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目的总结分析内审结果,维持实验室管理体系良好状态。方法对2005~2013年安徽省疾病预防控制中心实验室覆盖管理体系全要素和所有活动10次内部审核的结果进行比较、分析。结果内部审核中共发现109项不符合项,均为轻微不符合;2008年以后不符合项大幅减少,2005~2008年与2009年以后不符合项比较,差异有统计学意义(χ~2=5.31,P<0.05)。设备和记录的控制不符合分别占所有不符合的26%和20%,是不符合的最主要因素。质量管理体系实施效果不符合占72%。结论安徽省疾病预防控制中心质量管理体系运行总体情况良好,但存在人力资源配置不合理问题。
Objective To summarize and analyze the results of internal audit and maintain the good condition of laboratory management system. Methods To compare and analyze the results of all the elements of laboratory coverage management system of Anhui Province Center for Disease Control and Prevention from 2005 to 2013 and the results of 10 internal audits of all activities. Results The CCP found 109 nonconformities in the internal audit, all of which were minor nonconformities. The nonconformities decreased significantly after 2008, with no significant difference between 2005-2008 and 2009 (χ ~ 2 = 5.31 , P <0.05). Control of equipment and records does not meet 26% and 20% of all nonconformities, respectively, which is the most unacceptable factor. The implementation of quality management system does not meet the effect of 72%. Conclusion The overall quality control system of Anhui Provincial Center for Disease Control and Prevention is running well, but there is unreasonable allocation of human resources.