【正文】 s requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see ).組織應根據提供符合組織要求產品的能力來評估和選擇供方。 Design and development outputs 設計和開發(fā)輸出The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.設計和開發(fā)過程的輸出應提供一種格式﹐以驗証設計和開發(fā)的輸入及實現(xiàn)的預先設計。()。 建立產品所需的流程﹑文件及提供資源。b) to enhance customer satisfaction by meeting customer requirements. 通過符合客戶要求提高客戶滿意度。　 Management representative 管理者代表Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes最高管理者應指定一名管理者﹐不受其他職務﹑責任影響﹐應具有以下責任及權力﹕a) ensuring that processes needed for the quality management system are established, implemented and maintained, 確保建立﹑實施和維持質量管理體系所需的程序。 Control of records 質量記錄的控制Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.質量記錄應被建立和保持以証明質量管理體系得到有效的運行并符合本國際標準的要求。()NOTE 1 Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained.備注1﹕要本國際標準中出現(xiàn)的朮語’文件化程序’﹐是要求建立﹑形成文件﹑實施程序并予以保持。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.在整個標準中所使用的朮語’產品’在這里同樣包括’服務’。 文件的要求有了較大的靈活性﹐﹕文件控制記錄控制內部審核不合格品控制糾正措施預防措施﹐主要指產品實現(xiàn)過程所需的文件。 將20個要素的形式變成四部分﹐這種結構具有普遍的適用性。ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.ISO 9000:2000質量管理體系基礎知識和朮語3 Terms and definitions 朮語和定義For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.出于本國際標準的目的﹐使用的朮語和定議在ISO9000中給出。c) documented procedures required by this International Standard,本國際標準要求的程序文件。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。 Quality management system planning 質量管理體系策劃Top management shall ensure that最高管理層應確保﹕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 。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管理評審輸出應包括與以下有關的決定及措施﹕a) improvement of the effectiveness of the quality management system and its processes, 質量管理體系及其流程的有效性改進。In planning product realization, the organization shall determine the following, as appropriate:在計劃產品實現(xiàn)時組織應適當?shù)臎Q定如下各項﹕a) quality objectives and requirements for the product。b) contract or order requirements differing from those previously expressed are resolved, and 解決合約或訂單內容與先前所敘不同處。c) where applicable, information derived from previous similar designs, and 以前類似設計開發(fā)之適用資訊。Records of the results of the review of changes and any necessary actions shall be maintained (see ).變更評審結果的記錄及隨后的跟進措施應予以保存() Purchasing 采購 Purchasing process 采購流程The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.組織應確保采購的產品符合采購需求。 Verification of purchased product 采購產品的驗証The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.組織應識別并實施對采購進行驗証或其他必須的活動﹐確保采購的產品符合采購需求。c) contain or reference product acceptance criteria, and 包括或引用設計或開發(fā)產品接受的標準。NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.備注﹕在特殊情況下如網絡銷售等每一訂單都進行正式的評審是不現(xiàn)實的﹐可以審查相關的產品的信息如﹕型號﹑廣告材料等。d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). 提供証明程序執(zhí)行和產品符合要求的記錄The output of this planning shall be in a form suitable for the organization39。b) provide training or take other actions to satisfy these needs, 提供培訓或其他方式以滿足這些需求。NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.備注﹕管理者代表的職責還包括與質量管理體系有關的外部聯(lián)絡。5 Management responsibility 管理職責 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最高管理層應提供以下証據﹐以顯示品質管理系統(tǒng)的發(fā)展與實施并進行有效的改善的承諾。c) the petence of personnel. 人員的能力。b) determine the sequence and interaction of these processes, 確定這些流程之順序及相互關系。b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements. 目的在于通過系統(tǒng)的有效運作以達到客戶的滿意﹐包括持續(xù)改善系統(tǒng)的流程和確保符合客戶滿及適用 法規(guī)的需求。4. ISO19011質量和環(huán)境審核指南取代了現(xiàn)行的ISO10011 (包括3個分標準) 和ISO14010﹑ISO14011﹑ISO14012 標準。2 Normative reference 引用標準The following normative document contains provisions which, through reference in this text, consti