Biobanks

Accredited activity

Biobanking

Description of the activity

A biobank is an infrastructure that operates to ensure the quality of the biological material it stores and distributes, as well as the associated data, for research and development purposes. Specifically, the organization collects and stores, as well as processes, manipulates, analyzes, transports, and distributes biological materials from human, animal, plant, and microorganism organic entities, and manages related information.

Biobanks that handle biological material intended for food/animal feed production, laboratories performing analyses for food/animal feed production, and/or for therapeutic use are excluded from accreditation.

Accreditation standards

ISO 20387
Biotechnology — Biobanking — General requirements for biobanking

Document issued

The biological material report is the document issued by the accredited biobank that managed the conservation activities, including one or more of the following: collection, processing, handling, analysis, transportation, and distribution of the material.

What the report guarantees

The report guarantees that the biological material in question was managed by the accredited biobank according to standardized and traceable methods and that the associated data are of appropriate quality.

What the report does NOT guarantee

The report issued under accreditation covers the biological material and associated data stored by research biobanks and does not apply to clinical diagnostic and therapeutic biobanks or those belonging to already regulated sectors, such as agri-food and pharmaceuticals.

General Regulations for accreditation

RG-22
Regulation for the accreditation of Research and Development Biobanks
RG-09
Regulation for the use of the ACCREDIA logo and mark

Other Regulations for accreditation

RT-38
Requirements for the accreditation of Research and Development Biobanks
RT-39
Requirements for participation in proficiency testing (PT) and/or interlaboratory comparisons (ILC)

Complete list of standards and reference documents for accreditation

LS-16
List of reference standards and documents for the accreditation of Biobanks for research and development

Application for accreditation

DA-00
Application for Accreditation
DA-12
Application for accreditation of Biobanks (BBK)
DA-12 All.1
Fields – sectors (biobanking)
MD-09-12-S-DT
System assessor – Checklist for the assessments of a Biobank – UNI EN ISO 20387:2024