[Quality management of medical laboratory--a survey for National University Hospital].

Since ISO (International Organization for Standardization) 15189 for medical laboratories was established in Japan in 2003, 60 medical laboratories had been certified until April 2011. Among them, 10 medical laboratories belong to national university hospitals. To investigate the current status for the development of a quality management system, we carried out a questionnaire survey targeting all national university hospitals. ISO and ISO 15189 have already been introduced in about 70% of all laboratories and 53% are ready to accept them. In medical laboratories that have already accepted ISO 15189, it was suggested that their quality management systems have been functioning effectively and a gradual decrease of the number of the incidents has been confirmed.