ISO 20387 (Biobanking)

ISO 20387:2018, <em>Biotechnology — Biobanking — General requirements for biobanking</em>, is the international standard specifying requirements for the competence, impartiality, and consistent operation of biobanks. It applies to organisations biobanking biological material and associated data from humans, animals, plants, fungi, and microorganisms for research and development, covering the full chain of collection, preparation, preservation, storage, and distribution of biospecimens. Structurally, it draws on the general competence requirements of ISO/IEC 17025 (testing and calibration laboratories) and the quality-management-system requirements of ISO 9001, adapted specifically for biobanking. A biobank meets ISO 20387 when a national accreditation body (for example UKAS in the UK or ANAB in the US, both operating under the same international accreditation framework as ISO/IEC 17025 labs) has formally assessed and accredited its quality management system, sample traceability, and impartiality — not merely when it follows informal best-practice guidance.

ByCASRAI Editorial Board

· Last updated 18 Jul 2026

Worked examples

Is an instance

A university biorepository that stores tumour tissue and associated clinical data for external researcher access applies for ISO 20387 accreditation through a national accreditation body (e.g. UKAS or ANAB) to formally demonstrate its quality management system meets the standard's requirements for sample handling, traceability, and impartiality.

Is an instance

A multi-site biobank consortium requires every participating biobank to hold, or be actively pursuing, ISO 20387 accreditation as a condition of contributing samples to pooled studies, using the standard as a common, third-party-audited baseline rather than relying on each site's own internal SOPs.

Looks similar, but isn't

Not an instance

A biobank that closely follows the ISBER Best Practices for Repositories or the NCI Best Practices for Biospecimen Resources and Biorepositories is following well-regarded operational guidance, but that adherence alone is not ISO 20387 accreditation: ISO 20387 requires formal third-party assessment against a published international standard by an accreditation body, not just internal conformance to a guidance document. See <a href='/guides/isber-vs-nci-best-practices-biorepositories'>ISBER vs. NCI Best Practices for Biorepositories</a> for how those two guidance documents differ from each other and from ISO 20387.

What ISO 20387 covers

ISO 20387:2018 is published by the International Organization for Standardization (ISO) under the title Biotechnology — Biobanking — General requirements for biobanking. It sets out requirements covering biobank structure, personnel competence, facilities and equipment, the biobank’s quality management system, and the technical processes of collecting, preparing, preserving, storing, and distributing biological material and its associated data. The scope extends beyond human biospecimens to material from animals, plants, fungi, and microorganisms used for research and development, and covers the full lifecycle from initial collection through to eventual distribution or disposal, with an explicit emphasis on traceability at every step.

How it relates to ISO/IEC 17025 and ISO 9001

ISO 20387 was not written in isolation. It is structured to align with two existing, widely recognised ISO frameworks: ISO/IEC 17025, which specifies general requirements for the competence of testing and calibration laboratories, and ISO 9001, the general quality-management-system standard used across many industries. Biobanks pursuing ISO 20387 accreditation are, in effect, being assessed against a biobanking-specific adaptation of those two frameworks combined — which is part of why accreditation bodies that already accredit testing laboratories to ISO/IEC 17025 (such as UKAS in the United Kingdom or ANAB in the United States) are typically also the bodies offering ISO 20387 accreditation.

Accreditation vs. best-practice guidance

It is worth distinguishing ISO 20387 clearly from the two most widely used biobanking best-practice documents: the ISBER Best Practices for Repositories and the US National Cancer Institute’s Best Practices for Biospecimen Resources. Both of those are detailed, respected operational guidance documents that many biobanks use to shape their internal standard operating procedures — but neither is a formal accreditation scheme. A biobank can follow ISBER or NCI guidance closely without ever being independently assessed against it. ISO 20387, by contrast, is a certifiable international standard: conformance is verified by an independent, third-party accreditation body through a formal audit process, and the result is a public accreditation status that can be checked and cited — closer in kind to laboratory accreditation under ISO/IEC 17025 than to voluntary guidance. For a detailed side-by-side of how the two guidance documents compare to each other, see ISBER vs. NCI Best Practices for Biorepositories; that comparison covers guidance-document differences and does not itself address formal accreditation, which is the specific role ISO 20387 plays.

Who uses ISO 20387

ISO 20387 is used by biobanks themselves as a target to design their quality management system around; by accreditation bodies (national accreditation bodies operating within the International Accreditation Forum/International Laboratory Accreditation Cooperation framework) to assess and accredit biobanks; by funders, regulators, and multi-site research consortia that want an externally verifiable, auditable quality baseline for participating biobanks rather than relying on self-reported adherence to guidance; and by biobank users (researchers, pharmaceutical and biotech partners) who want independent assurance that a biobank’s samples and data meet a consistent quality and traceability bar before relying on them in downstream research.

Related terms

See also Biobank, Biorepository, Tissue bank, and Sample repository for the underlying entities ISO 20387 sets accreditation requirements for.

Use in your systems

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Schema.org DefinedTerm (JSON-LD)

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