From ISO 9001:2015 to ISO 20387:2018: a proposed implementation roadmap for biobanks.

A practical implementation roadmap enables ISO 9001:2015-certified biobanks to adopt ISO 20387:2018 within 17–20 weeks, addressing biobank standardization needs.

• Why it matters: Biobanks are crucial for biomedical research, but their adoption of biobank-specific standards like ISO 20387:2018 remains limited, hindering quality and consistency.
• What they did: The study conducted a literature review and clause-level analysis of ISO 9001:2015 and ISO 20387:2018, identifying overlaps and additional requirements, then developed a structured, time-bound transition framework.
• The result: The roadmap leverages existing systems to facilitate adoption, potentially making accreditation more accessible for resource-limited biobanks, though further validation of feasibility and benefits is needed.