浅析医疗器械生产企业质量管理体系内审的相关问题

On Issues Related to Medical Device Quality Management System Internal Audit of Enterprises

目的内部审核是医疗器械行业推进质量管理体系有效运行和持续改进的重要手段。该文分析了医疗器械生产企业内审中存在的问题,提出了思想重视,人员培训,分级管理、内审流程、审核技巧等改进方向,有助于提高内审质量。

Internal audit is the important means to promote the effective operation of the quality manage- ment system and continually improve the medical device industry. This paper analyzes the existence of internal au- dit of medical equipment production enterprises in the problem, put forward the idea of value, personnel training, improvement of internal audit process, classification management, audit skills, help to improve the internal audit quality.