【正文】 ment 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(guān)國際標(biāo)準(zhǔn)所包含條文﹐通過在本標(biāo)準(zhǔn)中引用而構(gòu)成為本標(biāo)準(zhǔn)的條文﹐由于引用的條文會逐漸過時﹑陸續(xù)修正或改版﹐造成引用的國際標(biāo)準(zhǔn)不再適用。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(biāo)準(zhǔn)的要求會因組織或產(chǎn)品的特性因素而不適用﹐可以考慮排除。s 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 processbased quality management systemQuality management systems — Requirements1 Scope 范圍 General 總則This International Standard specifies requirements for a quality management system where an organization本國際標(biāo)準(zhǔn)規(guī)定的質(zhì)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(xù)提供符合客戶需求及適用法規(guī)要求產(chǎn)品的能力。但其并不強求組 織更改其質(zhì)量管理體系的結(jié)構(gòu)或其文件﹐以和本國際標(biāo)準(zhǔn)的結(jié)構(gòu)保持一致﹐組織 的質(zhì)量管理體系文件的規(guī)定應(yīng)適合于其特有的活動方式。4. ISO19011質(zhì)量和環(huán)境審核指南取代了現(xiàn)行的ISO10011 (包括3個分標(biāo)準(zhǔn)) 和ISO14010﹑ISO14011﹑ISO14012 標(biāo)準(zhǔn)。 ISO9001質(zhì)量管理體系標(biāo)準(zhǔn)要素詳解 ISO9001:2000 Quality management systems —Requirements (Third edition 20001215)一﹑合理的簡化 2000版ISO9000標(biāo)準(zhǔn)將其簡化為以下五個標(biāo)準(zhǔn)1. ISO9000﹕2000質(zhì)量管理體系基本原理和朮語﹐取代了ISO8402標(biāo)準(zhǔn)和ISO90001。5. ISO10012測量控制系統(tǒng)﹐取代現(xiàn)行的ISO100121, 2標(biāo)瘁 94版的ISO9001有20個要素﹐現(xiàn)改為4個部份﹐相互新聞系如下圖﹕ISO 9001:2000ISO 9001:19941 Application應(yīng)用23 概述＋ 品質(zhì)手冊 文件的管制++ 品質(zhì)記錄的管制+++、職權(quán)、溝通6資源管理+++7 產(chǎn)品實現(xiàn) 產(chǎn)品實現(xiàn)的規(guī)劃++ 客戶相關(guān)流程 產(chǎn)品有關(guān)需求的決定+ 產(chǎn)品有關(guān)需求的審查++ 客戶溝通++++++++++++++++++8量測、分析及改善+++++++++++二﹑詞語的使用更加準(zhǔn)確或符合組織的習(xí)慣 “質(zhì)量管理體系”取代了 “質(zhì)量保証體系”﹔ “文件控制” 取代了 “文件和資料控制”﹔ “顧客的財產(chǎn)”取代了 “顧客提供的產(chǎn)品”﹔﹕ “承包方供方顧客” 改為﹕ “供方組織顧客”﹔ “最高管理者”取代 “負(fù)有執(zhí)行職責(zé)的管理者”。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(dá)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。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 organization39。然而﹐使用本國際標(biāo)準(zhǔn)的各方應(yīng)探討使用下列相關(guān)國際標(biāo)準(zhǔn)之最新版本的可能性。同樣用朮語供方取代了朮語分供方。b) determine the sequence and interaction of these processes, 確定這些流程之順序及相互關(guān)系。f) implement actions necessary to achieve planned results and continual improvement of these processes. 執(zhí)行所需要的活動﹐來達(dá)成計劃并持續(xù)改進(jìn)這些流程。 Documentation requirements 文件需求 General 一般要求The quality management system documentation shall include質(zhì)量管理體系文件應(yīng)包括﹕a) documented statements of a quality policy and quality objectives, 文件化的質(zhì)量方針和質(zhì)量目標(biāo)。e) records required by this International Standard (see ).本國際標(biāo)準(zhǔn)要求的記錄。c) the petence of personnel. 人員的能力。c) a description of the interaction between the processes of the quality management system. 描述質(zhì)量管理體系各流程的相互作用關(guān)系。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(tài)進(jìn)行標(biāo)識。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(yù)期使用﹐如需保留以備它用﹐則應(yīng)作出適當(dāng)?shù)臉?biāo)識。5 Management responsibility 管理職責(zé) 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(yīng)提供以下証據(jù)﹐以顯示品質(zhì)管理系統(tǒng)的發(fā)展與實施并進(jìn)行有效的改善的承諾。e) ensuring the availability of resources. 確保資源得以取用。 Planning 策劃 Quality objectives 質(zhì)量目標(biāo)Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 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(yīng)確保在組織的各級相關(guān)職能部門都建立質(zhì)量目標(biāo)﹐質(zhì)量目標(biāo)應(yīng)可被測量﹐并與質(zhì)量方針及持續(xù)改進(jìn)的承諾相一至。 Responsibility, authority and munication 職責(zé)﹑權(quán)力與溝通 Responsibility and authority 職責(zé)與權(quán)力Top management shall ensure that responsibilities and authorities are defined and municated within the organization.最高管理層應(yīng)確保員工的職責(zé)和權(quán)力被確定并在組織內(nèi)進(jìn)行偉達(dá)。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(zé)還包括與質(zhì)量管理體系有關(guān)的外部聯(lián)絡(luò)。該評審包括評估質(zhì)量管理體系的改進(jìn)機(jī)會及改進(jìn)需要﹐包括質(zhì)量方針和質(zhì)量目標(biāo)的評審。e) followup actions from previous management reviews, 上一次管理評審的跟蹤情況。c) resource needs. 資源需求6 Resource management 資源管理 Provision of resources 資源的提供The organization shall determine and provide the resources needed組織應(yīng)確定和提供所需資源a) to im