This practical handbook supports biobanks in establishing and continuously improving their Quality Management Systems (QMS). It covers key areas including legal, safety, ethical and IT requirements, and is aligned with ISO 20387:2018 Biotechnology – Biobanking – General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. It is also compatible with recommendations from OECD, IARC and ISBER.
Written for biobank staff and other stakeholders, the handbook provides accessible guidance and examples of common practice. It can be applied across different types of biological material and biobanking settings, supporting responsible and transparent quality management.
