When relying on a biobank, it is essential that its activity is based on the pillars of quality, traceability and confidentiality. It must have competent technical personnel and the necessary, adequate equipment and infrastructure to carry out its activities. In addition, it must apply valid and appropriate methods and procedures for taking, acquiring, preparing, preserving, analysing, storing and distributing biological material and its associated information and it must establish controls to ensure the quality of all biobanks that play an essential role in research and development in fields such as health, food or the pharmaceutical sector, among others.
In addition, biobanks currently play an increasing key role in biomedical research, as biomedical research makes use of the clinical information associated with their maintained biological samples. So, it is essential that the service they provide guarantees technical competence in managing, receiving, processing, storing and transferring samples, as well as their associated data, for researchers in biomedical studies.
Therefore, accreditation provides professionals in the different application fields with the necessary confidence, as it is the tool established internationally to demonstrate, among others, that these organizations are technically competent and therefore reliable.
The reference standard for accreditation of biobanks managing biological material from multicellular organisms and microorganisms intended for research in different fields, is ISO 20387 which sets out the "general requirements for biobanks' technical competence, impartiality and functioning, including quality control requirements to ensure the appropriate quality of biological material and associated data collections". All ENAC documentation on biobank accreditation criteria and procedures can be found in the DOCUMENTS section.
Is an accreditation the same as an ISO 9001 certification?
No. When a biobank obtains accreditation according to the international ISO 20387 standard, it implies that it has shown the national accreditation body, ENAC, in the case of Spain, that it has all the necessary means and knowledge (staff, equipment, facilities, methods...) to carry out its activity with technical competence and that, in addition, it has an adequate management system to ensure a consistent service at the time. By contrast, ISO 9001 certification refers only to the organization's quality management system and it has demonstrated it to a certification authority.