Okada Ken, Itoshima Kouichi
Division of Medical Support, Okayama University Hospital, Okayama 700-8558, Japan.
Rinsho Byori. 2012 Jul;60(7):660-6.
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.
自2003年日本引入用于医学实验室的ISO（国际标准化组织）15189以来，截至2011年4月已有60家医学实验室获得认证。其中，10家医学实验室隶属于国立大学医院。为调查质量管理体系的发展现状，我们针对所有国立大学医院开展了问卷调查。约70%的实验室已引入ISO及ISO 15189，53%的实验室准备接受。在已接受ISO 15189的医学实验室中，表明其质量管理体系运行有效，且已确认事故数量逐渐减少。
