《精编》第4部分质量管理系统

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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 fundamental concepts of continual improvement, probl

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