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

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Quality management systems —

Requirements

Systèmes de management de la qualité — Exigences

INTERNATIONAL

STANDARD

ISO

9001

Fifth edition

2015-09-15

Reference number

ISO 9001:2015(E)



                  



the requester.



Ch. de Blandonnet 8 • CP 401

CH-1214 Vernier, Geneva, Switzerland

Tel. +41 22 749 01 11

Fax +41 22 749 09 47



www.iso.org

ISO 9001:2015(E)

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

  ..................................................................................................................................................................................... 1

4 Context of the organization ....................................................................................................................................................................... 1

4.1 Understanding the organization and its context ....................................................................................................... 1

4.2 Understanding the needs and expectations of interested parties .............................................................. 2

  ............................................................................. 2

  .......................................................................................................... 2

5 Leadership .................................................................................................................................................................................................................. 3

5.1 Leadership and commitment ..................................................................................................................................................... 3

5.1.1 General...................................................................................................................................................................................... 3

5.1.2 Customer focus .................................................................................................................................................................. 3

  ............................................................................................................................................................................................................... 4

  ............................................................................................................................. 4

  .................................................................................................................... 4

5.3 Organizational roles, responsibilities and authorities.......................................................................................... 4

6 Planning ......................................................................................................................................................................................................................... 4

6.1 Actions to address risks and opportunities ................................................................................................................... 4

  ...................................................................................................... 5

6.3 Planning of changes ............................................................................................................................................................................ 5

7 Support ........................................................................................................................................................................................................................... 6

7.1 Resources ..................................................................................................................................................................................................... 6

7.1.1 General...................................................................................................................................................................................... 6

7.1.2 People ........................................................................................................................................................................................ 6

7.1.3 Infrastructure ..................................................................................................................................................................... 6

7.1.4 Environment for the operation of processes ........................................................................................... 6

7.1.5 Monitoring and measuring resources ........................................................................................................... 7

7.1.6 Organizational knowledge ....................................................................................................................................... 7

7.2 Competence ............................................................................................................................................................................................... 8

7.3 Awareness ................................................................................................................................................................................................... 8

7.4 Communication ...................................................................................................................................................................................... 8

7.5 Documented information ............................................................................................................................................................... 8

7.5.1 General...................................................................................................................................................................................... 8

7.5.2 Creating and updating ................................................................................................................................................. 9

7.5.3 Control of documented information ............................................................................................................... 9

8 Operation ..................................................................................................................................................................................................................... 9

8.1 Operational planning and control .......................................................................................................................................... 9

8.2 Requirements for products and services ...................................................................................................................... 10

8.2.1 Customer communication .....................................................................................................................................10

8.2.2 Determining the requirements for products and services ....................................................... 10

8.2.3 Review of the requirements for products and services ..............................................................10

8.2.4 Changes to requirements for products and services ..................................................................... 11

8.3 Design and development of products and services ..............................................................................................11

8.3.1 General................................................................................................................................................................................... 11

8.3.2 Design and development planning ................................................................................................................ 11

8.3.3 Design and development inputs ...................................................................................................................... 11

8.3.4 Design and development controls .................................................................................................................12

8.3.5 Design and development outputs .................................................................................................................. 12

8.3.6 Design and development changes .................................................................................................................. 12

Contents Page

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标签： #ISO #质量管理

摘要：

ISO 9001:2015是国际标准化组织（ISO）发布的质量管理体系标准，其核心在于“以顾客为关注焦点”，并采用“过程方法” 和“基于风险的思维”来引导组织建立、实施、保持和改进质量管理体系。该标准适用于任何类型与规模的组织，它不规定具体的产品/服务质量标准，而是提供一个系统性的管理框架，要求组织识别内外部环境、理解相关方需求和期望，将各项活动和资源作为相互关联的过程进行管理，并积极应对风险和机遇。通过贯彻PDCA（策划-实施-检查-处置）循环，旨在持续改进过程，确保稳定地提供满足顾客和适用法律法规要求的产品与服务，最终旨在增强顾客满意度。获得ISO 9001认证标志着组织已建立起一套规范、有效的质量管理体系。

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