【正文】 rganization 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。Section 7 Product realization第七章 產(chǎn)品實現(xiàn) Planning of product realization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。個人安全c) awareness of hazardous environment, and[5] Training Content – Where the potential for hazardous conditions exists, training content shouldinclude the following:培訓(xùn)內(nèi)容－有潛在危險的地方，培訓(xùn)內(nèi)容應(yīng)包括：a) task execution,員工應(yīng)該知曉培訓(xùn)的機會。 Responsibility, authority and munication職責(zé)、權(quán)限與溝通 Responsibility and authority職責(zé)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。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(yīng)積極參與到長期和短期質(zhì)量策劃中。 成本e) delivery mitments, and 顧客服務(wù)c) training,這些策劃應(yīng)注明：a) cycle time, 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 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。 以顧客為關(guān)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(guān)系－最高管理者應(yīng)積極參與建立并維護組織與顧客之間的相互受益的關(guān)系。所提供的級別應(yīng)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(dǎo)”） Quality policy質(zhì)量方針 Planning策劃 Quality objectives質(zhì)量目標(biāo) Quality Objectives – Objectives for quality shall include targets for the TL 9000 measurements defined in the TL 9000 Quality Management System Measurements Handbook.質(zhì)量目標(biāo)－質(zhì)量目標(biāo)應(yīng)包括在TL9000 質(zhì)量管理體系計算手冊中為TL9000定義的對象。 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(yīng)將顧客輸入納入質(zhì)量策劃中。 Management review管理評審 General總則 Review input評審輸入 Review output評審輸出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(xùn) Internal Course Development – When the organization 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(dāng)組織開展內(nèi)部培訓(xùn)課程時應(yīng)當(dāng)建立并維護一個程序以確保課程的計劃、開展及實現(xiàn)。 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(xùn)－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(yīng)接受靜電放電培訓(xùn)，以確保他們開展工作。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。 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。 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。 [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。[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。 [9] 2: The product acceptance plan should include as appropriate:注解2：產(chǎn)品驗收策劃應(yīng)當(dāng)包括以下內(nèi)容作為補充：a) acceptance review process, 驗收標(biāo)準(zhǔn)c) documented test procedure(s), 檢測環(huán)境e) test cases, 檢測數(shù)據(jù)g) resources involved, 問題追蹤及解決方法，等I) required acceptance test reports. [10]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(guān)于問題的通知－ 組織應(yīng)建立并維護一套程序文件以通知可能受已報告的服務(wù)問題影響的所有顧客。 Problem Escalation – The organization shall establish and maintain a documented escalation procedure(s) to resolve customerreported problems. [11]問題升級－ 組織應(yīng)建立并維護一套程序文件解決升級的顧客報告問題。 該計劃應(yīng)包括：a) project organizational structure, 方案角色及職責(zé)c) interfaces with internal and external organizations, 計劃進度、跟蹤、問題決定及報告的方式e) budgets, staffing, and schedules associated with project activities,方法，標(biāo)準(zhǔn)，程序文件以應(yīng)用工具g) references to related plans (., development, testing, configuration management, and quality),方案詳細(xì)考慮的環(huán)境及物質(zhì)資源（例如：發(fā)展，用戶證書，測試及操作）I) customer, user, and supplier involvement during the product life cycle (., joint reviews, informal meetings, and approvals),方案質(zhì)量管理k) risk management and contingency plans (., technical, cost and schedules),執(zhí)行、保