Bureau Veritas Certification has renewed GenoScreen's ISO 9001:2015 and ISO 13485:2016 certifications for 3 years, demonstrating our continuous commitment to quality and efforts to satisfy our customers as best as possible, in compliance with legal and regulatory requirements.
The ISO 9001 certification covers the design, development, production and marketing activities of all our products, services, expertise and trainings in genomics and bioinformatics. This certification of our Quality Management System was first received in 2015.
The ISO 13845 certification covers the design, development, manufacturing, marketing and distribution of our in-vitro diagnostic kits. This includes our range of Deeplex® kits and its first commercialized product: Deeplex® Myc-TB, which identifies mycobacterial species and predicts antibiotic resistance in strains of the Mycobacterium tuberculosis complex. The CE/IVD marking of Deeplex® Myc-TB also allows us to meet the regulatory requirements for diagnostic products.
« These renewals demonstrate GenoScreen's deep commitment to Quality Management Systems. These certifications motivate us to adapt our working methods and processes, and are a real driver to better meet the requirements of our customers and partners. The ISO 9001 certification is therefore a recognition of the quality of our operations.
The renewal of the ISO 13485 certification testifies to the robustness of our procedures and the quality of our in-vitro diagnostic kits. It will facilitate our future achievements in this field. » declares Stéphane NION, Quality Manager at GenoScreen.