药品检验机构质量管理体系运行中质量监督与内部审核的比较及协同作用探讨  

Discussion on the Comparison and Synergy Between Quality Supervision and Internal Audit in the Operation of Auality Management System of Drug Inspection Institutions

作　　者：孙娴 赵萌 张权 SUN Xian;ZHAO Meng;ZHANG Quan(National Medical Products Administration Institute of Executive Development,Beijing 100073,China;National Institutes for Food and Drug Control,Beijing 102629,China;Administrative Matters Acceptance Service and Complaint Reporting Center of National Medical Products Administration,Beijing 100053,China)

机构地区：[1]国家药品监督管理局高级研修学院,北京100073 [2]中国食品药品检定研究院,北京102629 [3]国家药品监督管理局行政事项受理服务和投诉举报中心,北京100053

出　　处：《中国卫生产业》2024年第13期75-78,共4页China Health Industry

摘　　要：质量监督与内部审核是药品检验机构必不可少的质量活动,二者相互补充。在质量管理体系运行中充分发挥质量监督与内部审核的协同作用有助于药品检验机构内部质量控制的有效实施。本文基于质量监督与内部审核的定义及意义、工作程序,对二者的区别进行深入的对比性探究,并探讨二者的协同作用,从而促进质量监督与内部审核工作深度融合,确保质量管理体系规范化、科学化运行,推动实验室的不断优化和自我提升。Quality supervision and internal audit are essential quality activities in drug testing institutes,which complement each other.Giving full play to the synergistic effect of quality supervision and internal audit in the operation of quality management system is conducive to the effective implementation of internal quality control in drug testing institutes.Based on the definition,meaning and working procedures of quality supervision and internal audit,the article discusses their difference and synergies,so as to promote the deep integration of them,which can ensure the standardized and scientific operation of the quality management system,and promote the continuous optimization and self-improvement of laboratories.

关 键 词：药品检验机构 质量管理体系 质量监督 内部审核 协同作用 

分 类 号：R19[医药卫生—卫生事业管理]