【正文】 cess activities. 人員安全以達到產(chǎn)品質(zhì)量 產(chǎn)品安全性和降低對員工的潛在風險的方法 應 由組織提出，尤其是設計和開發(fā)過程及生產(chǎn)過程活動。 Training on the job The anization shall provide on the job training for personnel in any new or modified job affecting product quality including contract or agency personnel. Personnel whose work can affect quality shall be informed about the consequences to the customer of nonconformity to quality requirements. 47 ? 6 Resource managem 6 資源管理 員工的積極性和推動 組織 應 具備一過程以激勵員工達成質(zhì)量目標，做到持續(xù)改進，并創(chuàng)造一個促進革新的環(huán)境。 38 ? 5 Management responsibility 5 管理層職責 Review output The output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. 評審輸出 管理評審的輸出 應 包括與以下方面有關的任何決定和措施 : a) 質(zhì)量管理體系及其過程有效性的改進 b) 與顧客要求有關的產(chǎn)品的改進 c) 資源需求 . 39 6 Resource management 資源管理 40 ? 6 Resource management 6 資源管理 Provision of resources The anization shall determine and provide the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 資源提供 組織 應 確定并提供以下方面所需的資源 : a) 實施 ,保持質(zhì)量管理體系并持續(xù)改進其有效性 , b) 通過滿足顧客要求 ,增強顧客滿意 . 41 ? 6 Resource management 6 資源管理 Human resources General Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience. 人力資源 總則 基于適當?shù)慕逃?,培訓 ,技能和經(jīng)驗 ,從事影響產(chǎn)品質(zhì)量工作的人員 應 是能夠勝任的 . 42 ? 6 Resource management 6 資源管理 Competence, awareness and training The anization shall: a) determine the necessary petence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience. 能力 ,意識和培訓 組織 應 : a) 確定從事影響產(chǎn)品質(zhì)量工作的人員所必要的能力 , b) 提供培訓或采取其它措施以滿足這些需求 , c) 評價所采取措施的有效性 , d) 確保員工認識到所從事活動的相關性和重要性 ,以及如何為實現(xiàn)質(zhì)量目標作出貢獻 , e) 保持教育 ,培訓 ,技能和經(jīng)驗的適當記錄 . 43 ? 6 Resource management 6 資源管理 Product design skills The anization shall ensure that personnel with product design responsibility are petent to achieve design requirements and are skilled in applicable tools and techniques. Applicable tools and techniques shall be identified by the anization. 產(chǎn)品設計技術 組織 應 確保負責產(chǎn)品設計的人員有能力完成設計要求并熟練使用適用的工具和技巧。 所有班次的生產(chǎn)運作 應 有人員看管，或委派相關職責人員以確保產(chǎn)品質(zhì)量。 18 ? 4 Quality management system 4 質(zhì)量管理體系 Control of records Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records. 記錄控制 應 建立并保持記錄 ,以提供符合要求和質(zhì)量管理體系有效運行的證據(jù) .記錄應保持清晰 ,易于識別和檢索 .應 編制形成文件的程序 ,以規(guī)定記錄的標識 ,貯存 ,保護 ,檢索 ,保存期限和處置所需的控制 . 19 ? 4 Quality management system 4 質(zhì)量管理體系 NOTE 1: “ Disposition” above includes disposal. NOTE 2: “ Records” also include customerspecified records. Records retention The control of records shall satisfy regulatory and customer requirement. 注 1：上述的“處置”包括處理。 1 Quality system documentation progression 2 Key Words 關鍵詞語 ? Shall – mandatory requirements 應 – 強制性要求 ? Should – remendation 應該 – 建議 ? Note – guidance for understanding 注 – 指南以便明白 ? Such as – for guidance 例如 – 指導性 ? Documented procedure – must have documented system procedure 文件化程序 – 必須有文件化的體系程序 3 Process An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Process Approach The application of a system of processes within an anization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”. 過程 通過使用資源和管理 ,將輸入轉(zhuǎn)化為輸出的活動可視為過程。 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 包括 : a) 形成文件的質(zhì)量方針和質(zhì)量目標 b) 質(zhì)量手冊 c) 本標準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 行和控制所需的文件 e) 本標準所要求的記錄 (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 the quality management system documentation can differ from one anization to another due to: a) th