【正文】 Where traceability is requirement, the anization shall control and record the unique identification of the product (see ). 當(dāng)有可追溯要求時，組織應(yīng)管制和記錄產(chǎn)品的唯一的鑒別。 Where the anization or its customer intends to perform verification at the supplier’s premises, the anization shall state the intended verification arrangements and method of product release in the purchasing information. 當(dāng)組織或其顧客擬在供貨商現(xiàn)場進(jìn)行查證時，組織應(yīng)在采購信息中規(guī)定所訂的查證安排和產(chǎn) 品放行的方法。 (見 ) Purchasing 采購 Purchasing process 采購流程 The anization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. 組織應(yīng)確保采購的產(chǎn)品能符合所訂要求。查證的結(jié)果和任何所需的措施應(yīng)予以記錄。 These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not in conflict with each other. 這些輸入應(yīng)審查其適切性。取代審查可以包含相關(guān)產(chǎn)品信息，如型錄、廣告文宣等。 b) requirements not stated by the customer by necessary for specified or intended use, where known, 雖非顧客所規(guī)定的產(chǎn)品要求，但為原訂或特定使用之所必須。 In planning product realization, the anization shall determine the following, as appropriate : 在規(guī)劃產(chǎn)品實現(xiàn)時，組織應(yīng)適當(dāng)?shù)貨Q定下列： a) quality objectives and requirements of the product。 6 Resource management資源管理 Provision of resources 資源的提供 The anization shall determine and provide the resources needed 組織應(yīng)決定和提供所需要的資源： a) to implement and maintain the quality management system and continually improve its effectiveness, and 以實施和維持品質(zhì)管理系統(tǒng)和持續(xù)地改善其有效性；和 b) to enhance customer satisfaction by meeting customer requirements. 達(dá)成顧客滿意。 Management representative 管理代表 Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes 高階管理階層應(yīng)指定管理階層的一員作為管理代表，該代表不受其它職責(zé)影響，應(yīng)有的責(zé)任和權(quán)限，包括： 企業(yè) ()大量管理資料下載 7 a) ensuring that processes needed for the quality management system are established, implemented and maintained, 確保品質(zhì)管理系統(tǒng)所必須的流程已建立、實施及維持； b) reporting top management on the performance of the quality management system and any need for improvement, and 向高階管理階層報告品質(zhì)管理系統(tǒng)的績效和改善的需要； c) ensuring the promotion of awareness of customer requirements throughout the anization. 確保促進(jìn)組織全盤對顧客需求的認(rèn)知。應(yīng)建立一書面程序以鑒別、儲存、保護、調(diào)閱、保存期限及處置品質(zhì)記錄。 企業(yè) ()大量管理資料下載 4 NOTE 2 The extent of the quality management system documentation can differ from one anization to another due to 注 2：每個組織的品質(zhì)管理系統(tǒng)文件的程度可能有別于另一個組織，可歸因于： a) the size of anization and type of activities, 組織的規(guī)模及作業(yè)的型態(tài)； b) the plexity of processes and their interactions, and 流程的復(fù)雜性及其相 互作用； c) the petence of personnel. 人員的能力。 Throughout the text of this International Standard, wherever the term ―product‖ occurs, it can also mean ―service‖. 本國際標(biāo)準(zhǔn)全文上下，無論何處使用到用詞「產(chǎn)品」，亦能夠同義于「服務(wù)」 4 Quality management system品質(zhì)管理系統(tǒng) General requirements 一般要求 The anization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. 組織應(yīng)建立、文件化、執(zhí)行、維持一個品質(zhì)管理系統(tǒng)及持續(xù)不斷改善其功能以符合本國際標(biāo)準(zhǔn)之要求。企業(yè) ()大量管理資料下載 1 INTERNATIONAL STANDARD Quality management systemsRequirements 1. Scope 范圍 General 概述 This International Standard specifies requirements for a quality management where an anization 本國際標(biāo)準(zhǔn)所訂之品質(zhì)管理系統(tǒng)要求，當(dāng)一個組織 a) needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and 必須展現(xiàn)其提供符合顧客要求及符合適用法規(guī)要求一致的產(chǎn)品能力，及 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. 透過對系統(tǒng)有效應(yīng)用以增進(jìn)顧客滿意之目標(biāo)，包含對系統(tǒng)的持續(xù)改善各流程和對顧客要求及適用法規(guī)要求之符合的保證 NOTE In this International Standard, the term ―product‖ applies only to the product intended for, or required by, a customer. 注：本國際標(biāo)準(zhǔn)內(nèi)之『產(chǎn)品』一詞是指只適用于預(yù)期的或顧客要求的產(chǎn)品 Application應(yīng)用 All requirements of this International Standard are generic and are intended to be applicable to all anizations, regardless of type, size and product provided. 本國際標(biāo)準(zhǔn)的所有要求是通用的，并期望適用于不論型式 、規(guī)模大小與所提供產(chǎn)品的所有組織 Where any requirement(s) of this International Standard cannot be applied due to the nature of an anization and its product, this can be considered for exclusion. 當(dāng)本國際標(biāo)準(zhǔn)的任何要求因組織及其產(chǎn)品之性質(zhì)而無法適用，可以考慮加以排除 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 anization’s ability, or responsibility, to provide product that meets customer and applicable regulatory requirements. 當(dāng)排除進(jìn)行時，除非這些排除被限制在條文 7內(nèi)之要求，且這些排除不能影響組織能力或責(zé)任，及提供實現(xiàn)符合顧客與適用法規(guī)要求的產(chǎn)品，否則無法主張符合本國際標(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 企業(yè) ()大量管理資料下載 2 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 Standard. 本國際標(biāo)準(zhǔn)各項規(guī)定系由下列標(biāo)準(zhǔn)之規(guī)定所組成，并于全文中引述參考。 The anization shall 組織應(yīng) a) identify the processes needed for the quality management system and their application throughout the anization (see ), 鑒定品質(zhì)管理系統(tǒng)所需之流程 b) determine the sequence and interaction of these processes, 決定