【正文】 e) 確保文件保持清晰 ,易于識(shí)別 , f) 確保外來文件得到識(shí)別 ,并控制其分發(fā) , g) 防止作廢文件的非預(yù)期使用 ,若因任何原因而保留作廢文件時(shí) ,對(duì)這些文件進(jìn)行適當(dāng)?shù)臉?biāo)識(shí) . 16 ? 4 Quality management system 4 質(zhì)量管理體系 Engineering specifications The anization shall have a process to assure the timely review, distribution and implementation of all customer engineering standards/specifications and changes based on customer required schedule. Timely review should be as soon as possible, and shall not exceed two working weeks. The anization shall maintain a record of the date on which each change is implemented in production. Implementation shall include updates documents. 工程規(guī)范 組織 應(yīng) 有一過程以確保對(duì)所有客戶的工程標(biāo)準(zhǔn) /規(guī)范和更改和在客戶要求的時(shí)間表的基礎(chǔ)上進(jìn)行及時(shí)的評(píng)審，發(fā)放和實(shí)施。 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(jì)記錄或他們影響到生產(chǎn)零件審批過程，諸如控制計(jì)劃，F(xiàn)MEA等時(shí)，這些標(biāo)準(zhǔn) /規(guī)范中的每一個(gè)更改都要求客戶生產(chǎn)零件審批的更新記錄。 20 5 Management responsibility 管理層職責(zé) 21 ? 5 Management responsibility 5 管理層職責(zé) Management mitment Top management shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) municating to the anization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 管理承諾 最高管理者 應(yīng) 通過以下活動(dòng) ,對(duì)其建立 ,實(shí)施質(zhì)量管理體系并持續(xù)改進(jìn)其有效性的承諾提供證據(jù) : a)向組織傳達(dá)滿足顧客和法律法規(guī)要求的重要性 , b) 制定質(zhì)量方針 , c) 確保質(zhì)量目標(biāo)的制定 , d) 進(jìn)行管理評(píng)審 , e) 確保資源的獲得 , 22 ? 5 Management responsibility 5 管理層職責(zé) Process efficiency Top management shall review the product realization processes and the support processes to assure their effectiveness and efficiency. 過程有效性 最高管理層 應(yīng) 評(píng)審產(chǎn)品的實(shí)現(xiàn)過程和支持過程以確保它們的有效性和效率。 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。 32 ? 5 Management responsibility 5 管理層職責(zé) Internal munication Top management shall ensure that appropriate munication processes are established within the anization and that munication takes places regarding the effectiveness of the quality management system. 內(nèi)部溝通 最高管理者 應(yīng) 確保在組織內(nèi)建立適當(dāng)?shù)臏贤ㄟ^程 ,并確保對(duì)質(zhì)量管理體系的有效性進(jìn)行溝通 . 33 ? 5 Management responsibility 5 管理層職責(zé) Management review General Top management shall review the anization39。 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(píng)審輸入 管理評(píng)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(píng)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(píng)審輸入 補(bǔ)充 管理評(píng)審的輸入 應(yīng) 包括對(duì)實(shí)際和潛在使用失效的分析以及它們對(duì)質(zhì)量，安全或環(huán)境的影響。執(zhí)行特殊任務(wù)的員工 應(yīng) 具備資格，特殊關(guān)注按照滿足客戶要求。對(duì)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(duì)客戶的后果。 Employee motivation and empowerment The anization shall have a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (see d). 49 ? 6 Resource management 6 資源管理 Infrastructure The anization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable a) buildings, workspace and associated utilities, b) process equipment, (both hardware and software), and c) supporting services (such as transport or munication). 基礎(chǔ)設(shè)施 組織 應(yīng) 確定 ,提供并維護(hù)為達(dá)到產(chǎn)品符合要求所需的基礎(chǔ)設(shè)施 .適用時(shí) ,基礎(chǔ)設(shè)施包括 : a) 建筑物 ,工作場(chǎng)所和相關(guān)的設(shè)施 b) 過程設(shè)備 (硬件和軟件 ) c) 支持性服務(wù) (如運(yùn)輸或通訊 ). 50 ? 6 Resource managem 6 資源管理 工廠，設(shè)施和設(shè)備策劃 組織 應(yīng) 采用多方論證方式 (見) 以開發(fā)工廠，設(shè)施和設(shè)備的計(jì)劃。 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(jì)劃 組織 應(yīng) 準(zhǔn)備應(yīng)急計(jì)劃以在緊急情況下，諸如供應(yīng)中斷，勞動(dòng)力短缺，關(guān)鍵設(shè)備故障和市場(chǎng)退回時(shí)，滿足客戶要求。 b) the need to establish processes, documents, and provide resources specific to the product。 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(jì)劃的一部分。 63 ? 7 product realization 7 產(chǎn)品實(shí)現(xiàn) Change control The anization shall have a process to control and