ISO 20387:2018 Accreditation for Biobanks
Quality You Can Trust. Confidence You Can Demonstrate.
What Is ISO 20387?
ISO 20387 provides a framework for quality and competence in biobanking, helping ensure biological materials and associated data are fit for their intended research and development purposes.
The standard can apply to biobanks handling materials from humans, animals, plants, fungi, microorganisms, data and other sources, depending on their scope of activities.
Why Commit to ISO 20387:2018?
Demonstrate Competence
Show researchers, partners and stakeholders that your biobank operates within an internationally recognized quality framework.
Strengthen Consistency
Standardized processes can help reduce variability and support more reliable biobanking operations.
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Build Confidence
Provide greater assurance that biological materials and associated data are managed through controlled and documented processes.
Why COLA?
Are your samples and data consistently fit for purpose?
ISO 20387 helps biobanks and biorepositories establish consistent processes, strengthen quality control and maintain traceability throughout the lifecycle of biological materials and associated data.
COLA accreditation helps you demonstrate your commitment to quality, which gives researchers, partners and stakeholders greater confidence in your biobank’s and biorepository’s operations.
Your Path to ISO 20387
Step 1 — Purchase the Standard
Obtain the ISO 20387:2018 standard
Step 2 — Define Your Scope
Determine which processes will be included in your ISO 20387:2018 accreditation
Step 2 — Apply
Submit your application for ISO 20387:2018 accreditation with COLA
Step 3 — Prepare
Implement the standard and prepare your laboratory for assessment
Step 4 — Assessor Assignment
COLA assigns qualified assessors with the expertise needed for your laboratory
Step 5 — Laboratory Assessment
COLA assessors evaluate your laboratory against ISO 20387:2018 requirements
Step 6 — Review Findings
Review any nonconformities identified during the assessment
Step 7 — Corrective Action
Address findings and submit your corrective action response when applicable
Step 8 — Accreditation Decision
The ISO Accreditation Board reviews the assessment and makes the accreditation decision
Step 9 — Accreditation
Receive ISO 20387:2018 accreditation with COLA and demonstrate your commitment to quality and competence
Ready to Get Started? → Talk to COLA
Take the Next Step Toward Quality Biobanking
Whether you are establishing a new biobank or strengthening an established operation, ISO 20387 accreditation can provide a structured framework for demonstrating competence and maintaining confidence in your biological materials and associated data.
Let’s talk about your accreditation goals.
