【正文】 needs and achieving petence of all personnel performing activities affecting product quality. Personnel performing specific assigned tasks shall be qualified， as required with particular attention to the satisfaction of customer requirements. 培訓(xùn) 組織 應(yīng) 建立和保持文件化程序以識別培訓(xùn)需求和影響產(chǎn)品質(zhì)量的所有員工具備能力。 Employee motivation and empowerment The anization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole anization. 48 ) ? 6 Resource managem 6 資源管理 員工的積極性和推動 組織 應(yīng) 具備一測量過程以保證其人員了解他們活動的恰當(dāng)性和重要性及他們?nèi)绾斡兄谶_(dá)到質(zhì)量目標(biāo) (見 d)。 56 ) 7 Product Realization 產(chǎn)品實現(xiàn) 57 ) ? 7 product realization 7 產(chǎn)品實現(xiàn) Planning of product realization The anization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see ). a) quality objectives and requirements for the product。 (見 ) 62 ) ? 7 product realization 7 產(chǎn)品實現(xiàn) Confidentiality The anization shall ensure the confidentiality of customer cont。 c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。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。 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。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)過程的實質(zhì)部分。 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。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。 注：見 和 11 ) ? 4 Quality management system 4 質(zhì)量管理體系 Documentation requirements General The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this international Standard, d) documents needed by the anization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see ) Documentation requirements 總則 質(zhì)量管理體系文件 應(yīng) 包括 : a) 形成文件的質(zhì)量方針和質(zhì)量目標(biāo) b) 質(zhì)量手冊 c) 本標(biāo)準(zhǔn)所要求的形成文件的程序 d) 組織為確保其過程的有效策劃 ,運(yùn) 行和控制所需的文件 e) 本標(biāo)準(zhǔn)所要求的記錄 (見 ) 12 ) ? 4 Quality management system 4 質(zhì)量管理體系 NOTE 1: Where the term documented procedure appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2: The extent of th