Construction and evaluation of equipment management system conforming to the requirements of ISO 15189

<p>In July 2007, our hospital’s laboratory department achieved ISO 15189 accreditation. While maintaining and managing the ISO 15189 accreditation, it became a problem that the number of indications related to equipment management in internal audits did not decrease. Therefore, we developed an equipment management system to manage equipment easily and appropriately. We constructed our own relational database (RDB) using Microsoft Access installed in our hospital’s medical terminal and developed an application using Visual Basic for Applications (VBA) attached to it. When constructing the RDB, we were aware that the requirements of ISO 15189 could be managed just enough, and in order to make it possible to easily check the change history, we adopted a generation management mechanism for some tables. The constructed equipment management system was put into operation in June 2019, and so far it has worked with repeated version upgrades. Regarding the number of nonconformities related to equipment management in internal audits, the number of nonconformities decreased from 13 in 2013 before the implementation of the equipment management system to 7 in 2022 after the implementation. It is believed that the implementation of the equipment management system has made it possible to manage devices appropriately. It is also believed that the system is easy to maintain as it has been developed independently, so it is easy to fix bugs and add features, and it is easy to maintain a system that is appropriate for the current laboratory.</p>