Implementation and Long-Term Maintenance of ISO 20387:2018 in a Public Hospital Biobank: The Pisa Experience

Abstract

Background:

ISO 20387:2018 is the first international standard specifically designed for biobanks, defining requirements for competence, impartiality, and operational consistency. In 2022, the Multi-Specialistic Biobank of the Azienda Ospedaliero-Universitaria Pisana became the first biobank in Italy to achieve ISO 20387 accreditation, setting a national benchmark for public-sector quality governance.

Approach:

The accreditation pathway followed a structured 12-month plan combining gap analysis, document harmonization, competence development, and internal audits. A multidisciplinary quality working group redesigned the quality management system and aligned managerial and operational processes with ISO 20387 requirements. Fourteen quality documents were revised or newly developed to standardize workflows, strengthen traceability, and embed risk-based principles throughout the biobank’s activities.

Outcomes:

ISO 20387 accreditation was granted on July 14, 2022. Subsequent surveillance audits in 2023, 2024, and 2025 confirmed sustained compliance and progressive improvements, including expanded internal audits, enhanced risk assessment, digital competence tracking, and strengthened Corrective and Preventive Action effectiveness. Persistent challenges—including infrastructural constraints, limited information technology support, and delays in software modifications—reflected structural limitations typical of public health care settings.

Significance:

This article provides an integrated account of ISO 20387 implementation and long-term maintenance in a public hospital biobank. The Pisa experience offers a replicable model for institutions operating under similar constraints, demonstrating how technical rigor, coordinated governance, and a shared quality culture can sustain accreditation and advance national biobanking excellence.