【正文】 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(jiǎn)化 2000版ISO9000標(biāo)準(zhǔn)將其簡(jiǎn)化為以下五個(gè)標(biāo)準(zhǔn)1. ISO9000﹕2000質(zhì)量管理體系基本原理和朮語(yǔ)﹐取代了ISO8402標(biāo)準(zhǔn)和ISO90001。2. ISO9001: 2000質(zhì)量管理體系要求﹐取代了94版的3個(gè)質(zhì)量保証標(biāo)準(zhǔn)。3. ISO9004﹕2000質(zhì)量管理體系業(yè)績(jī)改進(jìn)指南﹐取代現(xiàn)行的ISO9004—1,2,3,4標(biāo)準(zhǔn)。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(gè)分標(biāo)準(zhǔn)) 和ISO14010﹑ISO14011﹑ISO14012 標(biāo)準(zhǔn)。5. ISO10012測(cè)量控制系統(tǒng)﹐取代現(xiàn)行的ISO100121, 2標(biāo)瘁 94版的ISO9001有20個(gè)要素﹐現(xiàn)改為4個(gè)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(cè) 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(shí)現(xiàn) 產(chǎn)品實(shí)現(xiàn)的規(guī)劃++ 客戶(hù)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(hù)溝通++++++++++++++++++8量測(cè)、分析及改善+++++++++++二﹑詞語(yǔ)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(cái)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”。三﹑更方便地適用于各種產(chǎn)品類(lèi)型和規(guī)模的組織。 將20個(gè)要素的形式變成四部分﹐這種結(jié)構(gòu)具有普遍的適用性。但其并不強(qiáng)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(guó)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(dòng)方式。 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(yù)防措施﹐主要指產(chǎn)品實(shí)現(xiàn)過(guò)程所需的文件。四﹑標(biāo)準(zhǔn)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。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(guó)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(shí)其持續(xù)提供符合客戶(hù)需求及適用法規(guī)要求產(chǎn)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(guò)系統(tǒng)的有效運(yùn)作以達(dá)到客戶(hù)的滿(mǎn)意﹐包括持續(xù)改善系統(tǒng)的流程和確保符合客戶(hù)滿(mǎn)及適用 法規(guī)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(guó)際標(biāo)準(zhǔn)中﹐述語(yǔ)’產(chǎn)品’指的是客戶(hù)訂購(gòu)或客戶(hù)需求的產(chǎn)品。 Application 應(yīng)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(guó)際標(biāo)準(zhǔn)規(guī)定的是一般和通用的要求﹐適用于所有組織﹐不論其類(lèi)型﹑規(guī)模和提供的產(chǎn)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(guó)際標(biāo)準(zhǔn)的要求會(huì)因組織或產(chǎn)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 organization39。s 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(hù)和適用的法律要求的產(chǎn)品的能力和責(zé)任的要求。否則就不能聲稱(chēng)符合本國(guó)際標(biāo)準(zhǔn)。2 Normative reference 引用標(biāo)準(zhǔn)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(guān)國(guó)際標(biāo)準(zhǔn)所包含條文﹐通過(guò)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(huì)逐漸過(guò)時(shí)﹑陸續(xù)修正或改版﹐造成引用的國(guó)際標(biāo)準(zhǔn)不再適用。然而﹐使用本國(guó)際標(biāo)準(zhǔn)的各方應(yīng)探討使用下列相關(guān)國(guó)際標(biāo)準(zhǔn)之最新版本的可能性。IEC和ISO成員都持有現(xiàn)行有效的國(guó)際標(biāo)準(zhǔn)。ISO 9000:2000, Quality management systems — Fundamentals and vocabulary.ISO 9000:2000質(zhì)量管理體系基礎(chǔ)知識(shí)和朮語(yǔ)3 Terms and definitions 朮語(yǔ)和定義For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.出于本國(guó)際標(biāo)準(zhǔn)的目的﹐使用的朮語(yǔ)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ISO9001﹕2000 描述供應(yīng)鏈所使用的朮語(yǔ)被改變?yōu)榻M織普遍使用的詞匯﹕ Supplier organization customer 供方 組織 客戶(hù)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(yǔ)’組織’取代了ISO9001:1994版使用的朮語(yǔ)’供方’,意思是適用于本國(guó)際標(biāo)準(zhǔn)的單位。同樣用朮語(yǔ)供方取代了朮語(yǔ)分供方。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.在整個(gè)標(biāo)準(zhǔn)中所使用的朮語(yǔ)’產(chǎn)品’在這里同樣包括’服務(wù)’。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 qualit