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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/TS22163:2017,The aim of this Technical Specification which has been prepared by UNIFE,the European Rail Industry Association,is th
2、e development and continual improvement of a business management system to ensure product quality and safety in the global rail sector.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。,The content include ISO 9001:2015 text and supplements has been originated by the UNIFE,IRIS Certificati
3、on working group.Whenever the ISO 9001:2015 text in this Technical Specification refers to“quality management system”,this term shall be considered as“business management system”,not limited to quality,so that it encompasses all business processes of the organization.Therefore,in the supplemental ra
4、il sector specific requirements,the term“business management system”is used outside the boxed text.本文内容包括ISO9001：2015的内容以及由UNIFE IRIS 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”。,Whenever this Technical Specification refers
5、to clause numbers,it is to be understood that all the requirements under this clause including sub-clauses are to be considered.Whenever this Technical Specification refers to“safety”,the term is to be understood as“product safety”,not to be confused with“occupational safety”.当本技术规范提及条款号，其可以理解为该条款下的
6、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。Whenever the ISO 9001:2015 text in this Technical Specification refers to“quality policy”or“quality objectives”these terms shall apply to“safety policy”or“safety objectives”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”。W
7、henever this Technical Specification requires documented processes(e.g.calibration and production),these processes can be defined within a single documented process(e.g.both defined within a“production management”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Fo
8、reword 前言0 Introduction 引言0.1 General 总则0.2 Quality management principles 质量管理原则0.3 Process approach 过程方法0.3.1 General 总则0.3.2 Plan-Do-Check-Act cycle PDCA循环0.3.3 Risk-based thinking基于风险的思维0.4 Relationship with other management system standards 与其他管理体系的关系1.1 Scope Supplemental 范围-补充2 Normative refer
9、ences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4.1 Understanding the organization and its context 理解组织及其背景环境4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望4.3 Determini
10、ng the scope of the quality management system确定质量管理体系的范围,4.4 Quality management system and its processes 质量管理体系及其过程4.4.3 Quality management system and its processes-Supplemental 质量管理体系及其过程-补充5 Leadership领导作用5.1 Leadership and commitment 领导作用和承诺5.1.1 General 总则5.1.2 Customer focus 以顾客为关注焦点5.2 Policy
11、方针5.2.1 Establishing the quality policy建立质量方针5.2.2 Communicating the quality policy 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5.3 Organizational roles,responsibilities and authorities 组织作用、职责和权限5.3.1 Organizational roles,responsibilities and authorities Supplemental组织作用、职
12、责和权限-补充5.3.2 Responsibilities and authorities of process owners过程所有者的职责和权限6 Planning策划6.1 Actions to address risks and opportunities 风险和机遇的应对措施6.1.1,6.1.3 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6.2 Quality objectives and planning to achiev
13、e them 质量目标及其实施的策划6.2.3 Safety objectives 安全目标6.3 Planning of changes 变更的策划6.4 Business planning 经营计划7 Support 支持7.1 Resources 资源7.1.1 General 总则7.1.1.1 General-Supplemental 总则-补充7.1.2 People 人员7.1.3 Infrastructure 基础设施7.1.4 Environment for the operation of processes 过程操作的环境7.1.5 Monitoring and meas
14、uring resources监视和测量资源7.1.5.1 General 总则7.1.5.2 Measurement traceability 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7.1.6 Organizational knowledge 组织的知识7.1.6.1 Organizational knowledge-Supplemental 组织的知识-补充,7.2 Competence 能力7.2.1 Competence-Supplemental 能力-补充7.3 Awarene
15、ss 意识7.3.1 Awareness-Supplemental 意识-补充7.4 Communication 沟通7.5 Documented information 形成文件的信息7.5.1 General 总则7.5.2 Creating and updating 编制和更新7.5.3 Control of documented information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8.1 Operational planning and cont
16、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.
17、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
18、.2 Requirements for products and services 产品和服务的要求8.2.1 Customer communication顾客沟通8.2.1.1 Customer communication-Supplemental 顾客沟通-补充8.2.2 Determining the requirements related to products and services 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
19、务相关要求的确定-补充8.2.3 Review of requirements related to products and services产品和服务相关要求的评审8.2.4 Changes to requirements for products and services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8.3 Design and development of products and services 产品和符合的设计和开发8.3.1 General 总则8
20、.3.1.1 General-Supplemental 总则-补充8.3.2 Design and development planning 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,8.3.3 Design and development inputs 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8.3.4 Design and development controls 设计和开发的控制8.3.4.1
21、Design and development controls Supplemental设计和开发的控制-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8.3.5 Design and development outputs 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8.3.6 Design and development changes 设计和开发的变更8.4 Co
22、ntrol 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508.4.1.1 General-Supplemental 总则-补充8.4.2 Type and extent of control 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,pro
23、cess or service verification after release 外部提供的产品、过程或服务放行后的验证 8.4.2.3 Monitoring of external provider performance,re-evaluation and ranking外部供方的绩效监视、再评估和评级,8.4.3 Information for external providers 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
24、 供应链管理8.5 Production and service provision生产和服务的提供8.5.1 Control of production and service provision 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8.5.2 Identification and traceability 标识和可追溯性8.5.
25、2.1 Identification and traceability Supplemental标识和可追溯性-补充8.5.3 Property belonging to customers or external providers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8.5.4 Preservation防护8.5.4.1 Preservation-Supplemental 防护-补充8.5.5 Post-delivery ac
26、tivities交付后活动8.5.5.1 Post-delivery activities-Supplemental 交付后活动-补充8.5.6 Control of changes 变更控制8.5.7 Production scheduling 生产计划,8.6 Release of products and services 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8.7 Control of nonconforming outputs 不合格输出的控制8.7.3 Control of n
27、onconforming 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 Obsolescence management 废弃管理8.11 Innovation management 创新管理9 Performance evaluation绩效评价9.1 Monitoring,measurement,analysis and evaluation 监视、测量、分析和评价9.1.1 General 总则9.1.1.1 General-Supplemental 总则-补充9.1.2
28、Customer satisfaction 客户满意9.1.2.1 Customer satisfaction-Supplemental 客户满意-补充9.1.3 Analysis and evaluation 分析和评价9.1.3.1 Analysis and evaluation-Supplemental 分析和评价9.2 Internal audit 内部审核,9.2.3 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9.3 Managemen
29、t review 管理评审9.3.1 General 总则9.3.1.1 General-Supplemental 总则-补充9.3.2 Management review inputs 管理评审-输入9.3.2.1 Management review inputs-Supplemental 管理评审输入-补充9.3.3 Management review outputs 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10 Improvement改进10.1 Gener
30、al 总则10.2 Nonconformity and corrective action 不符合及纠正措施10.2.3 Nonconformity and corrective action Supplemental 不符合及纠正措施补充10.3 Continual improvement 持续改进11 Bibliography 参考书目,0 Introduction引言0.1 General总则ISO 9001:2015,Quality management systems Requirements 质量管理体系-要求0.1 General总则The adoption of a quali
31、ty management system is a strategic decision for an organization that can help to improve its overall performance and provide 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 ma
32、nagement system based on this International Standard are:基于本国际标准实施一个质量管理体系对组织的潜在益处是：a)the ability to consistently provide products and services that meet 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 satisf
33、action;促进增强顾客满意的机会；c)addressing risks and opportunities associated with its context and objectives;应对与组织的背景和目标相关的风险和机遇；d)the ability to demonstrate conformity to 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 pa
34、rties.本标准可以用于于内部和外部。It is not the intent of this International Standard to imply the need for:以下需求不是本标准的目的：-uniformity in the structure of different quality 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 o
35、f the specific terminology of this International Standard within the organization.在组织内使用本国际标准中的特定术语。The quality management system requirements specified in this 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 Standa
36、rd employs the process approach,which incorporates the Plan-Do-Check-Act(PDCA)cycle and risk-based thinking.本标准采用过程方法，结合PDCA循环和基于风险的思维。The process approach enables 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
37、that its processes are adequately resourced and managed,and that opportunities for improvement are determined and acted on.PDCA循环使组织确保它的过程能够获得充分的资源并且得到充分管理，确定改进的机会并实施。Risk-based thinking enables an organization to determine the factors that could cause itsprocesses and its quality management system
38、to deviate from the planned results,to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise.基于风险的思维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 expec
39、tations poses a challenge for organizations in an increasingly dynamic and complex environment.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-or
40、ganization.在日益动态和复杂的环境下，持续满足要求并确定未来的需求和期望，以应对挑战。为了达成这个目标，组织可能发现除了纠正和持续改进还有必要采用不同形式的改进，例如突破性改变，创新和重组。,In this International Standard,the following verbal forms are 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;
41、“可”表明一种许可-“can”indicates a possibility or a capability.“可以”表明一种可能性或能力 Information marked as“NOTE”is for guidance in understanding or clarifying the associated 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 principle
42、s described in ISO 9000.The descriptions include a statement of each principle,a rationale of why the principle is important for the organization,some examples of benefits associated with the principle and examples of typical actions to improve the organizations performance when applying the princip
43、le.本标准是建立在ISO 9000中所阐述的质量管理原则，阐述包括每项原则的概述，管理原则对组织的重要性的基本原理，和原则相关利益的一些例子，以及应用这些原则改进组织绩效的典型的实例。The quality management principles are:质量管理原则有：customer focus;以顾客为关注焦点 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 manage
44、ment.关系管理,0.3 Process approach过程方法0.3.1 General总则This International Standard promotes the adoption of a process approach when developing,implementing and improving the effectiveness of a quality management system,to enhance customer satisfaction by meeting customer requirements.Specific requirements
45、 considered essential to the adoption of a process approach are included in 4.4.本标准鼓励在建立、实施质量管理体系以及改进其有效性时采用过程方法，通过满足顾客要求，增强顾客满意。本标准4.4条款包含了着重考虑采用过程方法的特定要求。Understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its int
46、ended results.This approach enables the organization 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
47、process approach involves the systematic definition 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 proce
48、sses and the system as a whole can be achieved using the PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of opportunities and 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
49、approach in a quality management system enables:在质量管理体系中应用过程方法能够：a)understanding and consistency in meeting requirements;理解并持续满足要求；b)the consideration of processes in 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 eval
50、uation of data and information.在数据和信息评价的基础上改进过程。Figure 1 gives a schematic representation of any process and shows the interaction of its elements.The monitoring and 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
