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Company news

08 October 2014

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

On September, Alkor Bio Group of Companies has been 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.

This time the auditor noted a significant improvement of the infrastructure as for the production area so for the office and also the readiness of Alkor Bio Group to use a new version of ISO 9001 planned for implementation at 2015, especially in terms of risk management.

In the near future Alkor Bio Group will be assessed  during the plan audit for compliance with the requirements of European Directive 98/79/EC for in vitro diagnostic medical devices. The audit will cover the kits of TORCH line manufactured by Alkor Bio.