Quality Handbook for Biobanks (QHB)

The Quality Handbook for Biobanks (QHB) is an implementation guide that supports biobanks in establishing, operating, and maintaining a quality management system (QMS) in line with ISO 20387:2018 (hereafter referred to as ISO 20387). Its aim is to help users understand the standard, interpret its provisions, and apply its requirements effectively across different biobank settings without replacing the normative document. The handbook addresses key aspects of ISO 20387 and biobank operations, including quality management, the life cycle of biological material and associated data, resources and infrastructure, ethical, legal and societal considerations, and risk management. It provides a flexible framework with examples and suggested practices that can be adapted to different operational models and scopes. The guide is intended for both new and established biobanks seeking to improve quality and achieve compliance with ISO 20387. The QHB serves as a practical reference bridging regulatory language and implementation. It does not cover national legal or regulatory requirements, which must be identified and implemented separately by each biobank and take precedence over ISO 20387 and this guidance. The handbook is intended for technical personnel, quality managers, and decision-makers responsible for implementing or maintaining compliance with the standard. This document draws on concepts and best practices from several established resources, including the Handbook for Quality Management in Biobanking (GBN), the Manual of Biobank Quality Management (BBMRI.pl), the BBMRI.be ISO 20387 Workbook, and the Swiss Biobanking Quality Manual. It is not intended as the only method for implementing ISO 20387 but as supportive guidance; biobanks may adopt alternative approaches depending on their context and regulatory environment.