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1、Section 4 Quality management system第四章 质量管理体系4.1 General requirements一般要求4.2 Documentation requirements文件要求4.2.1 General总则4.2.2 Quality manual质量手册4.2.3 Control of documents文件控制4.2.3.C.1 Control of Customer-Supplied Documents and Data The organization shall establish and maintain a documented procedu
2、re(s) to control all customer-supplied documents and data (e.g., 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.客户提供文件及数据控制 组织将建
3、立并且维护文件化程序以控制所有客户提供的文件和数据（例如，网络体系结构，布局，容量，安装结束任务及数据库）如果这些文件和数据影响设计，验证，确认，检查及测试，或服务于产品。4.2.4 Control of records记录控制Section 5 Management responsibility第五章管理职责5.1 Management commitment管理承诺5.2 Customer focus 以顾客为关注焦点5.2.C.1 Customer Relationship Development Top management shall demonstrate active involv
4、ementin establishing and maintaining mutually-beneficial relationships between the organization and itscustomers. 4发展顾客关系最高管理者应积极参与建立并维护组织与顾客之间的相互受益的关系。5.2.C.2 Customer Communication Procedures The organization shall establish and maintain adocumented procedure(s) for communicating with selected cus
5、tomers. The documented procedure(s) shall include:顾客沟通程序组织应建立并维护文件化的程序以确保与特定顾客之间的沟通。该程序文件应包括：a) a strategy and criteria for customer selection,选择顾客的策略及标准b) a method for the organization and its customers to share joint expectations and improve the quality of products, and组织和顾客共同参与策划及提高产品质量的方法，和c) a
6、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会同顾客安既定的时间间隔评审期望目标的状况，并且应有可以追踪决定流转的方法。5.2.C.2-NOTE 1: It is recognized that it is not possible for an organization to provide the same level of co
7、mmunication 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：众所周知，组织不可能对所有顾客提供同样级别的沟通。所提供的级别应依据与顾客的生意数量、历史问题、顾客期望值，以及其
8、它因素（参见附录F，“顾客沟通指导”）5.3 Quality policy质量方针5.4 Planning策划5.4.1 Quality objectives质量目标5.4.1.C.1 Quality Objectives Objectives for quality shall include targets for the TL 9000 measurements defined in the TL 9000 Quality Management System Measurements Handbook.质量目标质量目标应包括在TL9000 质量管理体系计算手册中为TL9000定义的对象。
9、5.4.2 Quality management system planning质量管理体系策划5.4.2.C.1 Long- and Short-Term Quality Planning The organizations quality planning activities shall include long- and short-term plans with goals for improving quality and customer satisfaction.长期和短期质量策划组织的质量策划行为应包括以提高质量和顾客满意度为目标的长期策划和短期策划。Performance
10、to these goals shall be monitored and reported. These plans shall address:实现这些目标需要监控和汇报。这些策划应注明：a) cycle time, 循环时间b) customer service, 顾客服务c) training, 培训d) cost, 成本e) delivery commitments, and 交货承诺，等f) product reliability. 产品可靠性5.4.2.C.1-NOTE 1: Top Management should demonstrate their active invol
11、vement in long- and short-term quality planning.注解1：最高管理者应积极参与到长期和短期质量策划中。5.4.2.C.2 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 custome
12、rs. 4顾客输入 组织应将顾客输入纳入质量策划中。组织应会同顾客建立质量改进程序。5.4.2.C.3 Supplier Input The organization shall implement methods for soliciting and using supplier input for quality planning activities. 4供应商输入组织应将供应商输入纳入质量策划中。5.5 Responsibility, authority and communication职责、权限与沟通5.5.1 Responsibility and authority职责和权限5.
13、5.2 Management representative管理者代表5.5.3 Internal communication内部沟通5.5.3.C.1 Organization Performance Feedback The organization shall inform employees of its quality performance and the level of customer satisfaction. 4组织成绩反馈组织应通知其员工关于质量成绩以及顾客满意程度。5.6 Management review管理评审5.6.1 General总则5.6.2 Review
14、input评审输入5.6.3 Review output评审输出Section 6 Resource management第六章 资源管理6.1 Provision of resources资源提供6.2 Human resources人力资源6.2.1 General 总则6.2.2 Competence, awareness and training能力、意识和培训6.2.2.C.1 Internal Course Development When the organization develops internal training courses, it shall establish
15、 and maintain a process for planning, developing, and implementing these courses. 4内部课程开展当组织开展内部培训课程时应当建立并维护一个程序以确保课程的计划、开展及实现。46.2.2.C.2 Quality Improvement Concepts Those employees that have a direct impact on the quality of the product, including top management, shall be trained in the fundamenta
16、l concepts of continual improvement, problem solving, and customer satisfaction. 4质量改进观念包括最高管理者在内的所有对产品质量有直接影响的员工应当接受持续改进、解决问题及顾客满意等基本观念的培训。46.2.2.C.3 Training Requirements and Awareness Training requirements shall be defined for all positions that have a direct impact on the quality of products. Em
17、ployees shall be made aware of training opportunities. 4培训需求和意识培训需求应针对所有对产品质量有直接影响的职位。员工应该知晓培训的机会。6.2.2.C.4 ESD Training All employees with functions that involve any handling, storage, packaging,preservation, or delivery of ESD-sensitive products shall receive training in electrostatic discharge (E
18、SD) protection prior to performing their jobs.ESD 培训所有包括操作、仓储、包装、保存及运输ESD敏感产品的员工都应接受静电放电培训，以确保他们开展工作。6.2.2.C.5 Advanced Quality Training The organization shall offer appropriate levels of advanced quality training. Examples of advanced quality training may include statistical techniques, process cap
19、ability, statistical sampling, data collection and analysis, problem identification, problem analysis, and corrective and preventive action. 5高级质量培训组织应体统适当更高层次的质量培训。高级质量培训可以包括统计技术、过程能力、统计取样、数据收集及分析、问题判断、问题分析积极纠正预防措施等。56.2.2.C.6 Training Content Where the potential for hazardous conditions exists, tr
20、aining content shouldinclude the following:培训内容有潜在危险的地方，培训内容应包括：a) task execution, 作业执行b) personal safety, 个人安全c) awareness of hazardous environment, and 危险意识，等d) equipment protection. 设备保护6.2.2.HV.1 Operator Qualification The organization shall establish operator qualification andrequalification re
21、quirements for all applicable processes. These requirements, at a minimum, shall address employee education, experience, training, and demonstrated skills. The organization shall communicate this information to all affected employees. 4HV.1 操作员资格组织应当为所有必要过程建立操作员资格及要求条件。这些要求应注明员工教育背景、工作经历、培训及技能。组织应将该
22、信息通知所有相关职工。6.3 Infrastructure基础设施6.4 Work environment工作环境6.4.C.1 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. 56.4.C.1 工作区用于操作、储存及包装产品的区域应保持干净、安全并且有序，以确保不会对质量或个
23、人造成负面影响。Section 7 Product realization第七章 产品实现7.1 Planning of product realization 产品实现的策划7.1.C.1 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, acti
24、vities, and tasks involved in the concept, definition, development, production, operation, maintenance, and (if required) disposal of products, spanning the life of the products. 10生命循环模式组织应当建立并维护一套覆盖产品生命循环的完整的指导手册。该框架应尽可能包括国过程、功能、以及观念、定义、发展、产品、操作、维护，以及产品的处理（如果必要），跨度产品的生命周期。7.1.C.2 New Product Intro
25、duction The organization shall establish and maintain a documented procedure(s) for introducing new products for General Availability.新产品介绍组织应建立并维护一套文件化的程序用以介绍新产品的一般性能。7.1.C.2-NOTE 1: The new product introduction program should include provisions for such programs as: quality and reliability predict
26、ion studies, pilot production, demand and capacity studies, sales and service personnel training, and new product post-introduction evaluations.注解1新产品介绍程序应包括以下程序：质量及可靠性预测计划，试制产品，需求及产量计划，销售及服务人员培训，新产品定位估计。7.1.C.3 Disaster Recovery The organization shall establish and maintain methods for disasterreco
27、very to ensure the organizations ability to recreate and service the product throughout its life cycle. 10事故处理组织应建立并维护事故处理的方法以确保组织有能力在生命周期内进行维修和服务。7.1.C.4 End of Life Planning The organization shall establish and maintain a documentedprocedure(s) for the discontinuance of manufacturing and/or suppor
28、t of a product by the operation and service organizations. The documented procedure(s) should include:最终策划组织应为保质期和服务组织终止生产或支持产品建立并维护一套文件化的程序。该程序文件应包括：a) cessation of full or partial support after a certain period of time, 一定时间后停止全部或部分支持，b) archiving product documentation and software, 保存产品文档及软件，c) r
29、esponsibility for any future residual support issues, 对任何残留问题支持的责任，d) transition to the new product, if applicable, and 如果适用，转化为新产品，等e) accessibility of archive copies of data. 10 数据拷贝存档的可达性7.1.HS.1 Configuration Management Plan The organization shall establish and maintain a configuration managemen
30、t plan, which should include: 配置管理策划组织应建立并维护一配置管理策划，其内容应包括：a) identification and scope of the configuration management activities, 配置管理活动的定义及范围b) schedule for performing these activities, 执行这些活动的进度表c) configuration management tools, 配置管理工具d) configuration management methods and documented procedure(
31、s), 配置管理方法及程序文件e) organizations and responsibilities assigned to them, 组织及分派给它的责任，f) level of required control for each configuration item, and 每个配置项目需要控制的级别g) point at which items are brought under configuration management. 10指明哪些条款置于配置管理的管辖范围。107.1.HS.1-NOTE 1: General work instructions defining g
32、eneral configuration management tasks and responsibilities need not be replicated as part of a specific documented configuration management plan.注解1：总的工作指令规定总的配置管理任务并且责任不必转述为配置管理策划的部分文件。7.1.S.1 Estimation The organization shall establish and maintain a method for estimating and tracking project fact
33、ors during project planning, execution, and change management. 11评估组织应建立并维护一种方法用以在方案策划、实施及更改过程中评估和跟踪方案因素7.1.S.1-NOTE 1: Project factors should include product size, complexity, effort, staffing, schedules, cost, quality, reliability, and productivity.注解1：方案因素应包括产品尺寸，复杂性，成就，员工，进度，成本，质量，可靠性及生产能力。7.1.S
34、.2 Computer Resources The organization shall establish and maintain methods for estimating and tracking critical computer resources for the target computer, the computer on which the software is intended to operate. Examples of these resources are utilization of memory, throughput, real time perform
35、ance, and I/O channels. 11计算机资源组织应建立并维护一种方法用以评估和追踪目标计算机的重要资源，计算机中的软件是否预期运行。这些资源包括存储器的效用、吞吐量、适时执行以及I/O通道。117.1.S.3 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 qua
36、lity method(s). Tools to be considered include: design and development tools, testing tools, configuration management tools, and documentation tools. 11支持软件及工具管理组织应该保证用在产品中的内部开发的支持软件及工具在整个产品生命周期中的质量。应当考虑的工具包括：设计开发工具、测试工具、配置管理工具，以及文件工具。117.1.V.1 Service Delivery Plan Suppliers that are responsible fo
37、r the delivery or implementation of a service, and are not responsible for the design and development of that service, shall comply with the Project Plan requirements of 7.3.1.C.1.服务交付策划 厂商有责任交货或提供服务，但是对服务的设计及发展不负责任，应符合7.3.1.C.1条方案策划要求。7.2 Customer-related processes与顾客有关的过程7.2.1 Determination of req
38、uirements related to the product 与产品有关的要求的确定7.2.2 Review of requirements related to the product与产品有关的要求的评审7.2.2.C-NOTE 1: The contract review process should include:注解1：合同评审过程应包括：a) product acceptance planning and review, 产品验收策划和评审b) handling of problems detected after product acceptance, including
39、customer complaints and claims, and 产品验收后发现问题的处理，包括客户投诉及要求，等c) responsibility of removal and/or correction of nonconformities after applicable warranty period or during product maintenance contract period. 9在保证期或维修合约有效期间有责任删除和/或修正不符合项目。97.2.2.C-NOTE 2: The product acceptance plan should include as a
40、ppropriate:注解2：产品验收策划应当包括以下内容作为补充：a) acceptance review process, 验收评审过程，b) acceptance criteria, 验收标准c) documented test procedure(s), 文件化的检测程序d) test environment, 检测环境e) test cases, 检测实例f) test data, 检测数据g) resources involved, 相关资源h) method(s) for problem tracking and resolution, and 问题追踪及解决方法，等i) req
41、uired acceptance test reports. 10 必要的检验报告7.2.3 Customer communication 顾客沟通7.2.3.C.1 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关于问题的通知 组织应建立并维护一套程序文件
42、以通知可能受已报告的服务问题影响的所有顾客。7.2.3.C.2 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 le
43、vel shall be used in determining the timeliness of the organizations response. 11问题严重性组织应根据对顾客的影响向顾客指明问题的严重程度，根据手册中的术语可分为严重，重大，一般问题。组织根据严重程度确定答复时间。7.2.3.C.2-NOTE 1: The customer and the organization should jointly determine the priority for resolving customer-reported problems.注解1：顾客和组织共同确定解决顾客报告问题的
44、优先程度。7.2.3.C.3 Problem Escalation The organization shall establish and maintain a documented escalation procedure(s) to resolve customer-reported problems. 11问题升级 组织应建立并维护一套程序文件解决升级的顾客报告问题。117.2.3.C.4 Customer Feedback The organization shall establish and maintain a documentedprocedure(s) to provide
45、 the customer with feedback on their problem reports in a timely manner.顾客反馈组织应建立并维护一套程序文件及时处理顾客问题反馈。7.2.3.H.1 Organizations Recall Process The organization shall establish and maintain a documented procedure(s) for identifying and recalling products that are unfit to remain in service.组织的回收过程组织应建立并
46、维护一套程序文件以鉴定和回收不适合维修的产品。7.3 Design and development设计和开发7.3.1 Design and development planning 设计和开发策划7.3.1.C.1 Project Plan The organization shall establish and maintain a project plan based on the defined product life cycle model. The plan should include:方案策划 组织应依据定义的产品生命周期模式建立并维护一个方案计划。该计划应包括：a) project organizational structure, 方案组织结构b) project roles and responsibilities, 方案角色及职责c) interfaces with