【正文】 lf product. This typically includes original equipment manufacturer (OEM) products used in manufacturing and mercial offtheshelf (COTS) products used in software systems. －注 1：程序文件應(yīng)適用于現(xiàn)有產(chǎn)品。這個(gè)程序文件應(yīng)包括下文提供的方法： a) 發(fā)行規(guī)劃信息（在發(fā)行之前充分發(fā)給客戶的） b) 給客戶的產(chǎn)品介紹和發(fā)行進(jìn)度表 c) 產(chǎn)品特征的詳細(xì)說(shuō)明和新軟件或發(fā)行中的變化 d) 建議客戶目前的或計(jì)劃的變化 Control of design and development changes 設(shè)計(jì)和開(kāi)發(fā)變化的控制 Change Management Process – The anization shall establish and maintain a process to ensure that all requirements and design changes, which may arise at any time during the product life cycle, are managed and tracked in a systematic and timely manner and do not adversely affect quality, reliability, and design intent. Management of changes should include: a) impact analysis, b) planning, c) implementation, d) testing, e) documentation, f) munication, and g) review and approval. [5] 變更管理制程－ 組織應(yīng)建立和維持一個(gè)制程以確保所有的需求和設(shè)計(jì)變更（在產(chǎn)品生命周期任何時(shí)候能出現(xiàn)的）被以一個(gè)系統(tǒng)的和即時(shí)的方式管理和追蹤，不影響質(zhì)量，可靠度和設(shè)計(jì)目的。 13 Requirements Allocation – The anization shall document the allocation of the product requirements to the product architecture. [9] 要求分配－組織應(yīng)編制文件將產(chǎn)品的要求分配到產(chǎn)品結(jié)構(gòu)。該計(jì)劃應(yīng)包括： a) methods and documented procedure(s), a) 方法和程序文件 b) responsibilities, b) 職責(zé) c) schedule for integration, and c) 綜合進(jìn)度，等 d) test requirements. [10] d)必要的檢測(cè)。 [11] 11 1: The anization should establish munication methods for dissemination of product requirements and changes to requirements to all impacted parties identified in the project plan. 注解 1：組織應(yīng)建立一種聯(lián)系方法來(lái)貫徹產(chǎn)品的要求并改進(jìn)各種要求以符合方案策劃的定義。 Design and development 設(shè)計(jì)和開(kāi)發(fā) Design and development planning 設(shè)計(jì)和開(kāi)發(fā)策劃 Project Plan – The anization shall establish and maintain a project plan based on the defined product life cycle model. The plan should include: 方案策劃－ 組織應(yīng)依據(jù)定義的產(chǎn)品生命周期模式建立并維護(hù)一個(gè)方案計(jì)劃。 1: The customer and the anization should jointly determine the priority for resolving customerreported problems. 注解 1：顧客和組織共同確定解決顧客報(bào)告問(wèn)題的優(yōu)先程度。 Customerrelated processes 與顧客有關(guān)的過(guò)程 Determination of requirements related to the product 與產(chǎn)品有關(guān)的要求的確定 Review of requirements related to the product 與產(chǎn)品有關(guān)的要求的評(píng)審 1: The contract review process should include: 注解 1：合同評(píng)審 過(guò)程應(yīng)包括： a) product acceptance planning and review, 產(chǎn)品驗(yàn)收策劃和評(píng)審 9 b) handling of problems detected after product acceptance, including customer plaints and claims, and 產(chǎn)品驗(yàn)收后發(fā)現(xiàn)問(wèn)題的處理，包括客戶投訴及要求，等 c) responsibility of removal and/or correction of nonconformities after applicable warranty period or during product maintenance contract period. [9] 在保證期或維修合約有效期間有責(zé)任刪除和 /或修正不符合項(xiàng)目。這些資源包括存儲(chǔ)器 的效用、吞吐量、適時(shí)執(zhí)行以及 I/O通道。該程序文件應(yīng)包括： a) cessation of full or partial support after a certain period of time, 一定時(shí)間后 停止全部或部分支持， b) archiving product documentation and software, 保存產(chǎn)品文檔及軟件， c) responsibility for any future residual support issues, 對(duì)任何殘留問(wèn)題支持的責(zé)任， d) transition to the new product, if applicable, and 如果適用，轉(zhuǎn)化為新產(chǎn)品，等 e) accessibility of archive copies of data. [10] 數(shù)據(jù)拷貝存檔的可達(dá)性 Configuration Management Plan – The anization shall establish and maintain a configuration management plan, which should include: 配置管理策劃－組織應(yīng)建立并維護(hù)一配置管理策劃，其內(nèi)容應(yīng)包括： a) identification and scope of the configuration management activities, 配置管理活動(dòng)的定義及范圍 b) schedule for performing these activities, 執(zhí)行這些活動(dòng)的進(jìn)度表 8 c) configuration management tools, 配置管理工具 d) configuration management methods and documented procedure(s), 配置管理方法及程序文件 e) anizations and responsibilities assigned to them, 組織及分派給它的責(zé)任， f) level of required control for each configuration item, and 每個(gè)配置項(xiàng)目需要控制的級(jí)別 g) point at which items are brought under configuration management. [10] 指明哪些條款置于配置管理的管轄范圍。 New Product Introduction – The anization shall establish and maintain a documented procedure(s) for introducing new products for General Availability. 新產(chǎn)品介紹－組織應(yīng)建立并維護(hù)一套文件化的程序用以介紹新產(chǎn)品的一般性能。組織應(yīng)將該信息通知所有相關(guān)職工。 Advanced Quality Training – The anization shall offer appropriate levels of advanced quality training. Examples of advanced quality training may include statistical techniques, process capability, statistical sampling, data collection and analysis, problem identification, problem analysis, and corrective and preventive action. [5] 高級(jí)質(zhì)量培訓(xùn)－組織應(yīng)體統(tǒng)適當(dāng)更高層次的質(zhì)量培訓(xùn)。 [4] Quality Improvement Concepts – Those employees that have a direct impact on the quality of the product, including top management, shall be trained in the fundamental concepts of continual improvement, problem solving, and customer satisfaction. [4] 質(zhì)量改進(jìn)觀念－包括最高管理者在內(nèi)的所有對(duì)產(chǎn)品質(zhì)量有直接影響的員工應(yīng)當(dāng)接受持續(xù)改進(jìn)、解決問(wèn)題及顧客滿意等基本觀念的培訓(xùn)。組織應(yīng)會(huì)同顧客建立質(zhì)量改進(jìn)程序。 Quality management system planning 質(zhì)量管理體系策劃 3 Long and ShortTerm Quality Planning – The anization’s quality planning activities shall include long and shortterm plans with goals for improving quality and customer satisfaction. 長(zhǎng)期和短期質(zhì)量策劃－組織的質(zhì)量策劃行為應(yīng)包括以提高質(zhì)量和顧客滿意度為目標(biāo)的長(zhǎng)期策劃和短期策劃。 Customer Communication Procedures – The anization shall establish and maintain a documented procedure(s) for municating with selected customers. The documented procedure(s) shall include: 顧客溝通程序－組織應(yīng)建立并維護(hù)文件化的程序以確保與特定顧客之間的溝通。 Control of records 記錄控制 2 Section 5 Management responsibility 第五章－管理職責(zé) Management mitment 管理承諾 Customer focus 以顧客為關(guān)注焦點(diǎn) Customer Relationship Development – Top management shall demonstrate active involvement in establishing and maintaining mutuallybeneficial relationships between the anization and its customers. [4] 發(fā)展顧客關(guān)系－最高管理者應(yīng)積極參與建立并維護(hù)組織與顧客之間的相互受益的關(guān)系。所提供 的級(jí)別應(yīng)依據(jù)與顧客的生意數(shù)量、歷史問(wèn)題、顧客期望值，以及其它因素（參見(jiàn)附錄 F，“顧客溝通指導(dǎo)”） Quality policy 質(zhì)量方針 Planning 策劃 Quality objectives 質(zhì)量目標(biāo) Quality Objectives – Objectives for quality shall include targets for the TL 9000 measurements defined in the