两种质量规范在生物化学检验质量管理中的应用

Application of two quality standards in quality management of biochemical detection

目的比较国家标准GB/T 20470-2006和行业标准WS/T 403-2012在生物化学检验质量管理中的应用。方法对该室已开展的室间质评项目进行σ水平、质量目标指数(QGI)、优先改进措施及性能评定等指标的比较。结果国家标准GB/T20470-2006和行业标准WS/T 403-2012性能评定的差异无统计学意义(P=0.069),2者σ值分级及优先改进措施的差异有统计学意义(P分别为0.007、0.012)。结论行业标准WS/T403-2012比国家标准GB/T20470-2006更严格。

Objective To compare the application of National Standard GB/T 20470-2006 and Industry Standard WS/T 403-2012 in quality management of biochemical detection .Methods Comparison of indexes such as σ level ,quality goal index （QGI ） , priority improvement measure and performance evaluation were conducted in projects of external quality assessment launched in this department .Results Differences of performance evaluation showed no statistically significant between National Standard GB /T 20470-2006 and Industry Standard WS/T 403-2012（P= 0 .069） ,while their differences of σ value classification and priority im-provement measure were statistically significant （P were 0 .007 ,0 .012 ,respectively ） .Conclusion Industry Standard WS/T 403-2012 is more stringent than National Standard GB/T 20470-2006 .