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Hannover Unified Biobank (HUB) accredited according to the international standard for biobanking (ISO 20387)
This article has 850 words and is a 4-minute read.
The Hannover Unified Biobank (HUB) has achieved accreditation under the DIN EN ISO 20387:2020 standard, titled “Biotechnology – Biobanking – General requirements for biobanking.” This makes HUB the first biobank in Germany to receive this accreditation for biobanking activities of liquid human biospecimens succeeding the accreditation of NCT Tissue Bank of Heidelberg in 2023.
Additionally, the Hannover Unified Biobank is the eighth biobank within the BBMRI-ERIC’s community to be accredited according to ISO 20387.
Speaking about the accreditation, as reported on the German Biobank Node (GBN) website , Prof. Dr. Thomas Illig, Head of Hannover Unified Biobank, emphasises:
“This accreditation is a clear sign of our commitment to excellent quality and continuous improvement. Our samples and data provide a reliable foundation for researchers.”
Around two million samples in stock
The Hannover Unified Biobank (HUB) serves as the central biobank for Hannover Medical School (MHH) and has been a partner biobank of the German Biobank Alliance (GBA) since 2017. Alongside its own collections, HUB stores a large number of sample collections from various MHH institutes and clinics, totaling nearly two million biosamples with associated data from clinical routine, research and clinical trials.
Andrea Wutte, MSc, Head of BBMRI-ERIC Quality Management says:
“We extend our congratulations to HUB on its accreditation by the German Accreditation Body (DAkkS), marking a significant milestone for our biobank community, and are particularly pleased that HUB has also applied for and successfully met the requirements of the BBMRI-ERIC audit programme, achieving the BBMRI-ERIC Quality Label.”
The HUB Biobank journey from implementing ISO 20387 to accreditation and BBMRI-ERIC Quality Label
Before the formal assessment by the German Accreditation Office (DAkkS), the Hannover Unified Biobank (HUB) underwent an intensive preparation process. This involved a thorough assessment of its processes and documentation to ensure full compliance with the requirements of DIN EN ISO 20387:2020.
Inga Bernemann, MSc., Quality Manager at HUB, comments:
“The support of GBN and the friendly audits were crucial in optimising our processes and successfully preparing us for accreditation.”
BBMRI-ERIC’s Head of Quality Management, Andrea Wutte, adds:
“The GBN Quality Programme ensures that German biobanks maintain high standards, safeguard sample integrity, comply with regulations, and strengthen their role as trusted partners in basic and applied research.”
The BBMRI-ERIC Quality Label for HUB
By mutual agreement between the quality management services of the National Node, in this case in particular with GBN, and the audit programme of BBMRI-ERIC, biobanks can be audited either by certified auditors from BBMRI-ERIC Headquarters or on their behalf by certified auditors in the countries.
The audits performed at HUB were conducted by a certified lead and auditor team from GBN, qualified in their scope for the BBMRI-ERIC Quality Label in accordance with ISO 20387.
The audits have been carried out with professionalism and expertise by:
- Regina Maushagen – Operative Management and Quality Management at Interdisciplinary Center for Biobanking-Lübeck (ICB-L)
- Gunter Wolf – Manager of Clinical Mass Spectrometry at Universitätsklinikum Carl Gustav Carus
- Supported by Nhutuyen Nguyen, MSc – Coordinator for Quality Management at the German Biobank Node.
BBMRI-ERIC Audit Programme and Quality Label
The BBMRI-ERIC Quality Label, which assesses the operation of biobanks according to European, international and community standards, has become a recognised certificate.
For achieving the Quality Label BBMRI-ERIC has set up an audit programme which provides a structured, multi-level approach to quality assessment in biobanking according to the biobanking standard ISO 20387 and other biobank relevant standards.
A first-level audit conducted by the biobank itself can be carried out using the BBMRI-ERIC Self-Assessment Survey (SAS). These SAS are complementing the international standards and allowing biobanks to internally validate the quality of their operations accordingly.
If the biobank is seeking an assessment from BBMRI-ERIC, biobanks can progress to a 2nd level audit by sending the SAS report to BBMRI-ERIC and request an audit.
The onsite-audit is conducted by BBMRI-ERIC Headquarters or on behalf by certified auditors. These audits follow BBMRI-ERIC criteria (BBMRI checklist / onsite audit / reporting / Quality Label recommendation). These audits are especially provided for biobanks planning to achieve a BBMRI-ERIC Quality Label and in addition very valuable for those who are preparing for a 3rd level accreditation assessment, conducted by a national accreditation body.
Biobanks that successfully complete the BBMRI-ERIC audit process can be awarded with a Quality Label. This BBMRI-ERIC Quality Label indicates that the biobank has set up and maintains its biobank operations according to the respective international and European standards.
BBMRI-ERIC’s Head of Quality Management, Andrea Wutte, explains:
“This BBMRI-ERIC Quality Label is particularly valuable for biobanks that are not seeking accreditation, due to multiple reasons, but still want to prove that their biobank works according to the highest quality criteria. All biobanks within the BBMRI-ERIC community can apply for this audit service.”
Currently, BBMRI-ERIC offers ten SAS options to assess sample quality following pre-examination process standards, and one for biobank operational quality, based on ISO 20387.
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