【正文】 nt. 改善建議 Review output 評(píng)審輸出The output from the management review shall include any decisions and actions related to管理評(píng)審輸出應(yīng)包括與以下有關(guān)的決定及措施﹕a) improvement of the effectiveness of the quality management system and its processes, 質(zhì)量管理體系及其流程的有效性改進(jìn)。 Management review 管理評(píng)評(píng)審習(xí) General 總則Top management shall review the organization39。 Quality management system planning 質(zhì)量管理體系策劃Top management shall ensure that最高管理層應(yīng)確保﹕a) the planning of the quality management system is carried out in order to meet the requirements given in , as well as the quality objectives, and 。b) establishing the quality policy, 建立質(zhì)量方針c) ensuring that quality objectives are established, 確保質(zhì)量目標(biāo)被建立。e) to ensure that documents remain legible and readily identifiable, 確保文件保持清楚易讀﹐可供識(shí)別并可追溯。 Quality manual 質(zhì)量手冊(cè)The organization shall establish and maintain a quality manual that includes組織就建立并保持個(gè)質(zhì)量手冊(cè)﹐包含以下內(nèi)容﹕a) the scope of the quality management system, including details of and justification for any exclusions (see ), 質(zhì)量管理體系的范圍﹐包括詳細(xì)內(nèi)容及任何排除情況和原因。c) documented procedures required by this International Standard,本國(guó)際標(biāo)準(zhǔn)要求的程序文件。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(yùn)行及管制。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。 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﹐不論其類型﹑規(guī)模和提供的產(chǎn)品如何。 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。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)。 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)過程所需的文件。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和適用的法律要求的產(chǎn)品的能力和責(zé)任的要求。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)’。These processes shall be managed by the organization in accordance with the requirements of this International Standard.組織應(yīng)對(duì)這些流程進(jìn)行管理使其與本國(guó)際標(biāo)準(zhǔn)的要求相一至。()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(guó)際標(biāo)準(zhǔn)中出現(xiàn)的朮語(yǔ)’文件化程序’﹐是要求建立﹑形成文件﹑實(shí)施程序并予以保持。 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﹐。 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(guó)際標(biāo)準(zhǔn)的要求。 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?？蛻舻男枨蟮靡汛_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?！?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。Records from management reviews shall be maintained (see ).管理評(píng)評(píng)審的記錄應(yīng)被保存。b) to enhance customer satisfaction by meeting customer requirements. 通過符合客戶要求提高客戶滿意度。b) process equipment (both hardware and software), and 流程設(shè)備﹐包括硬體及軟體。 建立產(chǎn)品所需的流程﹑文件及提供資源。b) requirements not stated by the customer but necessary for specified or intended use, where known, 并非客戶指定﹐但必須了解明定及已知的預(yù)期使用的需求。()。c) the responsibilities and authorities for design and development. 設(shè)計(jì)和開發(fā)人員的責(zé)任和權(quán)力。 Design and development outputs 設(shè)計(jì)和開發(fā)輸出The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.設(shè)計(jì)和開發(fā)過程的輸出應(yīng)提供一種格式﹐以驗(yàn)証設(shè)計(jì)和開發(fā)的輸入及實(shí)現(xiàn)的預(yù)先設(shè)計(jì)。Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see ).參與評(píng)審的人員包括各職能部門的參與設(shè)計(jì)和開發(fā)各階段評(píng)審的代表﹐評(píng)審的結(jié)果記錄及采取的相關(guān)行動(dòng)應(yīng)給予保存。s requirements. Criteria for selection, evaluation and reevaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see ).組織應(yīng)根據(jù)提供符合組織要求產(chǎn)品的能力來評(píng)估和選擇供方。 Validation of processes for production and service provision 確認(rèn)產(chǎn)品及服務(wù)準(zhǔn)備流程The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or mea