New Challenges for Biobanks: Accreditation to the New ISO 20387:2018 Standard Specific for Biobanks

Abstract

Background: The emergence of “multi-omics” and “multi-parametric” types of analysis based on a high number of biospecimens enforces the use of a great number of high-quality “Biological Materials and Associated Data” (BMaD). To meet the demands of biomedical research, several Biological Resource Centers (BRCs) or Biobanks world-wide have implemented a specific Quality Management System (QMS) certified ISO 9001:2015 or accredited by CAP9 ISO 20387:2018. For the first time, ISO, with the support of several Biobanking experts, issued the ISO 20387:2018 which is the first ISO norm specific for Biobanks. The fundamental difference with present certification/accreditation standards is that the ISO 20387:2018 focuses not only on the operational aspects of the Biobank, but also on the “competence of the Biobank to carry our specific Biobanking tasks”. Methods: The accreditation process for ISO 20387:2018 required the definition of: (1) objectives, goals and organizational structure of the Biobank, including procedures for governance, confidentiality and impartiality policies; (2) standard operating procedures (SOPs) of all activities performed, including acquisition, analysis, collection, data management, distribution, preparation, preservation, testing facility and equipment maintenance, calibration, and monitoring; (3) procedures for control of documents and records, the identification of risks and opportunities, improvements, corrective actions, nonconforming records and evaluation of external providers (4) an internal audit and management reviews, verification of QMS performance, monitoring of quality objectives and personnel qualification and competency in carrying out specific Biobanking tasks. Results: The accreditation process is performed by an independent authorized organization which certifies that all processes are performed according to the QMS, and that the infrastructure is engineered and managed according to the GDP and/or GMP guidelines. Conclusion: Accreditation is given by an accreditation body, which recognizes formally that the Biobank is “competent to carry out specific Biobanking tasks”.

Real‐life data from standardized preanalytical coding (SPREC) in tissue biobanking and its dual use for sample characterization and process optimization

“…Additional project‐related services are offered by the Translational Research Unit of the Institute of Pathology. TBB is attributed the OPTIMA label of the SBP, which relies on the ISO norm 20387 [ 29 ].…”

Need for a Dedicated Ophthalmic Malignancy Clinico-Biological Biobank: The Nice Ocular MAlignancy (NOMA) Biobank

“…The Côte d’Azur Biobank obtained the NF S96-900 certification (National French Standard) in 2010. In 2022, it obtained the ISO 9001 certification as well as the international ISO 20387 standard specific for biobanking activity [ 34 ]. These standards guarantee the high quality of the whole biobanking process.…”

Evolution of biobanks and ethical governance for the emerging applications in biomedical research

“…Biobanks are facing the challenges of moving forward from the ISO 9001:2015 to ISO 20387:2018 certification scheme. [ 40 ]…”

“…Biobanks are faced with new challenges of changing its focus from operational aspects such as QMS, SOPs, and technical instructions to the governance and management aspects as per the latest certification scheme. [ 40 ] The ISO 20387:2018 certification focuses on the following key objectives: (i) improving the quality of the specimen by implementing QMS; (ii) exchange of biological material and data between the biobank and researchers; (iii) promote public and private sector partnership; (iv) increase stakeholder confidence and assurance; (v) foster research and development (R&D); (vi) lessen the cost by avoiding repeatability; and (vii) reduce research waste by improving the biobank operations. [ 11 40 41 ] The ISO 20387:2018 standard of biobanking is currently implemented in several countries such as Austria, Australia, Belgium, Brazil, China, France, Germany, India, Italy, Poland, South Korea, South Africa, UK, and USA.…”

“…The guidelines and operational instructions for the biobank was previously released by several international biobanking organizations such as the International Society for Biological and Environmental Repositories (ISBER), European, Middle Eastern & African Society for Biopreservation and Biobanking (ESBB), Organization for Economic Co-operation and Development OECD, International Agency for Research in Cancer (IARC), Canadian Tissue Repository Network (CTRNet), Biobanking and Biomolecular Resources Research Infrastructures (BBMRI-ERIC), all of which have contributed to the harmonization of biobank activities and have also contributed to the drafting of ISO 20387:2018 standards developed specifically for biobanks. [ 40 42 ]…”