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Company news

25 October 2016

Alkor Bio Group of Companies has confirmed its compliance with international QMS standards ISO 9001:2008 and ISO13485:2003

 

   

On September, 26-30, Alkor Bio Group of Companies had been re-assessed for compliance with the International standards ISO 9001 and ISO 13485. The audit was traditionally performed by Lloyd`s Register – one of the world leader of the independent assessment and certification.

The audit results have confirmed the Alkor Bio Group ambitions to satisfy all needs of its customers. In this year four companies of the Group  were assessed: Alkor Bio Company, Alkor Bio, Vega and Alkor Impex.  

Alkor Bio Group QA Manager Irina Talynkova:

“During the audit the full assessment of manufacturing and design the diagnostic kits, including auxiliary processes such as raw materials purchase, humane recourses and infrastructure management, etc.,  was fulfilled accordingly all international standards requirements. As usual, the assessor confirmed the great condition of the infrastructure and manufacturing processes”. 

As result of the audit, Alkor Bio Group has the renewed certificate of conformance for three year. Next year, in 2017, during the planned inspection visit, Alkor Bio Group will be assessed in accordance with the new versions of the International Standards ISO 9001:2015 and ISO 13485:2016.