iso9001質(zhì)量管理體系標準要素詳解-全文預覽

　　

【正文】 igns, and 以前類似設計開發(fā)之適用資訊。The organization shall manage the interfaces between different groups involved in design and development to ensure effective munication and clear assignment of responsibility.組織應對設計和開發(fā)各小組之間的接口進行管理確保信息的有效傳達﹐并清楚的規(guī)定各部門職責。c) customer feedback, including customer plaints. 客戶反饋﹐包括客戶報怨。當顧客需求沒有提供書面陳述時﹐顧客要求應在被接受前組織需予以確認。b) contract or order requirements differing from those previously expressed are resolved, and 解決合約或訂單內(nèi)容與先前所敘不同處。c) statutory and regulatory requirements related to the product, and 與產(chǎn)品相關(guān)的法律﹑法規(guī)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 a specific product, project or contract, can be referred to as a quality plan.備注1﹕描述質(zhì)量管理體系過程如何在特定的產(chǎn)品﹑項目﹑或合同中實施的文件可以被看作為質(zhì)量計劃。c) required verification, validation, monitoring, inspection and test activities specific to the product and the ] criteria for product acceptance。In planning product realization, the organization shall determine the following, as appropriate:在計劃產(chǎn)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。c) supporting services (such as transport or munication). 支援服務如運輸﹑溝通。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到品質(zhì)目標的貢獻。 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﹐應有適當?shù)慕逃p訓練﹑技朮和經(jīng)驗。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(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。() Review input 管理評審輸入The input to management review shall include information on管理評審輸入應包括﹕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。 Management review 管理評評審習 General 總則Top management shall review the organization39。b) reporting to top management on the performance of the quality management system and any need for improvement, and 向最高管理層報告質(zhì)量管理體系的執(zhí)行成效及改善需求。 Quality management system planning 質(zhì)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 。c) provides a framework for establishing and reviewing quality objectives, 為目標的建立及評審提供框架。b) establishing the quality policy, 建立質(zhì)量方針c) ensuring that quality objectives are established, 確保質(zhì)量目標被建立。質(zhì)量記錄應保持清楚易讀并易于獲取。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。A documented procedure shall be established to define the controls needed建立一個文件化程序確定a) to approve documents for adequacy prior to issue, 發(fā)行前批準其適當性。 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﹐包括詳細內(nèi)容及任何排除情況和原因。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。c) documented procedures required by this International Standard,本國際標準要求的程序文件。Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.當組織遷擇會影響到產(chǎn)品符合要求的外部流程時﹐組織應確保這些外部流程得到控制﹐并在質(zhì)量管理體系中對這些流程進行鑒別。d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, 提供有效的資源和資訊﹐以支持這些流程的運行及管制。4 Quality management system 質(zhì)量管理體系 General requirements 一般要求The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.組織應建立﹑執(zhí)行并保持一個文件化的質(zhì)量管理體系﹐并持續(xù)改進其有效性使其與本國標標準要求相一至。ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.ISO 9000:2000質(zhì)量管理體系基礎(chǔ)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。否則就不能聲稱符合本國際標準。 Application 應用All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.本國際標準規(guī)定的是一般和通用的要求﹐適用于所有組織﹐不論其類型﹑規(guī)模和提供的產(chǎn)品如何。四﹑標準要求NOTE In addition, the methodology known as “PlanDoCheckAct” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization39。 將20個要素的形式變成四部分﹐這種結(jié)構(gòu)具有普遍的適用性。3. ISO9004﹕2000質(zhì)量管理體系業(yè)績改進指南﹐取代現(xiàn)行的ISO9004—1,2,3,4標準。2. ISO9001: 2000質(zhì)量管理體系要求﹐取代了94版的3個質(zhì)量保証標準。三﹑更方便地適用于各種產(chǎn)品類型和規(guī)模的組織。 文件的要求有了較大的靈活性﹐﹕文件控制記錄控制內(nèi)部審核不合格品控制糾正措施預防措施﹐主要指產(chǎn)品實現(xiàn)過程所需的文件。NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a cu