What is ISO 20387?

Key Takeaways

• ISO 20387 is a global standard specifically for biobanking, designed to provide a framework that ensures quality, competence, and consistency in how biobanks operate.
• The standard promotes confidence in biobank operations by focusing on the entire lifecycle of biological samples and associated data, from collection and processing through storage and distribution.
• Unlike general quality system standards, ISO 20387 is tailored to the unique challenges of biobanking, including traceability, data integrity, and ethical considerations such as consent and confidentiality.
• Accreditation to ISO 20387 demonstrates technical competence, meaning an independent body has verified that a biobank meets the standard’s requirements for personnel, facilities, processes, and documentation.
• By adhering to ISO 20387, organizations can strengthen quality culture, improve sample and data reliability, and build trust with research partners, funding bodies, and the public.

ISO 20387 is a global standard that provides a framework for quality and competence in biobanking. Its purpose is to promote confidence in biobank operations and to ensure biological materials and associated data they provide are of appropriate quality for research and development. The standard covers the entire lifecycle of a biospecimen, from collection and processing to storage and distribution. It is not just a certification for a quality management system; it is an accreditation that demonstrates the technical competence of a biobank. Unlike a generic quality standard, it specifically addresses the unique challenges of biobanking, including issues of traceability, integrity, and data security.

While ISO 21899 and ISO 15189 are related standards, they address different aspects of laboratory and medical practice. ISO 21899, for example, focuses on the validation and verification of processing methods for biological materials. It is a more specialized standard that complements ISO 20387 by providing detailed guidance on how to ensure your lab methods are fit for purpose. ISO 15189, on the other hand, is a standard for medical laboratories that specifies requirements for quality and competence, with a focus on patient care and diagnostic services. While a biobank may be part of a medical institution that is accredited to ISO 15189, this standard does not cover the specific requirements of biobanking. A biobank needs a dedicated standard like ISO 20387 to ensure its operations meet the highest level of quality and competence. The ISO 20387 standard provides a framework for the management system and technical operations of a biobank. It includes requirements for personnel, facilities, equipment, and processes to ensure all activities are performed consistently and reliably. It also addresses ethical considerations, such as consent and confidentiality, and the need for a documented system that protects the rights of donors and users.

This standard provides a comprehensive, multifaceted framework for the integrity of a biobank. It ensures that specimens are not only stored correctly but also have a complete, traceable verified history. It also helps to build a culture of quality within the organization, which is essential for attracting research partners and securing funding. APHL tells us laboratories that have moved from paper or manual entry to integrated systems consistently report higher accuracy and far fewer clerical errors, directly translating into better patient safety and fewer result corrections. The principles of ISO 20387 support this by requiring a robust management system that minimizes the risk of human error and ensures data integrity.

ISO 20387 Checklist

A key step in preparing for accreditation is completing an ISO 20387 checklist. This document serves as a self-assessment tool, allowing a biobank to systematically review its operations against the requirements of the standard. The checklist covers all aspects of the biobank’s operations, from general requirements for impartiality and confidentiality to detailed processes for collection, preservation, and distribution. It is a comprehensive guide that helps you identify any gaps in your current practices and develop a plan for addressing them.

While a what is ISO 20387 PDF might provide a summary of the standard, a detailed checklist goes much deeper. It prompts you to provide evidence of your compliance with each clause of the standard. For example, it will ask you to document your management system, including procedures and work instructions. It will also require you to demonstrate your organizational structure, your legal status, and your policies for handling risks and opportunities. The checklist is not just a list of questions; it is a roadmap for implementing a robust quality management system.

The checklist also covers the technical requirements of the standard. It will ask you to verify that you have the necessary resources, including competent personnel, suitable facilities, and well-maintained equipment. It will require you to demonstrate your methods for processing biological materials are validated and fit for purpose. It is a thorough review of your operations that ensures every aspect of your biobank is functioning at the highest level. By completing the checklist, you gain a clear understanding of your strengths and weaknesses, which is essential for a successful accreditation audit.

ISO 20387 Biobank Accreditation Program

The ISO 20387 biobank accreditation program is a formal, third-party assessment of a biobank’s competence and compliance with the ISO 20387 standard. Accreditation is not a one-time event; it is a process that involves a rigorous, unbiased evaluation of your biobank’s operations. The goal of the program is to provide assurance to researchers, funding bodies, and the public that the biobank is operating at the highest level of quality and integrity. It is an internationally recognized seal of approval that can help to attract new partnerships and collaborations.

When you begin the accreditation process, you will work with a recognized accreditation body. They will conduct an on-site assessment of your biobank, reviewing your documentation, interviewing your staff, and observing your processes. This audit is designed to verify your biobank meets all the requirements of the standard, from your quality management system to your technical operations. If any non-conformities are found, you will be required to develop and implement corrective actions.

While you may find an ISO 20387 PDF free download online, the document itself is only one part of the accreditation process. The real value comes from the implementation of the standard’s principles and the verification of your competence by a third party. The accreditation program provides a structured path for continuous improvement. Once accredited, your biobank will be subject to periodic re-assessments to ensure you are maintaining the necessary competencies and continue to meet the relevant requirements. This ongoing surveillance ensures your biobank remains a high-quality, reliable resource for the long term.

Choosing the Right Biobank Software

Selecting the best biobank software is a strategic decision that requires careful consideration of your needs and the vendor’s capabilities. You should consider a solution that offers a comprehensive approach to managing both physical biospecimens and their associated data. The ideal system will provide a full audit trail, robust data security, and the flexibility to adapt to your unique workflows. When you seek a new solution, consider the advanced capabilities of the SoftLIMS® and SoftBiobank® products from SCC Soft Computer. These products are designed to address the specific needs of modern biobanks, offering robust tools for sample tracking, data management, and regulatory compliance.

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