Spotlight on accreditation standards: the importance of ISO 20387:2018 for the accreditation of Biobanks

In the rapidly evolving field of biobanking, the establishment of robust and reliable standards ensures the quality and integrity of biological material storage. ISO 20387:2018 is a critical benchmark for biobanks around the world, emphasising the need for standardisation in the collection, storage, and use of biological materials and associated data for research and development.

ISO 20387 addresses the necessity for maintaining consistent and reliable practices in the biobanking sector. Recognising the broad and increasing applications of biobanking in various scientific fields, this standard ensures that biological materials and their associated data are handled appropriately to maintain their integrity and usability. ISO 20387 provides comprehensive requirements covering the entire spectrum of biobanking operations, including the collection, transportation, preparation, long-term preservation, and traceability of samples and associated data, from humans, animals, plants, fungi, and microorganisms.

The need for such a standard stems from the critical role that the quality, consistency, and traceability of banked biological materials play in research and other applications. Prior to ISO 20387, several standards partially addressed biobanking practices, but none provided a holistic framework that focused specifically on the unique challenges and requirements of biobanks. By establishing requirements for both the management system and technical operations of biobanks, ISO 20387 helps organisations ensure that their biobanking practices comply with these requirements, thereby enhancing the quality and reliability of the biological materials they manage.

Accreditation to ISO 20387 involves a rigorous, unbiased evaluation of a biobank’s competence and adherence to the standard, fostering confidence among users and stakeholders in the biobank’s capabilities and the quality of its biological resources. This accreditation is essential not only for upholding high standards within the biobanking community but also for facilitating the robust and reliable use of banked materials and associated data in scientific research and other sectors.

The UKAS pilot accreditation scheme

UKAS has established a pilot programme to develop an assessment approach and offer accreditation to biobanking Conformity Assessment Bodies (CAB)s operating biobanks in the areas of defined biological materials from human, animal, plant and microorganisms, as well as related information and data.

This initiative aims to establish a structured accreditation process tailored to the unique needs of biobanking operations, aligning them with ISO 20387:2018. The pilot development programme has progressed well, and we anticipate accreditation to ISO 20387 for Biobanks to be granted to several services over the course of 2024.

We are still able to accept applications for this project. For further information on this project please contact the Development Team.

Scope of ISO 20387:2018

ISO 20387, titled “General requirements for biobanking,” establishes a comprehensive framework for the operation and management of biobanks. The scope of the standard covers various critical aspects of biobanking, ensuring that these facilities operate under rigorous and reliable conditions to support scientific and medical research.

The key areas covered by ISO 20387 include:

Biological material collection: Requirements on how samples and associated data are to be collected, ensuring they are representative and maintain their intrinsic value and integrity.

Transportation: Protocols for the secure and safe transportation of samples to prevent contamination and degradation and maintain integrity.

Preparation and preservation: Methods for processing and storing biological materials and associated data to maintain their integrity over long periods. This includes procedures for cryopreservation, refrigeration, and other preservation techniques suitable for different types of samples.

Long-term storage: Requirements for storage facilities that ensure samples are safeguarded against environmental factors and contamination, and are accessible for future use. For both biological material and associated data.

Sample traceability: Systems to track the origin, storage conditions, handling, and usage of samples and associated data to ensure they are traceable throughout their lifecycle.

Quality management: Implementation of quality management systems to oversee the operation of biobanks, ensuring consistent practices that meet the requirements.

Technical competence: Ensuring biobank staff are competent in handling and processing biological materials and associated data according to the established protocols.

Ethical considerations: Compliance with ethical standards, particularly concerning consent and the use of human biological materials and associated data.

Data management: Effective management of data associated with biological samples, including demographic information, collection circumstances, storage conditions, and usage data, to support their future scientific utility.

Security and risk management: Protocols to protect the physical and data integrity of the biobank against unauthorized access, natural disasters, and other risks.

The importance of accreditation

Accreditation to ISO 20387:2018 signifies a biobank’s commitment to maintaining high standards in the management of biological materials. Accreditation to this standard acts as a seal of approval that assures researchers and stakeholders of the integrity and reliability of the biobank’s operations. Accreditation helps in mitigating risks, enhancing research quality, and promoting global collaboration by ensuring that biobanks meet international standards. For biobanks, accreditation is about embedding quality and competency into the very fabric of their operations.

The journey to accreditation

Biobanks wishing to apply for accreditation will undergo a rigorous assessment process that includes documentation review, on-site assessments, and annual surveillance assessments to ensure ongoing compliance with the standard. Biobanks seeking accreditation must demonstrate their operational competence and adherence to the procedures as specified in ISO 20387:2018. The process is comprehensive and is designed to challenge biobanks to embrace best practices in every facet of their operation.

Find out more

For biobanks aiming to excel in their field and ensure the highest quality in the management of biological resources, achieving accreditation under ISO 20387:2018 is a step forward. We encourage those interested accreditation to contact the Development Team at UKAS. By gaining accreditation, biobanks not only enhance their credibility but also contribute to the broader scientific community’s efforts in research and development. Reach out today to learn more about the accreditation process.