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PHILIPS验厂辅导---PHILIPS质量介绍(六)

P03.12  Identification

The organization shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.

The organization shall establish documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product组织应确定产品的合适的方法,在产品实现和应建立形成文件的程序,对这种产品的标识 。 组织应 建立     书面的程序,以确保返回给组织的医疗设备是确定和区分合格产品


P03.13  Traceability

The organization shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required. Where traceability is a requirement, the organization shall control and record the unique identification of the product组织应建立文件化的可追溯性控制程序。这种程序应规定产品可追溯性和记录所需的程度。当可追溯性为要求时,组织应控制并记录产品的唯一性标识


P03.16  Customer property

The organization shall exercise care with customer property while it is under the organization’s control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained. NOTE Customer property can include intellectual property or confidential health information. 本组织应爱护顾客财产时根据本组织的控制或正在使用的组织。组织应识别、验证、保护和维护供其使用或将纳入产品一部分的顾客财产。如果任何顾客财产发生丢失、损坏或发现不适合使用,应报告顾客,并保持记录。注意到一部分的顾客财产可包括知识产权或保密的健康信息。


P03.24  Process capability studies

The production process should be capable to produce goods parts. Capability could be expressed in Cpk indices. For example Cpk > 1,33生产过程应该有能力来生产货物的部件。Cpk指数可以表达能力。例如Cpk>1,33


P03.25  Sufficient production capacity

Necessary production capacity must be available. A systematic approach should evaluate the available capacity against updated customer forecasts. Sufficient flexibility must be built in in the production provision to absorb short term higher demand. 必要的生产能力必须可用。一个系统的方法应该评估对更新的客户预测的可用容量。足够的灵活性,必须建立在生产提供吸收短期内更高的要求。


P03.27  Statistical Techniques and Control

Manufacturer should use valid statistical techniques required for establishing, controlling and verifying the acceptability of process capability and product characteristics制造商应建、控制和验证过程能力和产品特性的可接受性所需的有效统计技术的应用


P04.04  Internal laboratory

An organization's internal laboratory facility shall have a defined scope that includes its capability to perform组织内部的实验室设施应有一个包括其有能力履行的定义的范围

the required inspection, test or calibration services. This laboratory scope shall be included in the quality所需的检验、试验或校准服务。实验室范围应包括在质量

management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for管理体系文件。实验室应指定和实现,作为最低技术要求

⎯ adequacy of the laboratory procedures, 实验室程序,足够

⎯ competency of the laboratory personnel, 实验室人员的胜任力

⎯ testing of the product, 测试的产品,

⎯ capability to perform these services correctly, traceable to the relevant process standard (such as ASTM,EN, etc.), and有能力履行这些服务是否正确,可追溯到相关的过程标准(如ASTM、 EN 等),和

⎯ review of the related records. 审查的相关记录。

NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate the organization's in-house laboratory conformity to this requirement but is not mandatory 请注意到 ISO/IEC 17025认证可用于证明组织内部实验室的整合。

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