企业质量管理体系(doc 24页)

企业质量管理体系(doc 24页)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 procedure(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5.4.2.C.1 Long- and Short-Term Quality Planning –The organization’s 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 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 involvement 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 customers. [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5.5.2 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 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 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。

[4]6.2.2.C.2 Quality Improvement Concepts – Those employees that have a direct impact onthe quality of the product, including top management, shall be trained in the fundamental 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。

[4]6.2.2.C.3 Training Requirements and Awareness – Training requirements shall be definedfor all positions that have a direct impact on the quality of products. Employees 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 (ESD) 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 capability, 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。

[5]6.2.2.C.6 Training Content – Where the potential for hazardous conditions exists, training 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 requirements 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. [4] HV.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。