Abstract:

By comparing the distribution of non-conformity clauses in the activity of medical laboratories accreditation,it was found that the first six clauses differed between our investigated 18 medical laboratories in Shanghai and the 31 ones nationwide from 2004 to 2008. In order to improve the quality and provide valuable information for laboratory accreditation, we analyzed root cause of nonconformity items that happen most in frequency, and the difference with the efforts to find the reasons, referred to the advanced experiences from overseas on quality management and then discussed the effective measures to make progress.

Key words: Medical laboratory accreditation, Nonconformity, Root cause analysis, Counterplan