肖 镜 殷 悦 李景云 毛 歆 项新华 张河战中国食品药品检定研究：，北京100050

    药品检验机构实验室质量管理体系内的人员管理

    肖镜殷悦李景云毛歆项新华张河战

    中国食品药品检定研究：，北京100050

    药品检验机构实验室的质量管理体系中，决定检验检测的正确性和可靠性的要素有很多，包括效果及其对炎症因子水平的影响，并探寻器设备尧样品处置等，人员是其中关键性的因素。本文根据药品检验机构实验室遵循的各项外部认证尧认可准则和实验室管理规范中的相关要求，以药品检验机构的业务特点为基础，结合了现代人力资源管理的新理念，对药品检验机构实验室质量管理体系内人员管理的含义尧控制要点尧基本工作流程和方法进行分析阐述。为保证质量管理体系的有效运行，药品检验机构实验室的人员管理系统中至少应包括确定岗位尧配置人员尧业务授权尧人员培训尧监督与考核以及人员管理的定期评审几个控制要点。

    药品检验曰质量管理体系曰人员管理

    [Abstract]Among the features that may affect the accuracy and reliability of the testing results of the quality management system of drug inspection laboratories,such as the facility&environment,the testing methods,the laboratory instruments and the handling of the sample,etc.Personnel is one of the key elements.To provide reference for the improvement of the personnel management of the drug inspection laboratories,this article introduced new concepts of the modern human resource management system into the old personnel management system of drug inspection laboratories in China,and analyzed the meaning,key points,general procedure and working methods of the personnel management in drug inspection laboratories.The modern personnel management system of drug inspection laboratories should at least include the control factors of position determination,personnel allocation,task authorization,staff training,supervising,evaluation and personnel management review. ......