摘要
目的:了解国内医疗器械经营企业质量管理体系飞行检查缺陷项目情况,找出企业存在的主要问题,提出加快推进落实经营质量管理规范的相关要求的对策和建议。方法:对国内2017年经营企业飞行检查的30家企业的缺陷项目进行汇总,对主要问题进行分类、归纳。结果与结论:应严格执行规定,加大培训力度,建立专职检查员队伍,妥善处理善后问题,确保规范得到正确贯彻实施。
Objective:Through analysis of defections founding in current unannounced inspections of quality management system in medical equipment business enterprises,find out the main problems of enterprises,and put forward countermeasures and suggestions for accelerating the implementation of relevant requirements of GSP.Methods:The defections of 30 enterprises in 2017 were reviewed,the main problems were classified and summarized.Results and conclusion:We should enforce the regulations strictly,increase training efforts,establish a full-time inspector team,properly deal with the problem of aftermath,and ensure GSP are properly implemented.
作者
温晶
杨志强
魏澜
尹宏文
王爱君
WEN Jing1;YANG Zhi-qiang;WEI Lan;YIN Hong-wen;WANG Ai-jun(Center For Food and Drug Inspection China Food and Drug Administration,Beijing 100061;China Food and Drug Administration,Beijing 100053)
出处
《中国医疗器械信息》
2018年第7期10-13,共4页
China Medical Device Information
关键词
经营质量管理规范
飞行检查
问题
对策
good supplying practice for medical devices
anannounced inspection
problems
countermeasures
