Biobank La Fe obtains UNE-EN ISO 20387 accreditation, certifying the highest standards in the management of research samples

With this achievement, Biobank La Fe, part of the Hospital Universitari i Politècnic La Fe, becomes the first biobank within a public hospital in Spain to obtain this accreditation. To date, it has only been awarded to two other biobanks nationwide.

This accreditation certifies full compliance with the highest international standards for the management of human biological sample collections intended for biomedical and translational research, reinforcing the biobank's commitment to quality, excellence and continuous improvement.

This milestone builds on more than ten years of ISO 9001 certification and participation in nine international proficiency testing programmes.

Biobank La Fe currently manages 89 collections of biological samples of high scientific value. Over the last seven years alone, it has incorporated more than 32,000 patient donations and provided the research community with almost 21,000 samples for biomedical, clinical and translational research projects.

The scope of the accreditation covers the acquisition, processing, quality control, preservation and distribution of a wide range of human biological samples and their derivatives. These include peripheral blood, bone marrow, cerebrospinal fluid, urine and faeces, as well as plasma, serum, genomic DNA and cell lysates.

The UNE-EN ISO 20387 standard certifies that the biobank operates with qualified personnel, appropriate facilities, technically validated procedures and a management system that ensures the traceability, integrity and quality of both biological samples and their associated data. This provides researchers with greater confidence by guaranteeing that biological materials have been collected, processed, preserved and distributed under controlled conditions and in accordance with internationally recognised standards.

The implementation of this specific accreditation scheme also represents a significant step forward for the Spanish scientific system, promoting the harmonisation of procedures and enhancing the reliability of biological resources used in biomedical research, both nationally and internationally.

Raquel Amigo, Head and Coordinator of Biobank La Fe, highlighted that obtaining UNE-EN ISO 20387 accreditation "recognises the work carried out over many years by the entire biobank team and by the clinical professionals whose collaboration makes it possible to incorporate high-quality samples for research. This accreditation is not a final destination, but rather a commitment to continuously improve our processes and provide the scientific community with a biological resource offering the highest standards of quality, traceability and safety."

José Cervera, Scientific Director of Biobank La Fe, also stressed that "the high level of commitment and dedication shown by the entire staff has undoubtedly been essential to achieving this accreditation, which will play a key role in strengthening the position of Biobank La Fe."

Meanwhile, José Luis Poveda, Chief Executive Officer of Hospital La Fe, stated that this recognition reaffirms the commitment of the Valencia La Fe Health Department to excellence in translational research. "Having a biobank accredited under the UNE-EN ISO 20387 standard strengthens our capacity to collaborate with national and international research groups and contributes to accelerating the development of new knowledge and therapies that ultimately lead to better patient care."