食品药品检验机构仪器设备规范化管理的探讨  

Discussion on Standardized Management of Equipment in Food and Drug Inspection Institutes

作　　者：王建宇[1] 祁景坤 王冠杰[1] 邹健[1] 田利[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2014年第5期524-526,共3页Chinese Pharmaceutical Affairs

摘　　要：目的仪器设备管理是实验室质量管理体系中的重要要素。分析食品药品检验机构仪器设备管理问题与风险,探讨建立仪器设备规范化的管理模式。方法通过对本院仪器设备管理工作的总结,从组织管理、采购管理、安装验收管理、运行管理、维护维修管理、计量管理、资产管理以及档案管理等方面,提出了一套完整的仪器设备规范化管理模式。结果与结论目前,食品药品检验机构仪器设备管理水平参差不齐,相关质量文件不统一。建立一套行之有效的仪器设备规范化管理模式,提升仪器设备管理水平,是各级食品药品检验机构必须解决的重要问题。Objective Equipment is one of the key factors in the lab management system. In this paper, the problems in equipment management and risks of the food and drug inspection agency have been analyzed, and the establishment of a standardized management mode was discussed. Methods The management of equipment in our institute was summarized and a standardized mode for equipment management, in terms of organization, purchasing, installation and acceptance, operation, maintenance, metrology, assets and archives management, was proposed. Results and Conclusion Currently, the equipment management levels in food and drug inspection institutes are uneven and quality documents concerned are not unified. It is important for the food and drug inspection institutes to establish a standardized mode for equipment management and improve their management levels.

关 键 词：药品检验机构 仪器设备管理 规范化管理模式 

分 类 号：R95[医药卫生—药学]