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ISCB accreditation services

Biobank Accreditation

Accreditation to ISO 20387 for biobanks ensures integrity, reliability, and ethical conduct, enhancing quality and global recognition.

Biobank Accreditation
Accreditation standardISO 20387

Competence. Impartiality. Consistency.

The overview

About 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 eligibility

Is 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

01

Enhanced 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.

02

Global 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.

03

Compliance 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.

04

Optimized 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.

05

Risk 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.

06

Continuous 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.

07

Public 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 pathway

How accreditation works

1Enquiry
2Application
3Scope review
4Document review
5Assessment
6Corrective action
7Decision
8Surveillance
Application evidence

Documents 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 basis

What shapes the quotation

Scope

Technical breadth

Activities, schemes, methods and technical sectors included.

Organisation

Sites and people

Locations, personnel, operating complexity and sampling needs.

Assessment

Review and witnessing

Document review, assessment days, witnessing and specialist expertise.

Request a formal quotation ↗
Controlled programme document

ISO 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 step

Find, price and apply

Use guided tools to confirm the likely route, request a scope-based quotation and apply when prepared.