We are delighted to announce that BLIRT has been awarded ISO 13485:2016 Quality Management System certification from Lloyd’s Register.
The ISO 13485:2016 certificate covers the entire activity of the company in the scope of: Designing services, development, production, and sale of biomolecular proteins and reagents to be used in in vitro diagnostic tests and biotechnological processes.
Manufacturers of in vitro diagnostics strive for the excellence of their products. They are obliged to comply with the introduced regulations, such as the new IVDR regulation coming into force on 26 May 2022. The supplier’s efficient QMS assures partners that the organization meets the critical requirements needed for a continuous supply of products that meet customer expectations.
In the light of diagnostics and its importance for the health and safety of patients, increased emphasis is placed on the appropriate selection of partners that have a significant influence on product quality.
One of such partners is a supplier of raw materials for the production of medical devices. Having a supplier with ISO 13485 certification in raw materials for the in vitro diagnostics minimizes the risk and assures greater control of the production process.
”The certificate guarantees the customers that we work strictly according to the standards of goal-and performance-based quality management. As the Lloyd’s Register auditor emphasized, BLIRT offers customers a strong quality system, substantive procedures, competence, and employee motivation. We strive to use those assets for continuous improvement of our QMS to manufacture and supply products to our partners that meet and exceed their expectations.” – Krzysztof Sołłohub, Director of Quality at BLIRT.