ISO9001-2015新版从框架到内容都作了较大改动,章节由现版的八章改为了十章,各章的内容主题如下:
1 Scope 范围
2 Normative references 参考文件
3 Terms and definitions 术语与定义
4 Context of the organization 组织背景
4.1 Understanding the organization and its context 认知组织及其背景
4.2 Understanding the needs and expectations of interested parties 认知利益相关方的需求与期待
4.3 Determining the scope of the quality management system 界定质量管理体系范围
4.4 Quality management system 质量管理体系
5 Leadership 领导力
5.1 Leadership and commitment 领导力与承诺
5.2 Quality policy 质量方针
5.3 Organizational roles, responsibilities and authorities 组织决色,责任及权限
6 Planning 策划
6.1 Actions to address risks and opportunities 界定风险与机会的行动
6.2 Quality objectives and planning to achieve them 质量目标及实现策划
6.3 Planning of changes 改变策划
7 Support 支持
7.1 Resources 资源
7.2 Competence 胜任能力
7.3 Awareness 意识
7.4 Communication 沟通
7.5 Documented information 文件化信息
8 Operation 运作
8.1 Operational planning and control 运作计划与控制
8.2 Determination of market needs and interaction with customers 确定市场需求及与顾客的联系
8.3 Operational planning process 运作计划过程
8.4 Control of external provision of goods and services 外购与外包的控制
8.5 Development of goods and services 产品与服务开发
8.6 Production of goods and provision of services 产品生产与服务准备
8.7 Release of goods and services 产品与服务提交
8.8 Nonconforming goods and services 不合格的产品与服务
9 Performance evaluation 绩效评估
9.1 Monitoring, measurement, analysis and evaluation 监视,测量,分析与评估
9.2 Internal audit 内部审核
9.3 Management review 管理评审
10 Improvement 改进
10.1 Nonconformity and corrective action 不合格与纠正措施
10.2 Improvement 改进
1 Scope 范围
2 Normative references 参考文件
3 Terms and definitions 术语与定义
4 Context of the organization 组织背景
4.1 Understanding the organization and its context 认知组织及其背景
4.2 Understanding the needs and expectations of interested parties 认知利益相关方的需求与期待
4.3 Determining the scope of the quality management system 界定质量管理体系范围
4.4 Quality management system 质量管理体系
5 Leadership 领导力
5.1 Leadership and commitment 领导力与承诺
5.2 Quality policy 质量方针
5.3 Organizational roles, responsibilities and authorities 组织决色,责任及权限
6 Planning 策划
6.1 Actions to address risks and opportunities 界定风险与机会的行动
6.2 Quality objectives and planning to achieve them 质量目标及实现策划
6.3 Planning of changes 改变策划
7 Support 支持
7.1 Resources 资源
7.2 Competence 胜任能力
7.3 Awareness 意识
7.4 Communication 沟通
7.5 Documented information 文件化信息
8 Operation 运作
8.1 Operational planning and control 运作计划与控制
8.2 Determination of market needs and interaction with customers 确定市场需求及与顾客的联系
8.3 Operational planning process 运作计划过程
8.4 Control of external provision of goods and services 外购与外包的控制
8.5 Development of goods and services 产品与服务开发
8.6 Production of goods and provision of services 产品生产与服务准备
8.7 Release of goods and services 产品与服务提交
8.8 Nonconforming goods and services 不合格的产品与服务
9 Performance evaluation 绩效评估
9.1 Monitoring, measurement, analysis and evaluation 监视,测量,分析与评估
9.2 Internal audit 内部审核
9.3 Management review 管理评审
10 Improvement 改进
10.1 Nonconformity and corrective action 不合格与纠正措施
10.2 Improvement 改进
