Alkor Bio Group of Companies has confirmed its compliance with international QMS standard 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 standard ISO 13485:2016. Transfer to new and more strict version of the standard 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 re-certifying 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.