某疾控中心质量管理体系内外审结果对比分析

摘要

目的 对质量管理体系内外审不符合项进行对比分析,探讨提高内审水平及加强质量控制的措施.方法 分析某疾控中心6年间内外审不符合项在要素、类别、性质以及审核结果差异等方面的分布规律.结果 内外审发现偶发独立的一般不符合项有79项,均显示实施性不符合项最多;同一要素历年反复出现不符合项计8项、67次;外审发现的体系性不符合项远高于内审.结论 质量管理体系的有效运行,内审同样发挥着重要作用,但对那些易出错的技术要素、历年反复出现不符合项的关键要素以及内审员对CNAS-CL01准则的理解等方面应进一步加强.%Objective To comparative analyze the nonconformance of internal and external audit results of quality management system and to explore measures to improve internal audit level and strengthen quality management.Methods Using the six years' audit data in the Center for Disease Control and Prevention (CDC),the regularities of distribution of elements,category,properties,departments and the difference between the internal and external audit results were analyzed.Results There were 79 nonconformities discovered which were occasional independent general nonconformities.The implementation items had most nonconformities.There were 8 recurring elements with totally 67 times.The system items were discovered far more in the external than in internal audit.Conclusion The quality management system in the CDC was running well,and internal audit played an important role.Further improvement should be taken on error-prone elements,recurrent nonconformities,understanding of CNAS-CL01 criteria by internal auditors,etc.