Biospecimens are essential raw materials for the advancement of applied
biotechnology. Awareness of the importance of sharing biospecimens has increased in
recent years and biobanking activities have facilitated access to them. However, the
sharing of such samples for Research & Development could be considerably improved
if there were a recognised global agreement about the standard by which to compare
their quality.
The Organization for Standardization (ISO) is the internationally recognised body that
provides guidelines and defines specifications to ensure standardisation of materials,
processes and products.The working group two (WG2) of the ISO Technical
Committee (TC) 276 established by the ISO on Biotechnology is dedicated to
Biobanking. The aim of this working group is to establish sets of standards that apply
to the biobanking field, to include human, animal, plant and microorganism samples,
thus ensuring that they are of appropriate quality. The availability of worldwide
recognized policies and procedures will support access and exchange of samples and
related data, giving a major impetus to global use of bioresources for market
application.
The standard set, which will be based on existing documents and guidelines, will be the
foundation of a quality management system (QMS) specifically for biobanking. ISO
QMS would enable the establishment of ad hoc global certification that products,
processes and/or services conform to relevant standards, technical specifications and
guidelines.
Keywords: Accreditation, Biobanking, Bioeconomy, Biological resources centres
(brc), Bioresource, Biospecimen, Biotechnology, Certification, Guidelines,
Harmonization, International Standard (is), International standard organization
(iso), Market, Personalized medicine, Quality Control (qc), Quality Management System (QMS), Repository, Standardization, Technical committee 2761.