Company news

08 October 2018

Alkor Bio Group of Companies has confirmed its compliance with international QMS standards ISO 9001:2015 and ISO 13485:2016

In October Alkor Bio Group of Companies – Russian designer and manufacturer of ELISA and PCR diagnostic kits - has been assessed for compliance with the International standards ISO 9001:2015 and ISO 13485:2016. Transfer to new and more strict versions of the standards was fulfilled by Alkor Bio Group in 2017. The main goal of the audit is the confirmation of the ability to  produce the medical devices which meet all requirements of the customer and regulatory bodies.

The surveillance audit was traditionally performed by Lloyd`s Register – 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. The audit results have confirmed the Alkor Bio Group ambitions to satisfy all needs of its customers.

During the audit whole quality management system of Alkor Bio Group has been assessed, including design and development, purchases, production, metrological control, sales, documentation and personnel.