广东省医疗器械生产企业质量体系考核情况分析

为了解广东省医疗器械生产企业执行质量体系的真实情况,我科对2007、2008、2009年近300家二类医疗器械生产企业进行了质量体系复查。从复查结果看,企业在生产中未能全面执行＂医疗器械生产企业质量体系＂的情况较为普遍,是什么原因导致这种结果？而企业对建立和保持质量体系又应当注意哪些问题呢？围绕这些问题,我们对2007、2008、2009三年质量体系考核和体系复查情况进行了较为全面和深入的统计分析,提出了一些改进的意见和建议,以供企业更好地理解和改进质量体系作参考。

Analysis of Quality Evaluation System for Medical Instrument Manufacturing Enterprises in Guangdong Province

To study the real perform situation of the medical instrument quality system among the medical instrument manufacturing enterprises in Guangdong Province,we reviewed the quality system in nearly 300 enterprises of second-class medical devices in 2007,2008 and 2009 respectively. The results showed that it was very common that these enterprises failed to match with the demand of quality system during the process of manufacture. What caused the results？ Meanwhile,what problems should be concerned while the enterprises established and maintained the quality system？ To solve these doubts,we comprehensively analyzed the quality evaluation system and the system review for 3 years during 2007-2009,and put forward some recommendations and suggestions to improve the quality evaluation system as a reference for the enterprises.