【正文】 1 目的及適用范圍.......................................................................................................72 術語、縮略語及定義................................................................................................83 質量管理原則...........................................................................................................94 質量管理體系.........................................................................................................10 總要求...............................................................................................................10 文件要求............................................................................................................11 總則.................................................................................................................11 質量手冊..........................................................................................................11 文件控制.........................................................................................................12 記錄控制.........................................................................................................145 管理職責.................................................................................................................16 管理承諾..........................................................................................................16 以顧客為關注焦點............................................................................................16 質量方針............................................................................................................17 策劃....................................................................................................................17 質量目標.........................................................................................................17 質量管理體系策劃...........................................................................................17 職責、權限和溝通...............................................................................................17 職責和權限......................................................................................................18 管理者代表......................................................................................................21 內部溝通.........................................................................................................21 管理評審............................................................................................................21 職責................................................................................................................21 評審程序.........................................................................................................21 相關記錄.........................................................................................................226 資源管理.................................................................................................................23 資源提供............................................................................................................23 人力資源............................................................................................................23 總則................................................................................................................23 能力、意識和培訓...........................................................................................23 基礎設施............................................................................................................24 工作環(huán)境............................................................................................................257 產品實現(xiàn).................................................................................................................26 產品實現(xiàn)的策劃...............................................................................................26 與顧客有關的過程...........................................................................................26 與產品有關的要求的確定...............................................................................26 與產品有關的要求的評審................................................................................27 顧客溝通.........................................................................................................27 設計和開發(fā)........................................................................................................28 采購...................................................................................................................28 采購過程控制..................................................................................................28 采購信息.........................................................................................................28 采購產品的驗證...............................................................................................29 生產和服務提供................................................................................................29 生產和服務提供的控制....................................................................................29 生產和服務提供的確認....................................................................................30 標識和可追溯性...............................................................................................30 顧客財產.........................................................................................................30 產品防護.........................................................................................................30 監(jiān)視和測量裝置的控制.......................................................................................308 檢查、分析和改進....................................................................................................32 總則..................