【正文】 he availability and use of monitoring and measuring devices, 提供并使用測(cè)量和監(jiān)控設(shè)備﹔e) the implementation of monitoring and measurement, and 執(zhí)行監(jiān)控活動(dòng)﹔f) the implementation of release, delivery and postdelivery activities. 實(shí)施規(guī)定的放行﹑交付和相應(yīng)的音樂會(huì)活動(dòng)。The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization39。b) to identify any problems and propose necessary actions. 識(shí)別問題并建議解決方案。These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other.應(yīng)對(duì)這些輸入的適用性進(jìn)行評(píng)審﹐所有的需求都應(yīng)滿足﹐表述清楚且各部分間接口清楚。b) the review, verification and validation that are appropriate to each design and development stage, and 設(shè)計(jì)和開發(fā)的每個(gè)階段的評(píng)審﹑驗(yàn)証和確認(rèn)的活動(dòng)。Records of the results of the review and actions arising from the review shall be maintained (see ).Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.評(píng)審結(jié)果和由于評(píng)審引起的活動(dòng)應(yīng)被記錄。 Customerrelated processes 客戶相關(guān)流程 Determination of requirements related to the product 決定有關(guān)產(chǎn)品的各項(xiàng)要求The organization shall determine組織應(yīng)決定a) requirements specified by the customer, including the requirements for delivery and postdelivery activities, 客戶指定之要求﹐包括運(yùn)送及郵寄之要求。b) the need to establish processes, documents, and provide resources specific to the product。 Infrastructure 資源結(jié)構(gòu)The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable組織應(yīng)確認(rèn)﹑提供﹑保持達(dá)成產(chǎn)品合格所需的資源結(jié)構(gòu)﹐資源結(jié)構(gòu)包括﹕a) buildings, workspace and associated utilities, 建筑﹑工作場(chǎng)地和相關(guān)設(shè)施。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 implement and maintain the quality management system and continually improve its effectiveness, and 執(zhí)行與維持品質(zhì)管理體系并持續(xù)改進(jìn)其有效性。該評(píng)審包括評(píng)估質(zhì)量管理體系的改進(jìn)機(jī)會(huì)及改進(jìn)需要﹐包括質(zhì)量方針和質(zhì)量目標(biāo)的評(píng)審。 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)。e) ensuring the availability of resources. 確保資源得以取用。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(shí)。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。e) records required by this International Standard (see ).本國(guó)際標(biāo)準(zhǔn)要求的記錄。f) implement actions necessary to achieve planned results and continual improvement of these processes. 執(zhí)行所需要的活動(dòng)﹐來達(dá)成計(jì)劃并持續(xù)改進(jìn)這些流程。同樣用朮語供方取代了朮語分供方。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。 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﹐取代了ISO8402標(biāo)準(zhǔn)和ISO90001。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。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。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)鏈所使用的朮語被改變?yōu)榻M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(guó)際標(biāo)準(zhǔn)的單位。e) monitor, measure and analyse these processes, and 監(jiān)控﹑測(cè)量及分析這些流程。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(shí)施和控制的文件。b) the documented procedures established for the quality management system, or reference to them, and 質(zhì)量管理體系建立的文件化程序或其援引。f) to ensure that documents of external origin are identified and their distribution controlled, and 確保外來文件已作標(biāo)識(shí)﹐并控制其發(fā)放。d) conducting management reviews, and 執(zhí)行管理評(píng)審。b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 當(dāng)質(zhì)量管理體系在規(guī)劃和執(zhí)行上有改變時(shí)﹐要維持質(zhì)量管理體系的完整性。s 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(yīng)每隔規(guī)定時(shí)間﹐審核品質(zhì)管理體系﹐確保質(zhì)量管理體系的持續(xù)適用性﹑正確﹑有效。b) improvement of product related to customer requirements, and 與客戶需求有關(guān)的產(chǎn)品改善。e) maintain appropriate records of education, training, skills and experience (see ). 保存有關(guān)教育﹑經(jīng)驗(yàn)﹑培訓(xùn)﹑技朮和經(jīng)驗(yàn)的記錄。 產(chǎn)品的質(zhì)量目標(biāo)和需求?！OTE 2 The organization may also apply the requirements given in to the development of product realization processes.。c) the organization has th