iso9001质量管理体系标准要素详解

ISO9001質量管理體系標准要素詳解 ISO9001:2000 Quality management systems Requirements (Third edition 2000-12-15)一合理的簡化 2000版ISO9000標准將其簡化為以下五個標准1. ISO90002000質量管理體系-基本原理和朮語取代了ISO8402標准和ISO9000-1。2. ISO9001: 2000質量管理體系-要求取代了94版的3個質量保証標准。3. ISO90042000質量管理體系-業績改進指南取代現行的ISO90041,-2,-3,-4標准。4. ISO19011質量和環境審核指南取代了現行的ISO10011 (包括3個分標准) 和ISO14010ISO14011ISO14012 標准。5. ISO10012測量控制系統取代現行的ISO10012-1, -2標瘁 94版的ISO9001有20個要素現改為4個部份相互新聞系如下圖ISO 9001:2000ISO 9001:19941.適用範圍11.1一般規定1.2 Application應用2.參考標準23.朮語及定義34.品質管理系統4.1一般要求4.2.14.2文件要求4.2.24.2.1 概述4.5.24.5.34.2.2 品質手冊4.2.14.2.3 文件的管制4.5.1+4.5.2+4.5.34.2.4 品質記錄的管制4.165.管理責任5.1管理承諾4.1+4.1.2.2+4.2.15.2以顧客為中心4.3.25.3品質政策4.1.15.4規劃5.4.1品質目標4.1.1+4.2.15.4.2品質管理系統規劃4.2.35.5責任、職權、溝通5.5.1責任與職權4.1.2.15.5.2管理代表4.1.2.35.5.3內部溝通5.6管理審查4.1.35.6.1概述4.1.35.6.2審查輸入4.1.35.6.3審查輸出4.1.36資源管理6.1資源的提供4.1.2.26.2人力資源6.2.1概述4.1.2.2+4.2.3+4.186.2.2培訓意識和能力4.186.3資源結構4.1.2.2+4.96.4工作環境4.97 產品實現7.1 產品實現的規劃4.2.3+4.9+4.10.17.2 客戶相關流程7.2.1 產品有關需求的決定4.3.2+4.4.47.2.2 產品有關需求的審查4.3.2+4.3.3+4.3.47.2.3 客戶溝通4.3.27.3設計與開發7.3.1設計與開發規劃4.4.2+4.4.3+4.4.6+4.4.7+4.4.87.3.2設計與開發輸入4.4.47.3.3設計與開發輸出4.4.57.3.4設計與開發審查4.4.67.3.5設計與開發驗證4.4.77.3.6設計與開發確認4.4.87.3.7設計的管制與開發變更4.4.97.4採購7.4.1採購過程4.6.1+4.6.27.4.2採購資訊4.6.37.4.3採購產品的驗證4.6.4+4.10.2+4.10.3+4.10.47.5生產及服務作業7.5.1生產與服務准許備管制4.9+4.10.3+4.15.6+4.197.5.2過程的確認4.97.5.3鑑別與追溯4.8+4.10.5+4.127.5.4客戶產品4.77.5.5產品的保存4.15.2+4.15.3+4.15.4+4.15.5+4.15.67.6量測與監控儀器的管制4.11.1+4.11.28量測、分析及改善8.1概括4.10+4.20.18.2量測與監控8.2.1客戶滿意8.2.2內部稽核4.178.2.3流程的監控與量測4.9+4.20.18.2.4產品的量測與監控4.10.2+4.10.3+4.10.4+4.10.5+4.208.3不合格品的管制4.13.1+4.13.28.4資料分析4.14.2+4.14.3+4.208.5改善8.5.1持續改善之規劃4.1.38.5.2矯正措施4.14.1+4.14.28.5.3預防措施4.14.1+4.14.3二詞語的使用更加准確或符合組織的習慣1.用 “質量管理體系”取代了 “質量保証體系”2.用 “文件控制” 取代了 “文件和資料控制”3.用 “顧客的財產”取代了 “顧客提供的產品”4.供應鏈由 “承包方-供方-顧客” 改為 “供方-組織-顧客”5.用 “最高管理者”取代 “負有執行職責的管理者”。三更方便地適用于各種產品類型和規模的組織1.以過程模式代替20個要素的模式。 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。但其并不強求組 織更改其質量管理體系的結構或其文件以和本國際標准的結構保持一致組織 的質量管理體系文件的規定應適合于其特有的活動方式。2.強調根據組織的具體情況設計適用的質量管理體系。 文件的要求有了較大的靈活性a.標准要求必須建立程序文件的共有6處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b.別一類的組織要求的文件主要指產品實現過程所需的文件。四標准要求NOTE In addition, the methodology known as “Plan-Do-Check-Act” (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 organizations policies.Do: implement the processes.Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.Act: take actions to continually improve process performance. Figure 1 Model of a process-based quality management systemQuality management systems Requirements1 Scope 范圍1.1 General 總則This International Standard specifies requirements for a quality management system where an organization本國際標准規定的質量管理體系要求組織a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 需証實其持續提供符合客戶需求及適用法規要求產品的能力。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. 目的在于通過系統的有效運作以達到客戶的滿意包括持續改善系統的流程和確保符合客戶滿及適用 法規的需求。NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.備注在本國際標准中述語產品指的是客戶訂購或客戶需求的產品。1.2 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.本國際標准規定的是一般和通用的要求適用于所有組織不論其類型規模和提供的產品如何。Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.本國際標准的要求會因組織或產品的特性因素而不適用可以考慮排除。Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.組織可以排除的條款僅限于條款7中的要求并且僅可以排除不影響組織提供符合客戶和適用的法律要求的產品的能力和責任的要求。否則就不能聲稱符合本國際標准。2 Normative reference 引用標准The following normative document contains provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent edition of the normative document indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards.下列相關國際標准所包含條文通過在本標准中引用而構成為本標准的條文由于引用的條文會逐漸過時陸續修正或改版造成引用的國際標准不再適用。然而使用本國際標准的各方應探討使用下列相關國際標准之最新版本的可能性。IEC和ISO成員都持有現行有效的國際標准。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.出于本國際標准的目的使用的朮語和定議在ISO9000中給出。The following terms, used in this edition of ISO 9001 to describe the supply chain, have been changed to reflect the vocabulary currently used:在ISO90012000 描述供應鏈所使用的朮語被改變為組織普遍使用的詞匯 Supplier organization customer 供方 組織 客戶The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies. Also, the term “supplier” now replaces the term “subcontractor”. 朮語組織取代了ISO9001:1994版使用的朮語供方,意思是適用于本國際標准的單位。同樣用朮語供方取代了朮語分供方。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.在整個標准中所使用的朮語產品在這里同樣包括服務。4 Quality management system 質量管理體系4.1 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.組織應建立執行并保持一個文件化的質量管理體系并持續改進其有效性使其與本國標標准要求相一至。The organization shall組織應a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), 認別實施質量管理系統及應用于整個組織所需的流程。b) determine the sequence and interaction of these processes, 確定這些流程之順序及相互關系。c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, 確定所需標准及方法以確保這些流程可達成有效作業及管制。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。e) monitor, measure and analyse these processes, and 監控測量及分析這些流程。f) implement actions necessary to achieve planned results and continual improvement of these processes. 執行所需要的活動來達成計划并持續改進這些流程。These processes shall be managed by the organization in accordance with the requirements of this International Standard.組織應對這些流程進行管理使其與本國際標准的要求相一至。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量管理體系中對這些流程進行鑒別。NOTE Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.備注在上面所述的質量管理所需的流程包括管理活動資源提供產品實現及測量流程。4.2 Documentation requirements 文件需求4.2.1 General 一般要求The quality management system documentation shall include質量管理體系文件應包括a) documented statements of a quality policy and quality objectives, 文件化的質量方針和質量目標。b) a quality manual, 質量手冊。c) documented procedures required by this International Standard,本國際標准要求的程序文件。d)documents needed by the organization to ensure the effective planning, operation and control of its processes, and組織需求的確保流程得到有效的實施和控制的文件。e) records required by this International Standard (see 4.2.4).本國際標准要求的記錄。(見行條款4.2.4)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要本國際標准中出現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。NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to備注2品質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, 組織的規模和類型。b) the complexity of processes and their interactions, and 流程的復雜程度和相互作用。c) the competence of personnel. 人員的能力。NOTE 3 The documentation can be in any form or type of medium.備注3文件化的程序和文件可存在任何形式的媒體。4.2.2 Quality manual 質量手冊The organization shall establish and maintain a quality manual that includes組織就建立并保持個質量手冊包含以下內容a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), 質量管理體系的范圍包括詳細內容及任何排除情況和原因。b) the documented procedures established for the quality management system, or reference to them, and 質量管理體系建立的文件化程序或其援引。c) a description of the interaction between the processes of the quality management system. 描述質量管理體系各流程的相互作用關系。4.2.3 Control of documents 文件控制Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.質量管理體系所需的文件應當是受控的記錄是一種特殊的文件應當參照條款4.2.4的要求進行控制。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, 發行前批准其適當性。b) to review and update as necessary and re-approve documents, 進行必要的審核和更新并重新獲得批准。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進行標識。d) to ensure that relevant versions of applicable documents are available at points of use, 在需要使用文件的場合確保得到相應文件的有效版本。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。f) to ensure that documents of external origin are identified and their distribution controlled, and 確保外來文件已作標識并控制其發放。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期使用如需保留以備它用則應作出適當的標識。4.2.4 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准的要求。質量記錄應保持清楚易讀并易于獲取。應建立程序文件以標識貯存追溯和保護質量記錄并規定保存期限和處理方法。5 Management responsibility 管理職責5.1 Management commitment 管理承諾Top management shall provide evidence of its commitment 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的發展與實施并進行有效的改善的承諾。a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, 向組織偉達符合客戶及規章/法令的重要性。b) establishing the quality policy, 建立質量方針c) ensuring that quality objectives are established, 確保質量目標被建立。d) conducting management reviews, and 執行管理評審。e) ensuring the availability of resources. 確保資源得以取用。5.2 Customer focus 客戶導向Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1).最高管理階層應確保客戶的需求得已確定并轉化為以實現客戶滿意的要求. (見7.2.1和8.2.1)5.3 Quality policy 質量方針Top management shall ensure that the quality policy最高管理層應確保質量方針a) is appropriate to the purpose of the organization, 與組織的目的相適應b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, 包括符合標准的要求及持續改進的承諾。c) provides a framework for establishing and reviewing quality objectives, 為目標的建立及評審提供框架。d) is communicated and understood within the organization, and 在組織內各部門間進行溝通并使各部門都能理解e) is reviewed for continuing suitability. 對質量方針的持續適用性進行評審。5.4 Planning 策划5.4.1 Quality objectives 質量目標Top management shall ensure that quality objectives, including those needed to meet requirements for product see 7.1 a, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.最高管理層應確保在組織的各級相關職能部門都建立質量目標質量目標應可被測量并與質量方針及持續改進的承諾相一至。質量目標應包含符合產品要求所需之內容。5.4.2 Quality management system planning 質量管理體系策划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 4.1, as well as the quality objectives, and 質量管理體系策划的執行要符合品質目標及條文4.1的要求。b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 當質量管理體系在規划和執行上有改變時要維持質量管理體系的完整性。5.5 Responsibility, authority and communication 職責權力與溝通5.5.1 Responsibility and authority 職責與權力Top management shall ensure that responsibilities and authorities are defined and communicated within the organization.最高管理層應確保員工的職責和權力被確定并在組織內進行偉達。5.5.2 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。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量管理體系的執行成效及改善需求。c) ensuring the promotion of awareness of customer requirements throughout the organization. 確保組織全體人員對客戶需求的充分知悉。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絡。5.5.3 Internal communication 內部溝通Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.最高管理層應確保在組織間應建立適當的溝通流程確保品質管理系統的有效。5.6 Management review 管理評評審習5.6.1 General 總則Top management shall review the organizations 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.最高管理應每隔規定時間審核品質管理體系確保質量管理體系的持續適用性正確有效。該評審包括評估質量管理體系的改進機會及改進需要包括質量方針和質量目標的評審。Records from management reviews shall be maintained (see 4.2.4).管理評評審的記錄應被保存。(見4.2.4)5.6.2 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, 審核的結果b) customer feedback, 客戶的反鑽c) process performance and product conformity, 過程的執行及產品的符合性。d) status of preventive and corrective actions, 預防及糾正措施的狀態。e) follow-up actions from previous management reviews, 上一次管理評審的跟蹤情況。f) changes that could affect the quality management system, and 可能影響質量管理體系的改進。g) recommendations for improvement. 改善建議5.6.3 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。b) improvement of product related to customer requirements, and 與客戶需求有關的產品改善。c) resource needs. 資源需求6 Resource management 資源管理6.1 Provision of resources 資源的提供The organization shall determine and provide the resources needed組織應確定和提供所需資源a) to implement and maintain the quality management system and continua