Why the ISO 20387 Standard?

ISO 20387 is a standard specifically designed for biobanks, regulating key aspects of their operations while offering numerous benefits. It provides a structured approach to quality management, risk mitigation, ethical compliance, and data management, which in turn strengthens the credibility and reliability of biobank operations. This is essential for supporting scientific research and innovation.

As an internationally recognized standard, ISO 20387 opens doors to global cooperation opportunities, ensuring that biobanks align their practices with international best standards while meeting both Hungarian and global expectations.

ISO 20387 underscores the institution’s commitment to quality, transparency, and responsible research practices.

 

Benefits of the ISO 20387 certification:

Quality management: ISO 20387 provides a framework for implementing a reliable quality management system, which is essential for ensuring the quality, reliability, and traceability of biobank samples and data.

Risk management: The standard highlights the importance of risk management, which is crucial to biobank operations. It focuses on identifying and mitigating potential risks related to the collection, storage, and handling of samples.

Sample integrity: ISO 20387 provides guidelines for the collection, handling, and storage of samples to preserve the integrity of biological materials. This is essential to ensure that the samples remain suitable for research purposes and retain their required quality.

Data management: The standard addresses data management, including data protection and confidentiality, which are critical when handling sensitive patient information and research data.

Ethical and legal compliance: The ISO 20387 standard includes provisions for ethical and legal compliance to ensure that biobanks operate in accordance with applicable laws, regulations, and ethical principles. This is essential for gaining and maintaining the trust of donors and researchers.

Interoperability: The standard encourages biobanks to adopt standardized procedures and terminology, facilitating collaboration with other biobanks and research institutions. This supports data sharing and comparison across different studies and locations.

Continuous improvement: ISO 20387 fosters a culture of continuous improvement, encouraging biobanks to regularly assess and enhance their processes. This ultimately leads to better research outcomes and more efficient resource management.

Reduced risk for researchers: Researchers working with samples and data from ISO 20387-certified biobanks can rely on the consistency and dependability of the materials, which helps minimize the risk of research errors.

ISO 20387 certification can enhance the reputation of biobanks. It demonstrates the institution’s commitment to quality, transparency, and responsible research practices, which can attract more researchers and donors.

Our biobank is dedicated to ensuring that all its operations fully comply with ISO 20387.