摘要
目的:了解全市三类医疗器械经营企业规范实施状况,找出存在的主要问题,并提出解决措施。方法:分层抽取32家调查对象,采用异地交叉结合监管技能比武形式,按《规范》要求进行检查。结果:企业主要存在忽视经营环节全生命周期的管理、员工培训和健康检查不到位、设施设备与经营规模不适应、制度不健全等问题。结论:应通过加强培训、示范引领、加强监督检查等,提升质量管理水平。
Objective： Through investigation on current situation of standardized implementation of medical device business enterprises in Hangzhou, fnd out the main problems of enterprises and put forward the measures to solve the problem. Methods： frst stratifed extraction of 32 subjects, and then used the foreign intersecting and combinated the supervision skills to investigate. Results： Enterprises mainly have the following problems： Neglecting the whole process management, Lack of training and health examination, Facilities and equipment mismatch, Unsound system, and so on. Conclusion： We should have more training, playing an exemplary role of excellent enterprise, Increasing supervision and inspection and so on to improve the quality management level of enterprise.
作者
董华胜
周杰
王庆
吴梅
DONG Hua-sheng;ZHOU Jie;WANG Qing;WU Mei(Market Supervision Administration of Hangzhou Municipality,Zhejiang Hangzhou 310009)
出处
《中国医疗器械信息》
2018年第19期38-40,共3页
China Medical Device Information
关键词
医疗器械经营
规范
调查
management of medical device
GSP
investigation
