The Mycobacterial Genetics Group obtains ISO 9001 certification for its quality management system for preclinical testing

The certification, issued by SGS International Certification Services Ibérica, S.A. and accredited by ENAC, covers a wide range of antimicrobial susceptibility assays performed in Biosafety Level 2 and Level 3 laboratories (BSL-2 and BSL-3), including work with Mycobacterium tuberculosis, the bacterium that causes tuberculosis.

Achieving ISO 9001 certification marks an important milestone made possible through the Antimicrobials Team’s participation in the European ERA4TB project (https://era4tb.org/).

From European collaboration to a certified quality system

The certification is the culmination of a transformation process undertaken by the Antimicrobials Team during six years of participation in ERA4TB, a European public-private consortium bringing together more than 30 academic, pharmaceutical and biomedical organisations to accelerate the development of new treatments for tuberculosis.

Working within this environment led the team to progressively review and structure its activities to meet pharmaceutical industry standards: harmonising methodologies, defining responsibilities, documenting procedures, and strengthening traceability and task monitoring. It also enabled the distribution and transfer of technical knowledge among different team members, reducing reliance on individual operators.

Over time, these practices became firmly established and evolved into the foundation of the quality management system that has now been certified.

“ERA4TB not only expanded our scientific capabilities but also transformed the way we organise our work,” says Santiago Ramón García, ARAID Research Professor affiliated with the Department of Microbiology at the University of Zaragoza. “ISO 9001 certification recognises a system that we have built progressively to ensure our processes are reproducible, traceable and sustainable, and to ensure that the knowledge acquired remains within the team beyond the duration of the project,” adds Diana A. Aguilar Ayala, senior researcher in the Antimicrobials Team and the person responsible for leading the certification process. “By leading the consortium’s activities related to the in vitro characterisation of compounds under development, we have been able to establish a robust management system that generates data suitable for use by the pharmaceutical industry in regulatory approval processes for new medicines,” explains Ainhoa Lucía Quintana, Associate Professor in the Department of Microbiology at the University of Zaragoza.

Santiago and Ainhoa lead the activities of the Antimicrobials Team within the Mycobacterial Genetics Group, which is recognised as a consolidated research group by the Government of Aragon.

A capability that remains at the University

ERA4TB will conclude on 31 December 2026. A new challenge now begins: ensuring that the scientific and organisational capabilities developed throughout the project remain embedded within the University of Zaragoza. ISO 9001 certification therefore strengthens the team’s capacity to participate in future academic collaborations, international projects and joint initiatives with the private sector. This enhanced level of quality may also be incorporated into the services offered by the University of Zaragoza.

Beyond its scientific results, ERA4TB leaves a lasting legacy in the form of specialised expertise, experimental platforms and a working structure prepared to support future translational research projects.