【正文】 cial 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。 適用的工具和技巧 應(yīng) 被組織識(shí)別 。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。 ? 6 Resource managem 6 資源管理 Cleanliness of premises The anization shall maintain its premises in a state of order， cleanliness and repair consistent with the product and manufacturing process needs. 廠區(qū)的清潔 組織 應(yīng) 保持廠區(qū)與產(chǎn)品一致的有序、清潔，并按產(chǎn)品和制造過(guò)程需求進(jìn)行適當(dāng)?shù)木S護(hù)。計(jì)數(shù)值抽樣的接受水準(zhǔn) 應(yīng) 為零缺陷。 d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). The output of this planning shall be in a form suitable for the anization’ s method of operations. 產(chǎn)品實(shí)現(xiàn)的策劃 組織 應(yīng) 策劃和開發(fā)產(chǎn)品實(shí)現(xiàn)所需的過(guò)程 .產(chǎn)品實(shí)現(xiàn)的策劃 應(yīng) 與質(zhì)量管理體系其它過(guò)程的要求相一致 (見 ). a) 產(chǎn)品的質(zhì)量目標(biāo)和要求 b) 針對(duì)產(chǎn)品確定過(guò)程 ,文件和資源的需求 c) 產(chǎn)品所要求的驗(yàn)證 ,確認(rèn) ,監(jiān)視 ,檢驗(yàn)和試驗(yàn)活動(dòng) ,以及產(chǎn)品接收準(zhǔn)則 d) 為實(shí)現(xiàn)過(guò)程及其產(chǎn)品滿足要求提供證據(jù)所需的記錄 (見 ) 策劃的輸出形式 應(yīng) 適用于組織的運(yùn)作方式 . ? 7 product realization 7 產(chǎn)品實(shí)現(xiàn) Planning of product realization NOTE 1: A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2: The anization may also apply the requirements given in to the development of product realization processes. 產(chǎn)品實(shí)現(xiàn)的策劃 注 1: 對(duì)應(yīng)用于特定產(chǎn)品 ,項(xiàng)目或合同的質(zhì)量管理體系的過(guò)程(包括產(chǎn)品實(shí)現(xiàn)過(guò)程 )和資源作出規(guī)定的文件可稱之為質(zhì)量計(jì)劃 . 注 2: 組織也可將 用于產(chǎn)品實(shí)現(xiàn)過(guò)程的開發(fā) ? 7 product realization 7 產(chǎn)品實(shí)現(xiàn) NOTE Some customers refer to project management or advanced product quality planning as a means to achieve product product quality planning embodies the concepts of error prevention and continual improvement as contrasted with error detection and is based on a multidisciplinary approach. 注 一些客戶借助項(xiàng)目管理或先期產(chǎn)品質(zhì)量策劃作為產(chǎn)品實(shí)現(xiàn)手段。應(yīng) 開發(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。 注 2 客戶特殊要求的一個(gè)例子是數(shù)字?jǐn)?shù)據(jù)的應(yīng)用。 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。 注：質(zhì)量目標(biāo)中應(yīng)該注明客戶的期望，并在所定期限內(nèi)可以達(dá)到。 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。 質(zhì)量管理體系的持續(xù)改進(jìn) 管理職責(zé) 測(cè)量，分析，改進(jìn) 產(chǎn)品實(shí)現(xiàn) 資源管理 客 戶 滿 意 客 戶 要 求 產(chǎn)品 增值的過(guò)程 信息傳遞的途徑 質(zhì)量管理體系 8大原則 ? 以客戶為關(guān)注焦點(diǎn) Customer Focus ? 領(lǐng)導(dǎo)作用 Leadership ? 全員參與 Involvement of People ? 過(guò)程方法 Process Approach ? 系統(tǒng)化管理 System Approach to Management ? 持續(xù)改進(jìn) Continual Improvement ? 基于事實(shí)的決策方法 Factual approach to Decision Making ? 與供方互利的關(guān)系 Mutually Beneficial Supplier Relationships 4 Quality management system 質(zhì)量管理體系 General requirements The anization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this international Standards. The anization shall: a) identify the processes needed for the quality management system and their application throughout the anization (see ), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, ? 4 Quality management system 4 質(zhì)量管理體系 總要求 組織 應(yīng) 按本標(biāo)準(zhǔn)的要求建立質(zhì)量管理體系 ,形成文件 ,加以實(shí)施和保持 ,并持續(xù)改進(jìn)其有效性 . 組織 應(yīng) : a) 識(shí)別質(zhì)量管理體系所需的過(guò)程及其在組織中的應(yīng)用 (見 ), b) 確定這些過(guò)程的順序和相互作用 , c) 確定為確保這些過(guò)程的有效運(yùn)行和控制所需的準(zhǔn)則和方法 , ? 4 Quality management system 4 質(zhì)量管理體系 General requirements d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the anization in accordance with the requirements of this international Standard. 總要求 d) 確?？梢垣@得必要的資源和信息 ,以支持這些過(guò)程的運(yùn)行和對(duì)這些過(guò)程的監(jiān)視 , e) 監(jiān)視 ,測(cè)量和分析這些過(guò)程 f) 實(shí)施必要的措施 ,以實(shí)現(xiàn)對(duì)這些過(guò)程策劃的結(jié)果和對(duì)這些過(guò)程的持續(xù)改進(jìn) . 組織 應(yīng) 按本標(biāo)準(zhǔn)的要求管理這些過(guò)程 . ? 4 Quality management system 4 質(zhì)量管理體系 Where an anization chooses to outsource any process that affects product conformity with requirements, the anization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. Note: Process needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 針對(duì)組織所選擇的任何影響產(chǎn)品符合要求的外包過(guò)程 ,組織 應(yīng) 確保對(duì)其實(shí)施控制 .對(duì)此類外包過(guò)程的控制 應(yīng) 在質(zhì)量管理體系中加以識(shí)別 . 注 :上述質(zhì)量管理體系所需的過(guò)程應(yīng)當(dāng)包括與管理活動(dòng) ,資源提供 ,產(chǎn)品實(shí)現(xiàn)和測(cè)量有關(guān)的過(guò)程 . ? 4 Quality management system 4 質(zhì)量管理體系 General requirements Supplemental Ensuring control over outsourced processes shall not absolve the anization of the responsibility of conformity to all customers requirements. NOTE See also and 總則 補(bǔ)充 確保控制外包過(guò)程 不應(yīng) 免除組織對(duì)符合所有客戶要求的職責(zé)。 記錄的保持 記錄控制 應(yīng) 滿足法規(guī)和客戶要求。包括選擇特殊特性、建立質(zhì)量目標(biāo)和相關(guān)的培訓(xùn)、糾正和預(yù)防措施、產(chǎn)品設(shè)計(jì)和開發(fā)。 ? 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。 Employee motivation and em