【正文】 ......................................................................... 25 總則 General .................................................................................................................... 25 培訓(xùn)、意識和能力 petence, awareness and raining ...................................................... 25 產(chǎn)品設(shè)計(jì)技能 Product design skills................................................................................. 26 培訓(xùn) Training ................................................................................................................. 26 員工積極性和授權(quán) employee motivation and empowerment ............................................ 26 基礎(chǔ)設(shè)施 Infrastructure ....................................................................................................... 26 場地、設(shè)施和設(shè)備的策劃 Plant, facility and equipment planning....................................... 27 偶發(fā)事故的應(yīng)急計(jì)劃 Contingency plans........................................................................... 27 工作環(huán)境 Work environment ............................................................................................... 27 員工安全 Personnel safety ................................................................................................ 27 生產(chǎn)現(xiàn)場的清潔 Cleanliness of Premises .......................................................................... 27 支持性文件 Supportive documents....................................................................................... 27 7. 產(chǎn)品實(shí)現(xiàn) Product Realization ................................................................................................ 27 目的與范圍 Goal and scope ................................................................................................. 27 實(shí)現(xiàn)過程的策劃 planning of product realization ................................................................... 28 與顧客有關(guān)的過程 Customer related processes .................................................................... 28 Determination of Requirements Related to Product ............................................................... 28 Review of Requirements Related to Product ......................................................................... 29 Customer munication ............................................................................................. 29 設(shè)計(jì)和開發(fā) Design and development ................................................................................... 29 采購 Purchasing .................................................................................................................. 30 Purchasing process.............................................................................................................. 30 Purchasing information ....................................................................................................... 30 Verification of Purchased Product ........................................................................................ 30 生產(chǎn)和服務(wù)提供 Production and service provision ................................................................ 30 生產(chǎn)和服務(wù)提供的控制 Control of production and service provision. ................................. 30 控制計(jì)劃 Control plan .................................................................................................... 31 作業(yè)指導(dǎo)書 Work instruction .......................................................................................... 31 作業(yè)設(shè)定的驗(yàn)證 Verification of job setups ..................................................................... 31 預(yù) 防性和預(yù)測性維護(hù) Preventive and predictive maintenance ........................................... 31 生產(chǎn)計(jì)劃 Production scheduling...................................................................................... 32 服務(wù)信息反饋 Feedback of information from service........................................................ 32 與客戶的服務(wù)協(xié)議 Service agreements with customer ..................................................... 32 標(biāo)識和可追溯性 Identification and traceability .................................................................. 33 顧客財(cái)產(chǎn) Customer Property............................................................................................. 33 產(chǎn)品防護(hù) Preservation of product ...................................................................................... 33 環(huán)境及 職業(yè)健康安全運(yùn)行控制 EHS Operation Control...................................................... 34 監(jiān)視和測量設(shè)備的控制 Control of monitoring and measuring devices .................................. 34 測量系統(tǒng)分析 MSA .......................................................................................................... 35 實(shí)驗(yàn)室要求 Laboratory requirements ................................................................................. 36 支持性文件 Supportive Document ....................................................................................... 36 8. 測 量、分析和改進(jìn) Measurement, Analysis and improvement ................................................. 36 目的與范圍 Goal and scope ................................................................................................. 36 總則 General ....................................................................................................................... 37 測量和監(jiān)視 Monitoring and measurement ............................................................................ 37 顧客滿意度 Customer satisfaction ..................................................................................... 37 內(nèi)部體系審核 internal audit.............................................................................................. 38 管理體系審核 Quality management system audit ............................................................. 38 過程質(zhì)量審核 Manufacturing process audit ..................................................................... 38 產(chǎn)品質(zhì)量審核 Product audit............................................................................................ 38 內(nèi)部審核計(jì)劃 Internal audi