ISO 13485:2016

Quality is an issue of high importance in all manufacturing industries and the essential value of the product in health and diagnostics. There is no room for compromise when it comes to human health.

IVD manufacturers, according to the new IVDR, will need to validate and assure the integrity of its quality management system. That includes the thorough scrutiny of their suppliers, and in particular, contract manufacturers.

BLIRT, driven by constant dynamic growth, and following more stringent quality and safety requirements, has undertaken an auditing process to obtain ISO 13485:2016 certification. Certification of this standard is a recognized mark of the highest quality set by the company, which strives for continuous improvements in the manufacturing processes.

Why is that important for you?

    Transparent communication with our partners, full traceability of the documentation, and monitoring the product life cycle.
    Stable supply chain, minimized risk by continuous verification and quality assurance at every manufacturing stage.
    Stringent QA validation methods to ensure consistency in enzyme/protein/kit manufacturing.

Due to the growing requirements, we have appointed a dedicated person from the quality assurance department to help our clients identify and meet their quality needs.

We are prepared for unannounced audits by Notified Bodies, meeting the high standards of supplier qualification, and helping customers to ensure the final product quality.


”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.