Testing in manufacturer’s labs
▪ The CPR gives rules for using manufacturer‘s labs (Art. 46: Use of facilities outside the testing laboratory of the notified body) CPR描述了在工厂实验室进行测试的相关章程
▪ Tests under the scope of the CPR maybe carried out by the Notified Body or under its supervision in the manufacturing plants using the test equipments of the internal laboratory of the manufacturer CPR相关项目的测试,可以在授权机构或授权机构监控的工厂进行
Rules:原则
Only on request of the manufacturer 仅当基于工厂的要求
Only allowed where justified by technical, economic or logistic reasons仅当基于技术,经济 和物流因素
• The Notified Body needs to have a system implemented to ensure that the results gained in the manufacturer’s labs are equivalent to the tests gained at the Notified Body itself
授权机构需建立相关系统对在工厂实验室出具的测试数据进行监控及评定,确保该测试数据与授权机 构出具的测试数据的一致性;
• But: an accreditation of the manufacturer’s lab according to ISO/IEC 17025 by an external accreditation body is NOT mandatory. ISO/IEC 17025对工厂实验室没有要求;