基于CNAS-CL01:2018与RB/T 214—2017标准的实验室质量管理体系设计
Design of laboratory quality management system based on CNAS-CL01:2018 and RB/T 214—2017
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摘要: 对比研究了CNAS-CL01:2018和RB/T 214—2017两个标准的异同点,得出基于CNAS-CL01:2018标准设计CMA(中国计量认证)和CNAS(中国合格评定国家认可委员会)二合一体系是可行的。提出了26个程序文件,这些文件能够同时覆盖CNAS-CL01:2018和RB/T 214—2017的要求,建立的二合一体系可节约时间和降低成本。实验室应抓住关键要素,保证设备符合要求,并开展人员培训、考核和能力监控,以确保检测结果的有效性;实验室应结合自身特点有效实施内审,将风险管理贯穿检测相关业务的全过程,以保证实验室质量管理体系的持续改进。Abstract: By comparing the similarities and differences between CNAS-CL01:2018 and RB/T 214—2017, it was concluded that the design of CMA(China Inspection Body and Laboratory Mandatory Approval) and CNAS(China National Accreditation Service for Conformity Assessment) two-in-one system based on CNAS-CL01:2018 was feasible. 26 program files were proposed, which could cover the requirements of CNAS-CL01:2018 and RB/T 214—2017 at the same time. The two-in-one system could save time and reduce costs. The laboratory should seize the key elements to ensure that the equipment met the requirements and carried out personnel training, assessment and capacity monitoring to ensure the effectiveness of the test results.The laboratory should effectively implement internal audit according to its own characteristics, and risk management should run through the whole process of testing related business to ensure the continuous improvement of laboratory quality management system.