【正文】 cess activities. 人員安全以達(dá)到產(chǎn)品質(zhì)量 產(chǎn)品安全性和降低對(duì)員工的潛在風(fēng)險(xiǎn)的方法 應(yīng) 由組織提出，尤其是設(shè)計(jì)和開發(fā)過(guò)程及生產(chǎn)過(guò)程活動(dòng)。 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(dòng) 組織 應(yīng) 具備一過(guò)程以激勵(lì)員工達(dá)成質(zhì)量目標(biāo)，做到持續(xù)改進(jìn)，并創(chuàng)造一個(gè)促進(jìn)革新的環(huán)境。 38 ? 5 Management responsibility 5 管理層職責(zé) 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(píng)審輸出 管理評(píng)審的輸出 應(yīng) 包括與以下方面有關(guān)的任何決定和措施 : a) 質(zhì)量管理體系及其過(guò)程有效性的改進(jìn) b) 與顧客要求有關(guān)的產(chǎn)品的改進(jìn) 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(yīng) 確定并提供以下方面所需的資源 : a) 實(shí)施 ,保持質(zhì)量管理體系并持續(xù)改進(jìn)其有效性 , b) 通過(guò)滿足顧客要求 ,增強(qiáng)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(dāng)?shù)慕逃?,培訓(xùn) ,技能和經(jīng)驗(yàn) ,從事影響產(chǎn)品質(zhì)量工作的人員 應(yīng) 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(shí)和培訓(xùn) 組織 應(yīng) : 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(xùn)或采取其它措施以滿足這些需求 , c) 評(píng)價(jià)所采取措施的有效性 , d) 確保員工認(rèn)識(shí)到所從事活動(dòng)的相關(guān)性和重要性 ,以及如何為實(shí)現(xiàn)質(zhì)量目標(biāo)作出貢獻(xiàn) , e) 保持教育 ,培訓(xùn) ,技能和經(jīng)驗(yàn)的適當(dāng)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(shè)計(jì)技術(shù) 組織 應(yīng) 確保負(fù)責(zé)產(chǎn)品設(shè)計(jì)的人員有能力完成設(shè)計(jì)要求并熟練使用適用的工具和技巧。 所有班次的生產(chǎn)運(yùn)作 應(yīng) 有人員看管，或委派相關(guān)職責(zé)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(yīng) 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(yùn)行的證據(jù) .記錄應(yīng)保持清晰 ,易于識(shí)別和檢索 .應(yīng) 編制形成文件的程序 ,以規(guī)定記錄的標(biāo)識(shí) ,貯存 ,保護(hù) ,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(guān)鍵詞語(yǔ) ? Shall – mandatory requirements 應(yīng) – 強(qiáng)制性要求 ? Should – remendation 應(yīng)該 – 建議 ? Note – guidance for understanding 注 – 指南以便明白 ? Such as – for guidance 例如 – 指導(dǎo)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(guò)程 通過(guò)使用資源和管理 ,將輸入轉(zhuǎn)化為輸出的活動(dòng)可視為過(guò)程。 注：見(jiàn) 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(cè) 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(guò)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(jiàn) ) 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