资源描述
,Quality management system Business management system requirements for rail organizations: ISO 9001:2015 and particular requirements for application in the rail sector ISO/TS22163:2017,The aim of this Technical Specification which has been prepared by UNIFE, the European Rail Industry Association, is the 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 Certification 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 rail 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 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”。 Whenever 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 Foreword 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 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 4.1 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 Determining 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 4.4.1 4.4.2 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 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 6.1.2,6.1.3 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 achieve them 质量目标及其实施的策划 6.2.1 6.2.2 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 measuring 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 Awareness 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 control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 8.1.3.5 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 8.2 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 8.3.1.1 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 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 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50 8.4.1.1 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, process or service verification after release 外部提供的产品、过程或服务放行后的验证 8.4.2.3 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 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 8.5.2.1 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 activities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 nonconforming outputs - Supplemental 不合格输出的控制-补充 8.8 RAMS / LCC 8.9 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 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 9.2.1 9.2.2,9.2.3 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 Management 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 General 总则 10.2 Nonconformity and corrective action 不符合及纠正措施 10.2.1 10.2.2 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 quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable 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 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 satisfaction; 促进增强顾客满意的机会； c) addressing risks and opportunities associated with its context and objectives; 应对与组织的背景和目标相关的风险和机遇； d) the ability to demonstrate conformity to specified quality management system requirements. 有能力证实对规定的质量管理体系要求符合性。,This International Standard can be used by internal and external parties. 本标准可以用于于内部和外部。 It is not the intent of this International Standard to imply the need for: 以下需求不是本标准的目的： - uniformity in the structure of different quality 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 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 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 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 its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimize negative effects and to make maximum use of opportunities as they arise. 基于风险的思维使组织能够确定那些可能导致它的过程和质量管理体系偏离策划的结果的因素，通过预防控制来减少负面的影响，而且最大化的利用它们产生的机遇。 Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary 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 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 principles described in ISO 9000. The descriptions include a statement of each principle, a rationale of why the principle is important for the organization, some examples of 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 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 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 intended 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 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 processes and the system as a whole can be achieved using the PDCA cycle with an overall focus on risk-based thinking aimed at taking advantage of opportunities and 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 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 evaluation of data and information. 在数据和信息评价的基础上改进过程。 Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The monitoring and 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 opportunities; 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; 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：通过使用资源和管理,将输入转化为输出的活动。 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,Do 实施,Check 检查,Act 处置,“P-D-C-A 循环”,过程单元,过程活动 + 各种资源,输入,输出,控制 (例如操作程序),0.2 过程方法,基本的过程模式,顾客 滿意,过程单元,培訓过程,输入： - 學员,- 導師 - 培訓設施,输出： - 學员,管理層 期望,增值： 知識,在课程结束时， 理解、 應用、 改變概念.,特性： 概念改变、澄清、理解、沟通、興趣,轉化过程,目標：,过程方法范例,过程单元 - 了解交互关系,过程单元 A,过程单元 D,过程单元 B,过程单元 C,输入 输出 控制,0.2 过程方法,顾客,顾客导向过程,输入,输出,管理过程,支持过程,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 (Customer Oriented Process),组织可能的顾客导向过程清单,Market Analysis / 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 支持过程举例： 培训 文件控制,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 (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,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,行动,行动,什么是过程管理?,过程 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”,由谁进行? (能力/技能/资格),过程名称 过程步骤流程图,输出 (我们将交付什么?),输入 (我们将收到什么?),使用什么方式? (材料/设备/装置),如何作? (方法/指导书/程序/技术),关键准则是什么? (测量/评估/绩效/指标),Support and linkage 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 E,外部顧客,反饋,外部顧客,过程 A,管理,支持,过程 B,管理,支持,过程 C,管理,支持,过程 E,管理,支持,过程 D,管理,支持,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, 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. Addressing 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 situation 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 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
展开阅读全文