【正文】 內(nèi)容應(yīng)包括：a) task execution, 作業(yè)執(zhí)行b) personal safety, 個人安全c) awareness of hazardous environment, and 危險意識，等d) equipment protection. 設(shè)備保護 Operator Qualification – The organization shall establish operator qualification andrequalification requirements for all applicable processes. These requirements, at a minimum, shall address employee education, experience, training, and demonstrated skills. The organization shall municate this information to all affected employees. [4] 操作員資格－組織應(yīng)當(dāng)為所有必要過程建立操作員資格及要求條件。這些要求應(yīng)注明員工教育背景、工作經(jīng)歷、培訓(xùn)及技能。組織應(yīng)將該信息通知所有相關(guān)職工。 Infrastructure基礎(chǔ)設(shè)施 Work environment工作環(huán)境 Work Areas – Areas used for handling, storage, and packaging of products shall be clean, safe, and organized to ensure that they do not adversely affect quality or personnel performance. [5] 工作區(qū)－用于操作、儲存及包裝產(chǎn)品的區(qū)域應(yīng)保持干凈、安全并且有序，以確保不會對質(zhì)量或個人造成負面影響。Section 7 Product realization第七章 產(chǎn)品實現(xiàn) Planning of product realization 產(chǎn)品實現(xiàn)的策劃 Life Cycle Model – The organization shall establish and maintain an integrated set of guidelines that covers the life cycle of its products. This framework shall contain, as appropriate, the processes, activities, and tasks involved in the concept, definition, development, production, operation, maintenance, and (if required) disposal of products, spanning the life of the products. [10]生命循環(huán)模式－組織應(yīng)當(dāng)建立并維護一套覆蓋產(chǎn)品生命循環(huán)的完整的指導(dǎo)手冊。該框架應(yīng)盡可能包括國過程、功能、以及觀念、定義、發(fā)展、產(chǎn)品、操作、維護，以及產(chǎn)品的處理（如果必要），跨度產(chǎn)品的生命周期。 New Product Introduction – The organization 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)建立并維護一套文件化的程序用以介紹新產(chǎn)品的一般性能。 1: The new product introduction program should include provisions for such programs as: quality and reliability prediction studies, pilot production, demand and capacity studies, sales and service personnel training, and new product postintroduction evaluations.注解1－新產(chǎn)品介紹程序應(yīng)包括以下程序：質(zhì)量及可靠性預(yù)測計劃，試制產(chǎn)品，需求及產(chǎn)量計劃，銷售及服務(wù)人員培訓(xùn)，新產(chǎn)品定位估計。 Disaster Recovery – The organization shall establish and maintain methods for disasterrecovery to ensure the organization’s ability to recreate and service the product throughout its life cycle. [10]事故處理－組織應(yīng)建立并維護事故處理的方法以確保組織有能力在生命周期內(nèi)進行維修和服務(wù)。 End of Life Planning – The organization shall establish and maintain a documentedprocedure(s) for the discontinuance of manufacturing and/or support of a product by the operation and service organizations. The documented procedure(s) should include:最終策劃－組織應(yīng)為保質(zhì)期和服務(wù)組織終止生產(chǎn)或支持產(chǎn)品建立并維護一套文件化的程序。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, 對任何殘留問題支持的責(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(yīng)建立并維護一配置管理策劃，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(zé)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。[10] 1: General work instructions defining general configuration management tasks and responsibilities need not be replicated as part of a specific documented configuration management plan.注解1：總的工作指令規(guī)定總的配置管理任務(wù)并且責(zé)任不必轉(zhuǎn)述為配置管理策劃的部分文件。 Estimation – The organization shall establish and maintain a method for estimating and tracking project factors during project planning, execution, and change management. [11]評估－組織應(yīng)建立并維護一種方法用以在方案策劃、實施及更改過程中評估和跟蹤方案因素 1: Project factors should include product size, plexity, effort, staffing, schedules, cost, quality, reliability, and productivity.注解1：方案因素應(yīng)包括產(chǎn)品尺寸，復(fù)雜性，成就，員工，進度，成本，質(zhì)量，可靠性及生產(chǎn)能力。 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(yīng)建立并維護一種方法用以評估和追蹤目標(biāo)計算機的重要資源，計算機中的軟件是否預(yù)期運行。這些資源包括存儲器的效用、吞吐量、適時執(zhí)行以及I/O通道。[11] Support Software and Tools Management – The organization shall ensure that internally developed support software and tools used in the product life cycle are subject to the appropriate quality method(s). Tools to be considered include: design and development tools, testing tools, configuration management tools, and documentation tools. [11]支持軟件及工具管理－組織應(yīng)該保證用在產(chǎn)品中的內(nèi)部開發(fā)的支持軟件及工具在整個產(chǎn)品生命周期中的質(zhì)量。應(yīng)當(dāng)考慮的工具包括：設(shè)計開發(fā)工具、測試工具、配置管理工具，以及文件工具。[11] Service Delivery Plan – Suppliers that are responsible for the delivery or implementation of a service, and are not responsible for the design and development of that service, shall ply with the Project Plan requirements of .服務(wù)交付策劃－ 廠商有責(zé)任交貨或提供服務(wù)，但是對服務(wù)的設(shè)計及發(fā)展不負責(zé)任，應(yīng)符合。 Customerrelated processes與顧客有關(guān)的過程 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)的要求的評審 1: The contract review process should include:注解1：合同評審過程應(yīng)包括：a) product acceptance planning and review, 產(chǎn)品驗收策劃和評審b) handling of problems detected after product acceptance, including customer plaints and claims, and 產(chǎn)品驗收后發(fā)現(xiàn)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