医疗器械检验报告审核及实验室管理模式

The Discussion of Medical Device Inspection report Audit and Laboratory Management Mode

医疗器械检验报告的审核在质量管理体系中占有重要地位,并直接关系到检验机构的形象。在报告审核工作中存在的主要问题有页面文字质量、样品基本信息、检验标准、检验结果填写、检验结论及其他等。从报告审核发现的问题出发,初步探讨管理模式的改进。

The medical device inspection report audit played an important role in the quality management system, and directly related to the image of inspection institute. The main problems existed in the work of report audit, such as the page text quality problem, sample basic information problem, inspection standard problems, test results fill in issues, inspection conclusion problems and others. Starting from problems which were found in report audit, in order to explore the improvement of the management mode.