【正文】 ure(s), 文件化的檢測程序d) test environment, 檢測環(huán)境e) test cases, 檢測實例f) test data, 檢測數據g) resources involved, 相關資源h) method(s) for problem tracking and resolution, and 問題追蹤及解決方法，等i) required acceptance test reports. [10] 必要的檢驗報告 Customer munication 顧客溝通 Notification About Problems – The organization shall establish and maintain a documented procedure(s) to notify all customers who may be affected by a reported problem that is service affecting. [5]關于問題的通知－ 組織應建立并維護一套程序文件以通知可能受已報告的服務問題影響的所有顧客。[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并且責任不必轉述為配置管理策劃的部分文件。 Infrastructure基礎設施 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、儲存及包裝產品的區(qū)域應保持干凈、安全并且有序，以確保不會對質量或個人造成負面影響。[4] Training Requirements and Awareness – Training requirements shall be defined for all positions that have a direct impact on the quality of products. Employees shall be made aware of training opportunities. [4]培訓需求和意識－培訓需求應針對所有對產品質量有直接影響的職位。Performance to these goals shall be monitored and reported. These plans shall address:實現這些目標需要監(jiān)控和匯報。Section 4 Quality management system第四章 質量管理體系 General requirements一般要求 Documentation requirements文件要求 General總則 Quality manual質量手冊 Control of documents文件控制 Control of CustomerSupplied Documents and Data – The organization shall establish and maintain a documented procedure(s) to control all customersupplied documents and data (., network architecture, topology, capacity, installation termination assignments, and database) if these documents and data influence the design, verification, validation, inspection and testing, or servicing the product.客戶提供文件及數據控制－ 組織將建立并且維護文件化程序以控制所有客戶提供的文件和數據（例如，網絡體系結構，布局，容量，安裝結束任務及數據庫）如果這些文件和數據影響設計，驗證，確認，檢查及測試，或服務于產品。這些策劃應注明：a) cycle time, 循環(huán)時間b) customer service, 顧客服務c) training, 培訓d) cost, 成本e) delivery mitments, and 交貨承諾，等f) product reliability. 產品可靠性 1: Top Management should demonstrate their active involvement in long and shortterm quality planning.注解1：最高管理者應積極參與到長期和短期質量策劃中。員工應該知曉培訓的機會。Section 7 Product realization第七章 產品實現 Planning of product realization 產品實現的策劃 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－組織應當建立并維護一套覆蓋產品生命循環(huán)的完整的指導手冊。 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：方案因素應包括產品尺寸，復雜性，成就，員工，進度，成本，質量，可靠性及生產能力。 Problem Severity – The organization shall assign severity levels to customer reportedproblems based on the impact to the customer in accordance with the definitions of critical, major, and minor problem reports contained in the glossary of this handbook. The severity level shall be used in determining the timeliness of the organization’s response. [11]問題嚴重性－組織應根據對顧客的影響向顧客指明問題的嚴重程度，根據手冊中的術語可分為嚴重，重大，一般問題。 2: General work instructions defining tasks and responsibilities mon to all development projects need not be replicated as part of a project plan.注解2：總的工作指令定義的對于所有的開發(fā)方案都有效的任務和職則不必再在方案策劃中重復引用。該策劃應包括如下內容：a) requirements analysis and definition of migration,a)必要的分析及遷移定義b) development of migration tools,b) 遷移工具的建立c) conversion of product and data,c) 產品及數據的轉換d) migration execution,d)遷移執(zhí)行e) migration verification, ande) 遷移驗證，等f) support for the old environment in the future. [10]f) 將來對舊環(huán)境的支持. [10] Design and development inputs 設計和開發(fā)輸入 Customer and Supplier Input – The organization shall establish and maintain methods for soliciting and using customer and supplier input during the development of new or revised product requirements. [4]顧客和廠商輸入－組織應建立并維護將顧客和廠商要求納入新產品開發(fā)或修改的方法?！?〕 Problem Resolution Configuration Management – The organization shall establish an interface between problem resolution and configuration management to ensure that fixes to problems are incorporated in future revisions. [11] 問題解決配置管理－組織應建立一個問題解決和配置管理之間的接口，以確保問題整理合并成將來的版本。安裝計劃應鑒別資源，所需信息和列出事情的次序。 Validation of processes for production and service provision 產品和服務提供的制程的確認 Operational Changes – Each time a significant change is made in the established operation (., a new operator, new machine, or new technique), a critical examination shall be made of the first unit(s)/service(s) processed after the change. [5] 操作變更－每次一個主要的變更發(fā)生在已建立的操作（如： 一個新的操作者，新設備，或新技術），變化之后的第一個元件/服務需經過嚴格的檢驗。每個產品及其副本，下面在他們存在處將被鑒定：a) 產品文件b) 對于重述產品創(chuàng)造必要的開發(fā)偶爾生產的工具c) 與其它產品的接口，和d) 軟硬件環(huán)境 Traceability for Recall – Field Replaceable Units (FRU) shall be traceable throughout the product life cycle in a way that helps organizations and their customers to identify products being recalled, needing to be replaced, or modified. 用于退還的可追溯性－域可替代的單位（FRU）在產品生命周期內應是可追溯的，運用可幫助組織和客戶鑒定退還的，需替換或修復的產品的方法?！?0〕 Patching Procedure(s) – The organization shall establish and maintain a documentedprocedure(s) that guide the decision to solve problems by patching.a) The documented procedure(s) shall address patch