【正文】 1 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 anization shall establish and maintain a documented procedure(s) to control all customersupplied documents and data (., work 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(shù)據(jù)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(shù)據(jù)（例如，網(wǎng)絡體系結構，布局，容量，安裝結束任務及數(shù)據(jù)庫）如果這些文件和數(shù)據(jù)影響設計，驗證，確認，檢查及測試，或服務于產(chǎn)品。 Control of records 記錄控制 2 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 involvement in establishing and maintaining mutuallybeneficial relationships between the anization and its customers. [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。 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－組織應建立并維護文件化的程序以確保與特定顧客之間的溝通。該程序文件應包括： a) a strategy and criteria for customer selection, 選擇顧客的策略及標準 b) a method for the anization and its customers to share joint expectations and improve the quality of products, and 組織和顧客共同參與策劃及提高產(chǎn)品質量的方法，和 c) a joint review with the customer at defined intervals covering the status of shared expectations and including a method to track the resolution of issues. [4] 會同顧客安既定的時間間隔評審期望目標的狀況，并且應有可以追蹤決定流轉的方法。 1: It is recognized that it is not possible for an anization 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 Customers”). 注解 1：眾所周知，組織不可能對所有顧客提供同樣級別的溝通。所提供 的級別應依據(jù)與顧客的生意數(shù)量、歷史問題、顧客期望值，以及其它因素（參見附錄 F，“顧客溝通指導”） Quality policy 質量方針 Planning 策劃 Quality objectives 質量目標 Quality Objectives – Objectives for quality shall include targets for the TL 9000 measurements defined in the TL 9000 Quality Management System Measurements Handbook. 質量目標－質量目標應包括在 TL9000 質量管理體系計算手冊中為 TL9000定義的對象。 Quality management system planning 質量管理體系策劃 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。 Performance to these goals shall be monitored and reported. These plans shall address: 實現(xiàn)這些目標需要監(jiān)控和匯報。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(chǎn)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。 Customer Input – The anization shall implement methods for soliciting and considering customer input for quality planning activities. The anization 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。組織應會同顧客建立質量改進程序。 Supplier Input – The anization shall implement methods for soliciting and using supplier input for quality planning activities. [4] 供應商輸入－組織應將供應商輸入納入質量策劃中。 Responsibility, authority and munication 職責、權限與溝通 Responsibility and authority 職責和權限 Management representative 管理者代表 Internal munication 內(nèi)部溝通 Organization Performance Feedback – The anization shall inform employees of its quality performance and the level of customer satisfaction. [4] 組織成績反饋－組織應通知其員工關于質量成績以及顧客滿意程度。 Management review 管理評審 4 General 總則 Review input 評審輸入 Review output 評審輸出 5 Section 6 Resource management 第六章 資源管理 Provision of resources 資源提供 Human resources 人力資源 General 總則 Competence, awareness and training 能力、意識和培訓 Internal Course Development – When the anization develops internal training courses, it shall establish and maintain a process for planning, developing, and implementing these courses. [4] 內(nèi)部課程開展－當組織開展內(nèi)部培訓課程時應當建立并維護一個程序以確保課程的計劃、開展及實現(xiàn)。 [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(nèi)的所有對產(chǎn)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。 [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(chǎn)品質量有直接影響的職位。員工應該知曉培訓的機會。 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(chǎn)品的員工都應接受靜 電放電培訓，以確保他們開展工作。 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 a