[The Activity to Successfully Acquire ISO 15189 Accreditation].

ABSTRACT

Our facilities acquired ISO 15189 accreditation in April 2011. The lead time was a little less than 2 years. I reported on the lead time and activity after ISO 15189 acquisition. I reported how creating a quality manual and SOP was advanced as preparation work. I showed the examination method in detail and the process after examination. I think an increase in per- sonnel as internal auditors is important for quality management system maintenance.