【正文】 efore acceptance. 當(dāng)顧客以非書面陳述提出要求時，顧客要求應(yīng)在組織接受之前加以確認(rèn)。 Review of requirements related to the product 與產(chǎn)品有關(guān)之要求的審查 The anization shall review the requirements related to the product. This review shall be conducted prior to the anization’s mitment to supply product to the customer (. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts of orders) and shall ensure that 組織應(yīng)審查與產(chǎn)品有關(guān)的要求。 c) statutory and regulatory requirements related to the product, and 與產(chǎn)品有關(guān)的法規(guī)和法令要求。 Customerrelated processes 顧客相關(guān)的流程 Determination of requirements related to the product 客戶需求的鑒定 The anization shall determine 組織應(yīng)決定： a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, 顧客所規(guī)定的產(chǎn)品要求，包含交貨和售后活動的要求。 NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to specific product, project or contract, can be referred to as a quality plan. 注 1：用以敘述品質(zhì)管理系統(tǒng)的流程（包括產(chǎn)品實現(xiàn)流程）和資源，而被應(yīng)用于 特定產(chǎn)品、項目或合約的文件，可被視為品質(zhì)計畫。 對規(guī)定產(chǎn)品所需的查證、確認(rèn)、監(jiān)督、檢驗和測試活動，和產(chǎn)品允收準(zhǔn)則； d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). 企業(yè) ()大量管理資料下載 10 提供實現(xiàn)流程和符合要求的最終產(chǎn)品之證據(jù)所必須的品質(zhì)記錄。 為了產(chǎn)品的品質(zhì)目標(biāo)和要求； b) the need to establish processes, documents, and provide resources specific to the product。產(chǎn)品實現(xiàn)流程的規(guī)劃應(yīng)和組織的品質(zhì)管理系統(tǒng)的其它要求一致。 Work environment工作環(huán)境 The anization shall determine and manage the work environment needed to achieve conformity to product requirements. 組織應(yīng)鑒別和管理工作環(huán)境所需的因素，以達(dá)成產(chǎn)品的符合性。 Infrastructure 基礎(chǔ)設(shè)施 The anization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable 組織應(yīng)鑒別、提供和維持所需的基礎(chǔ)設(shè)施，以達(dá)成產(chǎn)品的符合性。 Human resources 人力資源 General 概述 Personnel performing work affecting product quality shall be petent on the basis of appropriate education, training, skills and experience. 執(zhí)行會影響產(chǎn)品品質(zhì)工作之人員應(yīng)依適當(dāng)?shù)慕逃?、?xùn)練、技能和經(jīng)驗為基礎(chǔ)，具備能力。 Review output審查輸出 The output from the management review shall include any decisions and actions related to 來自管理階層審查的輸出應(yīng)包括下列相關(guān)的決策和措施： a) improvement of the effectiveness of the quality management system and related to 品質(zhì)管理系統(tǒng)和其流程的有效性之改善； b) improvement of product related to customer requirements, and 與顧客要求有關(guān)的產(chǎn)品之改善； c) resource needs. 所需求的資源。 Records from management reviews shall be maintained (see ). 保存管理審查的記錄（見 ）。 Management review 管理階層審查 General 概述 Top management shall review the anization’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. 高階管理階層應(yīng)在所規(guī)畫的期間審查組織的品質(zhì)管理系統(tǒng)，以確保其持續(xù)適用性、適切性和有效性。 NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 注：一位管理代表的責(zé)任 可包括就品質(zhì)管理系統(tǒng)有關(guān)事務(wù)與外部團體聯(lián)系。 Responsibility, authority and munication責(zé)任、權(quán)限與溝通 Responsibility and authority責(zé)任與權(quán)限 Top management shall ensure that responsibilities and authorities are defined and municated within the anization. 高階管理階層應(yīng)確保組織內(nèi)對責(zé)任、權(quán)限和其相互關(guān)系應(yīng)已加以界定和溝通。 Quality management system planning品質(zhì)管理系統(tǒng)規(guī)劃 Top management shall ensure that 高階管理階層應(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 品質(zhì)管理系統(tǒng)的規(guī)劃，已符合品質(zhì)目標(biāo)和 。 (見 ) Quality policy品質(zhì)政策 Top management shall ensure that the quality policy 高階管理階層 應(yīng)確保品質(zhì)政策： a) is appropriate to the purpose of the anization, 合于組織目的； 企業(yè) ()大量管理資料下載 6 b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, 包含符合要求和持續(xù)地改善品質(zhì)管理系統(tǒng)之有效性的承諾； c) provides a framework for establishing and reviewing quality objectives, 提供一個建立和審查品質(zhì)目標(biāo)之架構(gòu)； d) is municated and understood within the anization, 在組織內(nèi)被溝通和了解； e) and is reviewed for continuing suitability. 審查其持續(xù)適用性。 5 Management responsibility管理責(zé)任 Management mitment管理階層承諾 Top management shall provide evidence of its mitment to the development and implementation of the quality management system and continually improving its effectiveness by 高階管理階層應(yīng)藉由下述，提供其發(fā)展和改善品質(zhì)管理系統(tǒng)及持續(xù)改善其有效性之承諾的證據(jù)： a) municating to the anization the importance of meeting customer as well as statutory and regulatory requirements, 對組織溝通符合顧客要求和法規(guī)及法 令要求之重要性； b) establishing the quality policy, 建立品質(zhì)政策 c) ensuring that quality objectives are established, 確保已建立品質(zhì)目標(biāo)； d) conducting management reviews, and 執(zhí)行管理階層審查； e) ensuring the availability of resources. 確保資源的可用性。品質(zhì)記錄應(yīng)維持易讀、容易辨識和調(diào)閱。品質(zhì)記錄是一種特殊型態(tài)的文件，應(yīng)依據(jù) 加以管制。此品質(zhì)手冊包括以下： a) the scope of the quality management system, including details of an justification for any exclusions () 品質(zhì)管理系統(tǒng)的范圍，包含任何刪除范圍的細(xì)節(jié)及調(diào)整 (見 )； b) the documented procedures established for the quality management system, or reference to them, and 為品質(zhì)管理系統(tǒng)而建立的書面程序或 其參考引用； c) a description of the interaction between the processes of the quality management system. 敘述品質(zhì)管理系統(tǒng)內(nèi)流程間的相互關(guān)系。 NOTE 3 The documentation can be in any form or type of medium. 注 3：文件可以是任何格式或形式的媒體。 NOTE 1 Where the term ―documented procedure‖ appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. 注 1：出現(xiàn)在本國際標(biāo)準(zhǔn)內(nèi)的用詞「書面程序」，是指要「建立、文書化、實施和維持」此程序。 NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement. 注：品質(zhì)管理