【正文】 Identification and traceability 鑒定和可追溯性 Product Identification – The organization shall establish and maintain a process for the identification of each product and the level of required control. For each product and its versions, the following shall be identified where they exist:a) product documentation,b) development or production tools essential to repeat product creation,c) interfaces to other products, andd) software and hardware environment. [9] 產品鑒定－組織需建立和維持一個每個產品的鑒定方法和所需的控制水平。和安裝次序有關的結果寫在文件中。 Component Changes – The organization shall have a documented procedure(s) in place to ensure that material or ponent substitutions or changes do not adversely affect product quality or performance. The documented procedure(s) should include:a) functional testing,b) qualification testing,c) stress testing,d) approved parts listing, and/ore) critical parts listing. 組成變化－組織應有一個適當的程序文件去確保材料或成分替代或變化不反過來影響產品質量或性能。 Design and Development Requirements – Design and development requirements shall be defined and documented, and should include:設計和開發(fā)要求－設計和開發(fā)需求應定義并形成文件，并且應包括：a) quality and reliability requirements,質量和可靠性要求b) functions and capabilities of the product, 產品的功能和性能c) business, organizational, and user requirements, 商業(yè)、組織或用戶要求d) safety, environmental, and security requirements, 安全、環(huán)境和可靠性要求e) installability, usability, and maintainability requirements, 安裝性能，使用性能及維護性能要求f) design constraints, and 設計約束，等g) testing requirements. [10] 檢測要求. [10] Content of Requirements – The product requirements shall include, but are not limited to: 容量要求－產品要求應包括，但不局限于：a) nominal values and tolerances, 名稱數據及耐性b) maintainability needs, and 可維修性，必須，等c) enditem packaging requirements. [5] 最終包裝要求. [5] Identification of Software Requirements – The organization shall determine, analyze, and document the software ponent requirements of the system. [10] 軟件要求鑒定－組織應確定、分析、證明系統(tǒng)軟件組建的要求。 Requirements Traceability – The organization shall establish and maintain a method to trace documented requirements through design and test. [11] 必要的可追蹤性－組織應建立并維護一種方法對設計和測試過程的文件進行必要的追蹤。組織根據嚴重程度確定答復時間。 Computer Resources – The organization shall establish and maintain methods for estimating and tracking critical puter resources for the target puter, the puter on which the software is intended to operate. Examples of these resources are utilization of memory, throughput, real time performance, and I/O channels. [11]計算機資源－組織應建立并維護一種方法用以評估和追蹤目標計算機的重要資源，計算機中的軟件是否預期運行。該框架應盡可能包括國過程、功能、以及觀念、定義、發(fā)展、產品、操作、維護，以及產品的處理（如果必要），跨度產品的生命周期。 ESD Training – All employees with functions that involve any handling, storage, packaging,preservation, or delivery of ESDsensitive products shall receive training in electrostatic discharge (ESD) protection prior to performing their jobs.ESD 培訓－所有包括操作、倉儲、包裝、保存及運輸ESD敏感產品的員工都應接受靜電放電培訓，以確保他們開展工作。 Customer Input – The organization shall implement methods for soliciting and considering customer input for quality planning activities. The organization should establish joint quality improvement programs with customers. [4]顧客輸入－ 組織應將顧客輸入納入質量策劃中。 Control of records記錄控制Section 5 Management responsibility第五章－管理職責 Management mitment管理承諾 Customer focus 以顧客為關注焦點 Customer Relationship Development – Top management shall demonstrate active involvementin establishing and maintaining mutuallybeneficial relationships between the organization and itscustomers. [4]發(fā)展顧客關系－最高管理者應積極參與建立并維護組織與顧客之間的相互受益的關系。 Quality management system planning質量管理體系策劃 Long and ShortTerm Quality Planning – The organization’s quality planning activities shall include long and shortterm plans with goals for improving quality and customer satisfaction.長期和短期質量策劃－組織的質量策劃行為應包括以提高質量和顧客滿意度為目標的長期策劃和短期策劃。[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]質量改進觀念－包括最高管理者在內的所有對產品質量有直接影響的員工應當接受持續(xù)改進、解決問題及顧客滿意等基本觀念的培訓。組織應將該信息通知所有相關職工。該程序文件應包括：a) cessation of full or partial support after a certain period of time, 一定時間后停止全部或部分支持，b) archiving product documentation and software, 保存產品文檔及軟件，c) responsibility for any future residual support issues, 對任何殘留問題支持的責任，d) transition to the new product, if applicable, and 如果適用，轉化為新產品，等e) accessibility of archive copies of data. [10] 數據拷貝存檔的可達性 Configuration Management Plan – The organization shall establish and maintain a configuration management plan, which should include: 配置管理策劃－組織應建立并維護一配置管理策劃，其內容應包括：a) identification and scope of the configuration management activities, 配置管理活動的定義及范圍b) schedule for performing these activities, 執(zhí)行這些活動的進度表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) organizations and responsibilities assigned to them, 組織及分派給它的責任，f) level of required control for each configuration item, and 每個配置項目需要控制的級別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。 Customerrelated processes與顧客有關的過程 Determination of requirements related to the product 與產品有關的要求的確定 Review of requirements related to the product與產品有關的要求的評審 1: The contract review process should include:注解1：合同評審過程應包括：a) product acceptance planning and review, 產品驗收策劃和評審b) handling of problems detected after product acceptance, including customer plaints and claims, and 產品驗收后發(fā)現問題的處理，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任刪除和/或修正不符合項目。 Design and development設計和開發(fā) Design and development planni