以新版《检测和校准实验室能力认可准则》(CNAS-CL01: 2018)要求开展检测方法验证的问题及解决方法

Issues and solutions for verification of test methods with the requirement of new Guidelines for accreditation of testing and calibration laboratories (CNAS-CL01: 2018)

中文关键词:  CNAS  检测和校准实验室能力认可准则  检测方法验证

英文关键词:CNAS  guidelines for accreditation of testing and calibration laboratories  test method validation

中文摘要:

      检测实验室中检测结果的准确性至关重要, 对标准检测方法的验证是获得检测结果准确性的重要前提; 对申请CNAS认可的实验室而言, 如果方法验证不符合认可准则的要求, 将直接造成申请的技术能力不予认可。本文依据《检测和校准实验室能力认可准则》的要求, 以实际发生的案例为例, 通过分析问题产生原因, 从体系文件的控制、方法验证技术操作、记录的规范填写等3个方面, 对实验室开展方法验证的方法进行全面细致地讲解, 以期用于指导实验室有效地开展方法验证工作。

英文摘要:

      The accuracy of the test results in the testing laboratory is crucial, and verification of the standard test method is an important prerequisite for obtaining the accuracy of the test results. For laboratories applying for CNAS accreditation, if the method verification does not meet the requirements of the accreditation criteria, the technical ability of the application will be directly rejected. This article took the actual occurrence of the case as an example, based on the requirements of the Guidelines for accreditation of testing and calibration laboratories. By analyzing the causes of the problems, from the three aspects of system file control, method verification technology operation, and record specification filling, the method of laboratory verification is fully and carefully explained, in order to guide the laboratory to effectively carry out method validation work.