Itochu Logistics announced on December 10th that it has obtained certification for the international standard "ISO 13485:2016" for quality management systems of in vitro diagnostic medical devices.
<Certification to "ISO13485:2016">
ISO 13485 is an international standard that certifies that a quality and safety management system is properly established and operated throughout the entire process of manufacturing, storage, and distribution of medical devices and in vitro diagnostic medical devices. It requires product traceability, risk management, and a rigorous quality control system.
The company began registering and operating as a manufacturer of in vitro diagnostic pharmaceuticals and medical devices in May 2022, and has cultivated knowledge of medical logistics and a quality control system based at its Tsukuba Medical Logistics Center in Tsukuba City, Ibaraki Prefecture.
Furthermore, leveraging its global network and flexible operational structure, the company is working to provide one-stop solutions to diverse needs. Moving forward, it aims to further improve quality and safety, providing logistics services that inspire confidence and trust in its client companies.
The certification period is until October 30, 2028, and the certification body is BSI Group Japan.
