2011-2015年某省疾控中心质量管理体系内审结果分析  

Internal Audit Results of the Quality Management System of a Provincial CDC,2011-2015

作　　者：汪良枢[1,2] 毛素玲[2] 周琦[2] 刘以农[2] 许欣[1] 

机构地区：[1]四川大学华西公共卫生学院,成都610041 [2]四川省疾病预防控制中心

出　　处：《预防医学情报杂志》2016年第7期688-692,共5页Journal of Preventive Medicine Information

摘　　要：目的总结分析中心近五年的内审结果,采取相应的改进措施,为中心质量管理体系持续改进提供依据。方法依照2011-2015年内审存档资料,分析不符合项分类和分布情况,并对内部审核过程中发现的问题分析讨论。结果 2011-2015年内审不符合项总数分别为66、45、41、38和26项,主要涉及"记录的控制"、"文件控制"、"设备"、"设施和环境条件"等要素,主要分布在实验室部门、现场检测部门。结论中心质量管理体系运行良好,内审不符合项呈逐年减少趋势,但在记录控制、文件控制和设备管理等方面还有薄弱环节,应采取相应措施促进持续改进管理体系有效性。Objective To analyze the interual audit results of the quality management system of a CDC over the past five years so as to take appropriate measures for continual improvement. Methods The files of the internal audit over 2011 to 2015 were reviewed, the classification and distribution of nonconforming items were analyzed, and problems found in the process of internal audit were discussed. Results 66, 45, 41, 38 and 26 nonconforming items were found in internal audit in the years from 2011 to 2015, respectively. The nonconformity related mainly to control of records, document control, equipment, facilities and environmental conditions and other factors and occurred mainly in laboratories and field inspection departments. Conclusion The quality management system has been running well, and the number of nonconforming items has demonstrated a yearly decreasing trend. Relevant measures should be taken to continually improve the effectiveness of the management system, especially in control of records, document control and equipment.

关 键 词：ISO/IEC 17025 质量管理体系 内部审核 结果分析 

分 类 号：R197[医药卫生—卫生事业管理]