【正文】 60 ? 7 product realization 7 產(chǎn)品實(shí)現(xiàn) Planning of product realizationsupplemental Customer requirements and references to its technical specifications shall be included in the planning of product realization as a ponent of the quality plan. 產(chǎn)品實(shí)現(xiàn)的策劃 補(bǔ)充 客戶要求和參考的技術(shù)規(guī)范 應(yīng) 被包括在產(chǎn)品實(shí)現(xiàn)的策劃中作為質(zhì)量計劃的一部分。 Plant, facility and equipment planning NOTE These requirements should focus on lean manufacturing principles and the link to the effectiveness of the quality management system. 52 ? 6 Resource managem 6 資源管理 Contingency plans The anization shall prepare contingency plans to satisfy the customer requirements in the event of an emergency such as utility interruptions, labour shortages, key equipment failure, and field returns. 應(yīng)急計劃 組織 應(yīng) 準(zhǔn)備應(yīng)急計劃以在緊急情況下，諸如供應(yīng)中斷，勞動力短缺，關(guān)鍵設(shè)備故障和市場退回時，滿足客戶要求。對質(zhì)量有影響的員工，應(yīng) 被通知關(guān)于不符合質(zhì)量要求對客戶的后果。 36 ? 5 Management responsibility 5 管理層職責(zé) Review input The input to management review shall include information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) followup actions from previous management reviews, f) planned changes that could affect the quality management system, and g) remendations for improvement. 評審輸入 管理評審的輸入 應(yīng) 包括以下方面的信息 : a) 審核結(jié)果 b) 顧客反饋 c) 過程的業(yè)績和產(chǎn)品的符合性 d) 預(yù)防和糾正措施的狀況 e) 以往管理評審的跟蹤措施 f) 可能影響質(zhì)量管理體系的變更 g) 改進(jìn)的建議 37 ? 5 Management responsibility 5 管理層職責(zé) Review input Supplemental Input to management review shall include an analysis of actual and potential fieldfailures and their impact on quality, safety, or the environment. 評審輸入 補(bǔ)充 管理評審的輸入 應(yīng) 包括對實(shí)際和潛在使用失效的分析以及它們對質(zhì)量，安全或環(huán)境的影響。 賦有產(chǎn)品質(zhì)量職責(zé)的人員 應(yīng) 有權(quán)限停止生產(chǎn)以糾正質(zhì)量問題。 17 ? 4 Quality management system 4 質(zhì)量管理體系 NOTE: A change in these standards / specifications requires an updated record of customer production part approval when these specifications are referenced on the design record or if they affect documents of production part approval process, such as control plan, FMEAs, etc. 注：當(dāng)這些規(guī)范指向設(shè)計記錄或他們影響到生產(chǎn)零件審批過程，諸如控制計劃，F(xiàn)MEA等時，這些標(biāo)準(zhǔn) /規(guī)范中的每一個更改都要求客戶生產(chǎn)零件審批的更新記錄。請勿擴(kuò)散 。進(jìn)行及時的評審應(yīng)該盡早，并且不 應(yīng) 超過 2個工作周。 23 ? 5 Management responsibility 5 管理層職責(zé) Customer focus Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see and ). 以顧客為關(guān)注焦點(diǎn) 最高管理者 應(yīng) 以增強(qiáng)顧客滿意為目的 ,確保顧客的要求得到確定并予以滿足 (見 ). 24 ? 5 Management responsibility 5 管理層職責(zé) Quality policy Top management shall ensure that the quality policy. a) is appropriate to the purpose of the anization, b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is municated and understood within the anization, and e) is reviewed for continuing suitability. 質(zhì)量方針 最高管理者 應(yīng) 確保質(zhì)量方針 : a) 與組織的宗旨相適應(yīng) , b) 包括對滿足要求和持續(xù)改進(jìn)質(zhì)量管理體系有效性的承諾 , c) 提供制定和評審質(zhì)量目標(biāo)的框架 , d) 在組織內(nèi)得到溝通和理解 e) 在持續(xù)適宜性方面得到評審 . 25 ? 5 Management responsibility 5 管理層職責(zé) Planning Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product (see ) are established at relevant functions and levels within the anization. The quality objectives shall be measurable and consistent with the quality policy. 策劃 質(zhì)量目標(biāo) 最高管理者 應(yīng) 確保在組織的相關(guān)職能和層次上建立質(zhì)量目標(biāo) ,質(zhì)量目標(biāo)包括滿足產(chǎn)品要求所需的內(nèi)容 (見).質(zhì)量目標(biāo) 應(yīng) 是可測量的 ,并與質(zhì)量方針保持一致 . 26 ? 5 Management responsibility 5 管理層職責(zé) Quality objectives supplemental Top management shall define quality objectives and measurements that shall be included in the business plan and used to deploy the quality policy. NOTE: Quality objectives should address customer expectations and be achievable within a defined time period. 質(zhì)量目標(biāo) 補(bǔ)充 最高管理層 應(yīng) 確定質(zhì)量目標(biāo)和度量指標(biāo)，應(yīng) 包含于業(yè)務(wù)計劃和用來展開質(zhì)量方針。s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see ) 管理評審 總則 最高管理者 應(yīng) 按策劃的時間間隔評審質(zhì)量管理體系 ,以確保其持續(xù)的適宜性 ,充分性和有效性 .評審 應(yīng) 包括評價質(zhì)量管理體系改進(jìn)的機(jī)會和變更的需要 ,包括質(zhì)量方針和質(zhì)量目標(biāo) .. 應(yīng) 保持管理評審的記錄 (見 ). 34 ? 5 Management responsibility 5 管理層職責(zé) Quality management system performance These reviews shall include all requirements of the quality management system and its performance trends as an essential part of the continual improvement process. Part of the management review shall be the monitoring of quality objectives, and the regular reporting and evaluation of the cost of poor quality (see and ) 質(zhì)量管理體系績效 這些評審 應(yīng) 包括質(zhì)量管理體系的所有要求，并且將它的績效趨勢作為持續(xù)改進(jìn)過程的實(shí)質(zhì)部分。 45 ? 6 Resource managem 6 資源管理 Training NOTE 1 This applies to all employees affecting quality at all levels of the anization. NOTE 2 An example of the customer specific requirements is the application of digitized mathematically based data. 培訓(xùn) 注 1 適用于組織各個階層的對質(zhì)量有影響的所有員工。工廠的布局 應(yīng) 優(yōu)化材料的運(yùn)輸，搬運(yùn)及增值使用空間，并 應(yīng) 方便材料的同步流動。 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。 (見 ) 62 ? 7 product