【正文】 ....................................................................................................................... 27 設(shè)計驗證 ....................................................................................................................... 28 設(shè)計確認 ....................................................................................................................... 28 設(shè)計更改的控制 ............................................................................................................. 29 采購 ..................................................................................................................................... 29 采購過程 ....................................................................................................................... 29 采購信息 ....................................................................................................................... 30 采購產(chǎn)品的驗證 ............................................................................................................. 30 生產(chǎn)和服務(wù)的提供 ................................................................................................................ 31 生產(chǎn)和服務(wù)提供的控制 .................................................................................................. 31 生產(chǎn)和服務(wù)提供過程的確認 ........................................................................................... 34 標(biāo)識和可追溯性 ............................................................................................................. 35 顧客財產(chǎn) ....................................................................................................................... 35 產(chǎn)品防護 ....................................................................................................................... 36 監(jiān)視和測量裝置的控制 ......................................................................................................... 36 測量系統(tǒng)分析 ................................................................................................................ 37 校準(zhǔn) /驗證記錄 .............................................................................................................. 37 實驗室要求 .................................................................................................................... 388 測量、分析和改進 ....................................................................................................................... 40 總則 ..................................................................................................................................... 40 統(tǒng)計工具的確定 ............................................................................................................. 40 基礎(chǔ)統(tǒng)計概念知識 ......................................................................................................... 40 監(jiān)視和測量 ........................................................................................................................... 40 顧客滿意度 .................................................................................................................... 40 內(nèi)部審核 ....................................................................................................................... 40 過程的監(jiān)視和測量 ......................................................................................................... 42 產(chǎn)品的監(jiān)視和測量 ......................................................................................................... 43 不合格品控制 ....................................................................................................................... 44 不合格品控制 — 補充 ...................................................................................................... 44 返工產(chǎn)品的控制 ............................................................................................................. 45 顧客信息 ..........................................................................................................