【正文】 .....................................................................................................81. 范圍 ......................................................................................................................................112. 規(guī)范性引用文件 ..................................................................................................................113. 術語和定義 ..........................................................................................................................114. 組織環(huán)境 ..............................................................................................................................11 理解組織及其環(huán)境 .......................................................................................................11 理解相關方的需求和期望 ...........................................................................................12 確定質(zhì)量管理體系的范圍 ...........................................................................................13 質(zhì)量管理體系及其過程 ...............................................................................................135. 領導作用 ..............................................................................................................................13. 領導作用和承諾 .......................................................................................................13. 方針 ...........................................................................................................................14. 制定質(zhì)量方針 ................................................................................................14. 溝通質(zhì)量方針 ................................................................................................14 組織的崗位、職責和權限 ...........................................................................................156. 策劃 ......................................................................................................................................16. 應對風險和機遇的措施 ...........................................................................................16. 質(zhì)量目標及其實現(xiàn)的策劃 .......................................................................................17. 組織的質(zhì)量目標 ............................................................................................17. 質(zhì)量目標實現(xiàn)的策劃 ....................................................................................18. 變更的策劃 ...............................................................................................................187. 支持 ......................................................................................................................................19. 資源 ...........................................................................................................................19. 總則 ................................................................................................................19. 人員 ................................................................................................................19. 基礎設施 ........................................................................................................19. 過程運行環(huán)境 ................................................................................................20. 監(jiān)視和測量資源 ............................................................................................20. 組織的知識 ....................................................................................................21. 能力 ...........................................................................................................................21. 意識 ...........................................................................................................................22. 溝通 ...........................................................................................................................22. 形成文件的信息 .......................................................................................................23. 質(zhì)量管理體系文件結(jié)構(gòu) ................................................................................23. 形成文件的信息的控制 ................................................................................238. 運行 ......................................................................................................................................25. 運行策劃和控制 .......................................................................................................25. 產(chǎn)品和服務的要求 ...................................................................................................25. 顧客溝通 ........................................................................................................25. 與產(chǎn)品和服務有關的要求的確定 ................................................................26. 與產(chǎn)品和服務有關的要求的評審 ................................................................26. 產(chǎn)品和服務要求的更改 ................................................................................272 / 44. 產(chǎn)品和服務的設計和開發(fā) .......................................................................................27. 總則 ................................................................................................................27. 設計和開發(fā)策劃 ............................................................................................27. 設計和開發(fā)輸入 ............................................................................................28. 設計和開發(fā)控制 ............................................................................................28. 設計和開發(fā)輸出 ............................................................................................28. 設計和開發(fā)的更改 ........................................................................................29. 外部提供過程、產(chǎn)品和服務的控制 .................................................................29 總則 ....................................................................................................................29 控制類型和程度 ................................................................................................2