University of SzegedBiobank

Why ISO 20387?

 

ISO 20387 is a standard developed specifically for biobanks, which offers many benefits to such institutions, regulating most areas of their operations. ISO 20387 certification demonstrates an institution's commitment to quality, transparency, and responsible practices, which are necessary for better and more efficient biobanking activities. ISO standards are internationally recognized, so compliance with ISO 20387 can open doors to international cooperation. It aligns the biobank with global best practices, meeting Hungarian and international expectations.

 

 

Quality management. This is necessary to ensure the quality, reliability, and traceability of the samples and data stored in the biobank.

 

Risk management: The standard emphasizes the importance of risk management, which is key to the operation of a biobank. It is important to stress the importance of the role of a biobank in ensuring that the risks associated with the collection, storage, and handling of samples are identified and mitigated.

 

Sample integrity: ISO 20387 sets out guidelines for collecting, handling, and storing samples to ensure that the integrity of biological materials is maintained. This is essential to ensure that samples remain adequate and fit for research purposes.

 

Data management: The standard addresses data management, including privacy and confidentiality, which is critical when dealing with sensitive patient information and research data.

 

Ethical and legal compliance: ISO 20387 includes provisions for ethical and legal compliance, ensuring that biobanks operate under applicable laws, regulations, and ethical principles. This is essential to gain and maintain the trust of donors and researchers.

 

Interoperability: the standard encourages biobanks to adopt standardized procedures and terminology, facilitating cooperation with other biobanks and research institutions. This will facilitate data sharing and comparison between different studies and sites.

 

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.

 

Continuous Improvement: ISO 20387 promotes a culture of continuous improvement, encouraging biobanks to regularly evaluate and improve their processes, ultimately leading to better research outcomes and resource management.

 

Reduced risk for researchers: researchers using samples and data from ISO 20387-certified biobanks can have greater confidence in the quality and reliability of their materials, reducing the risk of research errors.

 

In summary, ISO 20387 benefits biobanks by providing a structured approach to quality management, risk mitigation, ethical compliance and data management. It enhances the overall credibility and reliability of biobank operations, which is key to supporting scientific research and innovation.

 

This is why our biobank is committed to conducting our activities in accordance with ISO 20387.