EN ISO 13485:2016
Quality management system for medical devices
Valid until 3 April 2027
Quality you can audit
Our quality management system has been certified since 2015. The certificates are issued by Kiwa, an accredited certification body.
Certified management systems
EN ISO 13485:2016 sets the quality management requirements for medical device manufacturers; ISO 9001:2015 covers quality management across the company. Both certificates are listed below with their certificate numbers and validity dates.
ISO 9001:2015
Quality management system
Valid until 3 April 2027
Standards we work to
- EN ISO 13485:2016
- Medical devices — quality management systems
- ISO 9001:2015
- Quality management systems
Policies
Our integrated management systems policy (PLT-04) is written in Turkish and English.