The IRCCS Ospedale San Raffaele Biological Resources Center (CRB) achieves the BBMRI‑ERIC Quality Label

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The Biological Resources Center (Centro Risorse Biologiche, CRB) of IRCCS Ospedale San Raffaele (Milan, Italy) has achieved the BBMRI‑ERIC Quality Label, recognising the biobank’s strong commitment to quality, harmonisation and excellence in support of biomedical research.  

Established in 2019, the CRB is the institutional biobank of IRCCS Ospedale San Raffaele and supports translational research through the standardised collection, processing, storage and distribution of high‑quality human biological samples and associated data. The biobank manages an extensive and diverse collection of liquid and solid biological samples supporting multidisciplinary research in cancer, immune‑mediated and autoimmune diseases, neurology and infectious diseases. 

A journey built on quality, governance and continuous improvement 

The path towards the BBMRI‑ERIC Quality Label was the result of a long‑term and structured effort, embedded in the CRB’s organisational strategy since its establishment. Over the years, the CRB progressively implemented and consolidated a robust QMS aligned with ISO 20387. 

Preparation for the audit involved a thorough review of processes, documentation and responsibilities, with particular focus on traceability, risk‑based thinking, staff competence, data protection, impartiality and ethical compliance. Extensive internal coordination and continuous training ensured that quality requirements were not only formally implemented but also fully integrated into daily operational activities. 

The audit itself was experienced as a challenging but constructive process characterised by open dialogue with the auditors and a valuable external assessment of the CRB’s organisational and quality framework. Beyond compliance, the audit proved to be a valuable opportunity to identify strengths, confirm good practices and supported the identification of areas for further improvement. 

As Dr. Cristina Tresoldi, Biobank Manager of CRB-OSR underlines: 

“Achieving the BBMRI‑ERIC Quality Label is the result of a shared vision and a collective effort. It represents a major milestone for our biobank and a recognition of the daily commitment of the entire team to quality, reliability and service to research. Receiving this label is a great honour for us and gives us confidence that we are on the right path towards ISO 20387 accreditation.”
 

Commenting the achievement, Dr. Elisa Cantarelli, Quality Manager of CRB-OSR highlights: 

“The audit provided a valuable opportunity to critically assess our QMS and strengthen a shared quality culture. The BBMRI‑ERIC Quality Label is not an endpoint, but a driver for continuous improvement, confirming our alignment with ISO 20387:2019 and our commitment to delivering high‑quality, reliable biological resources for clinical and translational research at national and international level. This recognition marks an important milestone in an ongoing journey towards excellence in biobanking.” 

Dr. Michela Grossi, Lab Technician of CRB-OSR, adds: 

“Being part of the CRB since its establishment has been a truly meaningful professional experience. Witnessing the growth of the biobank and contributing to this achievement has been a source of great pride. This recognition gives value to the daily work carried out in the laboratory and motivates us to continue improving in support of research.” 

Andrea Wutte, Head of Quality Management at BBMRI-ERIC, highlights:      

“The achievement of the BBMRI-ERIC Quality Label by CRB-OSR reflects a highly structured and mature approach to quality management. It is particularly encouraging to see how quality principles are not only implemented, but fully embedded in daily operations. This level of commitment is essential for ensuring trust in biobanking and for supporting high-quality biomedical research across Europe.”  

By obtaining the BBMRI-ERIC Quality Label, the CRB-OSR biobank joins a growing number of biobanks across Europe that maintain high standards in biobanking and quality management, reinforcing trust in biological resources used for research.