ISO 20387 Biobanks

The ISO 20387 international standard was developed to promote confidence in biobanking institutions and procedures. ISO 20387 establishes accreditation requirements for biological material and data quality that demonstrate an organization’s competence in proper handling, traceability, and long-term preservation of samples. ANAB recognizes the importance of biobanked material in multiple scientific disciplines and has implemented a program to accredit organizations to this international standard.

Biobanking Accreditation Requirements

Based on ISO 20387, General requirements for biobanking, and ISO 9001, Quality management systems - Requirements, ANAB’s ISO 20387 program includes four additional criteria for accredited organizations:

• Maintain a quality control plan which includes an evaluation of risk and is retained for a minimum of 4 years.
• Promptly notify ANAB of unsatisfactory results.
• Perform and document appropriate corrective action if ISO 20387 non-conformities are discovered.
• Prove metrological traceability (MT) to the International System of Units (SI).

ANAB ISO 20387 Accreditation Process

ISO 20387 accreditation involves an independent assessment of the biobanking organization that includes an examination of the quality management system, personnel qualifications and competence, material handling, storage environment and equipment, and reporting. Qualified assessors conduct a thorough evaluation of all factors affecting the storage of biological material and the demographic sample information.
To ensure continued compliance, accredited biobank organizations are regularly re-assessed to ensure they maintain their technical expertise and competence. Accredited organizations are also required to participate in proficiency testing programs (EQAs).

This diagram outlines the ANAB accreditation process:

Get Your Biobanking Organization Accredited by ANAB

To learn more about ANAB accreditation to ISO 20387, contact anab@anab.org or call 414-501-5494.