Alkor Bio Group switched to the new versions of ISO 9001 and ISO 13485

In mid-November, Alkor Bio Group, a Russian developer and manufacturer of test systems for ELISA and PCR analysis, received new certificates of conformity with ISO 9001 and ISO 13485. This time, it was for 2015 and 2016 versions of the standards, respectively.

The audit for conformity with the requirements of ISO 9001:2015 and ISO 13485:2016 was conducted by Lloyd’s Register EMEA (UK), a world’s leader in the area of certification. The audit was conducted in four companies of Alkor Bio Group, including Alkor Bio Company, Alkor Bio, Vega, and Alkor Impex. The audit was completed successfully and confirmed the commitment of the Alkor Bio Group to continuous improvement of its quality management system and fully meeting the customer needs.

Irina Talynkova, the Deputy General Director for Quality at Alkor Bio Group, said, “As it is usually the case, the new versions of standards are more stringent than the previous ones, and they require from companies even more efforts in the area of quality assurance. In particular, the new version of ISO 13485 includes a number of strictly mandatory provisions which, in the previous version, were optional. This applies to the issues of preparing the documents, informing the regulators, and to some other areas of the company’s activities. At the same time, in fact, little has changed for Alkor Bio Group, since we were already following the most stringent requirements and implementing the recommended provisions into the everyday practices of the enterprise. Today, this allowed us to successfully implement the new versions of standards, as not a single case of non-conformity was identified in our company during the audit.”

SOURCE: gmpnews.ru
SHARE
GMP news
Pharmaceutical industry News and events. Technology transfer and contract manufacturing of medicines.
Isaltis Banner