Certifications
Diag2tec certifications
Diag2Tec operates under a robust Quality Management System compliant with ISO 9001:2015 standards. Implemented and first certified in 2020 by an independent external body (with renew obtained in 2023), this system ensures that all our activities consistently meet stringent quality, regulatory, and customer requirements. Harmonized with European regulations, it supports the delivery of reliable, reproducible, and high-value preclinical services.
The certification covers all Diag2Tec operations, including preclinical services, marketing, and business activities. Our quality framework is built on a strong customer-centric approach, with fully controlled processes and standardized procedures aligned with international best practices. Particular attention is given to data integrity and the security of computerized systems, ensuring the protection, traceability, and reliability of all generated data throughout our workflows. This structured approach enables continuous improvement and operational excellence across all projects.
Partners certifications
Regarding certifications, our main partner, the Biological Resource Center (BRC) of Montpellier University Hospital, is engaged in a structured quality management approach based on dual certification: ISO 9001 (quality management systems) and ISO 20387 (specific to biobanking). These standards ensure sample traceability, control of processes (collection, preparation, storage, and distribution), as well as robust document management within a framework of continuous improvement. Furthermore, all centers collaborating with Diag2Tec hold an authorization for transfer to third parties issued by the French Ministry of Higher Education and Research (MESR), in compliance with the French regulatory framework. The associated data are pseudonymized and processed in accordance with the General Data Protection Regulation (GDPR – EU 2016/679).
Finally, depending on the inclusion context, patients are informed and involved either through a non-opposition procedure or by providing explicit informed consent.