基于《ISO/IEC 17025:2017实验室管理体系检测和校准实验室能力的一般要求》对实验室设施环境管理的几点思考  

Thinking about Laboratory Environment and Facilities Based on the ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

作　　者：马丽颖[1] 王洪[1] 邹健[1] 于婷[1] 倪训松[1] Ma Liying;Wang Hong;Zou Jian;Yu Ting;Ni Xunsong(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药师》2020年第10期2076-2078,共3页China Pharmacist

摘　　要：目的:为检验检测实验室环境设施变更时提供参考依据。方法:依据世界卫生组织《药品质量控制实验室质量管理规范》中关于药品质量控制实验室变更控制的相关要求和《检测和校准实验室能力认可准则》CNAS-CL01:2018中对于环境设施的管理规定,分析检验检测实验室在搬迁过程中如何有效管理实验室环境设施。结果:针对检验检测机构搬迁过程中存在的问题,提出了可行性建议,建立沟通联系机制,建立控制文件,做好日常管理,对于保障质量体系的正常运转起到了积极推动作用。结论:实验室是检验检测机构科研工作的重要场所,也是检测报告符合实验室质量管理体系的重要前提。如何实现实验室环境和设施的管理和维护,实验室基础设施改造的有效管理,资源的合理利用,环境设施监控和和记录的动态管理已经成为实验室能否有效培养人才,加强学科建设和对外服务的关键问题。Objective:To provide reference for the change of environmental facilities in laboratory.Methods:According to the WHO guideline and ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories,the paper analyzed how to effectively manage the laboratory environmental facilities in the process of relocation.Results:According to the problems in the process of relocation,the author offered suggestions,established communication mechanism,established control documents and completed daily management,which played a positive role in ensuring the normal operation of the quality system.Conclusion:Laboratory is an important place for scientific research in inspection and testing institutions,and also an important premise for the test report to conform to the laboratory quality management system.How to realize the management and maintenance of laboratory environment and facilities,the effective management of laboratory infrastructure transformation,the rational use of resources and the dynamic management of environmental facilities monitoring and recording has become a key issue to determine whether the laboratory can effectively train talents and strengthen discipline construction and external services.

关 键 词：实验室设施环境 质量控制 标准化 

分 类 号：R917[医药卫生—药物分析学]