【正文】 product and the ] criteria for product acceptance。b) the need to establish processes, documents, and provide resources specific to the product。In planning product realization, the organization shall determine the following, as appropriate:在計(jì)劃產(chǎn)品實(shí)現(xiàn)時(shí)組織應(yīng)適當(dāng)?shù)臎Q定如下各項(xiàng)﹕a) quality objectives and requirements for the product。7 Product realization 產(chǎn)品的實(shí)現(xiàn) Planning of product realization 產(chǎn)品實(shí)現(xiàn)的規(guī)劃The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see ).組織應(yīng)建立和實(shí)施產(chǎn)品實(shí)現(xiàn)所需的計(jì)劃和發(fā)展程序。c) supporting services (such as transport or munication). 支援服務(wù)如運(yùn)輸﹑溝通。 Infrastructure 資源結(jié)構(gòu)The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable組織應(yīng)確認(rèn)﹑提供﹑保持達(dá)成產(chǎn)品合格所需的資源結(jié)構(gòu)﹐資源結(jié)構(gòu)包括﹕a) buildings, workspace and associated utilities, 建筑﹑工作場地和相關(guān)設(shè)施。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 確保其員工能意識到他們活動的關(guān)聯(lián)性和重要性以及他們對達(dá)到品質(zhì)目標(biāo)的貢獻(xiàn)。b) provide training or take other actions to satisfy these needs, 提供培訓(xùn)或其他方式以滿足這些需求。 Human resources 人力資源 General 總則Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience.執(zhí)行與產(chǎn)品質(zhì)量有關(guān)工作的人員﹐應(yīng)有適當(dāng)?shù)慕逃p訓(xùn)練﹑技朮和經(jīng)驗(yàn)。c) resource needs. 資源需求6 Resource management 資源管理 Provision of resources 資源的提供The organization shall determine and provide the resources needed組織應(yīng)確定和提供所需資源a) to implement and maintain the quality management system and continually improve its effectiveness, and 執(zhí)行與維持品質(zhì)管理體系并持續(xù)改進(jìn)其有效性。g) remendations for improvement. 改善建議 Review output 評審輸出The output from the management review shall include any decisions and actions related to管理評審輸出應(yīng)包括與以下有關(guān)的決定及措施﹕a) improvement of the effectiveness of the quality management system and its processes, 質(zhì)量管理體系及其流程的有效性改進(jìn)。e) followup actions from previous management reviews, 上一次管理評審的跟蹤情況。() Review input 管理評審輸入The input to management review shall include information on管理評審輸入應(yīng)包括﹕a) results of audits, 審核的結(jié)果b) customer feedback, 客戶的反鑽c) process performance and product conformity, 過程的執(zhí)行及產(chǎn)品的符合性。該評審包括評估質(zhì)量管理體系的改進(jìn)機(jī)會及改進(jìn)需要﹐包括質(zhì)量方針和質(zhì)量目標(biāo)的評審。 Management review 管理評評審習(xí) General 總則Top management shall review the organization39。NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.備注﹕管理者代表的職責(zé)還包括與質(zhì)量管理體系有關(guān)的外部聯(lián)絡(luò)。b) reporting to top management on the performance of the quality management system and any need for improvement, and 向最高管理層報(bào)告質(zhì)量管理體系的執(zhí)行成效及改善需求。 Responsibility, authority and munication 職責(zé)﹑權(quán)力與溝通 Responsibility and authority 職責(zé)與權(quán)力Top management shall ensure that responsibilities and authorities are defined and municated within the organization.最高管理層應(yīng)確保員工的職責(zé)和權(quán)力被確定并在組織內(nèi)進(jìn)行偉達(dá)。 Quality management system planning 質(zhì)量管理體系策劃Top management shall ensure that最高管理層應(yīng)確保﹕a) the planning of the quality management system is carried out in order to meet the requirements given in , as well as the quality objectives, and 。 Planning 策劃 Quality objectives 質(zhì)量目標(biāo)Top management shall ensure that quality objectives, including those needed to meet requirements for product [see a]], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.最高管理層應(yīng)確保在組織的各級相關(guān)職能部門都建立質(zhì)量目標(biāo)﹐質(zhì)量目標(biāo)應(yīng)可被測量﹐并與質(zhì)量方針及持續(xù)改進(jìn)的承諾相一至。c) provides a framework for establishing and reviewing quality objectives, 為目標(biāo)的建立及評審提供框架。e) ensuring the availability of resources. 確保資源得以取用。b) establishing the quality policy, 建立質(zhì)量方針c) ensuring that quality objectives are established, 確保質(zhì)量目標(biāo)被建立。5 Management responsibility 管理職責(zé) Management mitment 管理承諾Top management shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness by最高管理層應(yīng)提供以下証據(jù)﹐以顯示品質(zhì)管理系統(tǒng)的發(fā)展與實(shí)施并進(jìn)行有效的改善的承諾。質(zhì)量記錄應(yīng)保持清楚易讀并易于獲取。g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 防止作廢文件的非預(yù)期使用﹐如需保留以備它用﹐則應(yīng)作出適當(dāng)?shù)臉?biāo)識。e) to ensure that documents remain legible and readily identifiable, 確保文件保持清楚易讀﹐可供識別并可追溯。c) to ensure that changes and the current revision status of documents are identified, 確保對文件修訂及修訂狀態(tài)進(jìn)行標(biāo)識。A documented procedure shall be established to define the controls needed建立一個(gè)文件化程序確定a) to approve documents for adequacy prior to issue, 發(fā)行前批準(zhǔn)其適當(dāng)性。c) a description of the interaction between the processes of the quality management system. 描述質(zhì)量管理體系各流程的相互作用關(guān)系。 Quality manual 質(zhì)量手冊The organization shall establish and maintain a quality manual that includes組織就建立并保持個(gè)質(zhì)量手冊﹐包含以下內(nèi)容﹕a) the scope of the quality management system, including details of and justification for any exclusions (see ), 質(zhì)量管理體系的范圍﹐包括詳細(xì)內(nèi)容及任何排除情況和原因。c) the petence of personnel. 人員的能力。NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to備注2﹕品質(zhì)管理體系文件的范圍可能因以下原因在組織間會有差異﹕a) the size of organization and type of activities, 組織的規(guī)模和類型。e) records required by this International Standard (see ).本國際標(biāo)準(zhǔn)要求的記錄。c) documented procedures required by this International Standard,本國際標(biāo)準(zhǔn)要求的程序文件。 Documentation requirements 文件需求