临床试验机构开展ISO9001质量管理体系认证的意义及体会  

Significance and Experience of ISO9001 Quality Management System Certification for Clinical Trial Institutions

作　　者：吴建元[1] 郑磊 杨有康 黄建英[1] WU Jian-yuan;ZHENG Lei;YANG You-kang;HUANG Jian-ying(Clinical Trial Center of Zhongnan Hospital,Wuhan University,Wuhan 430071,China;China Quality Mark Certification Group,Beijing 100048,China)

机构地区：[1]武汉大学中南医院临床试验中心,武汉430071 [2]方圆标志认证集团有限公司,北京100048

出　　处：《中国合理用药探索》2021年第3期12-16,共5页Chinese Journal of Rational Drug Use

基　　金：国家“重大新药创制”科技重大专项资助项目(2020ZX09201007);湖北省卫生健康委2021-2022年度面上项目(WJ2021M169);2021年武汉大学中南医院医学科技创新平台支撑项目(临床研发项目)。

摘　　要：本文以临床试验机构备案制新形势为切入点,分析了临床试验质量管理体系与ISO9001质量管理体系的联系;介绍了ISO9001质量管理体系认证的要求和流程;探讨了机构开展ISO9001质量管理体系认证的意义;揭示了ISO9001质量管理体系认证对机构建设发展的优势;提出了机构借助ISO9001质量管理体系推动临床试验的持续良性发展这一可行途径,以期为机构同行提供借鉴和参考。The new situation of record-keeping system about clinical trial institution was taken as the entry point.The relationship between clinical trial quality management system and ISO9001 quality management system is analyzed.The requirements and process of ISO9001 quality management system certification are introduced.The significance of ISO9001 quality management system certification is discussed.The superiority of ISO9001 quality management system on the construction and development of institutions is elaborated.A feasible way puts forward to promote the sustainable and benign development of clinical trials by means of ISO9001 quality management system,so as to provide reference for other institutions of concern.

关 键 词：临床试验机构 备案制 ISO9001 质量管理体系 干细胞临床研究 

分 类 号：R969.4[医药卫生—药理学]