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仪器设备的监控和管理是医药检测机构实验室质量体系建设中非常重要的环节,是保证实验室检测结果准确、有效的重要条件。由国际标准化组织和国际电工委1999年发布的《检测和校准实验室能力的通用要求》(即GB/T15481-2000)是目前实验室做好仪器设备监控和管理的重要指南。本文就ISO/IEC17025-1999标准对仪器设备管理提出的有关要求,如何在实际工作中实施,作一些浅显的探讨。
The monitoring and management of instruments and equipment is a very important link in the laboratory quality system construction of the pharmaceutical testing institutes and an important condition for ensuring the accurate and effective laboratory test results. The “General Requirements for Testing and Calibration Laboratory Capabilities” (ie GB / T15481-2000) issued by the International Organization for Standardization and the International Electrotechnical Commission in 1999 is an important guide for the laboratory to do well in the monitoring and management of the instrument and equipment. This article on ISO / IEC17025-1999 standard equipment and equipment management of the relevant requirements, how to implement in the actual work, make some simple discussion.