摘要
目的通过比对实验促进医疗器械检测能力和水平的整体提高。方法通过对2008年全国医疗器械检测机构比对实验工作的总结分析,找出医疗器械检验机构质量管理体系中存在的问题。结果发现个别检测机构在质量体系管理中存在漏洞,影响了检验质量。结论对医疗器械检验机构的监督管理提出了建设性意见。
Objective To improve the capability and level of testing medical devices.Methods Based on the summary of the interlaboratory comparisons of medical device testing institutions in 2008,the analysis was carried out on problems of the quality management in the institutions.Results The lacks of the quality management were found in the several institutions.Conclusion The suggestions were put forward for the supervision and administration to medical device testing institutions.
出处
《中国药事》
CAS
2010年第8期767-768,779,共3页
Chinese Pharmaceutical Affairs
关键词
医疗器械
比对实验
质量管理
medical device
interlaboratory comparison
quality management
