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HomeNews Releases › Obtaining of the ISO 13485 for lens export

We would like to announce that TOKAI OPTICAL CO., LTD obtained the ISO 13485 certification for the designing and manufacturing plastic spectacle lenses for export in December 2022.

Enacted in 1996 by the ISO (International Organization for Standardization) for governing Quality management systems specifically for the medical device industry., ISO 13485 has been adopted as the basis for quality management methods in regulations relating to medical devices in many countries around the world, including Japan.

This certification demonstrates the safety procedures taken in the manufacturing and supply of our medical devices. We hope not only to improve reliability, but also to expand the company’s business overseas with the obtaining of the certificate.