Nippon Express acquires ISO13485 certification for medical device quality management system
28 October 2009
SGS Certification Mark
UKAS Certification Mark
On September 17, Nippon Express Co., Ltd. (Masanori Kawai, President) was notified that its Narita Airport Logistics Center's quality management system for medical devices had been granted ISO13485 certification.
ISO13485 is a global standard for the medical devices field whose criteria have been widely adopted as requirements in the regulatory systems governing medical devices in Europe, Canada, Australia, Taiwan and elsewhere, and in Japan been reflected in the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostic Reagents ("QMS Ministerial Ordinance").
Nippon Express was licensed as a medical device manufacturer (packaging, labeling, storage) in June 2007, and certification of its compliance with the international standard ISO13485 further enhances its quality- and safety-conscious management system for medical devices.
The Company pledges to maintain a first-rate quality management system and provide its customers with higher quality service.
[Certification details]
| Standard applied: | ISO13485:2003 |
|---|---|
| Certification body: | SGS Japan |
| Date certified: | September 17, 2009 |
| Registration number: | JP09/040223 |
| Scope of registration: | packaging, labeling, and storage of medical devices |