【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。 5 Management responsibility 管理層職責(zé) ? 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 , ? 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. 過程有效性 最高管理層 應(yīng) 評(píng)審產(chǎn)品的實(shí)現(xiàn)過程和支持過程以確保它們的有效性和效率。進(jìn)行及時(shí)的評(píng)審應(yīng)該盡早，并且不 應(yīng) 超過 2個(gè)工作周。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(píng)審 總則 最高管理者 應(yīng) 按策劃的時(shí)間間隔評(píng)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(píng)審 應(yīng) 包括評(píng)價(jià)質(zhì)量管理體系改進(jìn)的機(jī)會(huì)和變更的需要 ,包括質(zhì)量方針和質(zhì)量目標(biāo) .. 應(yīng) 保持管理評(píng)審的記錄 (見 ). ? 5 Management responsibility 5 管理層職責(zé) 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(jī)效 這些評(píng)審 應(yīng) 包括質(zhì)量管理體系的所有要求，并且將它的績(jī)效趨勢(shì)作為持續(xù)改進(jìn)過程的實(shí)質(zhì)部分。工廠的布局 應(yīng) 優(yōu)化材料的運(yùn)輸，搬運(yùn)及增值使用空間，并 應(yīng) 方便材料的同步流動(dòng)。 (見 ) ? 7 product realization 7 產(chǎn)品實(shí)現(xiàn) Confidentiality The anization shall ensure the confidentiality of customer contracted products and projects under development, and related product information. 保密性 組織 應(yīng) 確?？蛻艏s定的產(chǎn)品，開發(fā)的項(xiàng)目和相關(guān)產(chǎn)品信息的保密性。 Employee motivation and empowerment The anization shall have a process to motivate employees to achieve quality objectives, to make continual improvements, and to create an environment to promote innovation. The process shall include the promotion of quality and technological awareness throughout the whole anization. ? 6 Resource managem 6 資源管理 員工的積極性和推動(dòng) 組織 應(yīng) 具備一測(cè)量過程以保證其人員了解他們活動(dòng)的恰當(dāng)性和重要性及他們?nèi)绾斡兄谶_(dá)到質(zhì)量目標(biāo) (見 d)。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)。 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程及其在組織中的應(yīng)用 (見 ), b) 確定這些過程的順序和相互作用 , c) 確定為確保這些過程的有效運(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 ,以支持這些過程的運(yùn)行和對(duì)這些過程的監(jiān)視 , e) 監(jiān)視 ,測(cè)量和分析這些過程 f) 實(shí)施必要的措施 ,以實(shí)現(xiàn)對(duì)這些過程策劃的結(jié)果和對(duì)這些過程的持續(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程 ,組織 應(yīng) 確保對(duì)其實(shí)施控制 .對(duì)此類外包過程的控制 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)的過程 .