【正文】 b) the need to establish processes, documents, and provide resources specific to the product。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。 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(guò)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(guò)程有效性 最高管理層 應(yīng) 評(píng)審產(chǎn)品的實(shí)現(xiàn)過(guò)程和支持過(guò)程以確保它們的有效性和效率。 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。 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。 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。 61 ? 7 product realization 7 產(chǎn)品實(shí)現(xiàn) Acceptance criteria Acceptance criteria shall be defined by the anization and， where required, approved by the customer. For attribute data sampling，acceptance level shall be zero defects. (see ) 接受準(zhǔn)則 接受準(zhǔn)則 應(yīng) 由組織規(guī)定，在需要時(shí)，由客戶審批。 Plant, facility and equipment planning The anization shall use a multidisciplinary approach (see ) for developing plant, facility and equipment plans. Plant layouts shall optimize material travel, handling and valueadded use of floor space, and shall facilitate synchronous material flow. Methods shall be developed and implemented to evaluate and monitor the effectiveness of existing operations. 51 ? 6 Resource managem 6 資源管理 工廠，設(shè)施和設(shè)備策劃 注 這些要求應(yīng)該關(guān)注于精益生產(chǎn)原則及與質(zhì)量管理體系有效性的連系。 35 ? 5 Management responsibility 5 管理層職責(zé) These results shall be recorded to provide, as a minimum, evidence of the achievement of: the quality objectives specified in the business plan, and customer satisfaction with product supplied. 這些結(jié)果 應(yīng) 被記錄，至少可提供作為證據(jù)達(dá)到： 業(yè)務(wù)計(jì)劃中規(guī)定的質(zhì)量目標(biāo)，和 客戶對(duì)產(chǎn)品提供的滿意度。實(shí)施 應(yīng) 包括更新文件。 組織 應(yīng) 保持在生產(chǎn)中的每一個(gè)更改實(shí)施日期的記錄。 管理評(píng)審的其中部分 應(yīng) 是質(zhì)量目標(biāo)的監(jiān)控，定期報(bào)告和評(píng)價(jià)不良質(zhì)量成本。應(yīng) 開(kāi)發(fā)和實(shí)施方法來(lái)評(píng)估和監(jiān)控現(xiàn)有運(yùn)作的有效性。計(jì)數(shù)值抽樣的接受水準(zhǔn) 應(yīng) 為零缺陷。這個(gè)過(guò)程 應(yīng) 包括整個(gè)組織對(duì)質(zhì)量和技術(shù)意識(shí)的提升。 30 ? 5 Management responsibility 5 管理層職責(zé) Management representative Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the anization. NOTE: The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 管理者代表 最高管理者 應(yīng) 指定一名管理者 ,無(wú)論該成員在其它方面的職責(zé)如何 ,應(yīng) 具有以下方面的職責(zé)和權(quán)限 : a) 確保質(zhì)量管理體系所需的過(guò)程得到建立 ,實(shí)施和保持 , b) 向最高管理者報(bào)告質(zhì)量管理體系的業(yè)績(jī)和任何改進(jìn)的需求 , c) 確保在整個(gè)組織內(nèi)提高滿足顧客要求的意識(shí) . 注 : 管理者代表的職責(zé)可包括與質(zhì)量管理體系有關(guān)事宜的外部聯(lián)絡(luò) . 31 ? 5 Management responsibility 5 管理層職責(zé) Customer representative Top management shall designate personnel with responsibility and authority to ensure the customer requirements are addressed. This includes selection of special characteristics, setting quality objectives and related training, corrective and preventive actions, product design and development. 客戶代表 最高管理層 應(yīng) 指派人員擁有職責(zé)和權(quán)限以確保滿足客戶要求。 過(guò)程方法 組織內(nèi)諸過(guò)程的系統(tǒng)的應(yīng)用，連同這些過(guò)程的識(shí)別和相互作用及其管理，可稱之為“過(guò)程方法”。 記錄的保持 記錄控制 應(yīng) 滿足法規(guī)和客戶要求。 44 ? 6 Resource managem 6 資源管理 Training The anization shall establish and maintain documented procedures for identifying training 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(shí)別培訓(xùn)需求和影響產(chǎn)品質(zhì)量的所有員工具備能力。 56 7 Product Realiz