The implementation of a Quality Management System in a Research Biobank - the experience of the University Hospital of Padova

Biobanks are essential infrastructures for biomedical research, providing high-quality biological samples and associated data within a strict ethical and regulatory framework. Over recent decades, their role has evolved from passive repositories to active research-support institutions, requiring robust organizational and quality management systems. At the University Hospital of Padova (AOUP), multiple independent biological collections have existed since the 1990s, preceding the formal establishment of a centralized biobank. In 2020, an institutional initiative was launched to unify these collections into a single certified biobank through the implementation of a Quality Management System (QMS) aligned with international standards. This study evaluates the impact of biobanking practices over a 30-year period (1993–2022) through a retrospective analysis of the General Surgery 3 biobank, including 23,143 records corresponding to 128,558 biological aliquots. The analysis demonstrates that historical, non–mission-driven sample collection resulted in sample underutilization and substantial long-term storage costs. The proportion of out-of-mission records decreased significantly over time, from 12.4% in 1993–2002 to 2.6% in 2013–2022 (p < 0.001), reflecting the progressive alignment of collection practices with the institutional mission. In parallel, a stakeholder survey revealed marked heterogeneity in pre-analytical sample handling across AOUP operational units, highlighting the absence of standardized procedures prior to hospital-wide harmonization. Within the General Surgery 3 biobank, the implementation of a Quality Management System was accompanied by improved mission alignment, increased data completeness, enhanced sample availability, and greater operational efficiency. In conclusion, this study demonstrates that the implementation of a structured, QMS-driven biobanking model is essential to ensure sustainability, optimize resource utilization, and maximize the scientific value of biobank collections in compliance with international quality standards.