Abstract: Objective To perform summary analysis on ISO15189 accreditation on-site review nonconformity items of 18 medical laboratories in Shanghai, to give the correct methods and pathways for the nonconformity items, and to provide reference for other medical laboratories. Methods ISO15189 accreditation on-site review nonconformity items of 18 medical laboratories in Shanghai were collected, screened and analyzed. According to the nonconformity description, cause analysis, corrective action, correct implementation and correct verification, the correct methods and pathways for common problems are put forward. Results A total of 297 nonconformity items were collected, including 76 items about management (25.6%) and 221 items about technique (74.4%). There were 61 items for the quality insurance of laboratory procedure, accounting for 20.5%(61/297), with 6 classes of 47 forms. Conclusions Through the summary and rearrangement analysis of nonconformity items, the causes of nonconformity items are cleaned up, and the qualities of medical laboratory and laboratory accreditation are improved with reference effects.

Key words: Medical laboratory, Accreditation, Nonconformity