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目的阐述密云辖区医疗机构医疗器械使用监管现场检查流程。方法通过对不同医疗机构医疗器械使用情况的调研,药监密云分局分析辖区医疗机构医疗器械使用监管重点、工作难点,并运用ISO9000质量管理理念,建立标准规范。结果与结论通过形成标准规范,以流程管理提高工作效率和现场检查水平,实现规范化、流程化管理和全过程控制。
Objective To explain the procedure of on-site medical device supervision in Miyun district medical institutions. Methods Through the investigation of the medical equipment usage in different medical institutions, Miyun Branch of the drug regulatory office analyzed the regulatory priorities and difficulties in the use of medical equipment in medical institutions under its jurisdiction, and established ISO9000 quality management standards to establish standards. Results and Conclusion Through the formation of standard specifications, process management to improve work efficiency and on-site inspection level, to achieve standardization, process management and the whole process of control.