Company news

01 September 2021

Alkor Bio Group of Companies has confirmed its compliance with International Standard ISO 13485:2016

During the last week of August Alkor Bio Group of Companies – Russian designer and manufacturer of ELISA, CLIA and PCR diagnostic kits - has been assessed for compliance with the International Standard ISO 13485:2016. Transfer to new and more strict version of the standard was fulfilled by Alkor Bio Group in 2017.

The surveillance audit was traditionally performed by Lloyd`s Register EMEA (the Great Britain) – one of the world leader of the independent assessment and certification. Four companies of the Alkor Bio Group have been involved into the assessment: Alkor Bio Company, Alkor Bio, Vega and Alkor IMPEX.

During the audit whole quality management system of Alkor Bio Group has been assessed, including design and development, purchases, production (including new industrial sites), metrological control, sales, documentation and personnel. The main goal of the audit as well as the certification itself was to confirm the ability of an organization to supply medical devices that meet all the requirements imposed by both customers and regulatory  bodies which was demonstrated during the audit.