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PHILIPS验厂辅导---PHILIPS质量介绍(七)

P04.05  External laboratory

External/commercial/independent laboratory facilities used for inspection, test or calibration services by the organization shall have a defined laboratory scope that includes the capability to perform the required  inspection, test or calibration, and either由组织用于检验、试验或校准服务的外部/商业/独立实验室设施须包括的能力来执行所需的检验、验或校准,并定义的实验室范围

⎯ there shall be evidence that the external laboratory is acceptable to the customer, or ⎯有须证据表明外部实验室是可以接受的客户,或

⎯ the laboratory shall be accredited to ISO/IEC 17025 or national equivalent. ISO/IEC 17025⎯实验室应派驻或相应国家标准。

NOTE 1 Such evidence may be demonstrated by customer assessment, for example, or by customer-approved second party assessment that the laboratory meets the intent of ISO/IEC 17025 or national equivalent. 注意1 这种证据可能由顾客评定,举个例子,证明,或由客户认可第二方评定证明实验室满足ISO/IEC 17025 或相应国家标准的意图。

NOTE 2 When a qualified laboratory is not available for a given piece of equipment, calibration services may be performed by the equipment manufacturer. In such cases, the organization should ensure that the requirements listed in ISO16949: 7.6.3.1 have been met. 一段给定的设备,校准服务可以由设备制造商不合格的实验室时,注意到2。在这种情况下,组织应确保在 ISO16949 中列出的要求︰7.6.3.1 遇到。


P05.05  Work place organization and housekeeping

Good work place organization supports the realization of quality parts. The 5S model is an excellent technique to bring workplace organization up to industry standards. 工作的好地方组织支持实现质量的零件。5S 模型是一种优秀的技术,使工作场所组织达到行业标准。


P05.06  ESD protection

Where ever ESD sensitive material is being used, adequate measures to prevent damage from shock should be applied在任何地方使用 ESD 敏感材料,则应适用适当措施,防止造成冲击的伤害


P06.01  Monitoring and measurement of manufacturing processes

The organization shall perform process studies on all new manufacturing (including assembly or sequencing) processes to verify process capability and to provide additional input for process control. The results of process studies shall be documented with specifications, where pplicable, for means of production, measurement and test, and maintenance instructions. These ocuments shall include objectives for manufacturing process capability, reliability, maintainability and availability, as well as acceptance criteria. 组织应执行过程研究,对所有新的制造(包括程序集或测序)工艺验证过程能力并为过程控制提供附加的输入。工艺研究的结果应记录与规格,在哪里铁芯,为生产、测量和测试,以及维修说明的手段。这些凭证应包括目标制造过程能力、 可靠性、可维护性和可用性,以及验收标准。

The organization shall maintain manufacturing process capability or performance as specified by the customer part approval process requirements. The organization shall ensure that the control plan and process flow diagram are implemented, including adherence to the specified组织应保持制造过程能力或性能作为指定由客户件批准过程的要求。组织应确保控制计划和过程流程图被执行,包括加入到指定的。

⎯ measurement techniques, ⎯ 测量技术

⎯ sampling plans, ⎯ 抽样计划

⎯ acceptance criteria, and⎯ 验收标准,和

⎯ reaction plans when acceptance criteria are not met. ⎯ 反应计划时不符合验收标准。

Significant process events, such as tool change or machine repair, shall be recorded. 应记录重要的过程事件,如模具的更换或机械维修。

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