食品药品检验机构仪器设备管理监督检查工作经验探讨  

Experience on Equipment Supervision and Inspection in Food and Drug Control Agency

作　　者：马颖[1] 田利[1] 祁景琨[1] 于欣[1] 陶维玲[1] 张河站[1] 邹健[1] 

机构地区：[1]中国食品药品检定研究院,北京市100050

出　　处：《中国医疗器械杂志》2013年第5期370-372,共3页Chinese Journal of Medical Instrumentation

摘　　要：为配合实验室管理体系的有效运行和认证认可工作的顺利推进,为内审、管理评审及持续完善管理体系提供具体建议和依据,建立了仪器设备管理监督检查方案。通过检查,找出了仪器设备运行及管理中存在的问题和不足,提出具体的改进建议,完善了工作程序。为检验科室出具的检验检测数据更加严谨、科学和公正,与国际接轨、达到数据互认提供硬件保障。To assure the effective operation of certification and accreditation in the laboratory management system, further strengthen the instruments and equipment management, and provide specific recommendations on improvement of internal audit, management review and continuous improvement of management system. The inspector program had been firstly established and complemented. Through the inspection, we identified many deficiencies, made many specific recommendations for improvement. After inspection, the working procedures were improved; data from department were more rigorous, scientific and just; hardware foundation was established for international mutual recognition.

关 键 词：监督检查 仪器设备 药品质量控制 实验室能力认证认可 

分 类 号：R197.1[医药卫生—卫生事业管理] F203[医药卫生—公共卫生与预防医学]