ISO 20387 accreditation consulting for biobank collections that researchers can trust.

What it is

What is ISO 20387 and what is it used for?

ISO 20387 is the international standard that sets general requirements for biobanking. In ISO's own summary, it covers the competence, impartiality and consistent operation of biobanks, including quality control so that collections of biological material and their associated data are of appropriate quality. It was developed by ISO's biotechnology committee, ISO/TC 276, and applies to any organisation that performs biobanking, whether the material comes from humans, animals, plants, fungi or microorganisms.

The point of the standard is confidence in what leaves the freezer. A researcher who receives an aliquot, or a dataset linked to it, needs to know how it was collected, processed, stored and tracked, and that the same thing will happen next time. ISO names biobank users, regulators, peer-assessment schemes and accreditation bodies among those who can use the standard to confirm or recognise a biobank's competence. That recognition is what accreditation provides; it is not a certificate issued by a certification body.

Current edition. ISO 20387:2018, the first edition, published in August 2018. After its systematic review, ISO decided on 15 December 2023 to revise it, and ISO/FDIS 20387, a second edition titled "General requirements for biobanks", was registered for formal approval on 22 June 2026. ISO's summary of the draft extends coverage to biological material and associated data derived from environmental samples such as soil, sediment, water and air. No publication date or transition period has been announced; until then, assessments are made against the 2018 edition.

Who it is for

Who needs ISO 20387 accreditation?

ISO 20387 fits any biobank that wants its collections trusted beyond its own walls: university and hospital research biobanks, population cohorts, commercial sample providers, microbial culture collections and plant or environmental repositories. The scope should name the collections and activities you want recognised. Biobanks usually come to Sterling from one of four starting points:

• Research partners and sponsors ask for proof. Pharmaceutical companies, consortia and funders want evidence that samples and data are fit for their studies before they commit to a collaboration or a supply agreement.
• A funding call or tender sets a quality expectation. Infrastructure programmes and tenders increasingly ask how a biobank controls quality. Accreditation gives a recognised answer, rather than a self-declaration.
• Regulators and ethics bodies look closely. National rules on human tissue, consent and data protection still apply alongside the standard. A system built to ISO 20387 makes it easier to show how those obligations are met day to day.
• A group or network wants one way of working. Hospital groups, university networks and multi-site biobanks use the standard to align processes and data across locations and share material with confidence.

Clinical laboratories working with human material for diagnosis and treatment should look first at ISO 15189, which ISO says applies first and foremost to that work.

Requirements

What are the main ISO 20387 requirements?

The requirement areas below follow ISO's own description of the standard and its scope. The list is a plain-language map, not the standard itself; your biobank's implementation is checked against the full text of the applicable edition during the programme.

• Competence: show that the biobank has the people, facilities, equipment and methods to carry out the biobanking activities it claims.
• Impartiality: identify pressures from funders, owners or users that could compromise decisions about material and data, and manage them.
• Consistent operation: run activities such as collection, processing, storage and distribution the same way every time, with defined and controlled processes.
• Quality control of biological material: confirm that samples are of appropriate quality for their intended use, and act when they are not.
• Associated data: keep the data linked to each sample accurate, traceable and controlled, since users rely on it as much as on the material.
• Scope of application: material from multicellular organisms and microorganisms; the draft second edition adds material derived from environmental samples.
• Exclusions: biological material intended for therapeutic use; the 2018 edition also excludes food and feed production.
• Regulation and clinical standards: international, national or regional rules can also apply, and ISO 15189 comes first for diagnostic and treatment material.

Accreditation process

How do you get ISO 20387 accreditation?

Your biobank builds and operates the system; an accreditation body then assesses it and decides. Sterling provides consulting and preparation. The decision stays with the accreditation body, and that independence is what gives the result its weight with users.

1. 01
   Define the scope and choose the accreditation body.Agree the collections, activities and sites to be covered, and confirm that the chosen body offers ISO 20387 accreditation for them.
2. 02
   Gap analysis against ISO 20387.Review current practice, keep what already works, and agree actions, owners, dates and resources for the rest.
3. 03
   Implement and build a record of operation.Put processes and quality controls into daily use, train staff and let the system run long enough to produce real evidence.
4. 04
   Internal audit and management review.Test the whole system, raise findings before the assessors do, close them with evidence and apply to the accreditation body.
5. 05
   The accreditation assessment and after.Assessors review documents and visit the biobank; you address their findings, the body decides, and surveillance and reassessment follow on its cycle.

Check the route before you sign. Accreditation comes from an accreditation body, not from a certification body or a consultant, so an "ISO 20387 certificate" from anyone else is not accreditation. Ask the body whether ISO 20387 is within its accreditation services, and check its standing on the Global ACI list of recognised accreditation bodies. How to choose a credible ISO 20387 provider · The accreditation buyer's checklist

Cost

How much does ISO 20387 accreditation cost?

No single figure fits every biobank. A focused collection at one site with written procedures needs far less work than a multi-site network storing human, microbial and environmental material under different systems. What we commit to is a proposal in which every component is visible and nothing is added later.

Timeline

How long does ISO 20387 accreditation take?

Procedures can be written in weeks; a record of consistent operation cannot. Samples need to move through collection, storage and distribution under the new controls, and the accreditation body's schedule sits outside your control. As an estimate, a first accreditation takes six to twelve months.

If a partner agreement or funding deadline depends on accreditation, tell us at the start. We will say plainly what is achievable, and which decisions need to be made early to get there.

Your engagement

What your ISO 20387 engagement includes

Sterling OS™ runs every engagement, adapted to the way a biobank works. Sterling does not accredit: the accreditation body assesses your biobank and makes the accreditation decision. You choose the level of support that suits your team.

• Design™: guided support

  Your biobank staff write the procedures and records; a Sterling consultant sets the method, reviews each output and coaches the process owners.

• Drive™: managed support

  The alternative to Design™ for teams short of time: Sterling drafts the quality system with your people and runs the programme through to the assessment.

• Sustain™: after accreditation

  Internal audits, competence reviews, preparation for surveillance and reassessment, and support when you add collections or move to the new edition.

• Automate™: Effivity

  Your biobank's quality system runs in Effivity, included with the engagement at no additional cost.

• Training for your people

  Internal auditor training, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

Accreditation decisions remain with the accreditation body.

Often combined with

Standards organisations pair with ISO 20387

• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• ISO 10012ISO 10012 Measurement Management certification consulting: measurement processes and equipment controlled for valid results, ready for a certification audit.
• ISO 14065ISO 14065 accreditation and requirements for bodies verifying environmental information: GHG statements, footprints, the route, cost and timing factors.
• ISO 15189ISO 15189 accreditation consulting for medical laboratories: quality and competence for reliable, timely results, prepared for the accreditation assessment.
• ISO 15190ISO 15190 laboratory safety for medical labs: gap and risk assessment, procedures, training and internal audit alongside ISO 15189.
• ISO 17034ISO 17034 accreditation consulting for reference material producers: competence and consistent operation evidenced and prepared for accreditation assessment.