【文章內(nèi)容簡(jiǎn)介】 and any need for improvement, and 向高階管理階層報(bào)告品質(zhì)管理系統(tǒng)的績(jī)效和改善的需要； c) ensuring the promotion of awareness of customer requirements throughout the anization. 確保促進(jìn)組織全盤對(duì)顧客需求的認(rèn)知。 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(tuán)體聯(lián)系。 Internal munication內(nèi)部溝通 Top management shall ensure that appropriate munication processes are established within the anization and that munication takes place regarding the effectiveness of the quality management system. 高階管理階層應(yīng)確保在組織內(nèi)已建立適當(dāng)?shù)臏贤鞒?，并?duì)有關(guān)于品質(zhì)管理系統(tǒng)的有效性加以溝通。 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。此審查應(yīng)包括評(píng)鑒改善機(jī)會(huì)和包括品質(zhì)政策和目標(biāo)在內(nèi)的品質(zhì) 管理系統(tǒng)變更的需求。 Records from management reviews shall be maintained (see ). 保存管理審查的記錄（見(jiàn) ）。 Review input審查輸入 The input to management review shall include information on 輸入到管理階層審查應(yīng)包括的信息，有關(guān)下列： a) results of audits, 稽核結(jié)果； b) customer feedback, 顧客回饋； c) process performance and product conformity, 流程績(jī)效與產(chǎn)品符合性； d) status of preventive and corrective actions, 預(yù)防和矯正措施的狀況； 企業(yè) ()大量管理資料下載 8 e) followup actions from previous management reviews, 上一次管理階層審查的跟催措施； f) changes that could affect the quality management system, and 可能影響品質(zhì)管理系統(tǒng)的所 規(guī)劃的變更； g) remendations for improvement 為了改善的推薦。 Review output審查輸出 The output from the management review shall include any decisions and actions related to 來(lái)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。 6 Resource management資源管理 Provision of resources 資源的提供 The anization shall determine and provide the resources needed 組織應(yīng)決定和提供所需要的資源： a) to implement and maintain the quality management system and continually improve its effectiveness, and 以實(shí)施和維持品質(zhì)管理系統(tǒng)和持續(xù)地改善其有效性；和 b) to enhance customer satisfaction by meeting customer requirements. 達(dá)成顧客滿意。 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(huì)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(yàn)為基礎(chǔ)，具備能力。 Competence, awareness and training能力、認(rèn)知和訓(xùn)練 The anization shall 組織應(yīng)： a) determine the necessary petence for personnel performing work affecting product quality, 鑒別執(zhí)行會(huì)影響品質(zhì)活動(dòng)之人員的能力需求； b) provide training or take other actions to satisfy these needs, 提供訓(xùn)練或采取其它措施以滿足這些需求； c) evaluate the effectiveness of the actions taken, 評(píng)估所采取措施的有效性； 企業(yè) ()大量管理資料下載 9 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 確保組織的人員認(rèn)知他們活動(dòng)的關(guān)聯(lián)及重要性和他們?nèi)绾螌?duì)于品質(zhì)目標(biāo)的達(dá)成有所貢獻(xiàn)； e) maintain appropriate records of education, training, skills and experience (see )) 維持教育、訓(xùn)練、技能和經(jīng)驗(yàn)的記錄 (見(jiàn) )。 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?；A(chǔ)設(shè)施可能包括： a) buildings, workspace and associated utilities, 建物、工作空間和相關(guān)的設(shè)施； b) process equipment (both hardware and software), and 流程設(shè)備，包括硬件和軟件； c) support services (such as transport or munication). 支持服務(wù) (如運(yùn)輸、通信 )。 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。 7 Product realization產(chǎn)品實(shí)現(xiàn) Planning of product realization產(chǎn)品實(shí)現(xiàn)的規(guī)劃 The anization 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)規(guī)劃和發(fā)展為了產(chǎn)品實(shí)現(xiàn)所需的流程。產(chǎn)品實(shí)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。 In planning product realization, the anization shall determine the following, as appropriate : 在規(guī)劃產(chǎn)品實(shí)現(xiàn)時(shí)，組織應(yīng)適當(dāng)?shù)貨Q定下列： a) quality objectives and requirements of the product。 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。 建立流程和文件的需要，和產(chǎn)品所規(guī)定的資源； c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance。 對(duì)規(guī)定產(chǎn)品所需的查證、確認(rèn)、監(jiān)督、檢驗(yàn)和測(cè)試活動(dòng)，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(shí)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。 The output of this planning shall be in a form suitable for the anization’s method of operations. 這規(guī)劃的輸出應(yīng)以適用于組織作業(yè)的方法之型式。 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(shí)現(xiàn)流程）和資源，而被應(yīng)用于 特定產(chǎn)品、項(xiàng)目或合約的文件，可被視為品質(zhì)計(jì)畫。 NOTE 2 The anization may also apply the requirements given in to the development of product realization processes. 注 2：條文 。 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