The overviewAbout this accreditation
Accreditation to ISO 20387 for biobanks is a pivotal step toward ensuring the integrity, reliability, and ethical conduct of biobanking activities. ISCB, a distinguished provider of accreditation, highlights the significant benefits that ISO 20387 accreditation offers to biobanks and the broader scientific community.
Programme eligibilityIs this programme suitable?
Applies to organisations performing biobanking of biological material and associated data for research and development within a defined scope.
- Define the scope by types of biological material and associated data, lifecycle activities, methods, storage conditions, locations and intended uses.
- Establish governance for access, consent or lawful authority, confidentiality, custodianship, material transfer and permitted use.
- Control acquisition, collection, transport, receipt, preparation, preservation, storage, retrieval, distribution and disposal with complete chain of custody.
Why accreditation matters
Benefits for your organisation
01Enhanced Quality and Integrity
ISO 20387 accreditation establishes a robust framework for quality management in biobanks, encompassing the collection, processing, storage, and distribution of biological materials. By adhering to this standard, biobanks uphold the highest standards of integrity, ensuring the accuracy and traceability of samples and data throughout their lifecycle.
02Global Recognition and Collaboration
Accreditation to ISO 20387 enhances the credibility of biobanks on an international scale, fostering trust among stakeholders including researchers, regulatory authorities, and funding agencies. Accredited biobanks are more likely to attract collaborations, partnerships, and research opportunities, facilitating knowledge sharing and scientific advancement.
03Compliance with Regulatory Requirements
ISO 20387 provides a comprehensive framework for compliance with regulatory requirements and industry best practices in biobanking. Accredited biobanks demonstrate a commitment to meeting ethical, legal, and regulatory obligations, minimizing the risk of non-compliance and associated penalties.
04Optimized Research Outcomes
Accredited biobanks play a critical role in supporting biomedical research by providing high-quality, well-characterized biological samples and associated data. ISO 20387 accreditation ensures that samples are collected, stored, and distributed according to standardized protocols, thereby enhancing the reliability and reproducibility of research outcomes.
05Risk Management and Contingency Planning
Accredited biobanks implement robust risk management processes to identify, assess, and mitigate potential risks associated with biobanking activities. ISO 20387 encourages the development of contingency plans to address unforeseen events such as equipment failure, natural disasters, or data breaches, safeguarding the integrity and availability of biological samples and data.
06Continuous Improvement Culture
ISO 20387 promotes a culture of continuous improvement within biobanks, encouraging ongoing evaluation of processes, procedures, and performance metrics. Accredited biobanks regularly review their quality management systems, identify areas for enhancement, and implement corrective actions to drive continuous improvement and innovation.
07Public Confidence and Trust
Accreditation to ISO 20387 enhances public confidence in biobanking activities by demonstrating adherence to internationally recognized standards for quality, safety, and ethical conduct. Accredited biobanks prioritize transparency, accountability, and stakeholder engagement, fostering trust among patients, donors, and the broader community. If you are interested in accreditation please contact us at info@iscbonline.com
Transparent assessment pathwayHow accreditation works
1Enquiry
2Application
3Scope review
4Document review
5Assessment
6Corrective action
7Decision
8Surveillance
Application evidenceDocuments to prepare
Legal identity, governance, ethics and impartiality controls
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Proposed material/data scope and lifecycle map
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Consent, access, privacy and material-transfer controls
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Personnel competence and authorization records
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Collection, processing, storage and distribution procedures
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Equipment qualification, monitoring, alarm and continuity records
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Quality-control, traceability and representative transaction records
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Internal audit, management review, risk, incident and corrective-action records
Provide current, approved evidence relevant to the activities and locations in your proposed scope. ISCB may request additional records after scope review.
Clear fee basisWhat shapes the quotation
ScopeTechnical breadth
Activities, schemes, methods and technical sectors included.
OrganisationSites and people
Locations, personnel, operating complexity and sampling needs.
AssessmentReview and witnessing
Document review, assessment days, witnessing and specialist expertise.
Request a formal quotation ↗Controlled programme documentISO 20387 applicant requirements
Read the ISCB requirements online or download the controlled PDF guide covering eligibility, impartiality, competence, operating evidence, assessment and continued accreditation.
Take the next stepFind, price and apply
Use guided tools to confirm the likely route, request a scope-based quotation and apply when prepared.