Biobanks play an integral role in the life science industries, particularly in medical research and development. When Dr. Marta Castelhano, Associate Research Professor from Cornell University and Director of the Cornell Veterinary Biobank (CVB), approached A2LA with a request to create a program for the newly published ISO 20387:2018 General Requirements for Biobanking, we were happy to develop a program for Biobanking organizations. This initial effort was led by Accreditation Officer Jason Poore, now positioned as A2LA’s Contracts Manager, and later transitioned to Cory Arant, Program Manager for the Biological field in the Life Sciences department. A2LA created the initial program to facilitate the first ever ISO 20387 Biobank assessment for Cornell University. In order to be considered for ISO 20387:2018 accreditation, the biobank must acquire and store biological material and/or the associated data, as well as at least one other activity to include collection, preparation, preservation, testing, analysis, and distribution. Not only did CVB need to document its processes and maintain strict record retention according to the requirements of ISO 20387:2018, but they also had to meet the applicable requirements imposed by A2LA. True to A2LA’s vision of ‘Accreditation Accepted Everywhere’ the program must include applicable requirements set forth by ISO/IEC 17011:2017 and the International Laboratory Accreditation Cooperation (ILAC).
In April 2019, CVB successfully received their accreditation demonstrating competence in their processes and activities in the field of Biobanking becoming the first biobank in the world to receive accreditation to ISO 20387:2018 – see below CVB press release:
Since that first assessment, led by Jason Poore and long-time biological assessor Tina Buffington, A2LA has performed 8 assessments resulting in 5 Biobanking organizations gaining accreditation. This is a giant step that our accredited Biobanks took towards ensuring the quality of their biological material is at the highest level for research and development purposes.
A2LA underwent our quadrennial Asia Pacific Accreditation Cooperation (APAC) re-evaluation in June 2022; the first evaluation to include ISO 20387 Biobanking under the MRA. The APAC MRA Council rendered their affirmative recognition decision on October 15, 2022, marking A2LA as the first Accreditation Body in the world to achieve regional Mutual Recognition for our ISO 20387 Biobanking program.