浅谈医疗器械检验机构实验室如何正确实施标准化管理

How to implement standardized management correctly in laboratories of medical device inspection institutions

随着我国医疗卫生事业的蓬勃发展,我国的民生问题得到了保障,但对医疗器械的质量与安全性提出了更高的要求。而医疗器械检验机构的实验室担负着检测医疗器械的质量安全的任务,在实施国家强制性标准的同时,也要对实验室进行合理的管理,这样才能更好地发挥医疗器械检验机构实验室的作用,以提供准确、科学、高效的检测结果。因此,本论文以规范化管理为研究理念,通过对医疗器械检验机构实验室的管理现状和内容的分析,发现其在操作过程中可能出现的问题,并针对这些问题提出相应的改进措施。

With the booming development of China's medical and health care,China's livelihood issues have been safeguarded,but the quality and safety of medical devices put forward higher requirements.The laboratory of medical device testing organisations is responsible for testing the quality and safety of medical devices,in the implementation of national mandatory standards,but also to have a reasonable management of the laboratory,how to better play the role of the laboratory of medical device testing organisations,in order to provide accurate,scientific and efficient test results.Therefore,this thesis takes standardised management as the research concept,through the analysis of the current situation and content of the management of the laboratory of the medical device inspection agency,to find out the problems that may occur in the process of its operation,and put forward the corresponding improvement measures for these problems.