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isots 169492002 標準講解(206頁)(文件)

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【正文】 t safety and means to minimize potential risks to employees shall be addressed by the anization, especially in design and development process and in the manufacturing process 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。工廠的布局 應 優(yōu)化材料的運輸,搬運及增值使用空間,并 應 方便材料的同步流動。 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。 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 注 1 適用于組織各個階層的對質(zhì)量有影響的所有員工。 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。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 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 包括評價質(zhì)量管理體系改進的機會和變更的需要 ,包括質(zhì)量方針和質(zhì)量目標 .. 應 保持管理評審的記錄 (見 ). 34 ) ? 5 Management responsibility 5 管理層職責 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 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)改進過程的實質(zhì)部分。 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。 23 ) ? 5 Management responsibility 5 管理層職責 Customer focus Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction (see and ). 以顧客為關注焦點 最高管理者 應 以增強顧客滿意為目的 ,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 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 確保質(zhì)量方針 : a) 與組織的宗旨相適應 , b) 包括對滿足要求和持續(xù)改進質(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 Planning Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product (see ) are established at relevant func
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