Nippon Express Korea Co., Ltd. (Yasuhiro Sugi, President; hereinafter, "NE Korea"), a local subsidiary of Nippon Express Co., Ltd. (Mitsuru Saito, President), last month obtained ISO 13485 certification of compliance with the ISO standard for medical device quality management systems at its business location at Incheon International Airport in Seoul, Korea.
(NE Korea's Incheon Airport Warehouse)
Medical devices are precision instruments whose use can literally be a matter of life or death, so their handling demands high quality and exacting management. In addition, sales/procurement logistics for medical devices are global in scale, requiring compliance with a variety of regulations that differ by country.
Since the outbreak of the coronavirus pandemic, governmental and supervisory authorities in the Republic of Korea have been promoting increased exports of medical devices, and laws and regulations have been tightened accordingly. Stricter regulation of storage, delivery and incidental services is also expected.
NE Korea is the first Japanese forwarder to obtain ISO 13485 certification in the ROK, and this certification evidences its commitment to managing its operations and providing safe and secure logistics services for medical devices in line with this ISO standard.
A standard for quality management systems in the medical device industry designed to ensure the provision of services satisfying both customer and regulatory demands