SK-Telemed GmbH reaffirmed its compliance with international standards in the field of quality management system (QMS), and at the end of April 2021 successfully passed another audit by international auditors. We are now certified in accordance with ISO 9001:2015 and 13485:2016.
Quality Austria has issued an IQNet recognized certificate that SK – Telemed GmbH has implemented and maintains QUALITY MANAGEMENT SYSTEMS which fulfils the requirements of the ISO 9001:2015 and 13485:2016 standards for the following scope: design and manufacturing of telehealth medical diagnostic systems, software and cloud database for remote diagnostic and monitoring.
“After receiving the ISO 9001:2015 and ISO 13485:2016 certificates, it must be confirmed annually and the most important is to stick to high standards. We have successfully passed audits again and confirmed compliance with the requirements of the ISO standard”, — the founder and managing owner Dr. Sergiy Kutsevlyak comments.
Our certificates:
- IQNet ISO 9001:2015
- IQNet ISO 13485:2016
- Certificate ISO 9001:2015 (en)
- Certificate ISO 13485:2016 (en)
