Contents 目次

Foreword 前言
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
0.4 Relationship with other management system standards 与其他管理体系标准的关系
1 Scope 范围
2 Normative references 规范性引用文件
3 Terms and definitions 术语和定义
4 Context of the organization 组织背景
4.1 Understanding the organization and its context 理解组织及其背景
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 确定质量管理体系范围 4.4 Quality management system and its processes 质量管理体系及其过程
5 Leadership 领导力
5.1 Leadership and commitment 领导力和承诺
5.1.1 General 总则
5.1.2 Customer focus 以顾客为关注焦点
5.2 Quality policy 质量方针
5.2.2 Developing the quality policy 制定质量方针
5.2.2 Communicating the quality policy 沟通质量方针
5.3 Organizational roles, responsibilities and authorities 组织的角色、职责和权限 6 Planning for the quality management system 质量管理体系策划
6.1 Actions to address risks and opportunities 应对风险和机会的措施
6.2 Quality objectives and planning to achieve them 质量目标和实现计划
6.3 Planning of changes 变更的策划
7 Support 支持
7.1 Resources 资源
7.1.1 General 总则
7.1.2 People 人员
7.1.3 Infrastructure 基础设施
7.1.4 Environment for the operation of processes 过程运行环境

ISO FDIS 9001:2015
7.1.5 Monitoring and measuring resources 监视和测量资源
7.1.6 Organizational knowledge 组织知识
7.2 Competence 能力
7.3 Awareness 意识
7.4 Communication 沟通
7.5 Documented information 文件化信息
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
8 Operation 运行
8.1 Operational planning and control 运行的策划和控制
8.2 Determination of requirements for products and services 产品和服务要求的确定
8.2.1 Customer communication 顾客沟通
8.2.2 Determination of requirements related to products and services 与产品和服务有关的

要求的确定
8.2.3 Review of requirements related to products and services 与产品和服务有关的要求的 评审
8.2.4 Change to requirements for products and services 产品和服务要求的变更
8.3 Design and development of products and services 产品和服务的设计和开发
8.3.1 General 总则
8.3.2 Design and development planning 设计和开发的策划
8.3.3 Design and development Inputs 设计和开发的输入
8.3.4 Design and development controls 设计和开发的控制
8.3.5 Design and development outputs 设计和开发的输出
8.3.6 Design and development changes 设计和开发的更改
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
8.4.2 Type and extent of control 控制类型和程度
8.4.3 Information for external providers 外部供方信息
8.5 Production and service provision 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
8.5.2 Identification and traceability 标识和可追溯性
8.5.3 Property belonging to customers or external providers 顾客或外部供方的财产 8.5.4 Preservation 防护

ISO FDIS 9001:2015
8.5.5 Post-delivery activities 交付后活动
8.5.6 Control of changes 变更的控制
8.6 Release of products and services 产品和服务的放行
8.7 Control of nonconforming process outputs 不合格输出的控制
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
9.1.2 Customer satisfaction 顾客满意
9.1.3 Analysis and evaluation 分析和评价
9.2 Internal audit 内部审核
9.3 Management review 管理评审
9.3.1 General 总则
9.3.2 Management review input 管理评审输入
9.3.3 Management review output 管理评审输出
10 Improvement 改进
10.1 General 总则
10.2 Nonconformity and corrective action 不合格和纠正措施
10.3 Continual improvement 持续改进
Annex A (informative) Clarification of new structure, terminology and concepts 附录 A(资

料性附录)新结构、术语和概念说明
Annex B (informative) Other International Standards on quality management and quality

management systems developed by ISO/TC176 附录 B(资料性附录)ISO/TC176 开发的其他有关质量管 理和质量管理体系的国际标准