【正文】 rmative 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。IEC和ISO成員都持有現(xiàn)行有效的國際標(biāo)準(zhǔn)。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’,意思是適用于本國際標(biāo)準(zhǔn)的單位。Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.在整個標(biāo)準(zhǔn)中所使用的朮語’產(chǎn)品’在這里同樣包括’服務(wù)’。The organization shall組織應(yīng)a) identify the processes needed for the quality management system and their application throughout the organization (see ), 認(rèn)別實(shí)施質(zhì)量管理系統(tǒng)及應(yīng)用于整個組織所需的流程。c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, 確定所需標(biāo)準(zhǔn)及方法﹐以確保這些流程可達(dá)成有效作業(yè)及管制。e) monitor, measure and analyse these processes, and 監(jiān)控﹑測量及分析這些流程。These processes shall be managed by the organization in accordance with the requirements of this International Standard.組織應(yīng)對這些流程進(jìn)行管理使其與本國際標(biāo)準(zhǔn)的要求相一至。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(zhì)量管理所需的流程包括管理活動﹑資源提供﹑產(chǎn)品實(shí)現(xiàn)及測量流程。b) a quality manual, 質(zhì)量手冊。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。()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(biāo)準(zhǔn)中出現(xiàn)的朮語’文件化程序’﹐是要求建立﹑形成文件﹑實(shí)施程序并予以保持。b) the plexity of processes and their interactions, and 流程的復(fù)雜程度和相互作用。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。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。 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 .質(zhì)量管理體系所需的文件應(yīng)當(dāng)是受控的﹐記錄是一種特殊的文件﹐。b) to review and update as necessary and reapprove documents, 進(jìn)行必要的審核和更新﹐并重新獲得批準(zhǔn)。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(yīng)文件的有效版本。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﹐并控制其發(fā)放。 Control of records 質(zhì)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(zhì)量記錄應(yīng)被建立和保持以証明質(zhì)量管理體系得到有效的運(yùn)行并符合本國際標(biāo)準(zhǔn)的要求。應(yīng)建立程序文件以標(biāo)識﹑貯存﹑追溯和保護(hù)質(zhì)量記錄﹐并規(guī)定保存期限和處理方法。a) municating to the organization the importance of meeting customer as well as statutory and regulatory requirements, 向組織偉達(dá)符合客戶及規(guī)章/法令的重要性。d) conducting management reviews, and 執(zhí)行管理評審。 Customer focus 客戶導(dǎo)向Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see and ).最高管理階層應(yīng)確保客戶的需求得已確定﹐并轉(zhuǎn)化為以實(shí)現(xiàn)客戶滿意的要求. () Quality policy 質(zhì)量方針Top management shall ensure that the quality policy最高管理層應(yīng)確保質(zhì)量方針﹕a) is appropriate to the purpose of the organization, 與組織的目的相適應(yīng)﹔b) includes a mitment to ply with requirements and continually improve the effectiveness of the quality management system, 包括符合標(biāo)準(zhǔn)的要求及持續(xù)改進(jìn)的承諾。d) is municated and understood within the organization, and 在組織內(nèi)各部門間進(jìn)行溝通﹐并使各部門都能理解e) is reviewed for continuing suitability. 對質(zhì)量方針的持續(xù)適用性進(jìn)行評審。質(zhì)量目標(biāo)應(yīng)包含符合產(chǎn)品要求所需之內(nèi)容。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﹐要維持質(zhì)量管理體系的完整性。　 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(yīng)指定一名管理者﹐不受其他職務(wù)﹑責(zé)任影響﹐應(yīng)具有以下責(zé)任及權(quán)力﹕a) ensuring that processes needed for the quality management system are established, implemented and maintained, 確保建立﹑實(shí)施和維持質(zhì)量管理體系所需的程序。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。 Internal munication 內(nèi)部溝通Top management shall ensure that appropriate munication processes are established within the organization and that munication takes place regarding the effectiveness of the quality management system.最高管理層應(yīng)確保在組織間應(yīng)建立適當(dāng)?shù)臏贤鞒泰o確保品質(zhì)管理系統(tǒng)的有效。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。Records from management r