基于医疗器械良好生产规范的质量管理探讨.pdfVIP

中国医学装备2013年6月第10卷第6期 China Medical Equipment 2013 June Vol.10 NO.6 管理论坛 基于医疗器械良好生产规范的质量管理探讨 吴永东① [文章编号] 1672-8270(2013)06-0073-02 [中图分类号] R197.39 [文献标识码] A [摘要] 目的： 方法： 从医疗器械良好生产规范(GMP)角度探讨医疗器械质量管理。 对我国医疗器 械GMP的定义、研究背景、目前医疗器械质量管理体系现状以及在质量管理体系中实施医疗器 械GMP的价值等方面进行分析探讨。结果：医疗器械质量管理体系的完善除需制定各个环节质 量管理规定外，还需在风险管理过程中实施，风险管理为重要组成部分。结论：我国医疗器械质 理管理体系属于运态发展阶段，有一个循序渐进的发展过程，随着医疗器械GMP的实施，将为 医疗器械质量管理体系的快速发展铺平道路，使整体得到全面的发展。 [关键词] 医疗器械；良好生产规范；医疗器械质量管理 DOI: 10.3969/J.ISSN.1672-8270.2013.06.025 Discussion on quality management perspective based on medical devices GMP/WU Yong- dong// China Medical Equipment,2013,10(6):73-74. [Abstract] Objective: To investigate the quality management perspective that based on 作者简介 medical devices Good Manufacture Practice (GMP). Methods: To discuss and analyze the 吴永东,男,(1972- ), definition, research background, current medical equipment quality management system status in China and the value of implementing medical devices GMP. Results: The medical 本科学历，主管技师。 quality management system improvement not only based on the rules setting on quality 湖北中医药高等专科学 management in every stage, but also applied during risk management. Conclusion: Chinese 校公共基础部，研究方 medical equipment quality management is a dynamic development system that being a 向：医疗器械维修、保 gradual process. The medical devices GMP implementing can provide a good opportunity 养、医疗器械管理和售 for the development of medical equipment quality management system and promote overall 后服务。 development. [Key words] Medical equipment; GMP; Medical equipment quality management [First-author’s address] Department of Public and Basic, Hubei College of Traditional Chinese Medicine, Jingzhou 434020, China. 社会经济的迅猛发展带动了医疗科技的进步，