【正文】 ......................................................................................................... 15 基礎(chǔ)設(shè)施 .............................................................................................................................. 17 工廠、設(shè)施和設(shè)備策劃 .................................................................................................. 17 應(yīng)急計(jì)劃 ....................................................................................................................... 17 工作環(huán)境 .............................................................................................................................. 18 確保人員安全以達(dá)到產(chǎn)品質(zhì)量 ........................................................................................ 18 生產(chǎn)現(xiàn)場(chǎng)的清潔 ............................................................................................................. 18 7 產(chǎn)品實(shí)現(xiàn) ............................................................................................................................................ 20 產(chǎn)品實(shí)現(xiàn)的策劃 .................................................................................................................... 20 產(chǎn)品實(shí)現(xiàn)的策劃 —補(bǔ)充 .................................................................................................. 20 接收準(zhǔn)則 ....................................................................................................................... 20 保密 .............................................................................................................................. 20 更改控制 ....................................................................................................................... 21 與顧客有關(guān)的過程 ................................................................................................................ 21 與產(chǎn)品 相關(guān)的要求的確定 ............................................................................................... 21 與產(chǎn)品有關(guān)要求的評(píng)審 .................................................................................................. 22 顧客溝通 ....................................................................................................................... 22 設(shè)計(jì)和開發(fā) ........................................................................................................................... 23 設(shè)計(jì)和開發(fā)的策劃 ......................................................................................................... 23 設(shè)計(jì)輸入 ....................................................................................................................... 24 設(shè)計(jì)輸出 ....................................................................................................................... 24 設(shè)計(jì)評(píng)審 ....................................................................................................................... 25 設(shè)計(jì)驗(yàn)證 ....................................................................................................................... 25 設(shè)計(jì)確認(rèn) ....................................................................................................................... 26 設(shè)計(jì)更改的控制 ............................................................................................................. 26 采購(gòu)過程 .............................................................................................................................. 27 法規(guī)的符合性 ................................................................................................................ 27 供方質(zhì)量管理體系的開發(fā) ............................................................................................... 27 顧客批準(zhǔn)的供方 ............................................................................................................. 27 采購(gòu)信息 ....................................................................................................................... 28 采購(gòu)產(chǎn)品的驗(yàn)證 ............................................................................................................. 28 生產(chǎn)和服務(wù)的提供 ................................................................................................................ 28 生產(chǎn)和服務(wù)提供的控制 .................................................................................................. 28 生產(chǎn)和服務(wù)提供過程的確認(rèn) ........................................................................................... 31 標(biāo)識(shí)和可追溯性 ............................................................................................................. 32 顧客財(cái)產(chǎn) ....................................................................................................................... 32 產(chǎn)品防護(hù) ....................................................................................................................... 33 監(jiān)視和測(cè)量裝置的控制 ......................................................................................................... 33 測(cè)量系統(tǒng)分析 ................................................................................................................ 34 校準(zhǔn) /驗(yàn)證記錄 .............................................................................................................. 34 實(shí)驗(yàn)室要求 .................................................................................................................... 35 8 測(cè)量、分析和改進(jìn) .............................................................................................................................. 36 總則 ..................................................................................................................................... 36 統(tǒng)計(jì)工具的確定 ............................................................................................................. 36 基礎(chǔ)統(tǒng)計(jì)概念知識(shí) ......................................................................................................... 36 監(jiān)視和測(cè)量 ........................................................................................................................... 36 顧客滿意度 ................................................................................