This quality manual template aims to guide and support biobanks through all stages of their development: from
their establishment, through the development of their activities, and towards improving their processes and quality.
From the very beginning a biobank can adopt this quality manual. Accordingly, the different chapters can be added following the scheme of the SBP labels, starting with the VITA and its focus on organisational requirements, followed by the NORMA and the documentation of standardised practices and finally reaching the OPTIMA with the global quality aspects of all operational processes..
A fully completed quality manual furthermore qualifies for the quality management system requirements from the ISO 20387-General requirements for Biobanking
This document is intended to be used internally for biobank personnel as a reference document and externally
for auditors, customers and external collaborators.
