管理体系文件理解、获取和执行存在的问题及改进建议  

On the Understanding Acquisition and Implementation of Management System Documents

作　　者：张莉[1] 杨德忠[1] 阮桂平[1] 隆颖[1] 刘逸韬 Zhang li;Yang Dezhong;Ruan Guiping;Long Ying;Liu Yitao(Guangdong Institute For Drug Control,Guangzhou 510180,China)

机构地区：[1]广东省药品检验所,广州510180

出　　处：《中国药事》2018年第12期1624-1627,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:为实验室管理体系文件的理解、获取和执行提供借鉴。方法:分析实验室在文件的理解、获取和执行方面存在的问题,结合工作实际采取相应的措施,以增强文件的执行力。结果:从内部文件的范围,文件的编制、审批和分发,流程的设计和信息化系统的应用,文件的查阅和文件简化受控版本的制定等方面采取相应的措施,确保文件的理解、获取和执行。结论:文件只有便于获取、易于理解、得以执行,才能发挥其应有的作用。Objective:To provide references for understanding,acquisition and implementation of management system documents of laboratory.Methods:Problems of understanding,acquisition and implementation of the documents were analyzed.Appropriate measures combined with the actual work were taken to enhance the implementation of the documents.Results:Corresponding measures were taken to ensure the understanding, acquisition and implementation of the documents from the following aspects,such as the scope of internal documents,preparation,approval and distribution of documents,process design and application of information system,documents access as well as the development of simplified version of controlled documents.Conclusion: Only when documents are accessible and easy to understand and to be implemented can it play their due role.

关 键 词：管理体系文件 文件编制 流程设计 信息化系统应用 文件查阅 

分 类 号：R95[医药卫生—药学]