A2LA First Accreditation Body to Include ISO 20387 for Biobanking in APAC Mutual Recognition Agreement

The accreditation body is now recognized by The Asia Pacific Accreditation Cooperation (APAC) to perform assessments and grant accreditation for the new standard.

UMMC Biobank Accredited by ANAB Under ISO 20387 Program for Biobanking
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The American Association for Laboratory Accreditation (A2LA), one of the largest conformity assessment accreditation bodies in the world, is proud to announce that ISO 20387 has been added to its Mutual Recognition Agreement (MRA) with The Asia Pacific Accreditation Cooperation (APAC).

According to the International Organization for Standards (ISO), the ISO 20387s standard is “applicable to all organizations performing biobanking, including biobanking of biological material from multicellular organisms (e.g. human, animal, fungus and plant) and microorganisms for research and development.Biobanks play an integral role in the life science industries, and even more important in the research and development field of medicine.

“It’s great to officially have biobanking fall under our MRA with APAC,” says Trace McInturff, A2LA Vice President of Accreditation Services. McInturff is also the MRA Council Chair of APAC, and through his advocacy, was able to fulfil a need in the biobanking industry. In addition, Adam Gouker, A2LA General Manager of Accreditation Services, is Chair of APAC Technical Committee (TC1) that oversees biobanking in the MRA.

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“We’ve been working hard to push this effort forward because we saw a need,” adds McInturff. “Previously, there was no independent reassurance of objective evidence that a biobank was competent. Now, biobanks can provide assurance to their end users that the biological material stored and processed by accredited biobanks is of the highest level for research and development purposes.”

After ISO 20387 was published in 2018, Marta G. Castelhano, Doctor of Veterinary Medicine at the Cornell Veterinary Biobank (CVB), who assisted in the development of the standard, requested A2LA create a biobanking accreditation program for CVB and other biobanks. After A2LA developed the program, CVB became the first biobank to become accredited to the ISO 20387 standard. CVB was also recently recognized by the Rosalind Franklin Society with an award for the academic paper detailing its accreditation journey.

In order to add ISO 20387 to the APAC MRA, A2LA was evaluated in June of 2022 by a working group of peers. A2LA’s program had to include applicable requirements set forth by ISO/IEC 17011:2017 and the International Laboratory Accreditation Cooperation (ILAC). APAC’s report was brought to the MRA council for a vote, and the expanded scope was approved on October 15, 2022.

“In four short years, APAC put an immense effort forth to embrace its stakeholders,” adds McInturff. “This approval is just the beginning of ISO 20387 accreditation in the biobanking industry, and A2LA is proud to be leading the way.”

In addition to CVB, A2LA has granted ISO 20387 accreditation to four additional biobanks. For biobanks that wish to achieve ISO 20387 accreditation, A2LA recommends obtaining a copy of the standard before seeking training. You can learn more about A2LA’s biobanking program at https://a2la.org/accreditation/iso-20387-biobanking/.