ISO 13485 Certificate is a document that shows that a manufacturer has established a quality management system that complies with the required standards and has successfully implemented this system. This document provides confidence to customers of medical device manufacturers regarding the quality management system and shows that their products comply with international standards.

The document can be obtained by applying to accredited international and Turkish accredited organizations. Companies that want to have this document must first go through a general preparation phase. Then, they can apply to accredited conformity assessment organizations and obtain the ISO 13485 certificate.