Reciprocal recognition between accredited biobanks and accreditation bodies marks a fundamental step towards building global trust in the competency of these facilities. Recently, an important Italian agency granted national accreditation to a research biobank located in the city of Genoa, thus marking significant progress in the sector.
Recently, during the General Assembly of the European Cooperation for Accreditation (EA), a crucial decision was made: the EN ISO 20387 standard was officially recognized as the harmonized standard for the accreditation of biobanks. This recognition not only enhances biobanking in Europe but also has global implications: the harmonization of accreditation criteria lays the groundwork for stronger and more effective international cooperation in the field of biological research.
The standard, published in Italy as UNI CEI EN ISO 20387:2024, establishes specific requirements for the competence and impartiality of biobanks, defined as structures dedicated to the systematic collection, preservation, and management of biological material and clinical data for research and development purposes. The projected significant impact of biobanks on the global economy is telling: according to recent estimates, by 2030, the sector will contribute 2.7% to global GDP.
In a context where biobanks are gaining increasing importance, European accreditation bodies have begun issuing the first certifications, and Italy has already witnessed the accreditation of two facilities. The harmonization of the ISO 20387 standard thus serves as a catalyst for the growth and reliability of biobanks, not only at the local level but also internationally.
The process of recognizing ISO 20387 as a harmonized standard is essential for establishing trust in biobanking worldwide. This trust is fundamental for a sector that is intrinsically global, where interactions among different nations and scientific institutions occur daily. Accreditation bodies are undergoing a peer evaluation process, a systematic activity that ensures their competence and uniformity of operations. Following this process, the biological materials and competence of accredited biobanks can be recognized in all member countries of the EA network, thereby facilitating the circulation of certified goods and services in global markets.
Peer evaluation checks represent a guarantee for both biobanks and users of biological materials, ensuring the equivalence of the accreditations issued and, consequently, the quality and reliability of the materials handled. This aspect is crucial in a historical moment where scientific rigor and research accuracy are demanded from every field, from medicine to biotechnology.
Recently, a research biobank obtained prestigious accreditation, becoming the second in Italy to receive this recognition, following another biobank that had already set an important precedent in 2022. This step is emblematic of a growing national context, where improving research and developing innovative biotechnologies are common goals to pursue.
In this scenario, accreditation is not just a quality mark but a determining factor in ensuring the necessary qualities, reliability, and scientific value of biological samples. Every phase of managing biological material—from collection to preservation, transport to distribution—must be conducted in a traceable manner and in compliance with very rigorous standards. Only in this way can biobanks ensure comparable and reproducible results in research.
Compliance with the ISO 20387 standard enables accredited biobanks to demonstrate not only their operational capabilities but also the suitability of their structure in terms of competence and impartiality. The established standards influence not only the procurement, preservation, and distribution of biological material but also supporting processes, such as quality management.
This adherence to standardized requirements is crucial for both academic and industrial research, as it produces more reliable results, contributing significantly to medicine.
