The Biobank of the Puerta de Hierro University Hospital in Majadahonda and the Sanitario Puerta de Hierro-Segovia Research Institute in Arana obtain the ISO 20387 accreditation

The Unidad becomes the first Biobank to obtain this accreditation at the regional level, the highest international recognition of quality that guarantees technical excellence, impartiality and compliance with the highest quality standards in its operation.

The Biobank of the Puerta de Hierro University Hospital in Majadahonda and the Sanitario Puerta de Hierro-Segovia Research Institute (IDIPHISA) in Arana become the first in the Community of Madrid to obtain accreditation in accordance with ISO 20387, an international recognition that validates the technical competence, quality and reliability of its processes in the management of biological samples and their data intended for biomedical research.

This Unit is a scientific-technical platform dedicated to the reception, processing, characterization, conservation, and transfer of human biological samples intended for biomedical research projects. Its activity allows samples such as blood, tissues, DNA, RNA, or other biomaterials, voluntarily donated by patients and managed under strict ethical and legal criteria, to be available to researchers. In this way, the availability of these resources contributes to the advancement of knowledge and the development of new diagnostic and therapeutic strategies.

The ISO 20387 accreditation, issued by the National Accreditation Body (ENAC), certifies that all these processes are carried out under the highest international standards of quality, technical competence, traceability and impartiality, guaranteeing the reliability of the samples and the associated data made available to the research community.

First accredited biobank in the Community of Madrid according to ISO 20387

According to Antonio J. Sánchez, head of the Unit and Scientific Coordinator, this recognition represents the highest international standard of technical competence for Biobanks. In this regard, he explains that the main motivation for obtaining the accreditation was “to demonstrate objectively and independently the quality, traceability and reliability of all its processes, from the collection and processing of samples to their conservation and distribution for research.”.

Currently, the Biobank is part of the Biobanks and Biomodels Platform of the Carlos III Health Institute, a national scientific infrastructure that coordinates and facilitates access to high-quality biological resources for biomedical research. This integration promotes collaboration between research centers, hospitals, and universities across Spain, maximizing the scientific impact of samples donated by patients.

Antonio J. Sánchez explains that the Biobank, “being integrated into a public reference hospital and a research institute, is essential to be able to offer researchers and patients the maximum guarantees that the biological samples and associated data are managed under the highest international standards of quality.” The Scientific Coordinator adds that “the accreditation also represents recognition of the collective effort and the commitment of the entire team involved.”.

More guarantees for researchers, patients and donors

Beyond ensuring scientific excellence and quality in the work of the Biobank, this achievement also strengthens the trust of researchers, patients, and donors, and contributes to the advancement of biomedical research.

In the case of researchers, Antonio J. Sánchez points out that accreditation provides confidence, as it “guarantees that samples and associated data meet internationally recognized standards of quality and traceability.” This can contribute to improving the reproducibility and reliability of scientific results, facilitating collaboration with national and international centers, and fostering the development of biomedical research projects.

For patients and donors, it represents an additional guarantee that their samples are managed with technical and ethical rigor. “It is important that they know that their contribution to research is carried out in a controlled environment that ensures the quality of the processes, the protection of their data, and the best possible utilization of the samples donated to generate biomedical knowledge and advance in the development of new diagnostic and therapeutic strategies,” explains the Scientific Coordinator.

With the ISO 20387 accreditation, the Puerta de Hierro Majadahonda University Hospital and IDIPHISA reaffirm their commitment to scientific excellence and quality, while strengthening the public's confidence in biomedical research and highlighting the essential contribution of patients to the advancement of scientific knowledge.

You can consult more information about the Biobank at Biobank – Puerta de Hierro Health Research Institute – Segovia de Arana.