【正文】 ed utilities, 建筑﹑工作場地和相關(guān)設(shè)施。b) process equipment (both hardware and software), and 流程設(shè)備﹐包括硬體及軟體。c) supporting services (such as transport or munication). 支援服務(wù)如運輸﹑溝通。 Work environment 工作環(huán)境The organization shall determine and manage the work environment needed to achieve conformity to product requirements.組織應(yīng)確定和管理達到產(chǎn)品合格要求所需的工作環(huán)境。7 Product realization 產(chǎn)品的實現(xiàn) Planning of product realization 產(chǎn)品實現(xiàn)的規(guī)劃The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see ).組織應(yīng)建立和實施產(chǎn)品實現(xiàn)所需的計劃和發(fā)展程序。產(chǎn)品實現(xiàn)的計劃應(yīng)與質(zhì)量管理體系的其它流程的要求相一至。In planning product realization, the organization shall determine the following, as appropriate:在計劃產(chǎn)品實現(xiàn)時組織應(yīng)適當(dāng)?shù)臎Q定如下各項﹕a) quality objectives and requirements for the product。 產(chǎn)品的質(zhì)量目標(biāo)和需求。b) the need to establish processes, documents, and provide resources specific to the product。 建立產(chǎn)品所需的流程﹑文件及提供資源。c) required verification, validation, monitoring, inspection and test activities specific to the product and the ] criteria for product acceptance。 針對產(chǎn)品及產(chǎn)品允收條件決定所需之各驗証﹑確認﹑監(jiān)控﹑檢查及測試之活動。d) records needed to provide evidence that the realization processes and resulting product meet requirements (see ). 提供証明程序執(zhí)行和產(chǎn)品符合要求的記錄The output of this planning shall be in a form suitable for the organization39。s method of operations.規(guī)劃結(jié)果應(yīng)以適合組織運作方法的格式輸出。NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.備注1﹕描述質(zhì)量管理體系過程如何在特定的產(chǎn)品﹑項目﹑或合同中實施的文件可以被看作為質(zhì)量計劃?！OTE 2 The organization may also apply the requirements given in to the development of product realization processes.。 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﹐包括運送及郵寄之要求。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) statutory and regulatory requirements related to the product, and 與產(chǎn)品相關(guān)的法律﹑法規(guī)的要求。d) any additional requirements determined by the organization. 組織應(yīng)確定任何額外要求。 Review of requirements related to the product 與產(chǎn)品相關(guān)要求的評審The organization shall review the requirements related to the product. This review shall be conducted prior to the organization39。s mitment to supply a product to the customer (. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that組織 應(yīng)對與產(chǎn)品相關(guān)的要求進行評審﹐該評審應(yīng)在產(chǎn)品決定或承諾交送客戶前(如接受合約或訂單﹐接受合同或訂單的變更)實施﹐以確保﹕a) product requirements are defined, 產(chǎn)品需求已確定。b) contract or order requirements differing from those previously expressed are resolved, and 解決合約或訂單內(nèi)容與先前所敘不同處。c) the organization has the ability to meet the defined requirements. 組織有能力滿足所定議的各項需求。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.評審結(jié)果和由于評審引起的活動應(yīng)被記錄。()。當(dāng)顧客需求沒有提供書面陳述時﹐顧客要求應(yīng)在被接受前組織需予以確認。Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.當(dāng)產(chǎn)品需求變更時﹐組織應(yīng)確保相關(guān)文件已被修訂﹐且要確保相關(guān)人員已知道變更之要求。NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.備注﹕在特殊情況下如網(wǎng)絡(luò)銷售等每一訂單都進行正式的評審是不現(xiàn)實的﹐可以審查相關(guān)的產(chǎn)品的信息如﹕型號﹑廣告材料等。 Customer munication 客戶溝通The organization shall determine and implement effective arrangements for municating with customers in relation to組織應(yīng)決定與實施與客戶進行有效溝通的安排﹐包括如下內(nèi)容﹕a) product information, 產(chǎn)品信息b) enquiries, contracts or order handling, including amendments, and 詢問﹑合同和訂單處理﹐包括修訂。c) customer feedback, including customer plaints. 客戶反饋﹐包括客戶報怨。 Design and development 設(shè)計和開發(fā) Design and development planning 設(shè)計和開發(fā)計劃The organization shall plan and control the design and development of product.組織應(yīng)計劃和控制產(chǎn)品的設(shè)計和開發(fā)During the design and development planning, the organization shall determine在設(shè)計和開發(fā)計劃中組織應(yīng)確定﹕a) the design and development stages, 設(shè)計和開發(fā)的進程。b) the review, verification and validation that are appropriate to each design and development stage, and 設(shè)計和開發(fā)的每個階段的評審﹑驗証和確認的活動。c) the responsibilities and authorities for design and development. 設(shè)計和開發(fā)人員的責(zé)任和權(quán)力。The organization shall manage the interfaces between different groups involved in design and development to ensure effective munication and clear assignment of responsibility.組織應(yīng)對設(shè)計和開發(fā)各小組之間的接口進行管理確保信息的有效傳達﹐并清楚的規(guī)定各部門職責(zé)。Planning output shall be updated, as appropriate, as the design and development progresses.隨著設(shè)計和開發(fā)的進行﹐計劃應(yīng)進行更新以確保適用性。 Design and development inputs 設(shè)計和開發(fā)的輸入Inputs relating to product requirements shall be determined and records maintained (see ). These inputs shall include與產(chǎn)品各項需求相關(guān)之輸入應(yīng)予定議和記錄()﹐其包括﹕a) functional and performance requirements, 功能與執(zhí)行的需求。b) applicable statutory and regulatory requirements, 適用法律法規(guī)的要求。c) where applicable, information derived from previous similar designs, and 以前類似設(shè)計開發(fā)之適用資訊。d) other requirements essential for design and development. 設(shè)計和開發(fā)必要的其他任何要求。These inputs shall be reviewed for adequacy. Requirements shall be plete, unambiguous and not