Certificate of conformity of quality management to GOST ISO
In October 2020, Alphalab received ISO 13485 certification, confirming its quality management and allowing it to collaborate with leading manufacturers and supply products to Russia and the CIS.
In October 2020, Alphalab received a quality management certificate of conformity with GOST ISO 13485:2017 (ISO 13485:2016).
This is an international quality management system standard designed to ensure a certain level of quality for manufactured medical devices.
This regulatory document also enables collaboration with major manufacturers and the supply of products within Russia, the Customs Union, and the CIS. Certification is conducted within the Russian management systems certification system of Rosstandart.
