【正文】 ng 設(shè)計和開發(fā)策劃 Project Plan – The organization 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一個方案計劃。該計劃應(yīng)包括：a) methods and documented procedure(s),a) 方法和程序文件b) responsibilities,b) 職責c) schedule for integration, andc) 綜合進度，等d) test requirements. [10]d)必要的檢測。這個程序文件應(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)行進度表c) 產(chǎn)品特征的詳細說明和新軟件或發(fā)行中的變化d) 建議客戶目前的或計劃的變化 Control of design and development changes 設(shè)計和開發(fā)變化的控制 Change Management Process – The organization 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, andg) review and approval. [5] 變更管理制程－組織應(yīng)建立和維持一個制程以確保所有的需求和設(shè)計變更（在產(chǎn)品生命周期任何時候能出現(xiàn)的）被以一個系統(tǒng)的和即時的方式管理和追蹤，不影響質(zhì)量，可靠度和設(shè)計目的。 Emergency Service – The organization shall ensure that services and resources areavailable to support recovery from emergency failures of product in the field throughout its expected life. [4] 緊急服務(wù)－組織應(yīng)確保服務(wù)和資源能支持產(chǎn)品從整個期望生命中緊急故障恢復。 Replication – The organization shall establish and maintain a documented procedure(s) for replication, which should include the following:a) identification of master copy,b) identification of replicate copies for delivery,c) quantity of replicates to deliver,d) type of media,e) labeling,f) identification of required documentation such as user guides,g) packaging of documentation, andh) control of environment to ensure repeatable replication. [9] 復制－組織將建立和維持一個用于復制的程序文件，應(yīng)包括如下：a) 原版的鑒定b) 傳遞的副本的鑒定c) 傳遞副本的數(shù)量d) 媒體類型e) 標簽f) 被要求文件如用戶指南的鑒定g) 文件包裝，和h) 確?？芍貜偷膹椭频沫h(huán)境控制 Software Used in Service Delivery – Organizations shall document and implement processes for the maintenance and control of software used in service delivery to ensure continued process capability and integrity. 用于服務(wù)傳遞的軟件－組織應(yīng)編制和實施用于軟件控制和維護的過程，這些軟件用在服務(wù)傳遞，以確保持續(xù)的制程容量和完整性。 Customer property 客戶所有權(quán)The organization shall exercise care with customer property while it is under the organization39。c) 組織應(yīng)提供客戶每個修補對客戶的操作影響的闡述。 Purchasing information 購買信息 Verification of purchased products所購產(chǎn)品的確認 Production and service provision 產(chǎn)品和服務(wù)提供 Control of production and service provision 產(chǎn)品和服務(wù)提供的控制 Organization’s Support Program – The organization shall ensure that customers are provided support to resolve product related problems. [5] 組織的支持計劃－組織應(yīng)確?？蛻舯惶峁┙鉀Q相關(guān)問題產(chǎn)品的支持。設(shè)計和開發(fā)輸出應(yīng)包括（但不限于）：a) 服務(wù)傳遞程序b) 資源和能力要求c) 對供應(yīng)商的信任d) 服從于客戶評估的服務(wù)特征e) 每個服務(wù)特征可接受性的標準f) Design and development review 設(shè)計和開發(fā)檢討 Design and development verification 設(shè)計和開發(fā)確認 Design and development validation 設(shè)計和開發(fā)確認 1: Organizations should include customer(s) or a third party during various validation stages, as appropriate.－注1：恰當?shù)卣f，在不同的確認階段組織應(yīng)該包括客戶或第三方。檢測策劃應(yīng)包括：a) scope of testing (., unit, feature, integration, system, acceptance),a) 檢測范圍（例如：單位、特性、綜合性能、系統(tǒng)、驗收）b) types of tests to be performed (., functional, boundary, usability, performance, regression,interoperability),b) 檢測的執(zhí)行形式（如：功能、范圍、用途、性能、退步、協(xié)同工作能力）c) traceability to requirements,c) 必要的可追蹤性d) test environment (., relevancy to customer environment, operational use),d) 檢測環(huán)境（例如：相關(guān)顧客環(huán)境，操作效用）e) test coverage (degree to which a test verifies a product’s functions, sometimes expressed as apercent of functions tested),e) 檢測規(guī)模（驗證產(chǎn)品功能的程度，有時表現(xiàn)為功能測試的百分比）f) expected results,f) 期望結(jié)果，g) data definition and database requirements,g) 數(shù)據(jù)分類及必要的數(shù)據(jù)庫h) set of tests, test cases (inputs, outputs, test criteria), and documented test procedure(s),h) 檢測裝置，檢測實例（輸入，輸出，檢測標準），及檢測程序文件，i) use of external testing, andi) 外部檢測方法，等j) method of reporting and resolving defects. [11]l) 報告方法及糾正措施. [11] 1: Testing may be covered at several levels. 注解1：檢測可能覆蓋幾個級別。[11] Customer Feedback – The organization shall establish and maintain a documentedprocedure(s) to provide the customer with feedback on their problem reports in a timely manner.顧客反饋－組織應(yīng)建立并維護一套程序文件及時處理顧客問題反饋。應(yīng)當考慮的工具包括：設(shè)計開發(fā)工具、測試工具、配置管理工具，以及文件工具。 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)。[5] Training Content – Where the potential for hazardous conditions exists, training content shouldinclude the following:培訓內(nèi)容－有潛在危險的地方，培訓內(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)當為所有必要過程建立操作員資格及要求條件。 Responsibility, authority and munication職責、權(quán)限與溝通 Responsibility and authority職責和權(quán)限 Management representative管理者代表 Internal munication內(nèi)部溝通 Organization Performance Feedback – The organization shall inform employees of its quality performance and the level of customer satisfaction. [4]組織成績反饋－組織應(yīng)通知其員工關(guān)于質(zhì)量成績以及顧客滿意程度。 1: It is recognized that it is not possible for an organization to provide the same level of munication with all its customers. The level provided may depend on the amount of business with the customer, the history of problems, customer expectations, and other factors (see Appendix F, “Guidance for Communication with Custo