医疗器械生产企业质量管理体系核查常见缺陷分析与对策  

Analysis of common defects in quality management system verification of medical device manufacturers and countermeasures

作　　者：李思媛 尹辰 陈建乐 索银科 LI Si-yuan;YIN Chen;CHEN Jian-le;SUO Yin-ke(Baoji Branch of Shaanxi Drug and Vaccine Inspection Center,Baoji 721013,Shaanxi Province,China;Shaanxi Drug and Vaccine Inspection Center,Xi'an 716000,China)

机构地区：[1]陕西省药品和疫苗检查中心宝鸡分中心,陕西宝鸡721013 [2]陕西省药品和疫苗检查中心,西安716000

出　　处：《医疗卫生装备》2024年第8期83-90,共8页Chinese Medical Equipment Journal

摘　　要：介绍了某地区67家医疗器械生产企业质量管理体系核查的总体情况,从医疗器械生产企业机构与人员、厂房与设施、设备、文件管理、设计开发、采购、生产管理、质量控制等11个方面总结了医疗器械生产企业质量管理体系核查存在的常见缺陷并分析了存在缺陷的原因,提出了加强对相关人员的培训和教育、不断改进质量管理体系、完善管理和执行机制、完善员工参与和激励机制等对策,为医疗器械生产企业质量管理体系的建立及运行提供了借鉴。The quality management system verification of 67 medical device manufacturers in some region was introduced generally.The common defects during the quality management system verification of medical device manufacturers were summarized from 11 aspects of organization and personnel,plant and facility,equipment,document management,design and development,procurement,production management,quality control and etc.The causes for the common defects were analyzed.Some countermeasures were proposed including strengthening the training and education of related personnel,continuously promoting quality management system,enhancing managment and execution mechanism and improving the mechanism of personnel participation and encouragement.References were provided for establishing and running the quality management system of medical device manufacturers.

关 键 词：医疗器械生产企业 质量管理体系 质量管理体系核查 缺陷分析 

分 类 号：R318[医药卫生—生物医学工程] R197.39[医药卫生—基础医学]