TS22163-2017

Table of contents目录

Table of contents目录............................................................................................... Foreword 前言........................................................................................................

0 Introduction 引言.............................................................................................................

0.1 General 总则 (8)

0.2 Quality management principles 质量管理原则 (9)

0.3 Process approach 过程方法 (10)

0.3.1 General 总则 (10)

0.3.2 Plan-Do-Check-Act cycle PDCA循环 (11)

0.3.3 Risk-based thinking基于风险的思维 (12)

0.4 Relationship with other management system standards 与其他管理体系的关系 (13)

1.1 Scope – Supplemental 范围-补充 (13)

2 Normative references引用标准 (14)

3 Terms and definitions 术语和定义 (14)

3.1 Terms and definitions for the rail sector铁路行业术语和定义 (14)

3.2 Abbreviations 缩写 (19)

4 Context of the organization 组织环境 (20)

4.1 Understanding the organization and its context 理解组织及其环境 (20)

4.2 Understanding the needs and expectations of interested parties理解相关方的需求和期望 (20)

4.3 Determining the scope of the quality management system确定质量管理体系的范围 (20)

4.4 Quality management system and its processes 质量管理体系及其过程 (21)

4.4.1 (23)

4.4.2 (23)

4.4.3 Quality management system and its processes - Supplemental 质量管理体系及其过程-补充 (21)

5 Leadership领导作用 (22)

5.1 Leadership and commitment 领导作用和承诺 (22)

5.1.1 General 总则 (22)

5.1.2 Customer focus 以顾客为关注焦点 (22)

5.2 Policy 方针 (23)

5.2.1 Establishing the quality policy建立质量方针 (23)

5.2.2 Communicating the quality policy 沟通质量方针 (23)

5.2.3 Quality policy – Supplemental 质量方针补充 (23)

5.2.4 Safety policy 安全方针 (23)

5.3 Organizational roles, responsibilities and authorities 组织岗位、职责和权限 (23)

5.3.1 Organizational roles, responsibilities and authorities – Supplemental组织岗位、职责和权限-补充 (24)

5.3.2 Responsibilities and authorities of process owners过程所有者的职责和权限 (24)

6 Planning策划 (24)

6.1 Actions to address risks and opportunities 应对风险和机遇的措施 (24)

6.1.1 (27)

6.1.2 (27)

6.1.3 Actions to address risks and opportunities - Supplemental 应对风险和机遇的措施-补充 (25)

6.1.4 Contingency planning 应急计划 (25)

6.2 Quality objectives and planning to achieve them 质量目标及其实现的策划 (26)

6.2.1 (28)

6.2.2 (28)

6.2.3 Safety objectives 安全目标 (26)

6.3 Planning of changes 变更的策划 (26)

6.4 Business planning 经营计划 (27)

7 Support 支持 (27)

7.1 Resources 资源 (27)

7.1.1 General 总则 (27)

7.1.1.1 General - Supplemental 总则-补充 (28)

7.1.2 People 人员 (28)

7.1.3 Infrastructure 基础设施 (28)

7.1.4 Environment for the operation of processes 过程运行环境 (28)

7.1.5 Monitoring and measuring resources监视和测量资源 (29)

7.1.5.1 General 总则 (29)

7.1.5.2 Measurement traceability 测量的可追溯性 (29)

7.1.5.3 Monitoring and measuring resources - Supplemental 监视和测量资源-补充 (29)

7.1.6 Organizational knowledge 组织的知识 (30)

7.1.6.1 Organizational knowledge - Supplemental 组织的知识-补充 (30)

7.2 Competence 能力 (31)

7.2.1 Competence - Supplemental 能力-补充 (31)

7.3 Awareness 意识 (32)

7.3.1 Awareness - Supplemental 意识-补充 (32)

7.4 Communication 沟通 (32)

7.5 Documented information 成文信息 (33)

7.5.1 General 总则 (33)

7.5.2 Creating and updating 创建和更新 (33)

7.5.3 Control of documented information成文信息的控制 (33)

7.5.4 Control of documented information - Supplemental 成文信息的控制-补充 (34)

8 Operation 运行 (34)

8.1 Operational planning and control运行的策划和控制 (34)

8.1.1 Planning for the outsourcing or transfer of processes外包和转包过程的策划 (35)

8.1.2 Tender management 投标管理 (35)

8.1.3 Project management 项目管理 (36)

8.1.3.1 Project integration management项目整合管理 (37)

8.1.3.2 Project scope management 项目范围管理 (38)

8.1.3.3 Project time management项目时间管理 (38)

8.1.3.4 Project cost management项目成本管理 (38)

8.1.3.5 Project quality management 项目质量管理 (39)

8.1.3.6 Project human resource management项目人力资源管理 (39)

8.1.3.7 Project communications management项目沟通管理 (39)

8.1.3.8 Project risk and opportunity management 项目风险和机遇管理 (40)

8.1.3.9 Project procurement management 项目采购管理 (40)

8.1.4 Configuration management 技术状态管理 (40)

8.1.5 Change management 变更管理 (41)

8.2 Requirements for products and services 产品和服务的要求 (42)

8.2.1 Customer communication顾客沟通 (42)

8.2.1.1 Customer communication - Supplemental 顾客沟通-补充 (43)

8.2.2 Determining the requirements related to products and services 产品和服务相关要求的确定 (43)

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 (43)

8.2.3 Review of requirements related to products and services产品和服务相关要求的评审 (43)

8.2.4 Changes to requirements for products and services产品和服务相关要求的变更 (44)

8.2.5 Requirements for products and services - Supplemental产品和服务相关要求-补充 (44)

8.3 Design and development of products and services 产品和服务的设计和开发 (45)

8.3.1 General 总则 (45)

8.3.1.1 General - Supplemental 总则-补充 (45)

8.3.2 Design and development planning 设计和开发策划 (45)

8.3.2.1 Design and development planning - Supplemental设计和开发策划-补充 (46)

8.3.3 Design and development inputs 设计和开发输入 (47)

8.3.3.1 Design and development inputs - Supplemental设计和开发输入-补充 (47)

8.3.4 Design and development controls 设计和开发控制 (47)

8.3.4.1 Design and development controls – Supplemental设计和开发控制-补充 (48)

8.3.4.2 Design reviews设计评审 (48)

8.3.4.3 Design verification设计验证 (48)

8.3.4.4 Design validation设计确认 (48)

8.3.5 Design and development outputs 设计和开发输出 (49)

8.3.5.1 Design and development outputs - Supplemental 设计和开发输出-补充 (49)

8.3.6 Design and development changes 设计和开发变更 (50)

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 (50)

8.4.1 General 总则 (50)

8.4.1.1 General - Supplemental 总则-补充 (51)

8.4.2 Type and extent of control 控制的类型和程度 (53)

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 (53)

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 ..54

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 (54)

8.4.3 Information for external providers 提供给外部供方的信息 (55)

8.4.3.1 Information for external providers - Supplemental 提供给外部供方的信息-补充.55 8.4.4 Supply chain management 供应链管理 (56)

8.5 Production and service provision生产和服务提供 (56)

8.5.1 Control of production and service provision 生产和服务提供控制 (56)

8.5.1.1 Control of production and service provision - Supplemental 生产和服务提供控制-补充 (57)

8.5.1.2 Special processes 特殊过程 (58)

8.5.1.3 Production equipment 生产设备 (59)

8.5.2 Identification and traceability 标识和可追溯性 (60)

8.5.2.1 Identification and traceability – Supplemental标识和可追溯性-补充 (60)

8.5.3 Property belonging to customers or external providers顾客或外部供方的财产 (60)

8.5.3.1 Property belonging to customers or external providers - Supplemental 顾客或外部供方的财产-补充 (60)

8.5.4 Preservation防护 (61)

8.5.4.1 Preservation - Supplemental 防护-补充 (61)

8.5.5 Post-delivery activities交付后活动 (61)

8.5.5.1 Post-delivery activities - Supplemental 交付后活动-补充 (62)

8.5.6 Control of changes 更改控制 (62)

8.5.7 Production scheduling 生产计划 (62)

8.6 Release of products and services 产品和服务的放行 (63)

8.6.1 Release of products and services - Supplemental 产品和服务的放行-补充 (63)

8.7 Control of nonconforming outputs 不合格输出的控制 (63)

8.7.3 Control of nonconforming outputs - Supplemental 不合格输出的控制-补充 (64)

8.8 RAMS / LCC (65)

8.9 First article inspection 首件检验 (66)

8.10 Obsolescence management 老化管理 (66)

8.11 Innovation management 创新管理 (67)

9 Performance evaluation绩效评价 (67)

9.1 Monitoring, measurement, analysis and evaluation 监视、测量、分析和评价 (67)

9.1.1 General 总则 (67)

9.1.1.1 General - Supplemental 总则-补充 (67)

9.1.2 Customer satisfaction 客户满意 (69)

9.1.2.1 Customer satisfaction - Supplemental 客户满意-补充 (69)

9.1.3 Analysis and evaluation 分析和评价 (69)

9.1.3.1 Analysis and evaluation - Supplemental 分析和评价-补充 (69)

9.2 Internal audit 内部审核 (69)

9.2.3 Internal audit - Supplemental 内部审核-补充 (70)

9.2.3.1 Audit programme 审核计划 (70)

9.2.3.2 Auditors management 审核员管理 (71)

9.3 Management review 管理评审 (71)

9.3.1 General 总则 (71)

9.3.1.1 General - Supplemental 总则-补充 (72)

9.3.2 Management review inputs 管理评审输入 (72)

9.3.2.1 Management review inputs - Supplemental 管理评审输入-补充 (72)

9.3.3 Management review outputs 管理评审输出 (72)

9.3.3.1 Management review outputs - Supplemental 管理评审输出-补充 (73)

9.4 Process reviews 过程评审 (73)

10 Improvement改进 (74)

10.1 General 总则 (74)

10.2 Nonconformity and corrective action 不符合及纠正措施 (74)

10.2.3 Nonconformity and corrective action – Supplemental 不符合及纠正措施补充 (75)

10.3 Continual improvement 持续改进 (75)

11 Bibliography 参考书目 (76)

Foreword前言

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好安全。

The content inside the boxed text of this document is ISO 9001:2015 text. The text outside the boxes has been ori ginated 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. 本文中方框中的内容是ISO9001：2015的内容。方框外的内容由UNIFE IRIS 认证工作组开发。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 the ISO 9001:2015 text refers to “this International Standard”, this applies to this Technical Specification, including the text outside the boxes. 当ISO9001：2015文中提及“本国际标准”，其适用于本技术规范，包括方框中的内容。

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。

Notes for particular requirements for application in the rail sector are in italic. 对于在铁路行业应用的特定要求的注是斜体字。

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一项战略决策，能够帮助其提高整体绩效，为推动可持续发展奠定良好基础。

The potential benefits to an organization of implementing a quality management system based on this International Standard are:

组织根据本标准实施质量管理体系具有如下潜在益处：

a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements;持续提供满足顾客要求以及适用的法律法规要求的产品和

服务的能力；

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; 应对与组织环境和目标相关的风险和机遇；

d) the ability to demonstrate conformity to specified quality management system requirements.

证实符合规定的质量管理体系要求的能力

This International Standard can be used by internal and external parties.本标准可以用于于内部和外部各方。

It is not the intent of this International Standard to imply the need for:实施本标准并不意味着需要：

- uniformity in the structure of different quality management systems;

—统一不同质量管理体系的架构

- alignment of documentation to the clause structure of this International Standard;

—形成与本标准条款结构相一致的文件；

- the use of the specific terminology of this International Standard within the organization.

—在组织内使用本标准的特定术语。

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，该方法结合了PDCA（策划、实施、检查、处置）循环与基于风险的思维。

The process approach enables an organization to plan its processes and their interactions.

过程方法使组织能够策划其过程及其相互作用。

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 (see Clause A.4).基于风险的思维使组织能够确定可能导致其过程和质量管理体系偏离策划结果的各种因素，采取预防控制，最大限度地降低不利影响，并最大限度地利用出现的机遇（见附录A.4）。

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.在日益复杂的动态环境中持续满足要求，并针对未来需求和期望采取适当行动，这无疑是组织面临的一项挑战。为了实现这一目标，组织可能会发现，除了纠正和持续改进，还有必要采取各种形式的改进，如突破性变革、创新和重组。

In this International Standard, the following verbal forms are used:在本标准中使用如下助动词：

- “shall” indicates a requirement;“应”表示要求

- “should” indicates a r ecommendation;“宜”表示建议；

- “may” indicates a permission;“可以”表示允许；

- “can” indicates a possibility or a capability.“能”表示可能或能够

Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement. “注”的内容是理解和说明有关要求的指南。

0.2 Quality management principles 质量管理原则

ISO 9001:2015, Quality management systems — Requirements质量管理体系-要求

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 organization’s performance when applying the principle. 本标准是在GB/T 19000所述的质量管理原则基础上制定的。每项原则的介绍均包含其释义、该原则对组织的重要性的理论依据、应用该原则的主要益处示例以及应用该原则改进组织绩效的典型措施示例。

The quality management principles are: 质量管理原则是：

—customer focus;以顾客为关注焦点

—leadership;领导作用

—engagement of people;全员积极参与

— process approach;过程方法

—improvement;改进

—evidence-based decision making;循证决策

—relationship management.关系管理

0.3 Process approach过程方法

0.3.1 General总则

ISO 9001:2015, Quality management systems — Requirements 质量管理体系-要求

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.本标准倡导在建立、实施质量管理体系以及提高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。采用过程方法所需满足的具体要求见4.4。

Understanding and managing interrelated processes as a system contributes to the organization’s 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. 将相互关联的过程作为一个体系加以理解和管理,有助于组织有效和高效地实现其预期结果。这种方法使组织能够对体系过程之间相互关联和相互依赖的关系进行有效控制，以增强组织整体绩效。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. Management of the processes and the system as a whole can be achieved using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking advantage of opportunities and preventing undesirable results.

过程方法包括按照组织的质量方针和战略方向，对各过程及其相互作用，系统地进行规定和管理，从而实现预期结果。可通过采用PDCA循环（见0.3.2）以及始终基于风险的思维（见0.3.3）对过程和完整的体系进行管理，旨在有效利用机遇并防止发生非预期结果。

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;获得有效的过程绩效；

d) improvement of processes based on evaluation of data and information.在评价数据和信息的基础上改进过程。

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.

过程的各要素及其相互作用如图1所示。每一过程均有特定的监视和测量检查点，以用于控制，这些检查点根据不同的风险有所不同。

0.3.2 Plan-Do-Check-Act cycle策划-实施-检查-处置循环

The PDCA cycle can be applied to all processes and to the quality management system as a whole.PDCA循环能够应用于所有过程以及完整的质量管理体系。

Figure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.图2表明了本标准第4章至第10章如何组成PDCA循环。

The PDCA cycle can be briefly described as follows: PDCA循环可以简要描述如下

— Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities;

策划（Plan）：根据顾客的要求和组织的方针，建立体系的目标及其过程，确定实现结果所需的资源，并识别和应对风险和机遇。

— Do: implement what was planned; 实施（Do）：实施所做的策划；

— Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;检查（Check）：根据方针、目标、要求和经策划的活动，对过程以及形成的产品和服务进行监视和测量（适用时），并报告结果；

— Act: take actions to improve performance, as necessary

处置（Act）：必要时，采取措施提高绩效。

0.3.3 Risk-based thinking基于风险的考虑

Risk-based thinking (see Clause A.4) is essential for achieving an effective quality management system. 基于风险的思维（见附录A.4）是实现质量管理体系有效性的前提。

The concept of risk-based thinking has been implicit in previous editions of this International Standard including, for example 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.本标准以前的版本已经隐含基

于风险思维的概念，例如：采取预防措施消除潜在的不合格，对发生的不合格进行分析，并采取与不合格的影响相适应的措施,防止其再发生。

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.为了满足本标准的要求,组织需策划和实施应对风险和利用机遇的措施。应对风险和利用机遇可为提高质量管理体系有效性、实现改进结果以及防止不利影响奠定基础。

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.

某些有利于实现预期结果的情况可能导致机遇的出现，例如：有利于组织吸引顾客、开发新产品和服务、减少浪费或提高生产率的一系列情形。利于机遇所采取的的措施也可能包括考虑相关风险。风险是不确定性的影响，不确定性可能有正面的影响，也可能有负面的影响。风险的正面影响可能提供机遇，但并非所有的正面影响均可提供机遇。

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 A.1).本标准适用于ISO制定质量管理体系标准的框架，以提高与其他管理体系标准的协调一致性。（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.本标准使组织使用过程方法，并结合PDCA循环和基于风险的思维，将其质量管理体系与其他管理体系标准要求进行协调或一体化。This International Standard relates to ISO 9000 and ISO 9004 as follows:

本标准与ISO 9000 和 ISO 9004 的存在如下关系：

— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential background for the proper understanding and implementation of this International Standard; —ISO 9000 质量管理体系—基础和术语为正确的理解和实施本标准提供必要基础。

—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 《组织持续成功的管理—质量管理方法》为选择超出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 to other management systems, such as those for environmental management, occupational health and safety management, or financial management.

本标准不包括针对环境管理、职业健康和安全管理或财务管理等其他管理体系的特定要求。Sector-specific quality management system standards based on the requirements of this International Standard have been developed 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.

在本标准的基础上，已经制定了若干行业特定要求的质量管理体系标准。其中的某些标准规定了质量管理体系的附加要求，而另一些标准则仅限于提供在特定行业应用本标准的指南。

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: https://www.360docs.net/doc/af607129.html,/tc176/sc02/public.

本标准的章节内容与之前版本（GB/T 19001—2008）章节内容之间的对应关系见ISO/TC176/SC2（国际标准化组织/质量管理和质量保证/质量体系分委员会）的公开网站：

https://www.360docs.net/doc/af607129.html,/tc176/sc02/public。

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: 本标准为下列组织规定了质量管理体系要求：

a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and需要证实其具有持续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 conformity to customer and applicable statutory and regulatory requirements. 通过体系的有效应用，包括体系改进的过程，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 it provides本标准规定的所有要求是通用的，旨在适用于各种类型、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 be expressed as legal requirements.

注 2：法律法规要求可称作法定要求。

1.1 Scope – Supplemental 范围-补充

This document defines quality management system requirements in the rail sector(RQMS)本技术规范确定了铁路工业的质量管理体系要求（RQMS）

?applicable throughout the whole supply chain of railway industrial related products for the design & development, manufacturing and maintenance activities (excluding operations and services of rail transports)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）

?providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain在整个供应链进行持续改进、强调防错和减少浪费

?enhancing and sustaining product quality, including its safety aspects.强化和持续稳定的保证产品质量，包括产品安全方面。

NOTE This document allows organizations to have the same flexibility when determining the boundaries and applicability of the quality management system as described in ISO 9001:2015 4.3.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 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.

下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本（包括所有的修改单）适用于本文件。

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中所确立的术语和定义。

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— IEC Electropedia: available at https://www.360docs.net/doc/af607129.html,/

— ISO Online browsing platform: available at https://www.360docs.net/doc/af607129.html,/obp

3.1 Terms and definitions for the rail sector 铁路行业的术语和定义

3.1.1 application software 应用软件

Computer program that performs a set of functions to support the execution of a process. 执行一系列功能的计算机程序以支持过程的运行。

Note 1 to entry:This can be a software programme, database, computerized spreadsheet, electronic file or web tool, bought from the market or developed by the organization. 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。

3.1.2 availability可用性

Ability to be in a state to perform as required

（一个物品的）按照要求执行某种状态的能力。

Note 1 to entry: Availability depends upon the combined characteristics of the reliability, recoverability, and maintainability of the item, and the maintenance support performance. 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[SOURCE:IEC 60050-192:2015, 192-01-23].

3.1.3 commissioning 调试

Phase before handover to a customer, in which a product is final tested under operational conditions to verify it functions according to its specifications. The product is prepared to start operation. 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功能。产品准备开始运行。

Note 1 to entry: The product is then prepared to start operation.

备注：产品是为运行开始做准备

3.1.4 component 部件

Sub-device above the integration level of the smallest replaceable unit of a system in service or maintenance. 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。

3.1.5 configuration audit 技术状态（配置）审核

Audit performed in accordance with documented procedures to determine whether a product conforms to its requirements and product configuration information. [SOURCE: ISO 10007:2003, 5.6]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。【来源： ISO 10007：2003,5.6】

3.1.6 configuration baseline 技术状态基线

Approved product configuration information that establishes the characteristics of a product at a point in time that serves as reference for activities throughout the life cycle of the product. [SOURCE: ISO 10007:2003, 3.4]

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的产品配置信息。【来源： ISO 10007：2003,3.4】

3.1.7 configuration status accounting 配置状态统计

Formalized recording and reporting of product configuration information, the status of proposed changes and the status of the implementation of approved changes. 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。

[SOURCE: ISO 10007:2003, 5.5] 【来源： ISO 10007：2003,5.5】

3.1.8 consignment stock寄售库存

Stock owned by an external provider, but held by the organization to ensure availability of parts. 外部供方所有的库存，但是由组织控制以确保零件供应。

3.1.9 critical / criticality危险的/危险度

Objects having the potential of introducing high risks that can threaten quality, safety or business performance, based on a risk assessment. 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。

3.1.10 deferred work 延期工作

Activity which is part of a predetermined sequence in a process, that is delayed or postponed. 过程中作为预订顺序一部分的活动，被延期或延迟。

3.1.11 deliverables 可交付物

All types of output for the scope of supply to fulfil set requirements (EXAMPLE:. user manual, maintenance manual, test reports, test equipment, training, spare and support parts). 供货范围内满足设定要求的所有类型的输出（例如，用户手册、保养手册、试验报告、试验设备、培训、备品备件）

3.1.12 first article inspection 首件检验

Set of inspection and verification activities in order to validate a production process. 为了确认生产过程进行的一系列检验和验证活动。

3.1.13 Failure Reporting Analysis and Corrective Action System

FRACAS

Closed loop process used to improve dependability of current and future designs by feedback of testing, modification and use experience. 通过实验反馈、修改和利用经验，用来改进当前和将来设计可靠性的闭环过程。

[SOURCE:IEC 60050-192:2015, 192-12-04].

3.1.14 functional requirement 功能要求

Dedicated requirement or capability of a function within the functional breakdown structure. 在功能展开结构中，功能的能力和详细要求。

3.1.15 gate criteria 门准则

Acceptance criteria for deliverables at gates in order to support the decisions to be taken, such as accepted, conditionally accepted or rejected. 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。

3.1.16 handover 移交

Passing control authority of the subject item from one organization to another, including transfer of responsibilities to the receiving organization. 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

3.1.17 installation 安装

Phase after delivery at customer premises and prior to commissioning. 交付到客户处后和调试前的阶段

NOTE 1 to entry Installation is a typical phase of infrastructure activities. 注：安装是基础设施活动的典型阶段

3.1.18 integration maturity 集成成熟度

Degree of fulfilment of the integration requirements of a product (EXAMPLE. already or never integrated in the organization’s products).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）

3.1.19 integration requirements 集成要求

Requirements regarding integration of a system into a parent system and its fulfilment of functional requirements in this environment. 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。

3.1.20key performance indicator (KPI) 关键绩效指标

Indicator, selected by the top management, to evaluate the performance of the business management system. 由高层管理者选择用来评价运营管理体系绩效的指标。

3.1.21 life cycle costing (LCC) 生命周期成本

Process of economic analysis to assess the cost of an item over its life cycle or a portion thereof. 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。

[SOURCE: IEC 60050-192:2015, 192-11-11]

3.1.22 maintainability （物品的）可维护性

Ability to be retained in, or restored to a state to perform as required, under given conditions of use and maintenance. 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。Note 1 to entry: Given conditions would include aspects that affect maintainability, such as: location for maintenance, accessibility, maintenance procedures and maintenance resources. 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。[SOURCE:IEC 60050-192:2015, 192-01-27]

3.1.23 maintenance 维护

Combination of all technical and management actions intended to retain an item in, or restore it to a state in which it can perform as required. 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。

Note 1 to entry: Management is assumed to include supervision activities. 注1：进入：假设管理包括监督活动。

[ SOURCE: IEC 60050-192:2015, 192-06-01]

3.1.24 manufacturing 制造

Activities to realize products including overhaul and repair.产品实现的过程，包括翻新和修理. Note 1 to entry:Part of an organizations value chain. 组织价值链的一部分。

3.1.25 multidisciplinary approach 多方论证的方法

Way of working involving different functions (EXAMPLE. engineering, safety, procurement) in one team on a specific subject. 针对特定目标，引入不同职能进入团队的工作方式。

3.1.26 non-functional requirements 非功能要求

Frame conditions under which functional requirements are met,

Note 1 to entry: Some examples are: 在功能要求的前提下，框架要求应得到满足，如：

- standards / regulations / requirements for approval by authorities; 法规/标准/授权方批准的要求- operating profile / configuration; 作业面/技术状态

- additional, specific operator/customer non-functional requirements; 附加的、特定操作者或客户的非功能要求

- integration (physics / mechanics / electrics / control). 集成（物理、机械、电子、控制）

3.1.27 operational maturity

Degree of fulfilment of the functional requirements of a product or service (EXAMPLE.not existing, under development, ready to use). 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）

3.1.28 product configuration information 产品配置信息

Requirements for product design, realization, verification, operation and support. 产品设计、实现、验证、运行和支持所需的信息

[SOURCE：ISO 10007:2003, 3.9]

3.1.29 product life cycle 产品生命周期

Time of the entire life cycle of a product from inception, through design and manufacture, to service and disposal. 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。

3.1.30 production equipment 生产设备

Equipment used for production (example. machineries, tools, jigs, fixtures, templates, textures, test benches, software production tools). 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）。

Note 1 to entry:Handcraft equipment (e.g. hammer, screwdrivers) is not considered as production equipment. 手工设备（例如锤子、螺丝刀）不考虑为生产设备。

3.1.31 project core team 项目核心团队

People from different functions appointed to support the project manager in leading and controlling the project. 支持项目经理领导和控制项目的不同职能指定的人员。

3.1.32 project management 项目管理

Planning, organizing, monitoring, controlling and reporting of all aspects of a project, and the motivation of all those involved in it to achieve the project objectives. 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。

[SOURCE:ISO 10006:2003, 3.6]

3.1.33 quality assurance methods 质量保证方法

Methods applied to qualify, verify or validate the implementation of requirements in order to focus on error prevention rather than detection (EXAMPLE. in design and development). 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。

NOTE Quality assurance methods can be FMEA, FMECA, quality function deployment, etc. 注：质量保证方法可能是FMEA、FMECA、质量功能展开等。

3.1.34 quality deficiency cost (QDC) 质量失效成本

Additional costs resulting from nonconforming products, processes or equipment. 由于不合格产品、过程或设备导致的额外成本。

Note 1 to entry:QDC can be distinguished by causer (e.g. sales, engineering, production, purchasing, project management) and on phase of occurrence (e.g. tender, design, 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）

Note 2 to entry:QDC can include: 质量失效成本

a) additional labor, material or other direct costs in the context of failure or change due to incorrect design and the resulting actions taken (e.g. rework, redesign, repurchase, special shipments); 由于不正确设计或所采取措施（例如返工、再设计、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) costs due to downtimes; 故障停机导致的成本

c) costs of scrap; 废品成本

d) costs of products rendered unusable by or oversupply of storage; 产品不能使用或超量存储产生的成本

f) costs due to accepted third-party claims and costs due to claims not asserted by the organization against third parties; 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) costs due to penalties for default or delays. 违约或延期的处罚成本

Note 3 to entry:QDC can also be called nonconformity costs. 质量失效成本也称不合格成本

3.1.35 reliability 可靠性

Probability of performing as required for the time interval (t1, t2), under given conditions. 在给定条件下，在时间间隔（t1, t2）内执行要求的可能性。

Note 1 to entry: Given conditions include aspects that affect reliability, such as: mode of operation, stress levels, environmental conditions, and maintenance, where applicable. 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。Note 2 to entry: It is usually assumed that the item is in a state to perform as required at the beginning of the time interval. 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。[SOURCE: IEC 60050-192:2015, 192-05-05]

3.1.36 safety (product safety) 安全（产品安全）

Freedom from unacceptable risk of harm. 伤害不可能接受风险的自由度

[SOURCE: IEC 62278,3.35]

3.1.37 safety case 安全事例

Documented demonstration that the product complies with the specified safety requirements. 产品符合特定安全要求的文件化证明。

[SOURCE: IEC 62278:2002, 3.36]

3.1.38 safety integrity level (SIL) 安全完整性等级

One of a number of defined discrete levels for specifying the safety integrity requirements of the safety functions to be allocated to the safety related systems. 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。

[SOURCE: IEC 62278:2002, 3.38]

3.1.39 safety-related 安全相关

Carries responsibility for safety. 为安全承担的责任

[SOURCE: IEC 62425:2007, 3.1.54]

3.1.40 site 现场

Organization, having activities in design and development and (or) manufacturing and (or)

maintenance (fleet maintenance, refurbishment and component overhaul and (or) repairs) in

defined scopes placed in a single location. 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。

3.1.41 supply chain 供应链

System of organizations, people, activities, information and resources involved in transforming

materials and knowledge in a product or a service for the customer. 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。

3.1.42 transfer 转移

Complete or partial handover of process ownership for tasks or activities from internal product

realization to an internal entity. 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。

3.2 Abbreviations 缩写

Abbreviation Explanation 缩写的解释

EPPPS External Provided Product, Process or Service 外部提供的产品、过程或服务

FAI First Article Inspection 首件检验

FMEA Failure Mode and Effects Analysis 失效模式和影响分析

FMECA Failure Mode, Effects and Criticality Analysis 失效模式、影响和分析分析

FRACAS Failure Reporting Analysis and Corrective Action System 失效报告分析和纠正措施系统IEC International Electrotechnical Commission 国际电工委员会

ISO International Organization for Standardization 国际标准化组织

KPI Key Performance Indicator 关键绩效指标

LCC Life Cycle Costing 生命周期成本

PDCA Plan – Do – Check – Act 计划-做-检查-措施

QDC Quality Deficiency Cost 质量失效成本

RAM Reliability, Availability, Maintainability 可靠性、可用性和可维护性

RAMS Reliability, Availability, Maintainability, Safety. 可靠性、可用性、可维护性和安全性

RQMS Rail Quality Management System 铁路质量管理体系

SIL Safety Integrity Level 安全完整性等级

4 Context of the organization 组织环境

4.1 Understanding the organization and its context 理解组织及其环境

ISO 9001:2015, Quality management systems — Requirements

4.1 Understanding the organization and its context理解组织及其环境

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.

组织应确定与其宗旨和战略方向相关并影响其实现质量管理体系预期结果的能力的各种外部和内部因素。

The organization shall monitor and review information about these external and internal issues. 组织应对这些内部和外部因素的相关信息进行监视和评审。

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

注1：这些因素可能包括需要考虑的正面和负面要素或条件。

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：考虑来自于国际、国内、地区和当地的各种法律法规、技术、竞争、市场、文化、社会和经济环境因素，有助于理解外部环境。

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.

注3：考虑与组织的价值观、文化、知识和绩效等有关的因素，有助于理解内部环境。

4.2 Understanding the needs and expectations of interested parties

4.2 理解相关方的需求和期望

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:由于相关方对组织持续提供符合顾客要求和适用法律法规要求的产品和服务的能力具有影响或潜在影响，因此，组织应确定：

a) the interested 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 requirements. 组织应对这些相关方及其要求的相关信息进行监视和评审。

4.3 Determining the scope of the quality management system

4.3 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. 组织应确定质量管理体系的边界和适用性，以确定其范围。

When determining this scope, the organization shall consider: 在确定范围时，组织应考虑：

a) the external and internal issues referred to in 4.1； 4.1中提及的外部和内部因素；

b) the requirements of relevant interested parties referred to in 4.2; 4.2中提及的相关方的要求

c) the products and services of the organization. 组织的产品和服务。

The organization shall apply all the requirements of this International Standard if they are applicable within the determined scope of its quality management system. 如果本标准的全部要求适用于组织确定的质量管理体系范围,组织应遵循本标准的全部要求

The scope of the organization’s quality management system shall be available and be maintained as documented information. The scope shall state 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.

组织的质量管理体系范围应作为成文信息,可获得并得到保持。该范围应描述所覆盖的产品和服务类型，如果组织确定本标准的某些要求不适用于其质量管理体系范围，应说明理由。

Conformity to this International Standard may only be claimed if the requirements determined as not being applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.

只有当所确定的不适用的要求不影响组织确保其产品和服务合格的能力或责任，对增强顾客满意也不会产生影响时，方可声称符合本标准要求。

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 Standard.组织应按照本标准的要求，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，且应

a) determine the inputs required and the outputs expected from these processes; 确定这些过程所需的输入和期望输出；

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; 确定和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; 确定这些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 the requirements of 6.1; 根据6.1的要求应对风险和机遇；

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results; 评价这些过程，实施所需的变更，以确保实现这些过预期结果；

h) improve the processes and the quality management system. 改进过程和质量管理体系。

4.4.2 To the extent necessary, the organization shall: 在必要的范围和程度上，组织应：

a) maintain documented information to support the operation of its processes; 保持成文信息以支持过程运行

b) retain documented information to have confidence that the processes are being carried out as planned.保留成文信息以确信过程按照策划进行。

4.4.3 Quality management system and its processes – Supplemental 质量管理体系及其过程-补充When this documents requires a documented process, the process documentation shall cover as a minimum the requirements described in 4.4.1 a) to e). 当本文件要求文件化过程时，过程文件应至少包括4.4.1 a)到 e)的描述的要求。

NOTE Processes can be documented in procedures, instructions, method descriptions, flowcharts or workflows etc. supported by application software and templates.

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。The organization shall: 组织应：

a) document a hierarchical structure of its processes; 文件化其过程的分层结构

b) communicate processes (see 7.4) and ensure that people are aware of the processes; 就过程进行交流并确保员工了解过程（见7.4）

c) train people on processes and ensure understanding (see 7.2.1 f)); 培训过程相关员工并确保得到理解（见7.2.1f））

d) ensure processes are applied and people adhere to processes (see 9.2); 确保过程得到应有并且应该遵循过程（见9.2）

e) ensure and maintain conformity of the business management system and its processes with applicable statutory or regulatory requirements and standards. 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。

Documented processes required by this document shall be verified against the applicable requirements of this documents.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 management 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和承诺：

a) taking accountability for the effectiveness of the quality management system; 对质量管理体系的有效性负责；

b) ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization; 确保制定质量管理体系的质量方针和质量目标，并与组织环境相适应，与战略方向相一致；

c) ensuring the integration of the quality management system requirements into the organization’s business processes; 确保质量管理体系要求融入到组织的业务过程；d) promoting the use of the process approach and risk-based thinking; 促进适用过程方法和基于风险的思维；

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是可获得的；

f) communicating the importance of effective quality management and of conforming to the quality management system requirements; 沟通有效的质量管理和符合质量管理体系要求的重要性；

g) ensuring that the quality management 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; 促使人员积极参与，指导和支持他们为质量管理体系的有效性作出贡献；

i) promoting improvement; 推动改进；

j) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility. 支持其他相关管理者在其职责范围内发挥领导作用。

NOTE Reference to “business” in this International Standard can be interpreted broadly to mean those activities that are core to the purposes of the organization’s existence, whether the organization is public, private, for profit or not for profit.

注：本标准中的“业务”一词可广义地理解为涉及组织存在目的的核心活动，无论是公