凡是不注日期的引用文件，其最新版本适用于本标准（包括任何修订版）。ISO 9000:2015, Quality management systems Fundamentals and vocabulary. ISO 9000:2015 质量管理体系基础和术语3 Terms and definitions术语和定义For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply. 本标准采用ISO 9000:2015中所确

82、立的术语和定义。3.1Termsanddefinitionsfortherailsector铁路行业的术语和定义3.1.1applicationsoftware应用软件Computerprogrammethatperformsasetoffunctionstosupporttheexecutionofaprocess.执行一系列功能的计算机程序以支持过程的运行。Thiscanbeasoftwareprogramme,database,computerizedspreadsheet,electronicfileorwebtool,boughtfromthemarketordevelopedbyt

83、heorganization.这可能是一个市场购买或组织自行开发的软件程序、数据库、电子表格、电子文件或网络工具。3.1.2availability(ofanitem)可用性（一个物品的）Abilitytobeinastatetoperformasrequired按照要求执行某种状态的能力。Note1toentry:Availabilitydependsuponthecombinedcharacteristicsofthereliability,recoverability,andmaintainabilityoftheitem,andthemaintenancesupportperforma

84、nce.本条目注1：可用性是取决于物品的可靠性、可恢复性和可维护性以及维护支持绩效的综合参数IEC60050-192:2015,192-01-23.3.1.3commissioning调试Phasebeforehandovertoacustomer,inwhichaproductisfinaltestedunderoperationalconditionstoverifyitfunctionsaccordingtoitsspecifications.Theproductispreparedtostartoperation.交付给客户前的阶段，在此阶段在使用条件下进行最终试验根据其技术规范验证其

85、功能。产品准备开始运行。3.1.4component部件Sub-deviceabovetheintegrationlevelofthesmallestreplaceableunitofasysteminserviceormaintenance.应用于服务和维护保养中的最小维护单元之上的整合子装置。3.1.5configurationaudit技术状态（配置）审核Auditperformedinaccordancewithdocumentedprocedurestodeterminewhetheraproductconformstoitsrequirementsandproductconfigu

86、rationinformation.ISO10007:2003,35.6根据文件化程序进行审核以确定产品是否符合产品要求和产品技术状态（配置）信息。3.1.6configurationbaseline技术状态基线Approvedproductconfigurationinformationthatestablishesthecharacteristicsofaproductatapointintimethatservesasreferenceforactivitiesthroughoutthelifecycleoftheproduct. 在产品的整个生命周期中，经批准的以时间为基准建立产品特性

87、的产品配置信息。ISO10007:2003,3.43.1.7configurationstatusaccounting配置状态统计Formalizedrecordingandreportingofproductconfigurationinformation,thestatusofproposedchangesandthestatusoftheimplementationofapprovedchanges.产品配置信息的记录和报告，计划变更的状态和已批准变更的执行状态。ISO10007:2003,5.5.3.1.8consignmentstock寄售库存Stockownedbyanextern

88、alprovider,butheldbytheorganizationtoensureavailabilityofparts.外部供方所有的库存，但是由组织控制以确保零件供应。3.1.9critical/criticality危险的/危险度Objectshavingthepotentialofintroducinghighrisksthatcanthreatenquality,safetyorbusinessperformance,basedonariskassessment.在风险评估的基础上，具有引入高风险可能性的对象，风险可能影响质量、安全或运行绩效。3.1.10deferredwork

89、延期工作Activitywhichispartofapredeterminedsequenceinaprocess,thatisdelayedorpostponed.过程中作为预订顺序一部分的活动，被延期或延迟。3.1.11deliverables可交付物Alltypesofoutputforthescopeofsupplytofulfilsetrequirements(e.g.usermanual,maintenancemanual,testreports,testequipment,training,spareandsupportparts).供货范围内满足设定要求的所有类型的输出（例如，

90、用户手册、保养手册、试验报告、试验设备、培训、备品备件）3.1.12firstarticleinspection首件检验Setofinspectionandverificationactivitiesinordertovalidateaproductionprocess.为了确认生产过程进行的一系列检验和验证活动。3.1.13FRACASClosedloopprocessusedtoimprovedependabilityofcurrentandfuturedesignsbyfeedbackoftesting,modificationanduseexperience.通过实验反馈、修改和利用经

91、验，用来改进当前和将来设计可靠性的闭环过程。IEC60050-192:2015,192-12-04.3.1.14functionalrequirement功能要求Dedicatedrequirementorcapabilityofafunctionwithinthefunctionalbreakdownstructure.在功能展开结构中，功能的能力和详细要求。3.1.15gatecriteria门准则Acceptancecriteriafordeliverablesatgatesinordertosupportthedecisionstobetaken,suchasaccepted,cond

92、itionallyacceptedorrejected.为了支持所采取的决定（例如接受、条件接受或拒绝），在质量门处可交付物的接受准则。3.1.16handover移交Passingcontrolauthorityofthesubjectitemfromoneorganizationtoanother,includingtransferofresponsibilitiestothereceivingorganization.将主体项目的控制权从一个组织转移到另一个组织，包括接收组织的责任转移3.1.17installation安装Phaseafterdeliveryatcustomerprem

93、isesandpriortocommissioning.交付到客户处后和调试前的阶段NOTEInstallationisatypicalphaseofinfrastructureactivities.注：安装是基础设施活动的典型阶段3.1.18integrationmaturity集成成熟度Degreeoffulfilmentoftheintegrationrequirementsofaproduct(e.g.alreadyorneverintegratedintheorganizationsproducts).产品集成要求的满足程度（例如组织的产品已经集成或从未集成）3.1.19integr

94、ationrequirements集成要求Requirementsregardingintegrationofasystemintoaparentsystemanditsfulfilmentoffunctionalrequirementsinthisenvironment.针对系统集成到母系统的要求，以及在这个环境下功能要求的满足。3.1.20 keyperformanceindicator(KPI)关键绩效指标Indicator,selectedbythetopmanagement,toevaluatetheperformanceofthebusinessmanagementsystem.由

95、高层管理者选择用来评价运营管理体系绩效的指标。3.1.21lifecyclecosting(LCC)生命周期成本Processofeconomicanalysistoassessthecostofanitemoveritslifecycleoraportionthereof.评价物品生命周期或生命周期一部分的成本的经济学分析过程。IEC60050-192:2015,192-11-113.1.22maintainability(ofanitem)（物品的）可维护性 Abilitytoberetainedin,orrestoredtoastatetoperformasrequired,underg

96、ivenconditionsofuseandmaintenance.在给定的使用和维护条件下，保持或恢复到执行规定要求的状态的能力。Note1toentry:Givenconditionswouldincludeaspectsthataffectmaintainability,suchas:locationformaintenance,accessibility,maintenanceproceduresandmaintenanceresources.注1进入：给定条件包括影响可维护性的方面，例如：维护的地点、可访问性、维护程序和维护资源。IEC60050-192:2015,192-01-27

97、3.1.23maintenance维护Combinationofalltechnicalandmanagementactionsintendedtoretainanitemin,orrestoreittoastateinwhichitcanperformasrequired.为了保持或恢复物品到能够执行规定要求的状态，技术和管理措施的结合。Note1toentry:Managementisassumedtoincludesupervisionactivities.注1：进入： 假设管理包括监督活动。IEC60050-192:2015,192-06-013.1.24manufacturing制造

98、Activitiestorealizeproductsincludingoverhaulandrepair.Partofanorganizationsvaluechain.产品实现的过程，包括翻新和修理.组织价值链的一部分。3.1.25multidisciplinaryapproach多方论证的方法Wayofworkinginvolvingdifferentfunctions(e.g.engineering,safety,procurement)inoneteamonaspecificsubject.针对特定目标，引入不同职能进入团队的工作方式。3.1.26non-functionalrequ

99、irements非功能要求Frameconditionsunderwhichfunctionalrequirementsshallbemet,suchas:在功能要求的前提下，框架要求应得到满足，如：-standards/regulations/requirementsforapprovalbyauthorities;法规/标准/授权方批准的要求-operatingprofile/configuration;作业面/技术状态-additional,specificoperator/customernon-functionalrequirements;附加的、特定操作者或客户的非功能要求-int

100、egration(physics/mechanics/electrics/control).集成（物理、机械、电子、控制）3.1.27operationalmaturityDegreeoffulfilmentofthefunctionalrequirementsofaproductorservice(e.g.notexisting,underdevelopment,readytouse).产品或服务功能要求满足的程度（例如不存在、开发中、可以使用）3.1.28productconfigurationinformation产品配置信息Requirementsforproductdesign,re

101、alization,verification,operationandsupport.产品设计、实现、验证、运行和支持所需的信息ISO10007:2003,3.93.1.29productlifecycle产品生命周期Timeoftheentirelifecycleofaproductfrominception,throughdesignandmanufacture,toserviceanddisposal.产品从导入、贯穿设计制造，直到服务和废弃的整个生命周期时间。3.1.30productionequipment生产设备Equipmentusedforproduction(e.g.mach

102、ineries,tools,jigs,fixtures,templates,textures,testbenches,softwareproductiontools).用于生产的设备（例如：机器、工具、夹具、模板、纹理样本、试验台、软件生产工具）。Handcraftequipment(e.g.hammer,screwdrivers)isnotconsideredasproductionequipment.手工设备（例如锤子、螺丝刀）不考虑为生产设备。3.1.31projectcoreteam项目核心团队Peoplefromdifferentfunctionsappointedtosupport

103、theprojectmanagerinleadingandcontrollingtheproject.支持项目经理领导和控制项目的不同职能指定的人员。3.1.32projectmanagement项目管理Planning,organizing,monitoring,controllingandreportingofallaspectsofaproject,andthemotivationofallthoseinvolvedinittoachievetheprojectobjectives.策划、管理、监视、控制和报告项目的所有方面，并且激励所有参与人员获得项目目标的积极性。ISO10006:2

104、003,3.63.1.33qualityassurancemethods质量保证方法Methodsappliedtoqualify,verifyorvalidatetheimplementationofrequirementsinordertofocusonerrorpreventionratherthandetection(e.g.indesignanddevelopment).为了关注于防错而不是探测（例如在设计开发中），应用于授权、验证或确认要求执行情况的方法。NOTEQualityassurancemethodscanbeFMEA,FMECA,qualityfunctiondeploy

105、ment,etc.注：质量保证方法可能是FMEA、FMECA、质量功能展开等。3.1.34qualitydeficiencycost(QDC)质量失效成本Additionalcostsresultingfromnonconformingproducts,processesorequipment.由于不合格产品、过程或设备导致的额外成本。QDCcanbedistinguishedbycauser(e.g.sales,engineering,production,purchasing,projectmanagement)andonphaseofoccurrence(e.g.tender,desig

106、n,production,post-delivery).质量失效成本可以通过原因区别（例如销售、工程、生产、采购、项目管理）和发生阶段区别（例如投标、设计、生产、交付后活动）QDCcaninclude:质量失效成本a)additionallabor,materialorotherdirectcostsinthecontextoffailureorchangeduetoincorrectdesignandtheresultingactionstaken(e.g.rework,redesign,repurchase,specialshipments);由于不正确设计或所采取措施（例如返工、再设计、

107、再采购、特殊发运）导致的变更或失效导致的额外工时、材料或其他直接成本b)costsduetodowntimes;故障停机导致的成本c)costsofscrap;废品成本d)costsofproductsrenderedunusablebyoroversupplyofstorage;产品不能使用或超量存储产生的成本f)costsduetoacceptedthird-partyclaimsandcostsduetoclaimsnotassertedbytheorganizationagainstthirdparties;接受的第三方投诉产生的成本以及组织不认可的第三方投诉产生的费用h)costsd

108、uetopenaltiesfordefaultordelays.违约或延期的处罚成本NOTEQDCcanalsobecallednonconformitycosts.质量失效成本也称不合格成本3.1.35reliability可靠性Probabilityofperformingasrequiredforthetimeinterval(t1,t2),undergivenconditions.在给定条件下，在时间间隔（t1,t2）内执行要求的可能性。Note1toentry:Givenconditionsincludeaspectsthataffectreliability,suchas:mode

109、ofoperation,stresslevels,environmentalconditions,andmaintenance,whereapplicable.注1：进入：给定条件包括影响可靠性的方面，例如：运行模式、施压等级、环境条件和适当时维护保养。Note2toentry:Itisusuallyassumedthattheitemisinastatetoperformasrequiredatthebeginningofthetimeinterval.注2： 进入：通常假定，对象在时间间隔的开始就处于执行状态。IEC60050-192:2015,192-05-053.1.36safety(

110、productsafety)安全（产品安全）Freedomfromunacceptableriskofharm.伤害不可能接受风险的自由度IEC62278,3.35IEC62425,3.1.453.1.37safetycase安全事例（安全例证）Documenteddemonstrationthattheproductcomplieswiththespecifiedsafetyrequirements.产品符合特定安全要求的文件化证明。IEC62278:2002,3.363.1.38safetyintegritylevel(SIL)安全完整性等级Oneofanumberofdefineddis

111、cretelevelsforspecifyingthesafetyintegrityrequirementsofthesafetyfunctionstobeallocatedtothesafetyrelatedsystems.用于描述分配给安全相关系统的安全功能的安全整合要求的一组确定离散等级的数据。IEC62278:2002,3.383.1.39safety-related安全相关Carriesresponsibilityforsafety.为安全承担的责任IEC62425:2007,3.1.543.1.40site现场Organization,havingactivitiesindesig

112、nanddevelopmentand(or)manufacturingand(or)maintenance(fleetmaintenance,refurbishmentandcomponentoverhauland(or)repairs)indefinedscopesplacedinasinglelocation.在单一地点确定范围内有设计开发和（或）制造和（或）维护保养（车辆维修、翻新、和部件大修和（或）修理）的组织。3.1.41supplychain供应链Systemoforganizations,people,activities,informationandresourcesinvol

113、vedintransformingmaterialsandknowledgeinaproductoraserviceforthecustomer.在提供给客户的产品和服务中参与材料和知识传递的系统，其包括组织、人员、活动、信息和资源。3.1.42transfer转移Completeorpartialhandoverofprocessownershipfortasksoractivitiesfrominternalproductrealizationtoaninternalentity.任务和活动的过程所有者从内部产品实现到一个内部实体的全部或部分交接3.2Abbreviations缩写Abbr

114、eviationExplanation缩写的解释EPPPSExternalProvidedProduct,ProcessorService外部提供的产品、过程或服务FAIFirstArticleInspection首件检验FMEAFailureModeandEffectsAnalysis失效模式和影响分析FMECAFailureMode,EffectsandCriticalityAnalysis失效模式、影响和分析分析FRACASFailureReportingAnalysisandCorrectiveActionSystem失效报告分析和纠正措施系统IECInternationalElect

115、rotechnicalCommission国际电工委员会ISOInternationalOrganizationforStandardization国际标准化组织KPIKeyPerformanceIndicator关键绩效指标LCCLifeCycleCosting生命周期成本PDCAPlanDoCheckAct计划-做-检查-措施QDCQualityDeficiencyCost质量失效成本RAMReliability,Availability,Maintainability可靠性、可用性和可维护性RAMSReliability,Availability,Maintainability,Safe

116、ty.可靠性、可用性、可维护性和安全性SILSafetyIntegrityLevel安全完整性等级4Contextoftheorganization组织的背景环境4.1 Understanding the organization and its context理解组织及其背景环境The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achie

117、ve the intended result(s) of its quality management system. 组织应确定外部和内部那些与组织的宗旨、战略方向有关、影响质量管理体系实现预期结果的能力的事宜。The organization shall monitor and review information about these external and internal issues. 组织应监视和评审这些外部和内部事宜相关的信息NOTE 1 Issues can include positive and negative factors or conditions for c

118、onsideration. 注1：事宜可以考虑包含正面和负面的因素或条件。NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local. 注2：通过考虑来自法律、技术、竞争、市场、文化、社会和经

119、济环境方面的事宜，不论是国际上、本国的、地区的或本地的，可以帮助理解外部的环境。NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization. 注3：通过考虑有关组织的价值观、文化、知识和绩效方面的事宜，可以帮助理解组织内部环境。4.2 Understanding the needs and expectations of interested

120、parties理解相关方的需求和期望Due to their effect or potential effect on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: 由于其影响或潜在影响组织稳定地提供满足顾客和适用法律法规要求的产品和服务的能力，组织应确定：a) the interes

121、ted parties that are relevant to the quality management system; 与质量管理体系有关的相关方b) the requirements of these interested parties that are relevant to the quality management system. 与质量管理体系有关的相关方的要求。The organization shall monitor and review information about these interested parties and their relevant re

122、quirements. 组织应监视和评审与这些相关方及其相关要求有关的信息。 4.3 Determining the scope of the quality management system确定质量管理体系的范围The organization shall determine the boundaries and applicability of the quality management system to establish its scope. 组织应界定质量管理体系的边界和应用，以确定其范围。 When determining this scope, the organizati

123、on shall consider: 在确定此范围时，组织应考虑：a) the external and internal issues referred to in 4.1 标准4.1条款中提到的外部和内部事宜；b) the requirements of relevant interested parties referred to in 4.2; 标准4.2条款中有关相关方的要求；c) the products and services of the organization. 组织的产品和服务。The organization shall apply all the requireme

124、nts of this International Standard if they are applicable within the determined scope of its quality management system. 当本标准的所有要求在质量管理体系确定的范围内适用，组织应采用本标准的所有要求。The scope of the organizations quality management system shall be available and be maintained as documented information. The scope shall stat

125、e the types of products and services covered, and provide justification for any requirement of this International Standard that the organization determines is not applicable to the scope of its quality management system. 组织应确定质量管理体系的范围并保持文件化的信息。范围里应表述所覆盖产品和服务的类型，以及本标准任一要求不适用的情况的正当理由。Conformity to th

126、is International Standard may only be claimed if the requirements determined as not being applicable do not affect the organizations ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction. 如果确定的要求不适用且不影响组织确保产品和服务的符合性和增强顾客满意的能力或责任，

127、则可以声称符合本标准。4.4 Quality management system and its processes质量管理体系及其过程4.4.1 The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standa

128、rd. 组织应按本标准的要求建立、实施、保持和持续改进质量管理体系， 包括所需过程及其相互作用。The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall: 组织应确定质量管理体系所需的过程及其在整个组织中的应用，并应： a) determine the inputs required and the outputs expected from these p

129、rocesses; 确定这些过程所需的输入和期望的输出；b) determine the sequence and interaction of these processes; 确定这些过程的顺序和相互作用；c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes; 确定

130、并应用所需的准则和方法（包括监视、测量及相关的绩效指标），以确保这些过程的有效运行和控制；d) determine the resources needed for these processes and ensure their availability; 确定过程所需的资源并确保其可获得e) assign the responsibilities and authorities for these processes; 分配这些过程的职责和权限；f) address the risks and opportunities as determined in accordance with t

131、he requirements of 6.1; 应对根据标准6.1的要求确定的风险和机遇；g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; 评价这些过程并实施必要的变更，以确保这些过程能够达成预期的结果；h) improve the processes and the quality management system. 改进这些过程和质量管理体系。4.4.2 To the extent neces

132、sary, the organization shall: 必要时，组织应： a) maintain documented information to support the operation of its processes; 保持文件化的信息以支持过程的运行b) retain documented information to have confidence that the processes are being carried out as planned. 保留文件化的信息以确信这些过程是按照策划来实施的。4.4.3Qualitymanagementsystemanditspro

133、cessesSupplemental质量管理体系及其过程-补充WhenthisTechnicalSpecificationrequiresadocumentedprocess,theprocessdocumentationshallcoverasaminimumtherequirementsdescribedin4.4.1a)toe).当技术规范要求文件化过程时，过程文件应至少包括4.4.1a)到e)的描述的要求。NOTEProcessescanbedocumentedinprocedures,instructions,methoddescriptions,flowchartsorworkfl

134、owsetc.supportedbyapplicationsoftwareandtemplates.注：过程可能通过应用软件和模板支持在程序、指导书、方法描述、流程图或工作流等中文件化。Theorganizationshall:组织应：a)documentahierarchicalstructureofitsprocesses;文件化其过程的分层结构b)communicateprocesses(see7.4)andensurethatpeopleareawareoftheprocesses;就过程进行交流并确保员工了解过程c)trainpeopleonprocessesandensureund

135、erstanding;培训过程相关员工并确保得到理解d)ensureprocessesareappliedandpeopleadheretoprocesses(see9.2);确保过程得到应有并且应该遵循过程e)ensureandmaintainconformityofthebusinessmanagementsystemanditsprocesseswithapplicablestatutoryorregulatoryrequirementsandstandards.确保并维持运营管理体系的符合性以及适用的法律或法规要求和标准在过程中的应用。Documentedprocessesrequir

136、edbythisTechnicalSpecificationshallbeverifiedagainsttheapplicablerequirementsofthisTechnicalSpecification.本技术规范所要求的文件化过程应针对本技术规范适用要求进行验证。5 Leadership领导作用5.1 Leadership and commitment领导作用与承诺5.1.1 General总则Top management shall demonstrate leadership and commitment with respect to the quality managemen

137、t system by: 最高管理者应通过以下方面证实其对质量管理体系的领导作用与承诺：a) taking accountability for the effectiveness of the quality management system; 承担质量管理体系有效性的责任；b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic d

138、irection of the organization; 确保质量管理体系的质量方针和质量目标被建立，并与组织的战略方向 及组织的背景环境相适应；c) ensuring the integration of the quality management system requirements into the organizations business processes; 确保质量管理体系要求纳入到组织的业务运作中；d) promoting the use of the process approach and risk-based thinking; 鼓励采用过程方法和基于风险的考虑；

139、 e) ensuring that the resources needed for the quality management system are available; 确保质量管理体系所需资源的获得；f) communicating the importance of effective quality management and of conforming to the quality management system requirements; 传达有效的质量管理以及满足质量管理体系要求的重要性； g) ensuring that the quality management

140、system achieves its intended results; 确保质量管理体系实现预期的结果；h) engaging, directing and supporting persons to contribute to the effectiveness of the quality management system; 保证、指导和支持员工参与对质量管理体系的有效性做出贡献i) promoting improvement; 促进改进；j) supporting other relevant management roles to demonstrate their leader

141、ship as it applies to their areas of responsibility. 支持其他的管理者在其负责的领域证实其领导作用。NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organizations existence, whether the organization is public, private, for p

142、rofit or not for profit. 注：本标准中的“业务”可以广泛地理解为对组织存在的目的核心的活动，无论该组织是公众的或私人的盈利或非盈利的。5.1.1.1 corporate responsibility 公司责任The organization shall define and implement corporate responsibility policy, including at a minimum an anti-bribery policy, an employee code of conduct, and an ethics escalation policy

143、 (whistle-blowing policy”) 组织应明确并实施公司责任方针，至少包括反贿赂方针、员工行为准则以及道德准则升级政策 (“举报政策”)5.1.1.2 process effectiveness and efficiency 过程有效性和效率Top management shall review the product realization processes and support processes to evaluate and improve their effectiveness and efficiency. The results of the process

144、 review activities shall be included as input to the management review (see section 9.3.2.1) 最高管理者应评审产品实现过程和支持过程，以评价并改进过程有效性和效率。过程评审活动的结果应作为管理评审的输入（见第9.3.2.1条）5.1.1.3 process owners 过程拥有者Top management shall identify process owners who are responsible for managing the organizations processes and rel

145、ated output. Process owners shall understand their roles and be competent to perform those roles (see ISO 9001, section 7.2). 最高管理者应确定过程拥有者，由其负责组织的各过程和相关输出的管理。过程拥有者应了解他们的角色，并且具备胜任其角色的能力（见ISO9001第7.2条）5.1.2 Customer focus以顾客为关注焦点Top management shall demonstrate leadership and commitment with respect

146、to customer focus by ensuring that: 最高管理者应通过确保以下方面，证实其针对以顾客为关注焦点的领导作用和承诺：a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met; 顾客要求和适用的法律法规要求被确定、理解并被持续地满足； b) the risks and opportunities that can affect conformity of products and services a

147、nd the ability to enhance customer satisfaction are determined and addressed; 那些可能影响产品和服务的符合性，增强顾客满意的能力的风险和机遇需确定和应对c) the focus on enhancing customer satisfaction is maintained. 保持以增强顾客满意为焦点。 5.2 Policy方针5.2.1 Establishing the quality policy建立质量方针Top management shall establish, implement and maintai

148、n a quality policy that: 最高管理者应建立、评审和保持质量方针，方针应：a) is appropriate to the purpose and context of the organization and supports its strategic direction; 与组织的宗旨及背景相适应并支持组织的战略方向b) provides a framework for setting quality objectives; 提供制定质量目标的框架；c) includes a commitment to satisfy applicable requirements

149、; 包括对满足适用要求的承诺；d) includes a commitment to continual improvement of the quality management system. 包括对持续改进质量管理体系的承诺。5.2.2 Communicating the quality policy沟通质量方针The quality policy shall: 质量方针应： a) be available and be maintained as documented information; 可获得并保持文件化的信息b) be communicated, understood and

150、 applied within the organization; 在组织内得到沟通、理解和运用c) be available to relevant interested parties, as appropriate. 适用时，可为相关方所获取。5.2.3QualitypolicySupplemental质量方针-补充Thequalitypolicyshalladdressfailurepreventionandcustomerexpectations.质量方针应确定失效的预防和客户期望。5.2.4Safetypolicy安全方针Topmanagementshallestablish,im

151、plement,maintainandcommunicateasafetypolicy.最高管理者应建立、执行、维护和沟通安全方针。Therequirementsdescribedin5.2.1and5.2.2shallbeappliedforthesafetypolicyaccordingly.在5.2.1和5.2.2中描述的要求应适用于对应的安全方针。5.3 Organizational roles, responsibilities and authorities组织的岗位、职责和权限Top management shall ensure that the responsibilitie

152、s and authorities for relevant roles are assigned, communicated and understood within the organization. 最高管理者应确保组织内相关岗位的职责、权限得到规定、沟通和理解。 Top management shall assign the responsibility and authority for: 最髙管理者应分配职责和权限以便： a) ensuring that the quality management system conforms to the requirements of t

153、his International Standard; 确保质量管理体系符合本标准的要求；b) ensuring that the processes are delivering their intended outputs; 确保过程产生其预期的输出；c) reporting on the performance of the quality management system and on opportunities for improvement (see 10.1), in particular to top management; 特别是向最高管理者报告质量管理体系的绩效和改进的机

154、会（见10.1）d) ensuring the promotion of customer focus throughout the organization; 确保在整个组织内提高以顾客为关注焦点的意识；e) ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 当质量管理体系的变更已被策划和实施时，确保保持质量管理体系的完整性。5.3.1Organ

155、izationalroles,responsibilitiesandauthoritiesSupplemental组织的岗位职责、职责和权限-补充Thetopmanagementshall:组织管理者应：a)appointprocessowners(see4.4.1e);指定过程所有者b)documentandcommunicateupdatesofownership;文件化并传达所有者的更新c)empowerrepresentativesindependent,fromtheprocessexecution,tostoptheprocessorproductorserviceprovisio

156、n,ifqualityorsafetyrequirementsarenotmet.如果质量或安全要求没有满足，授权独立代表来负责从过程执行到停止过程或产品或服务提供。Incaseofdelegationoftasks,thisdelegationshouldbedefinedandcommunicated.如果任务委托代理人，这个委托应该得到确定和交流。Theorganizationshallretainrelateddocumentedinformation.组织应保持相关的文件化信息。5.3.2Responsibilitiesandauthoritiesofprocessowners过程所

157、有者的职责和权限Processownershallberesponsiblefortheprocesscompliancetorequirementslistedin4.4exceptavailabilityofresources(see4.4.1d).过程所有者应负责过程符合条款4.4中除了资源获得外的要求。6 Planning策划6.1 Actions to address risks and opportunities风险和机遇的应对措施6.1.1 When planning for the quality management system, the organization shal

158、l consider the issues referred to in 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: 策划质量管理体系时，组织应考虑4.1和4.2的要求，确定需应对的风险和机遇，以便： a) give assurance that the quality management system can achieve its intended result(s); 确保质量管理体系实现期望的结果；

159、b) enhance desirable effects; 增强预期的影响 c) prevent, or reduce, undesired effects; 预防或减少非预期的影响；d) achieve improvement. 实现改进。6.1.2 The organization shall plan: 组织应策划：a) actions to address these risks and opportunities; 风险和机遇的应对措施b) how to: 如何：1) integrate and implement the actions into its quality manag

160、ement system processes (see 4.4); 在质量管理体系过程中整合和实施这些措施（见4.4）2) evaluate the effectiveness of these actions. 评价这些措施的有效性。 Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services. 釆取的风险和机遇的应对措施都应与其对产品和服务的符合性的潜在影响相适应。 NOTE

161、 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision. 注1：可选的风险应对措施包括风险规避、为追求一个机遇承担风险、消除风险的根源、改变可能性或后果、分享风险、或通过明智的决策保持风险。NOTE

162、 2 Opportunities can lead to the adoption of new practices, launching new products, opening new markets, addressing new customers, building partnerships, using new technology and other desirable and viable possibilities to address the organizations or its customers needs. 注2：机遇可能导致新实践的选择、新产品上市、开拓新市场

163、、应对新客户、建立伙伴关系、利用新技术和其他预期可行的可能来应对组织或客户的需求。6.1.3ActionstoaddressrisksandopportunitiesSupplemental风险和机遇的应对措施-补充Theorganizationshallestablish,implementandmaintainadocumentedriskmanagementprocess.组织应建立、执行并维护一个文件化的风险管理过程。Thisprocessshallconsider:过程应考虑：a)therequirementsdescribedin6.1.1and6.1.2;在6.1.1和6.1.2

164、中描述的要求b)regularreviewandupdateofrisksandactions;定期评审和更新风险和对应措施c)retentionofdocumentedinformationfromriskassessments,reviewsandactions.保持来自风险评估、评审和措施的文件化信息NOTE1FMEAcanbeappliedformanagingrisksinbusinessplanning,designanddevelopment,projectsorproduction.注1：FMEA可以用来管理经营策划、设计开发、项目或生产中的风险。NOTE2FMECAcanbe

165、appliedformanagingrisksofcriticalfunctionsoritems(e.g.safetyrelated).注2： FMECA可以用来管理关键功能或部件（例如安全相关的）风险。Inaddition,thisprocessshould:另外，过程应该：a)involvecustomerandexternalprovidersinjointworkonriskassessmentandresponse;引入客户和外部供方联合进行风险评估和应对；b)requireamultidisciplinaryapproachforriskreviews;在风险评估时要求使用多方论

166、证的方法；c)evaluateitseffectivenessbasedonQDCs.基于QDCs评估风险分析的有效性。Theorganizationshalldefinecriteriatodeterminethetypeandextentofcontrolsinitsprocessesbyriskassessmentmethodology.组织应提供风险评估的方法论定义准则来确定在其过程中控制的类型和程度6.1.4Contingencyplanning应急计划Theorganizationshallestablish,validate,whereapplicable,andregularl

167、yreviewitscontingencyplanbasedonanevaluationofitsbusinessrisks.组织应建立、确认（适当时）并基于运营风险评价定期评审其应急计划。NOTEBusinessriskscanconcernutilityinterruptions,interruptionsinthesupplychain,labourshortages,criticaltechnologies,keyproductionequipmentfailure,fieldreturns,successionplan,informationandcommunicationtechn

168、ology.注：运营风险可以考虑公共事业中断、供应链中断、劳动力短缺、关键技术、关键生产设备失效、市场退货、替代计划、信息和沟通技术。Incasetheorganizationidentifiestheneedtooutsourceaprocessduringthecontingencyplanning,theoutsourcingrequirementsdescribedin8.1.1shallbeapplied.在应急策划中，如果组织识别到过程外包的需求，应应用8.1.1中外包的要求。6.2 Quality objectives and planning to achieve them质量

169、目标及其达成的策划6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system. 组织应在相关职能、层次、质量管理体系所需的过程上建立质量目标。The quality objectives shall: 质量目标应a) be consistent with the quality policy; 与质量方针保持一致；b) be measurable; 可测量；c) take

170、 into account applicable requirements; 考虑适用的要求d) be relevant to conformity of products and services and to enhancement of customer satisfaction; 与产品和服务的符合性相关，能增强顾客满意；e) be monitored; 被监视；f) be communicated; 被沟通；g) be updated as appropriate. 适当时进行更新；The organization shall maintain documented informat

171、ion on the quality objectives. 组织应将质量目标保持文件化的信息。6.2.2 When planning how to achieve its quality objectives, the organization shall determine: 在策划目标的实现时，组织应确定：a) what will be done; 将做什么；b) what resources will be required; 所需的资源；c) who will be responsible; 责任人；d) when it will be completed; 完成的时间表；e) ho

172、w the results will be evaluated. 结果如何评价6.2.3Safetyobjectives安全目标Theorganizationshallestablishsafetyobjectives.Therequirementsdescribedin6.2.1and6.2.2shallbeappliedtothesafetyobjectivesaccordingly.组织应建立安全目标。在6.2.1和6.2.2中描述的要求应对应适用于安全目标。6.3 Planning of changes变更的策划When the organization determines the

173、need for changes to the quality management system, the changes shall be carried out in a planned manner (see 4.4). 当组织确定质量管理体系变更的需求，变更应以计划的方式实施（见4.4）。The organization shall consider: 组织应考虑： a) the purpose of the changes and their potential consequences; 变更的目的及其任何的潜在后果；b) the integrity of the quality

174、 management system; 质量管理体系的完整性；c) the availability of resources; 可获得的资源；d) the allocation or reallocation of responsibilities and authorities. 职责和权限的分配或再分配6.4Businessplanning经营计划Theorganizationshallestablish,implementandmaintaindocumentedbusinessplanning,reviewedonayearlybasis.组织应建立、执行和维护文件化经营计划，并在年

175、度基础上进行评审。Thebusinessplanningshallconsider:经营计划应考虑：a)objectives(see6.2);目标（见6.2）b)marketandproductstrategy,includingdevelopmentplansofnewproductsand(or)processesandphaseoutstrategies;市场和产品策略，包括新产品和（或）过程开发计划和退出策略；c)managementreviews(see9.3);管理评审（见9.3）d)budgetplanning(see7.1.1.1);预算策划e)risksandopportun

176、itiesoftheorganization(see6.1);组织的风险和机遇（见6.1）f)contingencyplan(see6.1.4);应急计划（见6.1.4）g)needsandexpectationsofcustomers;顾客的需求和期望h)impactofchangesintechnologiesandinstatutoryandregulatoryrequirements;技术和法律法规方面要求变更的影响i)companycapacityconsideringtheforecast;考虑预想的公司产能j)merger,acquisition,outsourcingandtr

177、ansfer.合并、收购、外包和转移。Thisbusinessplanningshouldconsider:经营计划应考虑：a)changeofexternaltrendsandinterestedpartiesneeds(e.g.economicpolicies,environmentalprotection,socialorculturalissues);外部趋势和相关方需求的变更（例如经济政策、环保、社会和文化问题）b)thefiscalyearcalendaroftheorganization;组织的财年c)anappropriatecommunicationofplanningout

178、puts.策划输出的适当沟通。7 Support支持7.1 Resources资源7.1.1 General总则The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system. 组织应确定、提供为建立、实施、保持和持续改进质量管理体系所需的资源The organization shall consider: 组

179、织应考虑：a) the capabilities of, and constraints on, existing internal resources; 现有内部资源的能力和局限b) what needs to be obtained from external providers. 需要从外部供方获得的。7.1.1.1GeneralSupplemental总则-补充Theorganizationshallestablish,implementandmaintainadocumentedprocessforbudgetplanning,approvalandcontrolling.组织应建立

180、、执行并维护一个用于预算策划、批准和控制的文件化过程Thisprocessshallconsider:过程应考虑：a)theresourcesneededforpeopleandinfrastructureasaminimumforexecutionofprocesses(see4.4.1d);为了过程执行的最低人员和设施需求b)thecurrentorderbookandforecast;当前订单和预测c)riskprovisions(e.g.incaseofpotentialscarcityofresources).风险源（例如：资源的潜在不足）Theorganizationshallre

181、tainrelateddocumentedinformation.组织应保持相关的文件化信息。7.1.2 People人The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes. 组织应确定并提供为质量管理体系有效实施、过程运行和控制所需的人员。7.1.3 Infrastructure基础

182、设施The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services. 组织应确定、提供和维护其过程运行和为达到产品和服务符合性所需的基础设施。NOTE Infrastructure can include: 注：基础设施可包括：a) buildings and associated utilities; 建筑物和相关设施；

183、b) equipment, including hardware and software; 设备包括硬件和软件；c) transportation resources; 运输资源；d) information and communication technology. 信息和通讯技术。7.1.3.1plant,facility,andequipmentplanning工厂、设施和设备策划Theorganizationshalluseamultidisciplinaryapproachincludingriskidentificationandriskmitigationmethodsford

184、evelopingandimprovingplant,facility,andequipmentplans.Indesigningplantlayouts,theorganizationshall:组织应使用多方论证的方法，包括风险识别和风险减缓方法，来开发并改进工厂、设施和设备的计划。在设计工厂布局时，组织应：Optimizematerialflow,materialhandling,andvalue-addeduseoffloorspaceincludingcontrolofnonconformingproductand;优化材料的流动和搬运，以及对空间场地的增值利用，包括对不合格的控制，

185、并且Facilitatesynchronousmaterialflow,asapplicable.在适用时，便于材料的同步流动。Methodsshallbedevelopedandimplementedtoevaluatemanufacturingfeasibilityfornewproductornewoperations.Manufacturingfeasibilityassessmentsshallincludecapacityplanning.Thesemethodsshallalsobeapplicableforevaluatingproposedchangestoexistingo

186、perations.应开发并实施对新产品或新操作的制造可行性进行评价的方法。 制造可行性评估应包括产能策划。这些方法还应适用于评价现有操作的提议更改。Theorganizationshallmaintainprocesseffectiveness,includingperiodicre-evaluationrelativetorisk,toincorporateanychangesmadeduringprocessapproval,controlplanmaintenance(seesection8.5.1.1)andverificationofjobset-ups(seesection8.5

187、.1.3)组织应保持过程有效性，包括定期风险复评，以纳入在过程批准、控制计划维护（见第8.5.1.1条）及作业准备的验证（见第8.5.1.3条）期间作出的任何更改。Assessmentsofmanufacturingfeasibilityandevaluationofcapacityplanningshallbeinputstomanagementreviews(seeISO9001,section9.3)制造可行性评估和产能策划的评价应成为管理评审的输入（见ISO9001第9.3条）Note1:theserequirementsshouldincludetheapplicationoflea

188、nmanufacturingprinciples.注1：这些要求应当包括对精益生产原则的应用Note2:Theserequirementsshouldapplytoon-sitesupplieractivities,asapplicable.注2：这些要求应当应用于现场供应商活动，如适用。7.1.4 Environment for the operation of processes 过程运行的环境The organization shall determine, provide and maintain the environment necessary for the operation

189、of its processes and to achieve conformity of products and services. 组织应确定、提供和维护其过程运行及达到产品和服务符合性所需的环境。NOTE A suitable environment can be a combination of human and physical factors, such as: 注：一个适宜的环境可以是人体和物理因素的结合，例如： a) social (e.g. non-discriminatory, calm, non-confrontational); 社会的（如非歧视，平静的，无对抗性）

190、b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective); 心理的（如减少压力，防止倦怠，感情保护）c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise). 物理的（如温度、热量、湿度、光照、气流、卫生、噪声） These factors can differ substantially depending on the products and services provided.

191、这些因素可根据所提供产品和服务的不同而完全不同。Note: where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to demonstrate the organizations conformity to the personnel safety aspects of this requirements. 注：在ISO45001（或等效标准）第三方认证被认可的情况下，该认证可以证明组织符合本要求的人员安全方面。7.1.5 Monitoring and measuri

192、ng resources监视和测量资源7.1.5.1 General总则The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. 当监视或测量用作验证产品和服务符合规定要求时，组织应确定并提供为确保有效可靠的结果所需的资源。 The organ

193、ization shall ensure that the resources provided: 组织应确保提供的资源：a) are suitable for the specific type of monitoring and measurement activities being undertaken; 与所采用的特定类型的监视和测量活动相适应； b) are maintained to ensure their continuing fitness for their purpose. 被维护以确保其持续地适合其目的。The organization shall retain ap

194、propriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. 组织应保留适当的文件化信息作为监视和测量资源适合目的的证据。7.1.5.2 Measurement traceability测量的可追溯性When measurement traceability is a requirement, or is considered by the organization to be an essential part of provid

195、ing confidence in the validity of measurement results, measuring equipment shall be: 当测量的可追溯性是一种要求或被组织认为是提供测量结果有效性证据的重要部分，测量仪器应被： a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; w

196、hen no such standards exist, the basis used for calibration or verification shall be retained as documented information; 对照能溯源到国际或国家标准的测量标准，按照规定的时间间隔或在使用前检定或校准或两者都有。当不存在这样的标准时，用于校准或检定的 依据应保留文件化信息；b) identified in order to determine their status; 识别以确定其校准状态； c) safeguarded from adjustments, damage or

197、 deterioration that would invalidate the calibration status and subsequent measurement results. 保护其不受使校准状态和随后的测量结果失效的调整、损坏、退化的影响。The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended

198、 purpose, and shall take appropriate action as necessary. 当发现测量仪器不适用于预期的目的，组织应确定是否对之前测量结果的有效性已有不利的影响，必要时，应采取适当的措施。Note: A number or another identifier traceable to the device calibration record meets the intent of the requirements in ISO 9001;2015. 注：一个可追溯到装置校准记录的编号或其它标识符，满足ISO 9001：2015 要求的意图。7.1.5

199、.3MonitoringandmeasuringresourcesSupplemental监视测量资源-补充Requirementsspecifiedin7.1.5.1and7.1.5.2shallapplyto:在7.1.5.1和7.1.5.2中描述的要求应应用于：a)allmonitoringandmeasuringresourcesusedforverifyingtheconformityofproductsandservicestotheirrequirements;用于验证产品和服务符合要求的所有监视和测量资源b)toolsusedinspecialprocesses(e.g.tor

200、quewrenchandcrimper).用在特殊过程的工具（例如扭矩扳手和压接钳）Theorganizationshallestablish,implementandmaintainadocumentedprocessforverificationorcalibration,orbothofmonitoringandmeasuringresources.Thisprocessshallinclude:组织应建立、执行和维护一个文件化过程来验证或校准，或校准和验证监视测量资源。这个过程包括：requirementsdefinedin7.1.5.1and7.1.5.2;7.1.5.1和7.1.5

201、.2中确定的要求b)howtoreactwhenmonitoringormeasuringresourcesarefoundtobeunfitfortheirintendedpurpose(see7.1.5.2).当发现监视或测量资源不符合其预期目的时，如何反应。Theorganizationshallretainrelateddocumentedinformation.组织应保持相关文件化信息。Theorganizationshallmaintainaregisteroftheseresourcesrecordingtheirtype,uniqueidentification,locatio

202、norpersonincharge,intervalsforcalibrationorverification(e.g.inacentralapplicationsoftware).组织应维护资源的登记册，记录他们的类型、唯一标识、使用的位置或人员、校准或验证的间隔（例如：中心应用软件）。NOTEMonitoringandmeasuringresourcescanbe:testhardware,testsoftware,AutomatedTestEquipment(ATE)orplottersusedtoproduceinspectiondata.Thisalsoincludesequipme

203、ntthatispersonallyowned,developedinhouseorsuppliedbythecustomeroranotherexternalprovider.注：监视和测量资源可能是试验硬件、试验软件、自动试验设备（ATE）或用于产生检测数据的绘图仪。这也包括个人拥有的设备、组织自己开发的或由客户或外部供方提供的设备。Incaseofinternalverificationorcalibration,theorganizationshall:如果内部校准或验证，组织应：a)establishrelatedmethodsandacceptancecriteria;建立相关方法

204、和接收准则；b)ensurethatambientconditionsaresuitabletocarryoutverificationorcalibration.确保适于执行验证和校准的环境Therecordsofmeasuringresultsshallprovide:测量结果的记录应提供：a)theuniqueidentificationofthemeasuringresourceused;测量资源使用的唯一标识b)thedateofmeasuring.测量数据7.1.6 Organizational knowledge组织的知识The organization shall determ

205、ine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. 组织应确定其过程运行及为达到产品和服务的符合性所必需的知识。This knowledge shall be maintained and be made available to the extent necessary. 知识应得到保持并在必需时能获得。When addressing changing needs and trends, the organizati

206、on shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. 在应对变化的需求和趋势时，组织应考虑现有的知识基础，确定如何获取或使用任何必要额外的知识和需要的更新。NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience.

207、It is information that is used and shared to achieve the organizations objectives. 注1：组织知识是组织特定的知识，它通常可从经验获得，它是可以使用和共享来达成组织目标的信息。 NOTE 2 Organizational knowledge can be based on: 注2：组织知识可以基于:a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from failu

208、res and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services); 内部资源（比如：知识产权、从经验中获得的知识、失败和成功的经验教训、获取和共享非文件化的知识和经验、过程、产品和服务改进的结果） b) external sources (e.g. standards; academia; conferences; gathering knowledge

209、 from customers or external providers). 外部资源（比如：标准、学术、会议、收集来自客户或外部供应商的知识）7.1.6.1OrganizationalknowledgeSupplemental组织的知识-补充Regardingorganizationalknowledge,theorganizationshall:对于组织的知识，组织应a)managereturnofexperienceincluding管理经验返回1)identification,documentation,implementationandupdateofbestpracticesan

210、dlessonslearned;学到的最佳实践和教训的识别、文件化、执行和更新2)communicationofbestpracticesandlessonslearnttorelevantprocessesandactiveprojects;交流从相关过程和进行的项目中学习的最佳实践和教训NOTEReturnofexperiencecanbederivedfromandnotlimitedtonon-conformities,RAM/LCCdata,customercomplaints,internalaudits,externalprovideraudits,benchmarks.注：经验

211、返回可以来源于，但不限于不合格、RAM/LCC数据、顾客抱怨、内部审核、外部供方审核、标杆。b)allocateresponsibilitiesforknowledgemanagementregardingproducts,processesandprojects;指定负责有关产品、过程和项目的知识管理负责人；c)transferknowledgewhenrequired,e.g.peoplejoiningorleavingtheorganization.当需要时，知识传递，例如人员加入或离开组织。Regardingorganizationalknowledge,theorganization

212、should:对于组织知识，组织应该：a)useapplicationsoftwaretoshareitsknowledge;用应用软件分享知识b)encourageknowledgesharingbynetworking;鼓励通过网络分享知识c)protectknowledgefromunintendeddisclosureoutsidetheorganization(e.g.byaccessrights,intellectualpropertyrights,documentationconfidentialityclasses).保护知识避免组织外部的非预期泄漏（例如：通过获取权限、专利产

213、权、文件保密级别）。7.2 Competence能力The organization shall: 组织应：a) determine the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the quality management system; 确定在组织控制下从事影响质量管理体系绩效和有效性工作的人员所必要的能力； b) ensure that these persons are competent on th

214、e basis of appropriate education, training, or experience; 基于适当的教育、培训或经验，确保这些人员是胜任的；c) where applicable, take actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken; 适用时，采取措施以获取必要的能力，并评价这些措施的有效性；d) retain appropriate documented information as evidence of com

215、petence. 保留适当的文件信息，以提供能力的证据。NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the reassignment of currently employed persons; or the hiring or contracting of competent persons. 注：适用的措施可包括，例如提供培训、辅导、当前工作人员的再分配、雇佣或签约能胜任的人员等.7.2.1CompetenceSupplemental

216、能力-补充Theorganizationshallestablish,implementandmaintainadocumentedprocessforcompetencemanagement.组织应该建立、执行和维护能力管理的文件化过程。NOTECompetencecanincludeproduct,processorprojectknowledge,applicationsoftware,techniquesandsoftskills.注：能力可能包括产品、过程或项目知识，应用软件、技术和软技能。Thisprocessshallinclude:过程应包括：a)requirementsdef

217、inedin7.2;7.2中定义的要求b)identificationofgapbetweenactualandnecessarycompetencies;识别实际能力和必要能力的差距c)theidentification,planning,organization,executionandmonitoringofactionstoacquirenecessarycompetence;获得必要能力措施的识别、策划、组织、执行和监视d)inductionfortemporaryworkersandnewcomers,coveringasaminimumproductqualityandsafet

218、y;临时工和新进员工的吸收，至少覆盖产品质量和安全e)inputfromorganizationalknowledge(e.g.bestpracticeusedfortrainings);来自组织知识的输入（例如用于培训的最佳实践）f)providingevidencethattraineesunderstoodthetrainingcontent(e.g.byresultsofwrittenororalexaminationsorkeepingsamplesofpracticalexercises)fortrainingdefinedbytheorganization.提供受训人员理解培训内

219、容的证据（例如口头或书面的考试结果或保留实践练习样本Theorganizationshallretaindocumentedinformationrelatedtocompetencemanagementactivities.组织应有关能力管理活动的文件化信息。Thisprocessshould:过程应该a)includeskillmatricesforpersonsperformingworkthataffectproductqualityandsafety;包括执行影响产品质量和安全工作人员的能力矩阵NOTE1Skillmatricescanbeusedtocomparethenecess

220、arycompetenciesversustheactualstate,consideringprogressivelevels(e.g.learner,basic,advanced,coach).注1：技能矩阵可以用于比较必要能力与实际状态，考虑进步水平（例如，学员、基础、高级、教练）NOTE2Personsperformingworkthataffectproductqualityandsafetyarenotlimitedtoquality,engineeringandproduction.Alsopeoplefromprocurement,fieldservicesorotherfun

221、ctionsoftheorganizationcanimpactaffectproductqualityandsafety.注2：影响产品质量和安全工作的人员不限于质量、工程和生产。也包括来自于采购、市场服务或可能影响产品质量和安全的其他职能。b)ensureregularreviewsandupdateofinternaltrainingmaterials;确保定期评审和更新内部培训材料c)includeinputfromnonconformitiesofproducts,servicesorprocesses(e.g.toevaluatetheeffectivenessoftraining

222、s).包括来自产品、服务或过程不合格的输入（例如：评价培训有效性）。7.3 Awareness意识The organization shall ensure that persons doing work under the organizations control are aware of: 组织应确保在组织控制下工作的人员意识到： a) the quality policy; 质量方针；b) relevant quality objectives; 相关的质量目标；c) their contribution to the effectiveness of the quality mana

223、gement system, including the benefits of improved performance; 他们对质量管理体系有效性的贡献，包括改进质量绩效的益处；d) the implications of not conforming with the quality management system requirements. 偏离质量管理体系要求的后果。7.3.1AwarenessSupplemental意识-补充Requirementsdefinedin7.3shallapplytothesafetypolicyandobjectivesaccordingly.在

224、7.3中定义的要求应对应应用于安全方针和目标。7.4Communication沟通The organization shall determine the internal and external communications relevant to the quality management system, including: 组织应确定与质量管理体系相关的内部和外部沟通的需求，包括： a) on what it will communicate; 沟通的内容；b) when to communicate; 沟通的时机；c) with whom to communicate; 沟通的对

225、象；d) how to communicate; 如何沟通；e) who communicates. 由谁沟通。7.5Documentedinformation文件信息7.5.1General总则The organizations quality management system shall include: 组织的质量管理体系应包括： a) documented information required by this International Standard; 本标准所要求的文件化信息；b) documented information determined by the organ

226、ization as being necessary for the effectiveness of the quality management system. 组织确定的为确保质量管理体系有效运行所需的文件化信息。NOTE The extent of documented information for a quality management system can differ from one organization to another due to: 注： 不同组织的质量管理体系文件化信息的多少与详略程度可以不同，取决于： the size of organization an

227、d its type of activities, processes, products and services; 组织的规模、活动类型、过程、产品和服务； the complexity of processes and their interactions; 过程及其相互作用的复杂程度； the competence of persons. 人员的能力。7.5.2 Creating and updating生成和更新When creating and updating documented information, the organization shall ensure approp

228、riate: 在生成和更新文件时，组织应确保适当的： a) identification and description (e.g. a title, date, author, or reference number); 标识和说明（例如：标题、日期、作者、索引编号等）；b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic); 格式（例如：语言、软件版本、图示）和媒介（例如：纸质、电子格式）；c) review and approval for suitability a

229、nd adequacy. 评审和批准以确保适宜性和充分性。7.5.3 Control of documented information文件化信息的控制7.5.3.1 Documented information required by the quality management system and by this International Standard shall be controlled to ensure: 质量管理体系和本标准所要求的文件化信息应被控制，以确保： a) it is available and suitable for use, where and when

230、it is needed; 需要文件的场所能获得适用的文件；b) it is adequately protected (e.g. from loss of confidentiality, improper use, or loss of integrity). 文件得到充分保护，（如防止泄密、误用、缺损）。7.5.3.2 For the control of documented information, the organization shall address the following activities, as applicable: 为管控文件化信息，适用时，组织应进行以下活

231、动：a) distribution, access, retrieval and use; 分发、访问、检索、使用；b) storage and preservation, including preservation of legibility; 存放、保存，包括保持清晰；c) control of changes (e.g. version control); 更改的控制（如：版本控制）；d) retention and disposition. 保留和处置。Documented information of external origin determined by the organi

232、zation to be necessary for the planning and operation of the quality management system shall be identified as appropriate, and be controlled. 组织所确定的策划和运行质量管理体系所需的外来文件化信息应确保得到适当的识别和控制。Documented information retained as evidence of conformity shall be protected from unintended alterations. 应保护作为符合性证据所

233、保留的文件化信息，避免非预期的变更。NOTE Access can imply a decision regarding the permission to view the documented information only, or the permission and authority to view and change the documented information. 注：“访问”指仅得到查阅文件的许可，或授权查阅和修改文件。7.5.4ControlofdocumentedinformationSupplemental文件化信息的控制-补充Theorganizationsh

234、allestablish,implementandmaintainadocumentedprocessforthecontrolofdocumentedinformation.组织应建立、执行和维护用于文件化信息控制的过程。Theprocessshallinclude:过程应包括：a)therequirementsdefinedin7.5;在7.5中定义的要求b)determinationofthehierarchyofdocumentedinformationofthebusinessmanagementsystem(e.g.policies,procedures,instructions,

235、templates);确定运营管理体系的文件化信息的层级结构（例如方针、程序、指导书、模板）c)authoritiesforandidentificationofpersonscreating,verifying,approvingandupdatingofdocumentedinformation;文件化信息创建、校对、批准和更新人员的识别和授权d)determinationofthetypesofrecords(e.g.reports,measurementsheets,drawing)andtheirretentionperiodstocomplywithstatutoryandregu

236、latory,contractualandbusinessmanagementsystemrequirements.确定记录的类型（例如：报告、测量表、图纸）以及符合法律法规、合同和运营管理体系的保存期限。Theorganizationshallretainrelateddocumentedinformation.组织应保持相关文件化信息。Theprocessshouldincludethedeterminationoflevelofconfidentiality(e.g.public,internalorconfidential),storagemediaandmethodofdestruc

237、tion.过程应该包括确定保密水平（例如公开、内部或保密）、存储媒体和销毁方法。Theorganizationshoulduseelectronicsystemstocontroldocumentedinformationanddefinetheirbackuproutines.组织应该用电子系统来控制文件化信息并确定备份规则。8.Operation运行8.1 Operational planning and control运行策划和控制The organization shall plan, implement and control the processes (see 4.4) need

238、ed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6, by: 组织应策划、实施和控制（见4.4条款）需满足产品和服务提供的要求和需实施标准条款6确定的措施的各过程，通过：a) determining the requirements for the products and services; 确定产品和服务的要求；b) establishing criteria for: 建立以下准则：1) the

239、 processes; 过程；2) the acceptance of products and services; 产品和服务的接收；c) determining the resources needed to achieve conformity to the product and service requirements; 确定达到产品和服务符合要求所需的资源；d) implementing control of the processes in accordance with the criteria; 按照准则实施对过程的控制；e) determining, maintaining

240、 and retaining documented information to the extent necessary: 确定、保持和保留必要程度的文件化信息1) to have confidence that the processes have been carried out as planned; 以确信过程已按策划实施；2) to demonstrate the conformity of products and services to their requirements. 以证实产品和服务符合要求。The output of this planning shall be s

241、uitable for the organizations operations. 这一策划的输出应适合于组织的运行。The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary. 组织应控制计划的变更，评价非预期变更的后果，必要时釆取措施减轻任何不良影响。 The organization shall ensure that outsourc

242、ed processes are controlled (see 8.4). 组织应确保外包过程按8.4得到控制。8.1.1Planningfortheoutsourcingortransferofprocesses过程转移和外包的策划Theorganizationshallestablish,implementandmaintainadocumentedprocessfortheplanningoftheoutsourcingofprocessesthatcanaffecttheorganizationsproductsorservicesquality.组织应建立、执行和维护一个文件化过程

243、，用来策划影响组织产品或服务质量的过程的外包。Thisprocessshallinclude:过程应包括：a)afeasibilitystudy;可行性研究b)ariskassessment(see6.1);风险评估c)planningofrequiredactionsforoutsourcing;策划外包所需的措施d)thecommunicationtocustomerwhenrequired;要求时，和顾客进行交流e)afirstarticleinspection(see8.9),e.g.incaseofoutsourcingofproductionprocess;首件检查（见8.9），例

244、如生产过程外包时f)retentionofdocumentedinformationfromoutsourcingactivities.保持来自外包活动的文件化信息Thisprocessshallbeimplementedbymulti-sitesorganizationtransferringaprocessfromonesitetoanother.当过程从一个现场转移到另一个现场时，多现场的组织应执行这个过程。NOTE1Planningfortheoutsourcingofprocessescanprepareamakeorbuydecisionpriortoimplementingreq

245、uirementfrom8.4.注1：在执行8.4中要求前，外包过程策划可能是准备制造或购买决定。NOTE2Thetriggerforoutsourcingcanbethescarcityofresourcesorastrategicdecision.注2：外包的触发器可能是资源缺乏或战略决定。NOTE3Thechangemanagementprocess(see8.1.5.)canbeimplementedforplanningoutsourcingortransferofprocesses.注3：策划过程的外包或转移可以执行变更管理过程。8.1.2Tendermanagement投标管理T

246、heorganizationshallestablish,implementandmaintainadocumentedprocesstomanagetenders.Thisprocessshallinclude:组织应建立、执行和维护管理投标的文件化过程。这个过程应包括：a)requirementsmanagement(see8.2);要求的管理（见8.2）b)thetypeandextentofcontrols(see6.1.3);控制的程度和类型（见6.1.3）c)riskandopportunitymanagement(see6.1),includingmonetaryevaluati

247、on;风险和机遇管理（见6.1），包括财务评估d)inputfromorganizationalknowledge(e.g.returnofexperience)(see7.1.6);来自组织的知识的输入（例如经验返回）（见7.1.6）e)planningofdeliverablesincludingcosts(e.g.time,pricing);交付的策划，包括成本（例如：时间、成本）NOTEThestandardcostaccountstructureofprojectscanbeusedforthecalculationinthetender.项目的标准成本计算结构可以用于投标的计算。f

248、)planningofresourcesforcontractexecution;合同执行所需资源的策划g)offerapproval.标书批准Theorganizationshallretaindocumentedinformationrelatedtotheirtendermanagementactivities.组织应保持投标管理活动相关的文件化信息。Theorganizationshalldefinerequiredcompetenciesandrelatedlevelsforpersonsdealingwithtender,regardingrequirementmanagement

249、.组织应根据要求管理确定处理投标人员所需的能力和相关级别。8.1.3Projectmanagement项目管理Theorganizationshallestablish,implementandmaintainadocumentedprocesstomanageprojects.组织应建立、执行和维护一个文件化过程来管理项目。NOTE1Thescopeoftheprojectmanagementprocessdependsonthebusinessmodelofanorganization.Inmostoftherailsectorcompaniesitisfromtenderphaseunt

250、iltheendofwarrantyperiod.However,inothercasesitmaybelimitedtodesignanddevelopmentonly(e.g.forthedevelopmentofanewproductfamilyorplatform).注1：项目管理的范围取决于企业的经营模式。 在大多数铁路行业公司，项目管理的范围从投标阶段直到保修阶段结束。然而，在另外一种情况，项目管理的范围可能仅限于设计开发（例如新产品族或平台的开发）Thisprocessshallinclude:这个过程应包括：a)requirementmanagement(see8.2);要求管

251、理（见8.2）b)thetypeandextentofcontrols(see6.1.3);控制的程度和类型（见6.1.3）NOTE2Theorganizationcanclassifyprojectsdependingontheriskandconsequentlydefiningthetypeandextentofcontrols.注2： 组织可以对项目进行分级，其取决于风险和对应确定的控制类型和程度。Thisprocessshouldinclude:这个过程应该包括：a)anescalationprocessincaseofrejectiondecisionfromphasereview

252、stofacilitateproblemsolving;当阶段评审出现拒绝决定时的降级过程，来促进问题解决；b)areviewwiththecustomerandkeyexternalprovidersregardingstrengthsandweaknesses,opportunitiesandthreats;根据强项、弱项、机会和威胁，与客户和外部供方一起评审c)identificationofbestpracticesandlessonslearnedduringprojectclosure,asaminimum,(see7.1.6).至少在项目结束期间识别最佳实践和吸取的教训。Theo

253、rganizationshallmanageitsprojectdocumentedinformationincluding:组织应管理项目的文件化信息，包括：a)review,storage(e.g.standardizedfolderstructure),controlandmaintenanceofprojectinformation;项目信息的评审、存储（例如标准化文件夹）、控制和维护b)retainingdocumentedinformation(e.g.plans,schedules,outputofreviews,reports,etc.),asrequiredin7.5.按照7

254、.5的要求，保持文件化信息（例如：计划、排程、评审输出、报告等）Phasereviewsshall:阶段评审应：a)beperformed:得到执行1)startingatdefinedlevelofworkbreakdownstructure;在工作分解结构的确定级别上启动2)atprojectlevelconsideringthereviewsofthedeliverables;在项目的级别上考虑可交付性的评审b)notbepassedunlessopenissuesofpriorphasereviewsareclosed.Otherwise,waivershallbeapprovedby

255、topmanagement.除非先前项目评审的开口项得到关闭，评审不能通过。否则，应由最高管理者让步批准。Theorganizationshalldefinemandatoryandoptionalparticipantsofphasereviews.组织应确定阶段评审强制的和可选的参与人员。8.1.3.1Projectintegrationmanagement项目整合管理Theorganizationshallestablishandimplementaprojectmanagementplan.Thisplanshallincludeorreferto:组织应建立和执行项目管理计划。这个计

256、划应包括或引用：a)aprojectorganizationchart;项目组织结构b)projecttargets,frameconditions,assignedresources,exclusions;项目目标、框架结构、指定的资源、责任免除c)specificresponsibilitiesandauthoritiesoftheprojectteammembers;项目成员的特定职责和权限d)specificrulestofollowduringprojectexecution;在项目执行中遵循的特定职责e)alignedplansfrominvolvedfunctions,sites

257、andconsortiumpartners,inordertocomeuptoaharmonizedprojectmanagementplan;平衡来自于相关职能、现场和合作伙伴的计划，以形成一个协调一致的项目管理计划；NOTE1Typicalfunctionsaresales,design,manufacturing,quality,production,purchasing,fieldsupportandotherappropriatepersonnelincludingexternalproviderandcustomerwhenappropriate.注1:典型职能是销售、制造、质量、

258、生产、采购、市场支持和其他适当的人员，适当时包括外部供方和客户。f)deliverablesperphase(e.g.contractualdeliverablesforcustomersordocumentedinformationofthedesignoutputsintendedforproductapproval)including:每阶段的可交付性（例如对于顾客的合同可交付性或为了产品批准目的的设计输出的文件化信息1)identificationofdeliverablestobeapprovedbythecustomer(e.g.customerproductacceptancep

259、oints)orregulatoryauthorities,whererequired;要求时，由顾客或法规官方批准的可交付物的识别（例如顾客产品接收点）2)externalproviderdeliverables(e.g.documents,material,services);外部供方的可交付性（例如文件、材料、服务）g)thecontrolofchanges(e.g.scope,time,costs)see8.1.5.变更的控制见8.1.5（例如范围、时间、成本）NOTE2Theprojectmanagementplancanincludeanyothersubsidiaryplansr

260、equiredin8.1.3(munication,humanresource,quality).注2:项目管理计划可以包括任何其他的8.1.3要求的子计划（例如沟通、人力资源、质量）.Incaseswhereaprojectinvolvesmultiplesitesorconsortiumpartners,theprojectmanagementplanshalladditionallyincludeorreferto:如果项目涉及多现场或合作伙伴，项目管理计划应额外包括或引用：a)worksplitandoperationalinterfaces;工作分解和操作接口b)specificre

261、sponsibilitiesandauthorities;特定的职责和权限c)communicationchannels(projectinternalandwiththecustomerorinterestedparties);沟通渠道（项目内部和顾客或相关方）d)applicableprocessesandotherdocumentedinformationrelatedtotheprocesses.过程有关的适用过程和其他文件化信息8.1.3.2Projectscopemanagement项目范围管理Regardingscopemanagement,theprojectmanagemen

262、tprocessshallinclude:对于范围管理，项目管理过程应包括：a)identificationofprojectrequirements(e.g.time,commercial,technical),see8.2;识别项目要求（例如时间、商务、技术），见8.2b)definitionofthescopeofwork;确定工作范围c)subdivisionofworkintoworkpackages(e.g.workbreakdownstructure);将工作分解进工作包（例如工作分解结构）d)assignmentofworkpackagestoworkpackageowners

263、;将工作包指定给工作包责任人e)verificationofworkpackages.工作包的验证Regardingscopemanagement,theprojectmanagementprocessshouldincludeastandardizedworkbreakdownstructure.关于项目管理，项目管理过程应该包括标准化的工作分解结构。NOTEScopemanagementindesignanddevelopmentisdetailedin8.3.2注：在设计开发中范围管理在8.3.2中描述。8.1.3.3Projecttimemanagement项目时间管理Regardin

264、gtimemanagement,theprojectmanagementprocessshallinclude:关于时间管理，项目管理过程应包括：a)definitionandsequencesofactivities;活动的定义和顺序b)estimationofresourcesanddurationsofactivities;活动周期和资源的估计c)schedulingconsidering时序考虑1)pastexperience;过往经验2)longleadtimeitems,managedjointlywithexternalproviders.长前置期项目，与外部供方一起管理Thep

265、rojectscheduleshall:项目计划应a)includeduration,start,finishandinterdependenciesoftheworkpackagesincludingthoseofexternalproviders;包括工作包的时长、开始、结束和相互作用b)includethecriticalpath;包括关键路径c)provideinputtothemasterproductionschedule(see8.5.7).为主生产计划提供输入Theprojectorganizationshoulduseapplicationsoftwareforschedul

266、ingandactivitytracking.项目组织应使用应用软件进行排程和活动追踪Theprojectorganizationshallnotchangethescheduleregardingthecustomerdeliverydatesunlessauthorizedbythecustomer.除非客户授权，项目组织不应变更影响客户交付日的计划8.1.3.4Projectcostmanagement项目成本管理Regardingcostmanagement,theprojectmanagementprocessshallinclude:关于成本管理，项目管理过程应包括：a)defin

267、itionofthebudgetbasedoncalculationfromtender;确定基于投标计算的预算b)assignmentofbudgettotherespectiveworkpackagesinacostaccountstructure;在成本核算结构中，针对每个工作包分配预算c)regularcontrolofcostsincludingactualandestimatedcostatcompletion.定期的成本控制，包括完成时实际和预算成本。Theprojectorganizationshouldusestandardizedapplicationsoftwarefor

268、costtracking.项目组织应该使用标准应用软件来进行成本追踪。Theprojectorganizationshallnotincreasetheprojectbudgetunlessauthorizedasdefinedbytheorganization.项目组织不应提高项目预算，除非得到组织授权。8.1.3.5Projectqualitymanagement项目质量管理Regardingqualitymanagement,theprojectmanagementprocessshallincludeplanningandimplementationofqualityassurance

269、andcontrolactivities.关于质量管理，项目管理过程应包括质量保证和控制活动的策划和执行。Theprojectshallestablishandimplementaprojectqualitymanagementplan.项目应建立和执行项目管理质量计划。NOTESeeISO10005andISO10006forguidance.注：见ISO10005和ISO10006.8.1.3.6Projecthumanresourcemanagement项目人力资源管理Regardinghumanresourcemanagement,theprojectmanagementprocess

270、shallinclude:关于人力资源管理，项目管理过程应包括：a)definitionanddescriptionofprojectroles(e.g.projectmanager,projectbuyer,projectqualitymanager)andresponsibilitiesversusthoseoflinefunctions,reportingrelationshipsandempowerment(e.g.financialapprovalauthorities,profit&lossresponsibilities,etc.);项目角色（例如：项目经理、项目采购、项目质量经

271、理）和职责的定义和描述与直线职能的对应，报告关系和授权（例如：财务批准权限、利润和亏损责任等）b)acquiringtheprojectteam;获取项目团队c)managingtheprojectteamintermsofpeople,competenceandawareness,accordingtorequirementsdefinedin7.1.2,7.2and7.3.根据7.1.2、7.2和7.3定义的要求，针对人员、能力和意识管理项目团队。Theprojectorganizationshallestablish,implementandmaintainahumanresourcep

272、lan.项目组织应建立、执行和维护人力资源计划。Thisplanshallinclude:这个计划应包括：a)assignmentofcoreteammembers;指定核心团队成员b)staffassignments(e.g.organizationchart).员工分配（例如；组织结构图）Theorganizationshalldefinerequiredcompetenciesandrelatedlevelsforprojectmanagersandprojectcoreteammembers,regardingthefollowing:组织应确定项目经理和项目核心成员关于以下内容所需能

273、力和相关级别：a)projectmanagement;项目管理b)projectmanagementapplicationsoftwareinuse;使用的项目管理应用软件c)teamworkandcommunication;团队工作和沟通d)projectqualitymanagement;项目质量管理e)risksandopportunitiesmanagement;风险和机遇管理f)productsandservicestobedelivered.拟交付的产品和服务Theorganizationshoulddefinerequiredcompetenciesandrelatedlevel

274、srequiredforprojectmanagersregardingthefollowing:组织应该确定关于以下内容所需的能力和相关级别：a)leadership;领导力b)projectfinancials.项目财务8.1.3.7 Project communications management 项目沟通管理Regardingcommunicationsmanagement,theprojectorganizationshall:关于沟通管理，项目组织应：a)applyrequirementsdefinedin7.4and8.2.1;应用7.4和8.2.1定义的要求b)establi

275、sh,implementandmaintainaprojectcommunicationmanagementplan;建立、执行和维护项目沟通管理计划c)performregularprojectreviewstomonitorprojectprogress,withtheattendanceofthecoreteammembers(see8.1.3.10).定期进行项目评审来监视项目进展，由项目核心团队成员参与（见8.1.3.10）Incaseofanimminentdeviationtotheprojectobjectives,theprojectorganizationshalliden

276、tifyandimplementappropriatecountermeasurestoavoidanyimpactoncustomerortheorganization.如果相对于项目目标有迫近的偏差，项目组织应识别和执行避免影响客户和组织的适当对策Projectreviewsshallinclude:项目评审应包括：a)theprojectperformance(actualsituationvs.plannedsituation)basedonKPIsasspecifiedin9.1.1(e.g.requirements,time,costs);基于在9.1.1中规定的KPIs（如要求、

277、时间、成本）的项目绩效（真实状态对比计划状态）b)theforecast(e.g.time,estimatedcostatcompletion);预测（例如时间、项目完成的预估成本）c)theactualrisks&opportunities,includingstatusofrelatedactions;实际的风险和机遇，包括相关措施的状态d)trackingofopenissuesandactionsfrompreviousreviews.先前评审的开口项及相应措施的追踪Theoutputofprojectreviewsshouldbereportedtomanagementlevelup

278、pertheprojectmanagerincludingissuesfordecisionorescalation.项目评审的输出应该向项目经理上一级管理层报告，包括决定和降级的事宜。8.1.3.8 Project risk and opportunity management 项目风险和机遇管理Regardingriskandopportunitymanagement,theprojectorganizationshall关于风险和机遇管理，项目组织应：a)applyrequirementsdefinedin6.1;应用6.1中定义的要求b)establish,implementandma

279、intainaregisterincludingafinancialanalysisofrisksandopportunities;建立、执行和维护登记册，包括风险和机遇的财务分析c)retaindocumentedinformationofriskandopportunitymanagement.保持风险和机遇管理的文件化信息Regardingriskandopportunitymanagement,theprojectorganizationshould:关于风险和机遇管理，项目组织应该：a)involvethefunctionallinemanagersinriskreviews;在风险

280、评审时，职能经理参与b)considerfunctionalandintegrationmaturitylevelsoftheproductsagreedwiththecustomerasinputsforrisksmanagement;考虑将客户同意的产品功能和集成成熟度水平作为风险管理输入c)manageopportunitiesforcostsavings(tobalancelosses)orcostenhancements(toincreasemargin),especiallyinordertorecovertheprojectbudgetdeteriorations.管理成本节约（

281、来平衡损耗）或成本夯实（来提高利润），尤其为了弥补项目预算差。8.1.3.9 Project procurement management 项目采购管理Regardingprojectprocurementmanagement,theprojectorganizationshallapplyrequirementsdefinedin8.4.关于项目采购管理，项目组织应应用于8.4中规定的要求。8.1.4 Configuration management 配置管理Theorganizationshallestablish,implementandmaintainadocumentedconfig

282、urationmanagementprocessappropriatetotheproduct.组织应建立、执行和维护适用于产品的文件化配置管理过程。NOTE The configuration management process is applicable for hardware and software.注：配置管理过程适用于硬件和软件。Thisprocessshallconsiderasaminimum:过程应至少考虑：a)theconfigurationmanagementplanning;配置管理策划b)theproductbreakdownstructureuntilthelo

283、westreplaceableunits;在最小可更换单元基础上的产品结构分解c)identificationofconfigurationitems,atleastthesafety-relatedones;配置零件的识别，至少安全相关d)configurationbaselinestobeestablished,asaminimumfor“as-designed”,“as-built”and“as-maintained”configurations;建立配置基线，至少基于 “设计”“制造”“维护”的配置e)thechangecontroloftheconfigurationaccordin

284、gto8.1.5;根据8.1.5进行配置变更的控制。f)configurationstatusaccounting;配置状态统计g)criteriaforidentificationoftraceability(e.g.serialization,batchnumber).可追溯性标识的标准（例如序列号、批次号）Theorganizationshallretainrelateddocumentedinformation.组织应保持文件化的相关信息。Thisprocessshould:过程应该a)considerregularinternalconfigurationaudits;考虑内部的定期

285、配置审核b)integrateexternalprovidersconfigurationmanagementsystem(e.g.interfacesfordatatransfer);整合外部供方的配置管理体系（例如数据传递的接口）c)considertoolsandsoftwareusedindesign,development,productionandmaintenanceasconfigurationitems;考虑设计、生产和维护中的使用工具或软件作为配置项d)besupportedbyanapplicationsoftware.由应用软件支持NOTESeeISO10007forg

286、uidance.注：ISO10007作为导则8.1.5 Change management 变更管理Theorganizationshallestablish,implementandmaintaindocumentedprocessestomanagechanges.Theseprocessesshallinclude:组织应建立、执行和维护变更管理的文件化过程。过程应包括：a)therequirementsdefinedinthisTechnicalSpecification,suchas:在本技术规范中定义的要求1)in8.2.4applicabletorequirementsforpr

287、oductsandservices;8.2.4中适用于产品和服务的要求2)in8.3.6applicabletodesignanddevelopmentchanges;8.3.6中适用于设计开发变更的要求3)in8.5.6applicabletoproductionandserviceprovision;8.5.6中适用于产品和服务提供的要求b)thechangerequest;变更需求c)causeanalysisincaseofchangesderivingfromfailures;如果是从失效中汲取的教训引起的变更，根本原因分析d)animpactanalysisofthechangec

288、onsideringrisksandopportunities;考虑风险和机遇的变更的影响分析e)verificationofproposedchangestoavoidadverseeffects;拟实施变更的验证以避免负面影响f)notificationtoandagreementwithcustomers,externalprovidersandauthorities,basedoncriteriaincluding,asaminimum,changesaffectingtheirrequirements;基于准则（其最低包括影响他们要求的变更）通知顾客、外部供方和官方并获得同意NOTE

289、1Achangeaffectingcustomerrequirementscantriggeradeviationpermit.注1：影响顾客要求的变更可能会触发偏差允许。NOTE2Achangerequestidentifiedfromadeviationpermitcanbeclosedwhenthechangeisapprovedbythecustomer.注2：当变更得到顾客批准时，由偏差允许识别的变更需求可以关闭。g)theassignmentofresponsibilitiesandauthoritiesfortheapprovalofchanges(e.g.changecontr

290、olboard);变更批准的责任人和授权的分配（例如变更控制委员会）h)theapprovalofchangebeforeimplementation;执行前变更的批准i)implementationofchanges;变更的执行j)theverificationofimplementationandfollow-up.执行的验证和跟踪Theseprocessesshallbesupportedbyanapplicationsoftware.这些过程应由应用软件支持。Theseprocessesshouldinclude:这些过程应该包括：a)planningofactionsinordert

291、ominimizetheimpactofchange;策划措施以最小化变更影响b)thetraceabilityofchangessupportedbyanapplicationsoftware.由应用软件支持变更的可追溯性。Fortechnicalproductorservicechanges,theseprocessesshallincludeinaddition:对于产品和服务的技术变更，这些过程应额外包括：a)ananalysisofthechangeimpacton变更影响的分析1)constituentpartsandproductsalreadydelivered;零件和已交付产

292、品2)customerspecificationandconfiguration;客户规范和配置3)relateddocumentedinformation(e.g.qualityassuranceplan,FMEAreport);相关文件信息（例如质量保证计划、FMEA报告）b)there-evaluationoffunctional,non-functionalandintegrationrequirements;功能、非功能和集成要求的再评估c)there-validationactivitiesdependingontheresultsoftheimpactanalysis;依据影响分

293、析的结果的再评估活动d)requirementsforretentionofdocumentedinformationaboutthedateand(or)theserialnumberofthechangedproductsandservices.变更的产品和服务的日期和（或）序列号有关的文件化信息的保持要求。NOTEChangescanbegeneratedbylackofreliability,obsolescence(productsorexternalproviders),evolutionofstandards,regulations,laws,needsforoperation,

294、costoptimization,orspecificevent:accident,incident,weatherorcustomervariationorder.注：变更可能因为可靠性缺乏、老化（产品或外部供方），标准的演化、法规、法律、操作需求、成本优化或特定事件（事故、异常、天气或顾客订单变化）。Fortechnicalproductorservicechanges,theseprocessesshouldincludeinadditionthere-evaluationofoperationalandintegrationmaturity.对于产品和服务的技术性变更，这些过程应该包括

295、额外的操作和集成成熟度的再分析。Thechangemanagementrequirementsshallapplyto:报告管理要求应应用于：a)projectmanagement(see8.1.3);项目管理（见8.1.3）b)requirementsforproductsandservices(see8.2.4);产品和服务要求（见8.2.4）c)designanddevelopmentofproductsandservices(see8.3.6);产品和服务的设计开发（见8.3.6）d)controlofexternallyprovidedprocesses,productsandser

296、vices(see8.4);外部提供的过程、产品和服务的控制e)productionandserviceprovision(see8.5.6)encompassingproductionprocesses,productionequipment,productionprograms(software)andproductionlocation.围绕生产过程、生产设备、生产程序（软件）和生产现场的产品和服务提供（见8.5.6）NOTE 1 Changescanbeinitiatedbyexternalproviderortheorganizationinordertoimproveortocor

297、rectthedesignorbythecustomerincaseofvariationorder.注1：报告可能由外部供方或组织提起以改进或纠正设计，或订单变化时由客户提出NOTE 2 Thetriggerpointtostartthechangeprocessistheintendedchangeofapproveddocumentedinformation.注2： 开始变更过程的触点是批准的文件化信息的预期变更。8.2 Requirements for products and services产品和服务的要求8.2.1 Customer communication顾客沟通Commun

298、ication with customers shall include: 顾客沟通应包括： a) providing information relating to products and services; 提供产品和服务的相关信息；b) handling enquiries, contracts or orders, including changes; 询问、合同、订单，包括变更的处理；c) obtaining customer feedback relating to products and services, including customer complaints; 获得与

299、产品和服务相关的顾客反馈，包括顾客抱怨；d) handling or controlling customer property; 处置或控制顾客财产；e) establishing specific requirements for contingency actions, when relevant. 相关时，建立应急措施的特定要求。8.2.1.1CustomercommunicationSupplemental顾客沟通-补充Theorganizationshallcommunicatetocustomerwhendelaysareforeseenbutcannotbeavoided(e.

300、g.delaysfromexternalproviders).组织在预知延期时应与顾客沟通而不是回避（例如由外部供方导致的延期）8.2.2 Determining the requirements for products and services与产品和服务有关要求的确定When determining the requirements for the products and services to be offered to customers, the organization shall ensure that: 当确定提供给顾客的产品和服务的要求时，组织应确保： a) the re

301、quirements for the products and services are defined, including: 产品和服务的要求应明确，包括：1) any applicable statutory and regulatory requirements; 任何适用法律法规的要求；2) those considered necessary by the organization; 那些组织认为必要的要求；8.2.2.1DeterminingtherequirementsrelatedtoproductsandservicesSupplemental与产品和服务有关要求的确定-补

302、充Whendeterminingtherequirements,theorganizationshallconsider:当确定要求时，组织应考虑：a)functional,non-functionalandintegrationrequirements;功能、非功能和集成度要求b)RAMS/LCCrequirements.RAMS/LCC要求Whendeterminingtherequirements,theorganizationshouldconsider:当确定要求时，组织应该考虑：a)experiencefromsimilarproducts/tenders/projects;来自相

303、似产品/投标/项目的经验b)requirementsresultingfrommarketanalysis;市场分析导出的要求c)obsolescencerequirements(e.g.informationcomingfrommarket,externalproviders,regulations);老化要求（例如来自市场、外部供方、法规的信息）d)criticalproductcharacteristics;关键产品特性e)requirementsregardingendofproductlife(e.g.disposal,recycling).产品生命终止的相关要求8.2.3Revie

304、woftherequirementsforproductsandservices与产品和服务有关要求的评审8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, t

305、o include: 组织应确保有能力满足提供给客户的产品和服务的要求。组织应在交付给客户产品和服务之前进行评审，包括： a) requirements specified by the customer, including the requirements for delivery and post-delivery activities; 顾客规定的要求，包括对交付和交付后活动的要求；b) requirements not stated by the customer, but necessary for the specified or intended use, when known

306、; 顾客虽然没有明示，但规定用途或已知的预期用途所必须的要求；c) requirements specified by the organization; 组织所明确的要求 d) statutory and regulatory requirements applicable to the products and services; 适用于产品和服务的法律法规要求；e) contract or order requirements differing from those previously expressed. 与以前表述不一致的合同或订单的要求。The organization sha

307、ll ensure that contract or order requirements differing from those previously defined are resolved. 组织应确保与与以前表述不一致的合同或订单的要求已得到解决。 The customers requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements. 若顾客没

308、有提供形成文件的要求，组织在接受顾客要求前应对顾客要求进行确认。NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead, the review can cover relevant product information, such as catalogues.注：在某些情况中，如网上销售，对每一个订单进行正式的评审可能是不实际的，作为替代方法，可对有关的产品信息，如产品目录等进行评审。8.2.3.2 The organization shal

309、l retain documented information, as applicable: 组织应保留文件化信息，适用时：a) on the results of the review; 评审的结果； b) on any new requirements for the products and services. 产品和服务的任何新要求。8.2.4 Changes to requirements for products and services产品和服务要求的变更The organization shall ensure that relevant documented informa

310、tion is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed. 当产品和服务的要求发生变更时，组织应确保相关的文件信息得到修改，并确保相关人员意识到变更的要求。8.2.5RequirementsforproductsandservicesSupplemental产品和服务要求-补充Theorganizationshallestablish,implementandm

311、aintainadocumentedprocesstomanagerequirements.组织应建立、执行和维护管理要求的文件化过程。Thisprocessshall:这个过程应：a)considertherequirementsdefinedin8.2;考虑8.2中确定的要求b)beapplicablefor:适用于：1)designanddevelopmentofnewproductsorservicesmeetingmarketexpectationspriortotender(e.g.platform,productfamily);2)tendermanagement(e.g.sub

312、missionoftenders,acceptanceofcontractsororders);3)projectexecution(e.g.acceptanceofchangestocontractsororders);项目执行（例如合同或订单变更的接受）4)changecontrol(see8.1.5);变更控制（见8.1.5）NOTE1Thisprocesscanbeincludedintheprojectmanagementprocess.注：这个过程可以包含在项目管理过程。c)performedbyamulti-disciplinaryapproachincludinginterna

313、landexternalstakeholderswhereapplicable;应用多方论证的方法，适当时包括内外部利益相关方d)includeasaminimumthesesteps:至少包括以下步骤：1)determination(see8.2.1.1);决定（见8.2.1.1）2)review(see8.2.3);评审（见8.2.3）3)verification;验证4)validation;确认e)ensurethatrequirementsare:确保要求得到：1)individuallycheckedforcomplianceclausebyclause;单独进行符合性的逐条评审2

314、)evaluatedandtakenintoaccount;得到评估并考虑评估结果3)assessedrelatedtoriskandopportunities;与风险和机遇相关的评估4)properlytransferred,understood,acknowledged,cascadeddownandcommittedto,byinvolvedpersons;让参与人员正确传达、理解、知悉、展开和承担责任。5)complete,unequivocal,verifiableandfeasible;完整的、明确的、可验证的和可行的6)aredocumentedinafunctionalandp

315、erformancespecificationfortechnicalrequirements;对于技术要求，在功能和性能规范中文件化NOTE2Thefunctionalandperformancespecificationcanbeprovidedbythecustomerorestablishedbytheorganization.功能和性能规范可能是客户提供也可能是组织建立。7)updatedincaseofchange.变更时得到更新8.3Designanddevelopmentofproductsandservices产品和服务的设计和开发8.3.1General总则Theorgan

316、izationshallestablish,implementandmaintainadesignanddevelopmentprocessthatisappropriatetoensurethesubsequentprovisionofproductsandservices.组织应建立、实施和保持一个设计和开发过程，以确保同后续提供的产品和服务相适应。8.3.1.1GeneralSupplemental总则-补充Therequirementsdefinedin8.3shallapplytothedesignanddevelopmentorintroductionofnewtechnologi

317、es(positeproducts,laserwelding).8.3中定义的要求适用于设计开发和新技术引入（例如：复合产品、激光焊接）。TheorganizationshallperformprocessFMEAfortheimplementationofnewtechnologies.当使用新技术时，组织应使用过程FMEA。Thedesignanddevelopmentprocessshall:设计开发过程应：a)considertherequirementsregardingplanning,inputs,controlsoutputsandchangesdescribedin8.3.2

318、,8.3.3,8.3.4,8.3.5,8.3.6;考虑在8.3.2,8.3.3,8.3.4,8.3.5,8.3.6中关于策划、输入、输出和变更控制的要求b)bedocumented;得到文件化c)requireasafetycaseinaccordancewithIEC62425orequivalentforsafety-relatedproductsinconjunctionwithIEC62278orequivalent.要求依据IEC62425的安全事例或结合IEC62278的安全相关产品或等同要求Theorganizationshalldefinerequiredcompetencie

319、sandrelatedlevelsforpersonsdealingwithdesignanddevelopment,regardingthefollowing:组织应执行设计开发人员所需能力和相关级别， 以下方面：a)requirementmanagement;要求的管理b)configurationmanagement;配置管理c)qualityassurancemethods.质量保证方法8.3.2 Design and development planning设计和开发策划In determining the stages and controls for design and dev

320、elopment, the organization shall consider: 在确定设计开发阶段和控制时，组织应考虑：a) the nature, duration and complexity of the design and development activities; 设计开发活动的性质、持续时间、复杂性；b) the required process stages, including applicable design and development reviews; 需要的过程阶段，包括适当的设计和开发评审；c) the required design and deve

321、lopment verification and validation activities; 需要的设计开发验证和确认活动；d) the responsibilities and authorities involved in the design and development process; 涉及设计开发过程的职责和权限；e) the internal and external resource needs for the design and development of products and services; 产品和服务的设计开发所需要的内部和外部资源；f) the need

322、 to control interfaces between persons involved in the design and development process; 需要对参与设计开发过程的人员之间的接口进行管控；g) the need for involvement of customers and users in the design and development process; 顾客和使用者参与设计开发过程的必要性； h) the requirements for subsequent provision of products and services; 产品和服务提供之

323、后的要求；i) the level of control expected for the design and development process by customers and other relevant interested parties; 客户和其他相关方期望的设计开发过程控制的程度；j) the documented information needed to demonstrate that design and development requirements have been met. 需要证实设计开发已满足要求的文件化信息。8.3.2.1Designanddeve

324、lopmentplanningSupplemental设计开发策划Indeterminingthestagesandcontrolsfordesignanddevelopment,theorganizationshallconsider:在确定设计开发阶段和控制时，组织应考虑：a)theobjectivesforeachprocessstage;每阶段的目标b)theproductarchitecture(e.g.productbreakdownstructure);产品构架（例如产品分解结构）c)theconfigurationcontrol,see8.1.4;配置控制，见8.1.4d)de

325、signreviews,verificationandvalidationatdefinedlevelsoftheproductarchitecture(e.g.startingfromcomponentdesignreview,thensub-systemdesignreviewanduptosystemdesignreview);在产品构架确定级别基础上的设计评审、验证和确认（例如从部件的设计评审开始，然后子系统设计评审并直至系统设计评审。e)designreviews,verificationandvalidationforspecialprocesses.特殊过程的设计评审、验证和确认

326、Thestagesandcontrolsfordesignanddevelopmentshallbedocumented(e.g.inaqualityassuranceplan).设计开发的阶段和控制应得到文件化（例如在质量保证计划中）NOTEDesignstagescanbeconceptualdesign,preliminarydesign,finaldesign.注：设计阶段可能是概念设计、初步设计、最终设计。Indeterminingthestagesandcontrolsfordesignanddevelopment,theorganizationshouldconsider:在确定

327、设计开发的阶段和控制时，组织应该考虑：a)thequalityassurancemethodsforeachdesignanddevelopmentstageinordertomeettheobjectives(e.g.definedinaqualityassuranceplan);为了满足目标（例如在质量保证计划中确定的），每个设计开发阶段的质量保证方法b)themethodtocontrolnon-functional,functional,performanceandintegrationrequirements;控制非功能、功能、性能和集成要求的方法c)themethodtocontr

328、oltheintegrationandoperationalmaturity.控制集成和操作成熟度的方法NOTE1Ifrequirementsofspecialprocessesareinputstothedesign,theriskassessmentofthesespecialprocessescanbepartofthedesignanddevelopmentprocess.注1：如果特殊过程的要求是设计输入时，特殊过程的风险评估可以是设计开发过程的一部分。NOTE2Collaborationwithexternalengineeringcanbeconsideredasexternal

329、lyprovidedservices(see8.4).注2：与外部工程合作可以视为外部提供的服务（见8.4）。8.3.3 Design and development inputs设计开发输入The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider: 组织应确定设计开发的产品和服务种型的必需的要求，组织应考虑： a)

330、 functional and performance requirements; 功能和性能要求；b) information derived from previous similar design and development activities; 来源于以前类似设计开发活动的信息;c) statutory and regulatory requirements; 法律法规要求；d) standards or codes of practice that the organization has committed to implement; 组织承诺实施执行的标准或指令；e) po

331、tential consequences of failure due to the nature of the products and services. 由于产品和服务的性质导致失败的潜在后果；Inputs shall be adequate for design and development purposes, complete and unambiguous. 输入应相对于设计开发的目的是充分的，完整的，清楚的。Conflicting design and development inputs shall be resolved. 输入中的矛盾应被解决。The organizati

332、on shall retain documented information on design and development inputs. 组织应保留设计开发输入的文件化信息。8.3.3.1DesignanddevelopmentinputsSupplemental设计开发输入的补充Regardingdesignanddevelopmentinputs,theorganizationshallconsidertherequirementsdefinedin8.2.1.1.关于设计开发输入，组织应考虑在8.2.1.1中定义的要求Theorganizationshallretainrelat

333、eddocumentedinformation.组织应保持相关的文件化信息。Inaddition,theorganizationshouldconsider:另外，组织应该考虑：a)productionandroutinetestingrequirements,includingspecialprocesses,sofarastheproductionfacilitiesareknownatthisstage;产品和例行试验要求，包括特殊过程，直到这个阶段已知的生产设施b)theapplicationofdesignconcepts(e.g.designformanufacturing,des

334、ignfortesting,designformaintainability).设计理念的应用（例如：可制造性设计，试验设计，维护性设计）。8.3.4 Design and development controls设计开发控制The organization shall apply controls to the design and development process to ensure that: 组织应控制设计开发过程，以确保：a) the results to be achieved are defined; 达到的结果得到确定；b) reviews are conducted t

335、o evaluate the ability of the results of design and development to meet requirements; 进行评审以评价设计开发结果满足要求的能力；c) verification activities are conducted to ensure that the design and development outputs meet the input requirements; 实施验证以确保设计开发输出满足输入的要求；d) validation activities are conducted to ensure tha

336、t the resulting products and services meet the requirements for the specified application or intended use; 实施确认以确保产生的产品和服务满足规定的应用要求或预期的使用要求；e) any necessary actions are taken on problems determined during the reviews, or verification and validation activities; 针对评审或验证和确认活动期间确定的问题，采取的任何必要的措施，；f) docu

337、mented information of these activities is retained. 这些活动的文件化信息需要保留。NOTE Design and development reviews, verification and validation have distinct purposes. They can be conducted separately or in any combination, as is suitable for the products and services of the organization. 注：设计和开发的评审、验证和确认具有不同的目

338、的，根据组织产品和服务的具体情况，可单独或以任意组合的方式进行8.3.4.1DesignanddevelopmentcontrolsSupplemental设计开发控制-补充Theorganizationshouldapplycontrolstothedesignanddevelopmentprocessconsidering:组织应该考虑以下方面进行控制：a)thefunctionalbreakdown;功能分解b)theintegrationandoperationalmaturity;集成和操作成熟度c)theimplementationofqualityassurancemethods

339、.质量保证方法的执行8.3.4.2Designreviews设计评审Regardingdesignreviews,theorganizationshalldefine:关于设计评审，组织应确定：a)criteriaforauthorizationofprogressiontothenextstage(e.g.checklist,rulesforacceptance);放行到下一阶段的授权准则b)mandatoryandoptionalparticipants.强制和可选的参与者Representativesoffunctionsjoiningdesignreviewsshallhavethed

340、efinedlevelofcompetenciesandrespectivedecisionmakingauthorities.参与设计评审的职能代表应确定决定授权代表及其能力水平。Theorganizationshallretaindocumentedinformationrelatedtodesignreviews.组织应保持设计评审相关的文件化信息。Theorganizationshouldperformdesignreviewswithamultidisciplinaryapproach.组织有关使用多方论证的方法进行设计评审。NOTE1Participantscanbeheadoff

341、unctions(e.g.RAMS,services),internalandexternalcustomers,expertsinproduction.注1：参与者可能是职能领导（例如RAMS，服务）、内外部客户、生产过程的专家。NOTE2Designreviewscanbepartoforaninputforprojectphasereviews(see8.1.3).注2：设计评审可能是项目阶段评审的输入或一部分。8.3.4.3Designverification设计验证Theorganizationshallensurethatperformancerequirementsareveri

342、fied.组织应确保性能要求得到验证。Theorganizationshallretaindocumentedinformationrelatedtodesignverification.组织应与设计验证有关的文件化信息。NOTEDesignverificationactivitiescanbefiniteelementanalysis,calculations,mock-up,designaccompanyingtests.注：验证活动可以是有限元分析、计算、模拟、设计原型试验。8.3.4.4Designvalidation设计确认Regardingdesignvalidation,theo

343、rganizationshall:关于时间确认，组织应：a)ensurethatfunctional,non-functionalandintegrationrequirementsarevalidated;确保功能、非功能和集成要求得到确认b)completevalidationpriortothedeliveryorendofcommissioningoragreeoncontrolplanswithcustomersandmonitorthemuntilcompletion.完成确认活动在交付前或调试结束或经客户同意的控制计划并监视到其完成。NOTEDesignvalidationact

344、ivitiesaree.g.qualificationtests,typetests,productapprovaltests,etc.注：设计确认活动是例如放行试验、型式试验、产品批准试验等。Whentestsarenecessaryforvalidation,theorganizationshallplan,controlandreviewthesetests.当试验对于确认是必要的，组织应策划、控制和评审试验。Theorganizationshallensurethat:组织应确保：a)testplans,specificationsorproceduresdefine:确定试验计划、规

345、范和程序1)testobjectives;试验目标2)testconditionsandreproducibleenvironment;试验条件和可再生环境3)theproducttobetested;要试验的产品4)resourcesneeded;所需资源5)acceptancecriteria;接收准则6)parameterstoberecorded;要记录的参数7)themethodofoperation;操作方法8)theperformanceofthetest;试验的性能b)thecorrectconfigurationoftheproductissubmittedforthetes

346、tsandrecordedasaconfigurationbaseline;提交试验的产品的正确配置并且记录为配置基线c)theacceptancecriteriaaremet.接收准则得到满足。Theorganizationshallretaindocumentedinformationofthetestresults.组织应保持试验结果的文件化信息。8.3.5 Design and development outputs设计开发输出The organization shall ensure that design and development outputs: 组织应确保设计开发输出：

347、a) meet the input requirements; 满足输入的要求；b) are adequate for the subsequent processes for the provision of products and services; 对随后的产品和服务提供过程是充分的；c) include or reference monitoring and measuring requirements, as appropriate, and acceptance criteria; 包含或引用监视和测量要求，适用时，包含或引用接收准则；d) specify the charact

348、eristics of the products and services that are essential for their intended purpose and their safe and proper provision. 规定对产品和服务的预期目的、安全和正常使用所必需的特性。The organization shall retain documented information on design and development outputs. 组织应保留设计开发输出的文件化信息。8.3.5.1DesignanddevelopmentoutputsSupplementa

349、l设计开发-补充Theorganizationshallensurethatdesignanddevelopmentoutputs:组织应确保设计开发输出：a)areverifiedandapprovedpriortorelease;在放行前得到验证和批准b)areverifiedagainstproductionprocessinputrequirement;针对生产过程输入要求进行验证c)includethedocumentation(e.g.operations,maintenancemanuals)andtrainingrelatedtotheapplication.包括与应用相关的文

350、件（例如操作、维护手册）和培训。Theorganizationshould组织应该a)ensurethetraceabilityofoutputstotheinputrequirements;确保输出对于输入要求的可追溯性b)defineauthoritiesandacceptancecriteriafordesignapproval;确定设计批准的授权和接收准则c)defineescalationrulesincaseacceptancecriteriaforapprovalarenotmet;如果批准的接收准则没有得到满足，确定降级规则d)ensurethatinformationforp

351、roductionandserviceprovisionincluderequirementsforthepreservationofproduct.确保生产和服务提供的信息，包括产品防护的要求。NOTEThedesignanddevelopmentoutputscanincludee.g.specificationsanddrawings(alsofromexternalproviders),informationonmaterials,productionprocessflowchartand(or)layout,inspectionandtestplan,workinstructions

352、forproduction,processandproductapprovalacceptancecriteria,resultsoferrorpreventionactivities(e.g.FMEA),asappropriate,methodsofrapiddetectionandfeedbackofproductand(or)productionprocessnonconformities.注：设计开发输出可以包括：例如规范和图纸（也可以来自外部供方），材料信息、生产过程流程图和（或）平面布置图、检验和试验计划、生产的作业指导书、过程和产品的批准接收准则、防错活动的结果（例如FMEA），

353、适当时，产品和（或）生产过程不合格的反馈和快速探测方法。8.3.6 Design and development changes设计开发更改The organization shall identify, review and control changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to req

354、uirements. 组织应识别、评审和控制在产品和服务的设计开发中及之后发生的变更，控制必要的程度以确保对要求的符合性没有负面影响。 The organization shall retain documented information on: 组织应保留如下文件化信息： a) design and development changes; 设计开发的变更； b) the results of reviews; 评审的结果； c) the authorization of the changes; 变更的授权；d) the actions taken to prevent adverse

355、impacts. 预防负面影响采取的措施。8.4 Control of externally provided processes, products and services外部提供的过程、产品和服务的控制8.4.1 General总则The organization shall ensure that externally provided processes, products and services conform to requirements. 组织应确保外部提供过程、产品、服务符合规定的要求。The organization shall determine the contro

356、ls to be applied to externally provided processes, products and services when: 组织应确定应用于外部提供过程、产品和服务的控制，当： a) products and services from external providers are intended for incorporation into the organizations own products and services; 外部供方提供的产品和服务计划纳入组织自身产品和服务的；b) products and services are provided

357、 directly to the customer(s) by external providers on behalf of the organization; 由代表组织的外部供方直接提供给顾客的产品和服务；c) a process, or part of a process, is provided by an external provider as a result of a decision by the organization. 一个过程或一个过程的部分由外部供方提供，作为组织决定的结果。The organization shall determine and apply cr

358、iteria for the evaluation, selection, monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements. The organization shall retain documented information of these activities and any necessary a

359、ctions arising from the evaluations. 组织应确定和应用外部供方的评价、选择、绩效监视、再评价准则，基于其按照规定的要求提供过程或提供产品和服务的能力。组织应保留这些活动和由评价引起的任何必要的措施的文件化信息。 8.4.1.1GeneralSupplemental总则-补充Theorganizationshalldeterminethetypeandextentofrequirementsfrom8.4thatapplytointernalandexternalproviders,withriskassessmentsbasedondefinedcriter

360、ia.组织应基于确定的准则进行风险评估，来确定适用于内外部供方的8.4中要求的程度和类型NOTEInternalprovidersareunderstoodasentitiesfromthesamecorporationdeliveringproducts,processesandservicestotheorganization.注：内部供方理解为来自于相同法人向组织交付产品、过程和服务的实体。Theorganizationshallestablish,implementandmaintainadocumentedprocessforexternallyprovidedprocesses,p

361、roductsandservices(EPPPS)describedin8.4.1toensureconformitytorequirements.组织应建立、执行并维护一个文件化的过程确保在8.4.1中描述的外部提供的过程、产品和服务（EPPPS）符合要求。Thisprocessshallincluderequirementsdefinedfor:过程应包括以下内容的要求a)classificationofexternalprovidersandEPPPS(see8.4.1.1.1);外部供方和EPPPS的分级（见8.4.1.1.1）b)externalproviderevaluation(

362、see8.4.1.1.2);外部供方的评价（见8.4.1.1.2）c)externalproviderapproval(see8.4.1.1.3);外部供方的批准（见8.4.1.1.3）d)externalproviderofferselection(see8.4.1.1.4);外部供方报价的选择（见8.4.1.1.4）e)informationforexternalproviders(see8.4.3);提供给外部供方的信息（见8.4.3）f)EPPPSapprovalofrelease(see8.4.2.1);放行EPPPS的批准（见8.4.2.1）g)EPPPSverificationa

363、fterrelease(see8.4.2.2);放行后EPPPS的验证（见8.4.2.2）h)monitoringofexternalproviderperformance,re-evaluationandranking(see8.4.2.3).外部供方绩效的监视、在评价和分级Inaddition,theorganizationshall:另外，组织应：a)managetheEPPPSrisksthroughoutthesupplychain;管理整个供应链的EPPPS风险b)identifyriskstobecommunicatedtoexternalprovidersandaskexter

364、nalprovidersfortheirfeedback;识别要与供应商交流的风险并要求外部供方提供反馈c)retaindocumentedinformationonexternalprovidercontrols.保持外部供方控制的文件化信息8.4.1.1.1Classificationofexternalprovidersandexternalprovidedproducts,processorService外部供方和外部提供产品、过程和服务的分级ClassificationofexternalprovidersandEPPPSshallbeperformedondefinedcriter

365、iatodeterminethetypeandextentofcontrolappliedtoexternalprovidersandtheEPPPS(see6.1.3).Asanoutput,keyexternalprovidersshallbeidentified.外部供方和EPPPS应的分级应执行确定的准则以确定适用于外部供方和EPPPS的控制类型和程度。作为输出，应识别关键外部供方。Theorganizationshallretainrelateddocumentedinformation.组织应保持相关文件化信息。Classificationcriteriashallincludet

366、heabilityofexternalprovidertoprovideEPPPSaccordingtorequirements.分级的准则应包括外部供方根据要求提供EPPPS的能力。Classificationcriteriashouldinclude:分级准则应该包括：a)strategicneeds;战略需求b)pastexperiences;以往经验c)availablemarketinformation;可获得的市场信息d)externalbenchmarks;外部标杆e)theoperationalandintegrationmaturityofexternallyprovided

367、products(e.g.readytouse).外部供方产品的操作和集成成熟度（例如：易于使用）Inaddition,theorganizationshallregularlyreviewtheclassificationofexternalproviders.另外，组织应定期评审外部供方的分级。8.4.1.1.2Evaluationofexternalproviders外部供方的评价Externalprovidersevaluationshallinclude:外部供方评价应包括：a)people,infrastructureandprocessesofexternalproviders;

368、外部供方的人员、设施和过程b)availabilityofexternalprovidersqualifications(e.g.certificatessuchasISO9001,orthisTechnicalSpecification).外部供方授权的可获得性（例如：证书，如ISO9001，或本技术规范）Theorganizationshallestablish,implement,maintainandmonitorastrategyforgetting:组织应建立、执行、维护和监视一个策略以获得：a)targetedexternalproviderscomplianttothisTec

369、hnicalSpecification;把符合本规范作为目标的外部供方b)targetedexternalproviderscomplianttoISO9001.把符合ISO9001作为目标的外部供方Externalproviderstargetedshallbeidentifiedconsideringtheirproductscopes,strategicrelevance,annualspendvolume,productcriticality,designactivities,turnoverintherailsectoranddeliveryandqualityperformance

370、.考虑其产品范围、战略考虑、年度采购额、产品关键性、设计活动、铁路行业的营业额以及交付和质量绩效，有识别外部供方的开发目标。Theorganizationshallretainrelateddocumentedinformation.组织应保持相关的文件化信息。8.4.1.1.3Approvalofexternalproviders外部供方的批准Theorganizationshall:组织应：a)establishcriteriatoapproveexternalproviders;建立准则以批准外部供方b)ensurethatfunctionshavingtheauthoritytoapp

371、rovehavealsotheauthoritytorejectalreadyapprovedexternalproviders;确保有批准权限的职能也有权限拒绝已批准的外部供方。c)maintainaregisterofapprovedexternalproviders,includingthedefinitionoftheirscopeofapproval.维护已批准外部供方的注册表，包括其批准范围的定义。Theorganizationshallretainrelateddocumentedinformation.组织应保持相关文件化信息。EPPPSshallbeprovidedexclu

372、sivelybyapprovedexternalproviders.应仅批准的外部供方可以提供EPPPS。8.4.1.1.4Externalproviderofferselection外部供方报价的选择Theorganizationshallensurethattheexternalprovidersofferisselectedonlyafterthoroughdocumentedanalysispriortonegotiation.Theanalysisshalltakeintoaccount:组织应确保在谈判前进行文件化分析后选择外部供方的报价。这个分析应考虑：a)thelevelofc

373、ompliancewiththerequirements,e.g.byclausebyclause;要求的符合水平，例如：逐条评审b)thetotalcostofownershipincludingLCC;所有者的总体成本包括LCCc)thequality,costanddeliveryperformanceoftheexternalproviderforpreviousEPPPS,includingQDCcausedbytheexternalprovider;外部供方以往EPPPS的质量、成本和交付绩效，包括外部供方导致的QDC。d)theclassificationoftheexterna

374、lprovidersconcernedbytheoffer.报价有关的外部供方分级。Theorganizationshallretainrelateddocumentedinformation.组织应保持文件化信息。Theanalysisshouldtakeintoaccount:分析应该考虑：a)theoutputofariskanalysis;风险分析的输出b)theoperationalandintegrationmaturityofexternallyprovidedproducts.外部提供产品的操作和集成成熟度Priortotheissuanceofapurchaseorder,t

375、heorganizationshouldensurethattheexternalproviderhasallfunctionalandnon-functionalrequirementsfullyunderstood,e.g.byajointcontractreview.采购订单发布前，组织应该确保外部供方已经完全理解所有功能和非功能的要求，例如：提供联合合同评审。8.4.2 Type and extent of control控制的类型和程度The organization shall ensure that externally provided processes, products

376、and services do not adversely affect the organizations ability to consistently deliver conforming products and services to its customers. 组织应确保外部提供的过程、产品和服务不对组织持续地交付给顾客符合的产品和服务的能力产生不利影响。 The organization shall: 组织应：a) ensure that externally provided processes remain within the control of its quality

377、 management system; 确保外部提供过程保持在组织质量管理体系的控制内；b) define both the controls that it intends to apply to an external provider and those it intends to apply to the resulting output; 同时确定计划应用于外部供方的控制和计划用于结果输出的控制； c) take into consideration: 考虑到：1) the potential impact of the externally provided processes,

378、products and services on the organizations ability to consistently meet customer and applicable statutory and regulatory requirements; 外部提供过程、产品和服务对组织持续满足顾客和适用法律法规要求的能力的潜在影响； 2) the effectiveness of the controls applied by the external provider; 外部供方应用的控制的有效性；d) determine the verification, or other

379、activities, necessary to ensure that the externally provided processes, products and services meet requirements. 必要时，为了确保外部提供过程、产品和服务满足要求，确定验证或其他活动。8.4.2.1Externalprovidedproducts,processorserviceapprovalofrelease外部提供产品、过程和服务放行的批准ApprovalofreleasefornewormodifiedEPPPSshallinclude:新的或修改的EPPPS放行的批准应包括

380、：a)determinationofapprovalmethods;批准方法的确定b)planningofverification,validationandapprovalactivities;验证、确认和批准活动的策划c)conductingFAIatexternalproviderpremises(see8.9),orappropriateincoming/outgoinginspection;在外部供方现场进行FAI，或进货或出货检验d)validationofexternallyprovidedproductsortechnologies(e.g.newdesignsoftware)

381、beforefirstuseinacustomercontractunlessotherwiseagreedwiththecustomer;除非得到顾客同意，在客户合同中首次使用前外部提供的产品或技术（例如：新设计的软件）得到确认e)approvalofrelease(e.g.tostartserialproduction);放行的批准（例如：开始批量生产）f)definitionorupdateofbaselineconsideringchangemanagement(see8.1.5).考虑变更管理的基线定义和更新Theorganizationshallretainrelateddocum

382、entedinformation.组织应保持相关文件化信息。ApprovalofreleasefornewormodifiedEPPPSshouldconsider:新的或修改的EPPPS放行的批准应该考虑：a)pre-manufacturingreviews;生产前评审NOTEPre-manufacturingreviewscanprovideevidenceofcontrolledconditionsandreadinessforstartoffirstarticleproduction.注： 生产前批准可能提供受控状态和首件生产开始准备就绪的证据。b)firstsystemintegra

383、tion.生产系统集成Theorganizationshouldreportprogressinachievingdesignanddevelopmentobjectivesandstatusofqualityassuranceactivitiestoitsexternalprovidersandviceversaoncriticalitems.在关键产品上，组织应该向外部供方报告在达成设计开发目标和质量保证活动状态的进展，反之亦然。8.4.2.2Externalprovidedproducts,processorserviceverificationafterrelease放行后外部提供产品

384、、过程和服务的验证TheEPPPSshallnotbeusedorprocesseduntilithasbeenverifiedasconformingtospecifiedrequirementsorunlessitisreleasedunderauthorizedconcession(see8.7.3).验证符合特定要求前或除非其在让步授权下的放行，EPPPS不应被使用或加工。ActivitiesforEPPSverificationafterreleaseshallinclude:放行后，EPPPS验证的活动应包括：a)planningofactivities(e.g.inaninspe

385、ctionandtestplan,includingthedeterminationoftheextent,frequency,samplesizeandmethodsofcontrolsee6.1.3);活动的策划（例如：在检验和试验计划中包含控制的类型、频次、样本大小和方法-见6.1.3）b)provisionofinstructions,checklistsortemplatesforverificationactivities;提供验证活动的作业指导书、检查表或模板c)obtainingevidencethattheEPPPSisconformtorequirements(e.g.by

386、checkofaccompanyingdocumentationsuchascertificateofconformity,testreports,statisticalrecords,processcontrolsheets);获得EPPPS符合要求的证据（例如：检查随附文件，如符合性证书、试验报告、统计记录、过程控制表）d)releaseoftheEPPPS;EPPPS的放行e)documentationofverificationactivities;验证活动的文件化f)managementofnon-conformingEPPPS.不合格EPPPS的管理Theorganizations

387、hallretainrelateddocumentedinformation.组织应保持相关的文件化信息。WheretheorganizationutilizestestreportstoverifyEPPPS,thedatainthosereportsshallbecomparablewithacceptancecriteriastatedonthereport,thatarederivedfrompurchasinginformation,e.g.specifications,standards,etc.当组织使用试验报告来验证EPPPS时，这些报告中的数据应与报告中接收准则可以比较，其来

388、源于采购信息，例如规范、标准等。Theorganizationshallestablish,implementandmaintainaplanforperiodicalverificationsofrawmaterialbasedonrisksassessment.组织应建立、执行和维护基于风险分析的原材料阶段性验证计划。Incaseofdelegationofverificationactivitiestotheexternalprovider,theorganizationshalldefinetherequirementsfordelegationandshalldefinecontro

389、ls,e.g.regularauditsatexternalproviderpremises.如果将验证活动委托外部供方，组织应确定委托要求并应确定控制，例如在外部供方现场定期审核。Wheretheorganizationdelegatesverificationactivitiestotheexternalprovider,thereshallbeevidencethattheexternalproviderhasacceptedsuchagreement.当组织将验证活动委托外部供方时，可以看到外部供方接受的证据，例如协议。Aregisterofexternalproviderdelega

390、tionsshallbeestablishedandmaintained.应建立并维护外部供方委托登记册。Anydelegationshouldbereviewedaftersubsequentchanges.在后续变更时，委托应该得到评审。NOTEEPPPSverificationafterreleasecanbetheincominggoodinspectionorpartofaqualitygateatexternalproviderpremises.注：放行后，EPPPS验证可能是进货检验或在外部供方现场质量门的一部分。Inspectionandtestingrequirementsa

391、sdefinedin8.6shallapplyforEPPPSverification.8.6中规定的检验和实验要求适用于EPPPS验证。8.4.2.3Monitoringofexternalproviderperformance,re-evaluationandranking外部供方绩效的监视、再评价和分级Monitoringperformance,re-evaluationandrankingofkeyexternalprovidersshallconsider:关键外部供方的绩效监视、再评估和分级应考虑：a)periodicalreviewsofexternalproviderperfo

392、rmance(see9.1.1.1forrelatedKPIs);外部供方绩效的定期评审（见9.1.1.1与KPIs相关）b)definitionofcriteriatoauditexternalproviders;确定审核外部供方的准则c)resultsofthesereviewsasabasisforestablishingthelevelofcontrolstobeimplemented;这些评审的结果作为建立要执行的控制水平的基础d)actionsplannedtobetakenwhenexternalproviderdoesnotmeettechnicaland(or)perform

393、ancetargets;当外部供方没有满足技术和（或）绩效目标时，计划采取的措施e)feedbacktobegiventotheexternalprovideroftheirperformance;绩效反馈给对应的外部供方f)regularjointperformancereviews.定期联合绩效评审Inaddition,theorganizationshall:另外，组织应a)identifyexternalproviderstobedeveloped;识别要开发的外部供方b)implementactionplansbasedonagreedobjectivestoimprovetheir

394、capabilities.基于为改进其能力达成共识的目标，执行措施计划Theorganizationshallretainrelateddocumentedinformation.组织应保持相关文件化信息。8.4.3 Information for external providers外部供方信息The organization shall ensure the adequacy of requirements prior to their communication to the external provider. 在与外部供方联络前，组织应确保规定要求的充分性。The organizat

395、ion shall communicate to external providers its requirements for: 组织应传达给外部供方以下组织的要求： a) the processes, products and services to be provided; 将提供的过程、产品和服务； b) the approval of: 以下的批准； 1) products and services; 产品和服务； 2) methods, processes and equipment; 方法、过程和设备； 3) the release of products and service

396、s; 产品和服务的放行； c) competence, including any required qualification of persons; 人员能力，包括人员所需任何资格； d) the external providers interactions with the organization; 外部供方同组织的联系；e) control and monitoring of the external providers performance to be applied by the organization; 组织对外部供方的绩效实施控制和监视；f) verification

397、or validation activities that the organization, or its customer, intends to perform at the external providers premises. 组织或其顾客拟在外部供方现场实施的验证或确认活动8.4.3.1InformationforexternalprovidersSupplemental外部供方信息-补充Regardinginformationforexternalproviders,theprocessrequiredin8.4.1.1shallconsider:关于外部供方信息，在8.4.1

398、.1中要求的过程应考虑：a)thatcustomerrequirementsarecascadeddownthroughthesupplychain;顾客要求展开至整个供应链b)incaseofchanges,thetraceabilityofrequirements(see8.2);如果变更，要求的可追溯性（见8.2）c)approvalofspecialprocessesbytheorganizationoritscustomer,whererequired.要求时，组织或其顾客的特殊过程批准。Inadditiontotherequirementsin8.4.3,theorganizati

399、onshallcommunicatetoexternalprovidersitsrequirementsfor：在8.3的要求外，组织应向外部供方交流其以下方面要求a)identificationandapplicablerevisionsofspecifications,drawings,processrequirementsincludingforspecialprocesses,inspectioninstructions,appropriatedetailsfromtheorganizationsqualityplanandotherrelevanttechnicaldata;规范、图

400、纸、过程要求（包括特殊过程）、检验指导书、来自于组织质量计划和其他相关技术数据的识别和适用版本b)deliverablesassociatedtotheEPPPS(e.g.EPPPSdocumentation)andtherelatedschedule;与EPPPS相关的可交付性（例如：EPPPS文件）和相关的排程c)managementofchangesandnonconformingoutputs;变更和不合格输出的管理d)deliveryscheduleofEPPPS;EPPPS的交付排程e)informationabouttheproductcriticality(e.g.safety

401、critical);产品关键特性信息（例如关键安全性）f)rightofaccessbytheorganization,theircustomerorotherrelevantparties(e.g.regulatoryauthorities)tofacilitiesinvolvedintheorderandtoapplicabledocumentedinformation.组织、其客户或其他相关方对于订单相关现场和适用的文件化信息的访问权限。NOTEFurtherrequirementscommunicatedtoexternalproviderscanberelatedto:注： 向外部供

402、方交流的进一步要求可能有关于：-designreviews;设计评审-testsamples(e.g.productionmethod,number,storageconditions)forinvestigationordesignapproval;用于调研和设计批准的试验样本（例如：生产方法、数量、存储状态）-production:routinetesting,inspectionandacceptance,includingrelatedinstructions;生产：例行试验、检验和接收、包括相关指导书-obsolescence;老化-auditing;审核-supplychainlo

403、gisticsincludingpackagingandlabelling;供应链物流包括包装和标识-cascadingrequirementstoitsexternalproviders.向其外部供方展开要求8.4.4Supplychainmanagement供应链管理Theorganizationshall组织应a)requestacknowledgementofitspurchaseorderstotheexternalprovideruntilreceipt,andretaindocumentedinformationofthisacknowledgement;要求外部供方对采购订单进

404、行承认直到接受，并且保持接受的文件化信息b)documentrequestsofchangessenttotheexternalproviders(see8.4.3.1).文件化发给外部供方的变更需求。Theorganizationshallcommunicateupdateddeliveryschedulesandforecaststoitsexternalproviderinordertogiveinputsfortheirresourcesplanning.Thisshallincludedelaystothedeliveriesofcomponentsfromtheorganizati

405、ontotheexternalprovider.组织应向外部供方沟通交付排程的更新和预测，以便为外部供方资源策划提供输入。这应包括由组织交付给外部供方的部件的交期延误。Theorganizationshouldagreeanearlywarningpolicywithitsexternalprovidersregardingtheirdelayedprovisionsforeseen,otherwisetheorganizationshouldregularlycheckthedeliveryschedule.Thisearlywarningpolicyshouldalsoincludeobs

406、olescenceissues.组织应该与外部供方达成关于他们预见的延期交付的早期报警策略，否则组织应该定期检查交付排程。这个早期报警策略应该也包括老化问题。Supplychaininformation(e.g.deliverydates,quantities),exchangedwithcustomers,externalprovidersandinternalfunctions(e.g.design,production),shallbemanagedandbemaintainedupto-datewithanapplicationsoftware(e.g.EnterpriseResour

407、cePlanning).与客户、外部供方和内部职能（例如设计、生产）交流供应链信息（如：交付日期、数量），应该通过应用软件（如：公司资源策划）来实时进行管理和维护。8.5Productionandserviceprovision生产和服务提供8.5.1 Control of production and service provision生产和服务提供的控制The organization shall implement production and service provision under controlled conditions. 组织应在受控条件下进行生产和服务提供。 Contr

408、olled conditions shall include, as applicable: 适用时，受控条件应包括：a) the availability of documented information that defines: 获得以下界定的文件化信息：1) the characteristics of the products to be produced, the services to be provided, or the activities to be performed; 生产的产品、提供的服务或实施的活动的特性； 2) the results to be achiev

409、ed; 达成的结果；b) the availability and use of suitable monitoring and measuring resources; 获得和使用适宜的监视和测量资源；c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, h

410、ave been met; 在适当阶段实施监视和测量活动以验证过程控制或输出控制的准则，以及产品和服务的接收准则已得到满足；d) the use of suitable infrastructure and environment for the operation of processes; 使用适当的基础设施和过程运行的环境；e) the appointment of competent persons, including any required qualification; 胜任人员的任命，包括人员资格的要求；f) the validation, and periodic reval

411、idation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement; 当输出结果不能被后续的监视和测量所验证，达到生产和服务提供过程策划结果的能力的确认及定期再确认； g) the implementation of actions to prevent human error; 防

412、止人为错误的措施的实施； h) the implementation of release, delivery and post-delivery activities. 放行、交付和交付后活动的实施。Note：Suitable infrastructure includes appropriate manufacturing equipment required to ensure product compliance. Monitoring and measuring resources include appropriate monitoring and measuring equipm

413、ent required to ensure effective control of manufacturing processes. 注：适当的基础设施包括保证产品符合性所需的适当制造设备。监视和测量资源包括确保制造过程有效控制所需的适当监视和测量设备。8.5.1.1ControlofproductionandserviceprovisionSupplemental生产和服务控制-保持NOTEProductioninthespiritofthisclausecanalsoapplyatcustomerpremises(e.g.duringcommissioningorinstallatio

414、nuntilhandover).注：在本条款关于生产的精神也适用于在客户现场（例如：调试期间或交付前安装）。Theorganizationshallestablish,implementandmaintainadocumentedprocessforproductionandserviceprovision.Thisprocessshall:组织应建立、执行和维护一个文件化过程用于生产和服务的提供。a)includerequirementsfor:包括以下要求1)productionscheduling(see8.5.7);生产计划（见8.5.7）2)activitiestoensurecon

415、trolledconditions(see8.5.1.1.1);确保受控状态的活动（见8.5.1.1.1）3)verificationoftheprocessforproductionandserviceprovision(see8.5.1.1.2);生产和服务提供过程的验证（见8.5.1.1.2）4)validationoftheprocessforproductionandserviceprovision(see8.5.1.1.3);生产和服务提供过程的确认（见8.5.1.1.3）5)activitiestocontrolproductionequipment(see8.5.1.3);控制

416、生产设备的活动（见8.5.1.3）6)activitiestoensureidentificationandtraceability(see8.5.2);确保标识和可追溯性的活动（见8.5.2）7)managementofpropertybelongingtocustomersorexternalproviders(see8.5.3);属于顾客或外部供方的财产的管理（见8.5.3）8)preservation(see8.5.4);防护（见8.5.4）b)referto:引用：1)firstarticleinspections(see8.9);首件检验（见8.9）2)configurationm

417、anagement(see8.1.4);配置管理（见8.1.4）3)changemanagement(see8.1.5);变更管理（见8.1.5）4)releaseofproductsandservices(see8.6);产品和服务的放行（见8.6）5)controlofnon-conformingoutputs(see8.7);不合格输出的控制（见8.7）6)specialprocesses(see8.5.1.2).特殊过程（见8.1.5.2）8.5.1.1.1Controlledconditions受控状态Controlledconditionsshallinclude:受控状态应包括：

418、a)approveddataforproductionandserviceprovisionactivities.Thesedatashallcontain:生产和服务提供活动的批准数据。这些数据应包括：1)drawings,billofmaterial,productionprocessflowcharts,inspectionandtestplanning,productiondocuments(e.g.:workinstructions,productionschedules,traveller,workorder,processcards);图纸、材料清单、生产过程流程图、检验和试验计

419、划、生产过程文件（例如：作业指导书、生产计划、跟踪卡、工作指令、流程卡）2)alistoftoolsandnumericalcontrolmachineprogramsrequiredandanyspecificinstructionsassociatedwiththeiruse;所需工具和数控程序清单，以及与其使用相关的特定指导书b)monitoringofproductionandserviceprovisioninallshifts(e.g.partsquantities,splitorders,nonconformingoutputs);在所有班次生产和服务提供的监视（例如：零件数量、

420、分解订单、不合格输出）c)evidencethatallproductionandserviceprovision,includinginspections,havebeenauthorizedandcompletedasplanned;所有生产和服务提供的证据，包括检验，按照策划得到授权和完成d)actionstopreventrecurrenceofpastproblems;过去问题预防再发生的措施e)assessmentofriskimpactofdeferredworktoensurecontrolofworktobecarriedoutwithoutaffectingqualitya

421、ndsafety.异常操作的风险影响分析，以确保在不影响质量和安全的情况下控制工作8.5.1.1.2Verificationoftheprocessforproductionandserviceprovision生产和服务提供过程的验证Verificationoftheprocessforproductionandserviceprovisionshallinclude:生产和服务提供过程的验证应包括：a)verificationofproductionprocessinputsagainstdesignanddevelopmentoutputsregardingcompleteness;生产

422、过程输入对应已完成的设计开发输出的验证b)verificationofproductionequipmentabilitytocomplywithdesignanddevelopmentrequirements(e.g.regardingproductionequipmenttolerancesorprecisionclasses);生产设备能力能满足设计开发要求的验证（例如：关于生产设备的变差或精度等级）c)risksevaluationatanearlystageoftheprocesswithapplicablemethods(e.g.productionprocessFMEA).使用适

423、宜的方法在过程早期阶段进行分析评估（例如生产过程FMEA）8.5.1.1.3Validationoftheprocessforproductionandserviceprovision生产和服务提供过程的确认Validationoftheprocessforproductionandserviceprovisionshallensurethat:生产和服务过程的确认应确保：a)designanddevelopmentrequirementsarefulfilled;满足设计开发要求b)controlledconditionsareachieved;达成受控状态c)firstarticleins

424、pectioniscompleted;完成首件检验d)validationiscompletedpriortohandover;交付前完成确认e)re-validationiscompletedaspartofchangesimplementation.作为变更执行的一部分，完成再确认。Validationoftheprocessforproductionandserviceprovisionshouldincluderegularfeedbacktodesignanddevelopmentinordertosupportcontinualimprovementofproductiondocu

425、mentation.生产和服务提供过程的确认应该包括向设计开发的定期反馈以支持生产文件的持续改进。8.5.1.2Specialprocesses特殊过程Theorganizationshallestablish,implementandmaintainadocumentedprocessforthemanagementofspecialprocesses,including:组织应建立、执行和维护用于特殊过程管理的文件化过程，包括：a)theidentificationofspecialprocessesthattheorganizationisplanningtouse;组织计划使用的特殊过

426、程的识别b)foreachspecialprocess,thedefinitionof:对于每个特殊过程，定义以下内容：1)responsibilitiesandauthorities;责任和授权2)applicablestandards;适用的标准3)riskassessmentwiththeapplicablemethod(s)(e.g.process-FMEA);使用适当方法的分析评估（例如过程FMEA）4)workinstructions,asaminimumwhenthereisnoapplicablestandard,including:作业指导书，当没有适用标准时，最低包括-ma

427、nagement;管理-manpower;人力-machine;机器-methods;方法-material;材料-mothernature(environmentalconditions);自然条件（环境条件）5)personnelcompetencesandqualification;人员能力和资格6)controlmethodsandrelateddocumentedinformation;控制方法和相关的文件化信息7)qualificationofthespecialprocess;特殊过程的资格确认8)validationforeachspecificapplication,and对

428、于每个特定应用的确认9)re-validationafterchanges.变更后的再确认c)retentionofdocumentedinformationaccordingtothepreviousrequirements.根据先前要求保持文件化信息NOTESpecialprocessescanbee.g.bondingandsealing,casting,crimping,heattreatment,riveting,surfacetreatment,includingpaintingandcoating,torquetightening,welding。注：特殊过程可能是，例如粘接和涂

429、胶、铸造、弯曲、热处理、铆接、表面处理，包括喷涂和涂覆、扭矩拧紧、焊接。8.5.1.3Productionequipment生产设备Regardingproductionequipment,theorganizationshall:关于生产设备，组织应a)planandimplementpreventivemaintenanceactivitiestoensurethatproductionequipmentis:策划和执行预防性维护活动以确保生产设备1)verifiedaccordingtodefinedmethodsandacceptancecriteria;根据给定的方法和接收准则进行验

430、证2)approvedpriortofirstuse;在首次使用前得到批准3)registeredwithindividualnumbers;使用独立的识别号注册4)protectedagainstdeterioration,includingstorageandpreservationasappropriate,whentheequipmentisnotinuse;防止退化的防护，适当时包括当设备不在使用状态的存储和防护5)inspectedfortheirconditionatplannedintervals(e.g.regardingdegradation,byvisualinspect

431、ion);在策划的间隔检查其状态6)re-verifiedatplannedintervals,dependingonriskandfailurerate;依据风险和失效率，在策划的间隔再验证b)adjusttheplannedintervalsandactivitiesaccordingtooccurrenceoffailures;根据失效的发生情况调整策划的间隔和活动c)periodicallyreviewtheproductionequipmentwiththefutureinmind(inputsfor7.1.1);考虑将来状况，阶段性评审生产设备（7.1.1的输入）d)ensuret

432、heavailabilityofsparepartsandconsumableswithlongleadtime;确保长前置期的备件和易损件的可获得性e)retaindocumentedinformationonthemaintenanceactivities.保持维护性活动的文件化信息。NOTEPreventivemaintenanceactivitiescanalsobepredictive.注：预防性维护活动可能是预见性。Theorganizationshould:组织应该a)applythedesignanddevelopmentprocess(see8.3)forproduction

433、equipmentasappropriate;适当时将设计开发过程（见8.3）应用于生产设备b)usemethodswhichpreventerrorsinproduction(e.g.PokaYoke).在生产中使用防错的方法（例如防误防错）NOTETheverificationoftheproductionequipmentcanbepartofthefirstarticleinspection(see8.9).注：生产设备的验证可以是首件检验的一部分（见8.9）。8.5.2 Identification and traceability标识和可追溯性The organization sh

434、all use suitable means to identify outputs when it is necessary to ensure the conformity of products and services. 必要时，为确保产品和服务的符合性，组织应使用适宜的方法识别输出。The organization shall identify the status of outputs with respect to monitoring and measurement requirements throughout production and service provision

435、. 组织应在产品和服务提供的全过程中，针对监视和测量要求识别输出的状态。 The organization shall control the unique identification of the outputs when traceability is a requirement, and shall retain the documented information necessary to enable traceability. 当有可追溯性要求时，组织应控制输出的唯一性标识，且保留必要的文件化信息以保证可追溯性。8.5.2.1Identificationandtraceabili

436、tySupplemental标识和可追溯性-补充Itemsshallbetraceablefromtheiroriginuptoatleasttheendofwarrantywheretraceabilityisrequiredbycontract,regulatoryorstatutorynorms,orconfigurationmanagement(see8.1.4).当合同、法律或法规、或配置管理（见8.1.4）要求可追溯性时，货品应该具有可追溯性，从其诞生至少直到保修期结束。Theorganizationshalldefinethemethodtoidentifyitems(e.g.b

437、ymachinereadablecodes,stamping,labelling).组织应确定标识货品的方法（例如：机器可读码、打字、贴标签）NOTEThemethodtoidentifyitemscanbeagreedwiththecustomer.注：标识货品的方法可能经过顾客同意。Theorganizationshouldusemachinereadableidentification.组织应该使用机器可读码。8.5.3 Property belonging to customers or external providers顾客或外部供方的财产The organization shal

438、l exercise care with property belonging to customers or external providers while it is under the organizations control or being used by the organization. 组织应爱护在组织控制下或组织使用的顾客或外部供方的财产。 The organization shall identify, verify, protect and safeguard customers or external providers property provided for

439、use or incorporation into the products and services. 组织应识别、验证、保护和维护供其使用或构成产品和服务一部分的顾客或外部供方的财产。 When the property of a customer or external provider is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer or external provider and retain documen

440、ted information on what has occurred. 当顾客或外部供方财产发生丢失、损坏或发现不适用的情况，组织应向顾客或外部供方报告，并保留其使用过程发生事情的文件化信息。 NOTE A customers or external providers property can include materials, components, tools and equipment, premises, intellectual property and personal data. 注：顾客或外部供方的财产可以包括原料、零件、工具和设备、经营场所、知识产权和个人资料。8.5

441、.3.1PropertybelongingtocustomersorexternalprovidersSupplemental顾客或外部供方财产-补充Theorganizationshoulddocumenttraceabilityofpropertybelongingtocustomerorexternalprovidersuptodeliveryorreturn.组织应该文件化顾客或外部供方财产的可追溯性直到交付或返还。Intheeventthatpropertyislost,damagedorotherwisefoundtobeunsuitableforuse,theorganizati

442、onshouldperformcauseanalysisandtakerequiredactions.如果财产丢失、损坏或发现不再适合使用，组织应该执行原因分析并采取所需措施。8.5.4 Preservation防护The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. 在生产和服务提供期间，组织应对输出进行必要程度的防护，以确保符合要求。 NOTE Pres

443、ervation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection. 注：防护可以包括标识、处理、污染控制、包装、储存、传递或运输、以及保护。8.5.4.1PreservationSupplemental防护-补充Theorganizationshallhavedocumentedspecificationsforpreservationinaccordancewithproductspec

444、ificationsandapplicableregulations,addressingthefollowingtillhandover:组织应有文件化的规范用于符合产品规范或适用法规的防护，明确以下要求直至交付：a)markingandlabellingregardingidentification;根据标识要求打号或贴标签b)specialhandlingforsensitiveproducts;敏感产品的同时处置c)cleaningregardingcontaminationcontrolandstorage;对应污染物控制的清洗和存储d)shelflifecontrolandstoc

445、krotation(e.g.firstin,firstout);保存期限控制和库存周转（例如先进先出）e)environmentalcondition(e.g.temperature,humidity).环境条件（例如温度、湿度）Conditionsregardingpreservationhavingimpactonproductconformityshallbeidentified,analysedandtakenintoaccountasinputsforthesedocumentedspecifications.对于产品符合性有影响的防护状态应进行识别、分析并考虑作为这些文件化规范的输

446、入。Thesedocumentedspecificationsshallbeappliedtophysicalitemsmanagedintheorganizationspremises(e.g.materialreceivedfromexternalprovider,propertybelongingtocustomer,workinprogressandproductsmanufacturedbytheorganization).这些文件化规范应应用于在组织现场物理货品的管理（例如：从外部供方接收材料、顾客财产、组织进行中的作业和制造的产品）。NOTEThesedocumentedspec

447、ificationscanapplytowarehouse,internalprocessing,deliveryprocessestothefinaldestination.注：这些文件化的规范可以适用于仓库、内部过程、交付过程直到目的地。8.5.5 Post-delivery activities交付后活动The organization shall meet requirements for post-delivery activities associated with the products and services. 组织应满足有关产品和服务交付后活动的要求。In determi

448、ning the extent of post-delivery activities that are required, the organization shall consider: 确定所需交付后活动的程度，组织应考虑： a) statutory and regulatory requirements; 法律法规要求； b) the potential undesired consequences associated with its products and services; 有关产品和服务潜在的非期望的影响； c) the nature, use and intended l

449、ifetime of its products and services; 产品和服务的特性、使用和预期的寿命；d) customer requirements; 顾客要求； e) customer feedback. 顾客反馈。 NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final

450、 disposal. 注：交付后活动可包括担保条件下的措施、合同义务如维护服务以及附加服务如回收或最终处置。8.5.5.1Post-deliveryactivitiesSupplemental交付后活动-补充NOTEPost-deliveryactivitiesareafterhandovertothecustomer,untilcontractobligationsend.注：交付后活动是交给顾客后，直至合同义务终止。Theorganizationshallestablish,implementandmaintainadocumentedprocessforpost-deliveryacti

451、vities.Thisprocessshallinclude:组织应建立、执行和维护用于交付后活动的。这个过程应包括：a)requirementsdefinedin8.5.5;在8.5.5中定义的要求b)thecontrolandupdatingoftechnicaldocumentation(e.g.operationalinstructions,maintenancemanual,sparepartslist);技术文件的更新和控制（例如：操作指导书、维护手册、备件清单）c)failureanalysisandcorrectiveactionsmethods(e.g.FRACAS)(see

452、8.8);失效分析和纠正措施方法（例如：FRACAS）d)theapproval,controlanduseofrepairinstructions;修理指导书的批准、控制和使用e)theprovisionofsparepartsandthemanagementofconsignmentstockwhereagreeduponbetweenthecustomerandtheorganization;当顾客和组织达成一致时，备件的提供和寄售库存的管理f)knowledgeofcustomercomplaintsasinputsfordesignanddevelopmentimprovement.

453、顾客投诉的知识作为设计开发改进的输入。8.5.6 Control of changes变更控制The organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements. 组织应必要时评审和控制生产或服务提供的变更，以确保持续符合要求。 The organization shall retain documented information descr

454、ibing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review. 组织应保留文件化信息描述变更评审结果、员工授权变更、以及由评审引起的任何必要的措施。8.5.7Productionscheduling生产计划Regardingproductionscheduling,theorganizationshall:对于生产计划，组织应：a)scheduleproduction(includingprod

455、uctionequipment)inshort-,mid-(MasterProductionSchedule)andlong-term(SalesandOperationPlan)inordertomeetthecustomerdeliveryrequirements;进行生产排程（包括生产设备）满足顾客交付要求，包括短期、中期（总体生产计划）和长期（销售和操作计划）b)besupportedbyaproductionschedulingapplicationsoftware(e.g.EnterpriseResourcePlanning)which:通过生产计划应用软件支持（例如ERP），其1

456、)coverstheproductionphases;覆盖生产阶段2)capturesupdatedproductionstatusinformation;获取实时的生产状态信息3)contentisupdatedoneachevent/changeofcustomercontract(variationorder);基于顾客合同的每个事件/变更，内容进行更新c)usecustomerandexternalproviderforecastsandorderstoplanandadjustregularlyitsresourcesaccordingtoitsworkload,takinginto

457、accountrisks(e.g.extraorderatthelastminute,externalproviderfailure);考虑风险（例如在最后期限的追加订单、外部供方失效），使用顾客和外部供方预测和订供给其工作量单来策划和调整资源d)identifybottlenecksinproduction.识别生产瓶颈Regardingproductionscheduling,theorganizationshould:根据生产计划，组织应该：a)consider:考虑1)resultsofriskanalysis;风险分析的结果2)pastexperience;以往经验3)efficie

458、ncymeasurements;效率测量b)establishimprovementactionplanaccordingly.建立对应的改进措施计划。8.6 Release of products and services产品和服务的放行The organization shall implement planned arrangements, at appropriate stages, to verify that the product and service requirements have been met. 组织应按策划的安排，在适当的阶段验证产品和服务是否满足要求。 The

459、release of products and services to the customer shall not proceed until the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority and, as applicable, by the customer. 除非得到有关授权人员的批准，适用时得到顾客的批准，否则在策划的安排己圆满完成之前，不应向顾客放行产品和交付服务。 The organization shall

460、 retain documented information on the release of products and services. The documented information shall include: 组织应保留产品和服务放行的文件化信息。文件化信息应包括： a) evidence of conformity with the acceptance criteria; 符合接收准则的证据； b) traceability to the person(s) authorizing the release. 授权放行人员的可追溯性。8.6.1Releaseofproduc

461、tsandservicesSupplemental产品和服务的放行-补充Theorganizationshalldefine:组织应确定：a)thesequenceofinspectionandtestingactivitiesalongtheproductionflowinaninspectionandtestplan,includingthedeterminationoftheextent,frequency,samplesizeandmethodsofcontrol(see6.1.3).Frequencyshallbeadoptedinaccordancewithrisklevelino

462、rdertopreventnonconformingoutputs;在检验和试验计划中伴随生产流的检验和试验活动顺序，包括确定控制的范围、频次、样本大小和方法（见6.1.3）。采用的频次与风险等级相适应以预防不合格输出b)requirementsforproductandserviceacceptanceininspectionandtestinstructions;在检验和试验指导书中产品和服务接收的要求c)authoritiesforrelease.放行的授权Theseinstructionsandplansshallbepartoftheproductioninputs(see8.5.1

463、).这些指导书和计划应是生产输入的一部分。Incaseplannedarrangementsarenotsatisfactorilycompleted,theorganizationshallrequestaconcessiontothecustomer(see8.7.3)priortothereleaseofproductsandservices.如果策划的安排没有完全满足，组织应在产品和服务放行前向顾客要求让步。Inspectionandtestinstructionsshallinclude:检验和试验指导书应包括：a)thecriteriaforacceptance;接收准则b)doc

464、umentedinformationforinspectionandtestresults;检验和试验结果的文件化信息。c)thetypeofmonitoringandmeasuringresourcesrequiredandanyspecificinstructionsassociatedwiththeiruse;所需监视和测量资源的类型和其使用相关的任何特定指导书。Inspectionandtestrecordsshallincludeactualresultsdatainaccordancewiththeinspectionandtestinstructions.检验和试验记录应包括依据

465、检验和试验指导书的实际结果数据。8.7 Control of nonconforming outputs不符合输出的控制8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery. 组织应确保不符合输出要求的输出得到识别和控制，以防止其非预期的使用或交付。 The organization shall take appropri

466、ate action based on the nature of the nonconformity and its effect on the conformity of products and services. This shall also apply to nonconforming products and services detected after delivery of products, during or after the provision of services. 组织应基于不符合的性质和其对产品和服务符合性的影响，采取适当的措施。这也可以应用于产品交付后、服

467、务提供期间或服务提供后发现的产品和服务的不符合。 The organization shall deal with nonconforming outputs in one or more of the following ways: 组织应处置不符合输出通过以下一种或几种方式： a) correction; 纠正；b) segregation, containment, return or suspension of provision of products and services; 产品和服务提供的隔离、围堵、返回、或暂停；c) informing the customer; 通知顾客

468、；d) obtaining authorization for acceptance under concession. 获得让步接收的授权。 Conformity to the requirements shall be verified when nonconforming outputs are corrected. 当不符合输出被纠正，应验证要求的符合性8.7.2 The organization shall retain documented information that: 组织应保留以下文件化信息：a) describes the nonconformity; 不符合的描述；b

469、) describes the actions taken; 采取的措施； c) describes any concessions obtained; 任何获得的让步； d) identifies the authority deciding the action in respect of the nonconformity. 识别关于不合格处置作出措施决定的授权人员8.7.3ControlofnonconformingoutputsSupplemental不合格输出的控制-补充Regardingcontrolofnonconformingoutputs,theorganizationsh

470、allestablish,implementandmaintainadocumentedprocessforthecontrolofnonconformingoutputs.对于不合格输出的控制，组织应建立、执行和维护一个用于不合格输出控制的文件化过程。Theprocessshallinclude:过程应包括：a)requirementsdefinedin8.7.1,8.7.2and10.2;在8.7.1、8.7.2和10.2中定义的要求b)identificationofcriteriaandauthoritiesfor:识别以下准则和授权1)rework,repairorscrap;返工、

471、返修或报废2)internalandcustomerconcessions;内部和顾客让步c)aregisterofnonconformingoutputs;不合格输出的登记册d)aregisterofconcessionsfromtheorganizationandexternalproviders,recordingexpirationdateandauthorizedquantities;来自于组织和外部供方的让步登记册，记录截至日期和授权数量f)regularmonitoringofthecorrectionofnonconformingoutputsandconcessions.不合

472、格输出和让步纠正的定期监视Regardingcontrolofnonconformingoutputs,theorganizationshallensure:对于不合格输出，组织应确保：a)whentheauthorizationoftheconcessionsexpires,thentheproductcannotbeusedanymore;当让步授权过期后，那么产品不能再使用b)incaseofconcessionsrequiringcustomerapproval:如果需要顾客批准让步：1)customerapprovalsshallbeobtainedpriortodelivery;交

473、付前应获得顾客批准2)concessionsfromexternalprovidersshallbeinternallyapprovedbeforesubmissiontothecustomer;在提交顾客前，来自外部供方的让步应得到内部批准3)identificationofproductunderconcessionisagreedwithcustomer;顾客同意让步状态下产品的标识4)recordingofconcessionsontheproductdeclarationofconformity.在产品符合性公告中记录让步NOTEThisprocesscanbepartofthepr

474、ocessnonconformityandcorrectiveactionsdefinedin10.2.3注：这个过程可能是过程不合格和10.2.3中定义的纠正措施的一部分。8.8RAMS/LCCTheorganizationshallestablish,implementandmaintaindocumentedprocessestomanageRAM/LCCactivities.组织应建立、执行和维护用来管理RAMS和LCC活动的文件化过程。Theseprocessesshallinclude:这些过程应该包括：a)calculationofRAM/LCCobjectivesduringt

475、enderordesignstages,tobeconsideredthroughtheentireproductlifecycle;在投标或设计阶段，RAM/LCC目标的计算，考虑整个产品生命周期b)implementationofRAM/LCCrequirementsintothedesignanddevelopmentalongthesupplychain;沿着供应链RAM/LCC要求进入设计开发执行c)datacollection(e.g.fielddataorrepairdata)duringpost-deliveryactivities,maintenance,replacemen

476、torrepaircontracts;在交付后活动、维护、更换和维修合同中进行数据收集（例如市场数据或维修数据）d)analysisandcomparisonwithfielddatafromprevioussimilarproducts(FRACAS);来自以往相似产品市场数据的分析和对比e)feedbackonRAM/LCCdatatorelevantoperationalteamstoimprovedesignconcepts,suchasdesignformaintenance;来自相关运行团队的RAM/LCC数据反馈用来改进概念设计，例如维护性设计f)sharingtheresult

477、sofRAM/LCCdataanalysiswithexternalprovidersregardingtheirsupplies;对于供应商，与外部供方分享RAM/LCC数据分析结果g)monitoringRAM/LCCobjectives.Incaseobjectivesarenotmettheorganizationshallprioritizefielddata,performcorrectiveactionsasrequiredin10.2.andfollowupfielddatauntilobjectivesaremet.监视RAM/LCC目标。如果目标没有满足，组织应设定市场数据

478、优先级，执行按照10.2要求的纠正措施，并且跟踪市场数据直到目标达成Causeanalysisshouldbeexecutedbasedonfailurecategoryandcomponentallocationandimpact(remedy&severity);原因分析应该基于失效类别和部件分配以及影响（补偿和严重性）Theorganizationshallretainrelateddocumentedinformation.组织应保持相关的文件化信息。Incasetheorganizationdoesnotexecutemaintenance,replacementorrepairco

479、ntractsitshouldrequestfielddatafromcustomersalsoafterwarranty.如果组织没有执行维护、更换或修理合同，应该也从顾客处索要保修期后市场数据。PersonsdealingwithRAM/LCCmattersshallhavecompetenciesinFRACAS.负责RAM/LCC事物的人员应有运用FRACAS的能力。TheorganizationshallidentifystandardssuchasIEC62278orequivalent,whichareapplicablefor:组织应识别像IEC62278类的标准或等同标准，其

480、适用于a)RAMSactivities;RAMS活动b)toolsdevelopedbytheorganizationforsafety-relatedproductsorservices(e.g.design,development,verificationortestingtools).组织为安全相关产品或服务开发的工具（例如：设计、开发、验证或试验工具）Incasetheorganizationdeliverssafety-relatedElectrical/Electronic/ProgrammableElectronicproductsorservices,itshallidenti

481、fy:如果组织组织交付安全相关电气/电子/可编程电子产品或服务，应识别a)safetyintegritylevelsinaccordancewithIECstandards(e.g.IEC61508andIEC62425)orequivalent;符合IEC标准（例如.IEC61508andIEC62425）或等同标准的安全集成水平b)applicablestandardssuchas:适用的标准，如：1)IEC62279orequivalentforsafety-relatedsoftwareprovidedbytheorganization;用于组织提供的安全相关软件的IEC62279或等

482、同标准2)IEC62425orequivalentforsafety-relatedelectronicsystemsprovidedbytheorganization.用于组织提供的安全相关电气系统的IEC62425或等同标准NOTESafety-relatedelectronicsystemscanalsobedoorsystems,brakingsystems,powersupplies.注：安全相关电气系统可能是门系统、制动系统、电力供应8.9Firstarticleinspection首件检验Theorganizationshallestablish,implementandmain

483、tainadocumentedprocessforfirstarticleinspection(FAI).组织应建立、执行和维护用于首件检验（FAI）的文件化过程。Thisprocessshallinclude:过程应包括：a)planningaccordingtodefinedcriteriainordertoidentifyproductssubjectedtotheFAI(see8.4.1.1);根据确定的准则进行策划以识别需要提交FAI的产品（见8.4.1.1）b)preparationofFAI;FAI准备c)inspectionandverificationactivities,i

484、ncludingreviewofproductionprocesseswithfocusoncriticalandspecialprocesses;检验和验证活动，包括关注于关键和特殊过程的生产过程评审d)criteria:为了以下方面的准则1)forreleaseoftheserialproduction;批量生产放行2)forconditionalrelease;有条件放行3)forrejection.拒绝e)follow-upofcorrectiveactions.纠正措施跟踪Theorganizationshallretainrelateddocumentedinformation.组

485、织应保持相关文件化信息。Inaddition,thisprocessshoulddefine:另外，这个过程应该确定：a)pre-conditionstobeevaluatedbeforeperformingtheFAI;执行FAI前，准备状况评估b)participantsoftheFAIdependingontheitem;根据项目确定FAI参与者c)criteriaandconditionstostartFAIactivities.启动FAI活动的准则和状况Firstarticleinspectionprocessshall:首件检验过程应：a)beappliedtointernalpr

486、oductsandEPPPS(see8.4)inordertoreleaseserialproductionandtovalidateproductionequipment(see8.5.1.3)andproductionprocesses(see8.5.1.1.3);适用于内部产品和EPPPS（见8.4），以放行批量生产和验证生产设备（见8.5.1.3）以及生产过程（见8.5.1.1.3）b)beconductedonarepresentativeitemfromthefirstseriesproductionrunofanewproductormajorupgradeofanexistin

487、gproduct,following:对来自于新产品首次批量生产运行或现有产品重要更新的代表性货品进行，下列情况1)theverificationoftheproductionprocessor生产过程的验证2)achangethatinvalidatesapreviousfirstarticleinspectionresult.以往首件检验结果不能验证的变更8.10Obsolescencemanagement老化管理Theorganizationshallestablish,implementandmaintainadocumentedprocesstoensure,theavailabil

488、ityofthesuppliedproductsandspareparts,ascontractuallyrequiredordefinedbytheorganization,asaminimumtillendofwarranty.组织应该建立、执行和维护一个文件化过程，以确保供应产品和备件按照合同要求或组织确定的要求的可获得性，最低要求直到保修期结束Thisprocessshallinclude:过程应包括a)definitionandregularreviewforupdateofaplancovering:包含以下内容的计划更新的定义和定期评审1)secondsourcestrategy

489、;第二资源策略2)storageapproach;存储方法3)form,fitandfunctioncompatibilityapproach,referringtothechangemanagementprocess(see8.1.5);外形、安装和功能兼容性方法，参考变更管理（见8.1.5）b)riskmanagementofobsoletepartsaccordingto6.1;依据6.1的老化零件的风险管理c)communicationwithcustomer.与顾客的沟通8.11Innovationmanagement创新管理Theorganizationshouldestablis

490、h,implement,maintainadocumentedprocesstomanageinnovationofnewproducts,servicesandtechnologies.组织应该建立、执行和维护一个文件化过程来管理新产品、服务和技术的创新。Thisprocessshouldinclude:这个过程应该包括：a)theidentificationofchangesintheorganizationsbusinessenvironment;组织经营环境变更的识别b)planningofinnovations;创新的策划c)prioritizationofinnovationsba

491、sedonthebalancebetweentheirurgency,theavailabilityofresources,andtheorganizationsstrategy;基于平衡紧迫性、资源可获得性和组织战略的创新优先级d)involvementofinterestedparties(e.g.externalproviders).相关方的参与（例如：外部供方）NOTEResearchanddevelopmentactivitiescanbeconsideredaspartofinnovationactivities.注：研究和开发活动可以作为创新活动的一部分。顾客滿意顾客滿意內部审核

492、內部审核过程过程产品产品测量、测量、分析和分析和和改进和改进是什么影响了顾客满意？ 投资 - 回報业绩业绩 业绩表现业绩表现Responsiveness減少文件化供应商过程的穩定性和一致性资源顾客滿意持续持续改进改进9.1 Monitoring, measurement, analysis and evaluation监视、测量、分析和评价9.1.1 General总则The organization shall determine: 组织应确定： a) what needs to be monitored and measured; 需要被监视和测量的对象；b) the methods fo

493、r monitoring, measurement, analysis and evaluation needed to ensure valid results; 需要监视、测量、分析和评价的方法，以确保有效的结果；c) when the monitoring and measuring shall be performed; 何时应实施监视和测量；d) when the results from monitoring and measurement shall be analyzed and evaluated. 何时应分析和评价监视和测量的结果。The organization shal

494、l evaluate the performance and the effectiveness of the quality management system. 组织应评价质量管理体系的绩效和有效性。The organization shall retain appropriate documented information as evidence of the results. 组织应保留适当的文件化信息作为结果的证据9.1.1.1GeneralSupplemental总则-补充Theorganizationshallidentify,establish,implementandmai

495、ntaindocumentedKPIstomonitorandimprovetheperformanceofitsprocesses,products,servicesandprojects.组织应识别、建立、执行和维护文件化的KPI以监视和改进其过程、产品、服务和项目绩效。Theorganizationshallcollectdatarelatingtoreportsofinternalandexternaltechnicalfailures,accordingtodefinedcriteria.根据确定的准则，组织应收集内外部技术失效报告有关的数据。ThedefinitionofeachK

496、PIshallspecify:每个KPI的定义应详细描述a)therelatedprocessitbelongsto;所属的相关过程b)howtheKPIiscalculated(e.g.formula);如何计算KPI（例如公式）c)therelatedtargetachievableinadefinedperiod;在确定的阶段，目标的可达成性d)whoprovidestheKPImeasures;谁提供KPI的测量e)whentheKPIisreportedandtowhom;KPI什么时候上报以及上报给谁f)whoisinchargeofdefiningrelatedactions.谁

497、负责制定相关措施KPIsshallmeasure:KPI应测量a)customersatisfaction(see9.1.2);顾客满意（见9.1.2）b)customerontimedelivery;顾客按时交付c)nonconformitiesraisedbythecustomer(see8.7);顾客提出的不符合（见8.7）d)internalnonconformities(see8.7);内部不符合（见8.7）e)externalprovidersnonconformities(see8.7);外部供方不符合（见8.7）f)externalprovidersontimedelivery

498、;外部供方的按时交付g)qualitydeficiencycosts;质量失效成本h)projectcosts(see8.1.3.8);项目成本（见8.1.3.8）i)requirementsmanagementprocess(see8.2.5);要求管理过程（见8.2.5）j)designanddevelopmentprocess(see8.3).设计开发过程（见8.3）KPIsshouldmeasure:KPI应该测量：a)responsetimeonnon-conformitiesandcomplaintsraisedbycustomer;顾客提出的不符合以及投诉的反应时间b)produ

499、ctioncapacityincludingforecast(includingformanufacturingandinfrastructureinstallation);生产能力包括预测（包括制造和设施安装）c)resolutiontimeofproblems,e.g.suchasopenissues;问题的解决时间，例如：开口项d)firstarticleinspections(see8.9);首件检验 （见8.9）e)downtimeofproductionequipment;生产设备停机时间f)internalauditprocess(see9.2);内审过程（见9.2）g)tend

500、ermanagementprocess(see8.1.2).投标过程（见8.1.2）9.1.2 Customer satisfaction顾客满意The organization shall monitor customers perceptions of the degree to which their needs and expectations have been fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this information

501、. 组织应监视顾客对其需求和期望已满足程度的感知。组织应确定获取、监视和评审这些信息的方法。 NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedback on delivered products and services, meetings with customers, market-share analysis, compliments, warranty claims and dealer reports. 注：监视顾客感知的例子可包括顾客调查、关于交付

502、产品和服务的顾客反馈、同顾客面谈、市场份额分析、顾客赞扬、索赔和经销商报告。9.1.2.1CustomersatisfactionSupplemental顾客满意Theorganizationshallmanagecustomercomplaintsby:组织应通过以下方面管理顾客投诉a)recordingthemandtheirresponsesinacentralizedapplicationsoftware;使用中央管理应用软件记录投诉及其反应b)communicationwiththecustomerintermsofacknowledgmentandrelatedcorrective

503、actionsaccordingto10.2.根据10.2的要求，与顾客沟通承诺及相关措施9.1.3 Analysis and evaluation分析和评价The organization shall analyze and evaluate appropriate data and information arising from monitoring and measurement. 组织应分析和评价来自监视和测量的适当的数据和信息。 The results of analysis shall be used to evaluate: 分析的结果应用于评价： a) conformity

504、of products and services; 产品和服务的符合性；b) the degree of customer satisfaction; 顾客满意的程度；c) the performance and effectiveness of the quality management system; 质量管理体系的绩效和有效性；d) if planning has been implemented effectively; 策划是否已有效实施；e) the effectiveness of actions taken to address risks and opportunities

505、; 应对风险和机遇所采取措施的有效性；f) the performance of external providers; 外部供方的业绩；g) the need for improvements to the quality management system. 质量管理体系改进的需求。 NOTE Methods to analyze data can include statistical techniques. 注：数据分析的方法可包括统计技术。 9.1.3.1AnalysisandevaluationSupplemental分析和评价-补充WhenKPItargetsarenotachi

506、eved,correctiveactionsshallbemanagedaccordingto10.2.当KPI目标没有达成时，纠正措施应依据10.2进行管理。Theorganizationshallanalyzeandevaluatedatacollectedinrelationtoreportsofinternalandexternaltechnicalfailures(see9.1.1.1).组织应分析和评价收集的与内外部技术失效报告相关的数据。Resultsofanalysisofdatashouldbesharedwithdefinedinterestedparties,suchas

507、internal,customers,externalproviders.数据分析的结果应该与确定的相关方分享，例如内部、顾客、外部供方。9.2 Internal audit内部审核9.2.1 The organization shall conduct internal audits at planned intervals to provide information on whether the quality management system: 组织应按照策划的时间间隔实施内部审核以提供信息关于质量管理体系是否； a) conforms to: 符合：1) the organizat

508、ions own requirements for its quality management system; 组织的质量管理体系自身的要求；2) the requirements of this International Standard本标准的要求；;b) is effectively implemented and maintained. 被有效地实施和保持9.2.2 The organization shall: 组织应： a) plan, establish, implement and maintain an audit programme(s) including the f

509、requency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organization, and the results of previous audits; 策划、建立、实施和保持一个或多个审核方案，包含频次、方法、职责、计划的要求和报告，有关过程的重要性、影响组织的变更以及以往内审的结果应加以考虑；b)

510、define the audit criteria and scope for each audit; 对每次审核确定审核准则和范围；c) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; 选择审核员并实施审核以确保审核过程的客观性和公正性；d) ensure that the results of the audits are reported to relevant management; 确保审核的结果报告给相关的管理人员；e) take

511、appropriate correction and corrective actions without undue delay; 无不当延误，采取适当的纠正和纠正措施；f) retain documented information as evidence of the implementation of the audit programme and the audit results. 保留文件化信息作为实施审核程序和审核结果的证据。 NOTE See ISO 19011 for guidance. 注：作为指南，参看ISO 19011标准。9.2.3InternalauditSupp

512、lemental内部审核-补充Theorganizationshallestablish,implementandmaintainadocumentedprocessforinternalauditstoverifycomplianceofprocesses,projects,productsandserviceswithinternalandexternalrequirements.组织应建立、执行和维护一个用于内部审核的文件化过程以验证过程、项目、产品和服务符合性。Thisprocessshallinclude:这个过程应包括a)requirementsdefinedin9.2.1and9

513、.2.2;9.2.1和9.2.2中定义的要求b)managementoftheauditprogramme(see9.2.3.1);审核方案的管理（见9.2.3.1）c)managementoftheinternalauditors(see9.2.3.2).内部审核员的管理（见9.2.3.2）Theorganizationshallretainrelateddocumentedinformation.组织应保持相关的文件化信息。Internalauditsshallprovideinputsforreturnofexperience(see7.1.6).内部审核应为经验反馈提供输入。9.2.3

514、.1Auditprogramme内部审核方案Inadditionto9.2.2,requirementsfortheauditprogrammeshallconsiderthefollowing:在9.2.2之外，审核方案的要求应考虑以下内容：a)processesidentifiedontheprocesshierarchicalstructureofthebusinessmanagementsystem(see4.4.3a);运营管理体系过程分层结构基础上识别的过程b)criticalprojects,productsandservices;关键项目、产品和服务c)thefrequency

515、ofauditstakesintoconsiderationthestatusandimportanceoftheauditscopebutshallbeasaminimumof3yearsforprocesses;依据审核范围的状态和重要性确定审核频次，但是至少每三年覆盖所有过程d)auditorsdonotaudittheirownwork;审核员不审核自己的工作e)theauditprogrammecoversallproductionshifts,ifapplicable.适用时，审核方案覆盖所有班次Requirementsfortheauditprogrammeshouldconsi

516、dermultidisciplinaryauditstoensurethatthenumberofinternalauditsisoptimizedandredundanciesareavoided.审核方案的要求应该考虑多方论证审核以确保内审的数量得到优化并且避免冗余。NOTE1Multidisciplinaryauditscanbeauditsinvolvingdifferentfunctions(e.g.procurement,projectmanagement,productionandfinance)oraprocessandaprojectatthesametime.多方论证审核可

517、以是在同时引入不同职能（例如：采购、项目管理、生产和财务）或过程或项目。NOTE2Organizationcanplancombinedaudits(e.g.qualityandenvironment)inordertoimproveefficiencyprovidedcoverageofthescopeisproperlybalancedbetweenthemanagementsystem.组织可以策划整合审核（例如质量和环境）以改进效率，在管理体系间平衡范围的正确覆盖9.2.3.2Auditorsmanagement审核管理Theorganizationshallensurethatthe

518、auditteamauditingtherequirementsofthisTechnicalSpecificationhave:组织应确保审核技术规范要求的审核团队有a)knowledgeandskillsabout:审核一个的知识和技能1)auditprinciples(e.g.personalbehaviour),processandmethods;审核原则（例如：个人举止）、过程和方法2)theauditscope(e.g.productorservice,organizationalfunction);审核范围（例如产品或服务、组织职能）3)relevantclausesofthis

519、TechnicalSpecificationaccordingtotheauditscope;依据审核范围，本技术规范的相关条款4)theauditcriteria(e.g.internalprocedures,thisTechnicalSpecification);审核准则（例如内部程序、本技术规范）b)auditexperience(e.g.auditwitness,regularconductofauditsorauditteamleading).审核经验（例如：审核见证、定期进行审核或审核组长）Regardingauditorsmanagement,theorganizationsho

520、uld:对于审核员的管理，应该a)appointauditorsfromrelevantfunctions(e.g.purchasing,engineering,projectmanagement);从相关职能指派审核员（例如：采购、工程、项目管理）b)maintainandimprovetheknowledge,skillsandexperienceasminimumthroughregularrefreshtrainingsandnumberofperformedaudits;至少通过定期更新的培训和执行审核的数量来维护和改进知识、技能和经验c)evaluatetheperformance

521、ofinternalauditorsbytheauditeesbasedoncriteriaandusedasinputsforthemanagementofauditorscompetencies;基于准则由被审核人员评价审核员绩效并且用作审核员能力管理的输入d)establishandmaintainalistofinternalauditorscontainingtheirqualificationandcompetenciesintermsofauditscope(e.g.functionalarea,products,standards).建立和维护一个审核员清单，包括他们的授权和对

522、应审核范围的能力（例如：职能领域、产品、标准）。9.3Managementreview管理评审9.3.1 General总则Top management shall review the organizations quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization. 最高管理者应按策划的时间间隔评审质

523、量管理体系，以确保其持续的适宜性、充分性和有效性，且同组织的战略方向保持一致。 9.3.1.1General-SupplementalTheorganizationshallensurethatplannedintervalsofmanagementreviewsdonotexceed12monthsandarealignedwiththebusinesscalendaroftheorganization.Theorganizationshallretaindocumentedinformationrelatedtomanagementreviews,includinginputsandout

524、puts.9.3.2 Management review inputs管理评审输入The management review shall be planned and carried out taking into consideration: 管理评审策划和实施时，应考虑：a) the status of actions from previous management reviews; 以往管理评审措施的状态；b) changes in external and internal issues that are relevant to the quality management syst

525、em; 与质量管理体系有关的外部或内部事宜的变更；c) information on the performance and effectiveness of the quality management system, including trends in: 有关质量管理体系绩效和有效性的信息，包括以下方面的趁势： 1) customer satisfaction and feedback from relevant interested parties; 顾客满意和来自相关方的反馈；2) the extent to which quality objectives have been m

526、et; 质量目标已满足的程度；3) process performance and conformity of products and services; 过程绩效和产品和服务的符合性； 4) nonconformities and corrective actions; 不符合和纠正措施；5) monitoring and measurement results; 监视和测量结果； 6) audit results; 审核结果； 7) the performance of external providers; 外部供方的业绩； d) the adequacy of resources;

527、资源的充分性e) the effectiveness of actions taken to address risks and opportunities (see 6.1); 应对风险和机遇所采取措施的有效性（见6.1）； f) opportunities for improvement. 改进的机会。9.3.2.1ManagementreviewinputsSupplemental管理评审输入-补充Managementreviewsshalltakeintoconsideration:管理评审应考虑：a)keyissuesfromprojectreviews;来自于项目评审的关键问题b)

528、selectedresultsofprocessreviews;过程评审收集的结果NOTEProcessreviewscanbeusedtoprovideanalysisofmandatoryKPIs.注：过程评审可能用于提供强制KPI分析c)reviewsoftheresultsfromanalysisofmandatoryKPIsdefinedin9.1.1asaminimum;至少9.1.1中定义的强制KPI分析结果的评审d)analysisofactualandpotentialinternalandexternaltechnicalfailuresandtheirimpactonsa

529、fety实际和潜在内外部技术失效的分析以其对安全的影响9.3.3 Management review outputs管理评审输出 The outputs of the management review shall include decisions and actions related to: 管理评审的输出应包括以下相关的决定和措施a) opportunities for improvement; 改进的机会；b) any need for changes to the quality management system; 质量管理体系任何变更的需求；c) resource needs.

530、 资源需求。The organization shall retain documented information as evidence of the results of management reviews. 组织应保留文件化信息，作为管理评审结果的证据。9.3.3.1ManagementreviewoutputsSupplemental管理评审输出-补充Theoutputsofthemanagementreviewshallincludedecisionsandactionsrelatedto:管理评审的输出应包括以下方面有关的决定和措施a)objectivesachievement

531、,includingqualityandsafetyobjectivesasaminimum;目标的达成，至少包括质量和安全目标b)customersatisfaction.顾客满意Correctiveactionsshallbemanagedaccordingto10.2whenobjectivesarenotachieved.目标未达成时，根据10.2的要求管理纠正措施。9.4Processreviews过程评审Regardingprocessreviews,theorganizationshall:关于过程评审，组织应：a)reviewthemandatoryprocessesrequi

532、redbythisTechnicalSpecificationatleastevery12months;至少每12个月评审本技术规范要求的强制过程b)ensurethat:确保1)processownersattendprocessreviewsaswellastopmanagementrepresentativesoftheprocessstakeholders;过程所有者和过程利益相关方的高层管理代表参加过程评审2)processconformitywithrequirementsof4.4.1isaddressedduringprocessreviews;在过程评审时，确定过程符合4.4

533、.1的要求3)actionsfrompreviousprocessreviewsaremonitored;监视以往过程评审的措施4)decisionsandactionsaretakenwhenrequired;需要时，采取的决定及措施5)outputsofprocessreviewsarereportedtothetopmanagement;向最高管理层报告过程评审的输出6)inputsandoutputsofprocessreviewsaredocumentedandretained;过程评审的输入和输出得到文件化和保持7)thenonconformingoutputsoftheproce

534、ssaremonitored;监视过程不合格输出8)resourcesareavailabilityandeffectivetoperformtheprocess.资源的可获得性和过程的有效执行Inaddition,processownersshouldensurethatprocessreviewsaddressthefollowing:另外，过程所有者应该确保过程评审明确以下内容：a)measurementanalysisofKPIsrelatedtotheprocess(see9.1.1.1),includingreviewofKPItargetachievement;过程相关KPI的测

535、量分析（见9.1.1.1），包括KPI目标达成情况的评审NOTERequirementsforanalysisandevaluationin9.1.3canapplytoKPIsforprocessreviews.注：9.1.3中关于分析和评价的要求可以应用于过程评审中的KPI。b)reviewoftheprocessKPIsrelevanceandactionstoadjustasnecessary;评审过程KPI的相关性，必要时采取措施调整c)correctiveactionsresultingfromaudits;来自于审核的纠正措施d)identificationofanynecess

536、aryacquisitionofknowledgeandchangeswithregardtocompetenciesfortheprocess.识别任何必要的知识需求和有关过程能力的变更。10 Improvement改进10.1 General总则The organization shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

537、组织应确定和选择改进机会，实施必要的措施以满足顾客的要求并增强顾客满意。These shall include: 这应包括：a) improving products and services to meet requirements as well as to address future needs and expectations; 改进产品和服务以满足要求以及应对未来的需求和期望； b) correcting, preventing or reducing undesired effects; 纠正、预防或减少非预期的影响；c) improving the performance an

538、d effectiveness of the quality management system. 改进质量管理体系的绩效和有效性。NOTE Examples of improvement can include correction, corrective action, continual improvement, breakthrough change, innovation and re-organization. 注：改进可以是纠正、纠正措施、持续改进、突破性改变、创新和重组。10.2 Nonconformity and corrective action不符合与纠正措施10.2.1

539、 When a nonconformity occurs, including any arising from complaints, the organization shall: 当发生不符合时，包括那些由投诉引起的，组织应： a) react to the nonconformity and, as applicable: 对不符合作出反应，适用时：1) take action to control and correct it; 采取措施控制和纠正不符合；2) deal with the consequences; 处理不符合造成的后果；b) evaluate the need fo

540、r action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: 评价消除不符合原因的措施的需求，通过采取以下措施防止不符合再次发生或在其他区域发生：1) reviewing and analyzing the nonconformity; 评审和分析不符合；2) determining the causes of the nonconformity; 确定不符合的原因；3) determining if similar nonconf

541、ormities exist, or could potentially occur; 确定类似不符合是否存在，或可能潜在发生；c) implement any action needed; 实施所需的措施；d) review the effectiveness of any corrective action taken; 评审所采取纠正措施的有效性；e) update risks and opportunities determined during planning, if necessary; 必要时，更新在策划时决定的风险和机遇；f) make changes to the qual

542、ity management system, if necessary. 必要时，对质量管理体系进行修改。Corrective actions shall be appropriate to the effects of the nonconformities encountered.纠正措施应与所遇到的不符合的影响程度相适应。10.2.2 The organization shall retain documented information as evidence of: 组织应保留文件化信息作为以下的证据：a) the nature of the nonconformities and

543、any subsequent actions taken; 不符合的性质及采取的任何的后续措施；b) the results of any corrective action. 任何纠正措施的结果。10.2.3NonconformityandcorrectiveactionSupplemental不合格和纠正措施-补充Theorganizationshallestablish,implementandmaintainadocumentedprocessformanagingnonconformitiesandcorrectiveactionsthatincludes:组织应建立、执行和维护一个

544、文件化的过程来管理不合格和纠正措施，其包括：a)requirementsdefinedin10.2.1and10.2.2;10.2.1和10.2.2中确定的要求b)definitionofcriteriatoevaluatetheneedforcorrectiveactions;定义评价纠正措施需求的准则c)applicationofproblemsolvingmethods(e.g.4D,8D);应用问题解决的方法（例如4D、8D）d)monitoringofcorrectiveactions.纠正措施的监视Theorganizationshallretainrelateddocumente

545、dinformation.组织应保持相关文件化信息。NOTETheserequirementscanapplytononconformityofproducts,services,processes,projectexecution.注：这些要求也适用于产品、服务、过程、项目执行的不合格。10.3 Continual improvement持续改进The organization shall continually improve the suitability, adequacy and effectiveness of the quality management system. 组织应持

546、续改进质量管理体系的适宜性、充分性和有效性。 The organization shall consider the results of analysis and evaluation, and the outputs from management review, to determine if there are needs or opportunities that shall be addressed as part of continual improvement. 组织应考虑分析和评价的结果和管理评审的输出，以确定是否存在应作为持续改进一部分的需求或机会。 11Bibliogra

547、phy参考文献1ISO9000:2015,QualitymanagementsystemsFundamentalsandvocabulary管理体系2ISO9001:2015,QualitymanagementsystemsRequirements3ISO10006,QualitymanagementsystemsGuidelinesforqualitymanagementinprojects4ISO10007,QualitymanagementsystemsGuidelinesforconfigurationmanagement5IEC60050-192:2015,International

548、electrotechnicalvocabulary-Part192:Dependability6IEC62278:2002,RailwayApplicationsSpecificationandDemonstrationofReliability,Availability,MaintainabilityandSafety(RAMS)7IEC62279:2012,Railwayapplications-Communication,signallingandprocessingsystems-Softwareforrailwaycontrolandprotectionsystems8IEC62425:2007,Railwayapplications-Communication,signallingandprocessingsystems-Safetyrelatedelectronicsystemsforsignalling9IEC61508:2010,ElectronicFunctionalSafetyPackageAny questions ?Thank you!