管理体系文件理解获取和执行存在的问题及改进建议-中国药事.PDFVIP

1624 管理体系文件理解、获取和执行存在的问题及改 进建议 * 张莉，杨德忠，阮桂平 ，隆颖，刘逸韬 （广东省药品检验所，广州 510180） 摘要 目的： 方法： 为实验室管理体系文件的理解、获取和执行提供借鉴。 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。 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 R95 A 1002-7777(2018)12-1624-04 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.12.007 On the Understanding Acquisition and Implementation of Management System Documents * Zhang li, Yang Dezhong, Ruan Guiping , Long Ying, Liu Yitao (Guangdong Institute For Drug Control, Guangzhou 510180, China) Abstract 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. Keywords ： management system documents; preparation; process design; application of information system; document access 实验室建立文件化的管理体系，以达到沟通 有便于获取、易于理解，方可执行。管理体系文 意图、统一行动、确保检验结果质量的目的。体 件的建立应明确文件的定义，做好前期策划，充 系文件及时地传达到有关人员，使其理解、获取