ISO9001质量管理体系要求中文Word格式文档下载.docx

ISO9001质量管理体系要求中文Word格式文档下载.docx

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前言....................................................................................I引言...................................................................................II0.1总则..................................................................................II0.2质量管理原则..........................................................................II0.3过程方法.............................................................................III0.4与其他管理体系标准的关系...............................................................V

1.范围....................................................................................1

2规范性引用文件..........................................................................1

3术语和定义..............................................................................1

4组织环境.................................................................................1

4.1理解组织及其环境.......................................................................1

4.2理解相关方的需求和期望.................................................................1

4.3确定质量管理体系的范围.................................................................1

4.4质量管理体系及其过程...................................................................25领导作用..................................................................................

5.1领导作用和承诺......................................................................2

5.1.1总则................................................................................2

5.1.2以顾客为关注焦点....................................................................2

5.2方针................................................................................3

5.2.1制定质量方针........................................................................3

5.2.2沟通质量方针........................................................................3

5.3组织的岗位、职责和权限..............................................................3

6策划....................................................................................3

6.1应对风险和机遇的措施...................................................................3

6.2质量目标及其实现的策划.................................................................4

6.3变更的策划.............................................................................4

7支持....................................................................................4

7.1资源...................................................................................4

7.2能力...................................................................................6

7.3意识...................................................................................6

7.4沟通...................................................................................6

7.5形成文件的信息.........................................................................6

8运行....................................................................................7

8.1运行策划和控制.........................................................................7

8.2产品和服务的要求.......................................................................7

8.2.1顾客沟通............................................................................7

8.2.2与产品和服务有关的要求的确定.........................................................7

8.2.3产品和服务有关的要求的评审...........................................................8

8.2.4产品和服务要求的更改.................................................................8

8.3产品和服务的设计和开发.................................................................8

8.3.1总则.................................................................................8

8.3.2设计和开发策划.......................................................................8

8.3.3设计和开发输入.......................................................................8

8.3.4设计和开发控制.......................................................................9

8.3.5设计和开发输出.......................................................................9

.......................................................................98.3.6设计和开发更改

8.4外部提供过程、产品和服务的控制......................................................9

8.4.1总则.................................................................................9

8.4.2控制类型和程度.....................................................................10

8.5生产和服务提供.....................................................................10

8.6产品和服务的放行......................................................................11

8.7不合格输出的控制......................................................................12

9绩效评价................................................................................12

9.1监视、测量、分析和评价................................................................12

9.2内部审核..............................................................................13

9.3管理评审...........................