At the beginning of November in Alkor Bio had ended the supervision audit which took place to confirm the companies compliance with the ISO 9001:2008 and ISO 13485:2003. We would like to remind that international certificates ISO 9001:2008 and ISO 13485:2003 were received by Alkor Bio company in November 2010, moreover ISO 13485:2003 certificate (international standard, comprising the requirements for quality management at the enterprises, manufacturing medical products.
The audit was carried out by the company «Lloyd`s Register EMEA», Great Britain (Lloyd`s Register Europe, Middle East and Africa). All components of the quality management system were checked: production, infrastructure and documentation. It’s needed to mentioned that audit, as well as certification itself, is voluntary and costly and the procedures main purpose is to confirm the companies ability to distribute medical products, complying both consumers and controlling organizations demands.
Deputy director, responsible for quality, Talynkova Irina Alekseevna, mentioned that the audit proved the companies infrastructure significant improvement. She pointed that the companies transfer to a new building favoured the substantial expansion of the manufacturing area, in addition new import equipment had been bought, particularly automated line for immunobiologist microplates.
In comparisons to previous, the new line has several advantages: it realizes the high-precision dozing of antigens and antibodies, gives the ability to apply individual labeling on each microplate, which is very important because it satisfies the most strict rules concerning the identification of medical products. Company Alkor Bio will have to pass the procedure of confirmation of its compliance with the ISO 9001:2008 and ISO 13485:2003 standards again - in a year, which corresponds to the companies management yearning for the quality management system to be of a highest quality.