Alkor Bio Group of Companies has transferred to the new versions of international QMS standards ISO 9001:2015 and ISO 13485:2016
Alkor Bio Group of Companies has transferred to the new versions of international QMS standards On November, Alkor Bio Group of Companies, Russian developer and manufacturer of the test kits for ELISA and PCR diagnostic In Vitro, has been received the new certificates conforming compliance with the International standards ISO 9001 and ISO 13485, versions 2015 and 2016. The audit was traditionally performed by Lloyd`s Register – one of the world leader of the independent assessment and certification. Four companies of the Group – Alkor Bio Company, Alkor Bio, Vega, Alkor IMPEX have taken part in audit. The audit results have confirmed the Alkor Bio Group ambitions to satisfy all needs of its customers.
Group of companies QA Manager Irina Talynkova:
The standards new versions are more strict than previous ones. For example, some articles of previous version of ISO 13485 were recommended but now they are mandatory. But in fact we implemented these recommended requirements in our practice before so we could transfer to new standards versions without non-conformances.
During the audit all main processes such as research and development, manufacture, sales, purchase and other have been checked and this audit has confirmed a possibility of the organization to manufacture and distribute the medical devices meet all requirements as customers and regulatory authorities.