Biobanco La Fe achieves ISO 20387 accreditation

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Biobanco La Fe, integrated into the Hospital Universitari i Politècnic La Fe de Valencia, has obtained accreditation from the National Accreditation Entity (ENAC) in accordance with the UNE-EN ISO 20387 standard, the international standard that establishes the requirements of competence, impartiality and operation of biobanks. 

Biobanco La Fe has an extensive track record in the field of quality. The biobank has a robust quality management system certified against the UNE-EN ISO 9001 standard for more than 10 years, and it regularly participates in national and international quality control programmes, with a total of eight international validations. All the biobank activities are carried out following process engineering principles, adopting lean methodologies with the aim of optimising turnaround times and improving the quality of the services provided. 

The new framework established by the UNE-EN ISO 20387 standard was both attractive and necessary. ISO 9001 has provided Biobanco La Fe with an appropriate framework for its day-to-day management (purchasing, supplier evaluation, strategy, etc.), and its implementation was crucial for the establishment of the biobank. However, the scientific and technical requirements of translational and clinical research, as well as those of personalised and precision medicine, are increasingly demanding, and Biobanco La Fe recognised the need to continue progressing. 

The first step, and from Biobanco La Fe’s point of view the most important one, was to define the scope of accreditation. Before starting, the biobank asked itself several questions: Which biological samples are meeting the actual needs of research and precision medicine? What are researchers requesting from the biobank? Which types of biological samples from Biobanco La Fe are generating the greatest scientific output? Based on these considerations, the biobank established a scope that would address scientific needs as comprehensively as possible, ensuring that the accreditation process would have a direct and positive impact on the services provided. The scope included peripheral blood, bone marrow, cerebrospinal fluid, urine, faeces, plasma, serum, genomic DNA, and cell lysates for subsequent RNA extraction. 

The external audits were carried out in December 2025. They were demanding and required a great deal of effort, not only because of the breadth of the scope but also because of the large number of cases and samples managed daily by Biobanco La Fe. Over the past seven years, the biobank has received 32,301 patient donations, processed more than 700 requests, and provided 20,640 samples. This process was highly enriching and helped the biobank focus on the need to further develop large-scale management of the variables associated with technical processes and their correlation with clinical and genomic information.  

Applying for the BBMRI-ERIC quality seal is an excellent opportunity to position the biobank in Europe, establish relationships with other European biobanks and share new approaches to improving its procedures. 

Raquel Amigo, Head and Coordinator of Biobanco La Fe, highlights: 

“Obtaining UNE-EN ISO 20387 accreditation represents recognition of the work carried out over many years by the entire biobank team and by the clinical professionals who make it possible to incorporate high-quality samples for research. This accreditation is not a destination, but rather a commitment to continuously improving our processes and providing the scientific community with a biological resource that offers the highest guarantees in terms of quality, traceability and safety”. 

José Cervera, Scientific Director of the biobank, emphasises: 

“The high level of commitment and dedication shown by all staff members has undoubtedly been essential to achieving this accreditation, which will be fundamental to strengthening the positioning of Biobanco La Fe.” 

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

“Biobanco La Fe’s achievement marks another important milestone in the growing number of ISO 20387-accredited biobanks across the BBMRI-ERIC community. As the third biobank in Spain accredited by ENAC, it demonstrates a strong dedication to internationally recognised standards and continuous improvement. 

What we particularly appreciate is Biobanco La Fe’s decision to go one step further by pursuing the BBMRI-ERIC Quality Label. Beyond demonstrating quality and competence, this represents a clear commitment to BBMRI-ERIC, an active engagement with our biobanking community, and a shared belief in the values we stand for.”