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Quality
Quality Management at BBMRI.at is one key competence.
Activities of BBMRI.at and its partners include:
- Development ISO standard and CEN/TS for sample-pre-analytics
- Implementation of these standards
- Contribution to the development of a BBMRI Self-Assessment-Tool for pre-analytical processes
- Quality Management cross audits in BBMRI.at partner biobanks
- Quality Management trainings
Pre-analytical sample quality:
BBMRI.at biobanks have committed themselves to handle biological samples from patients according to state-of-the-art procedures, i.e. pre-analytical standards for sample quality. These standards called "Molecular in vitro diagnostic examinations — Specifications for pre-examination processes" are published by the International Organization for Standardization (ISO) and / or the European Committee for Standardization (CEN). Experts from BBMRI.at contribute to the development of these standards.
Latest standards:
"Biobanking standard"
- EN ISO 20387:2020 Biotechnologie - Biobanking - Allgemeine Anforderungen an das Biobanking (dt.) ...order>
- EN ISO 20387:2018 08 15. Biotechnology -- Biobanking -- General requirements for biobanking (en) ...order>
Why is correct pre-analytical handling relevant?
see video "Misstand bei Bluttests" (Deutsches Fernsehen (SWR), by now, German version only)
https://www.swr.de/wissen/odysso/aexavarticle-swr-77780.html
Asset Publisher
Data Quality for Medical Data Lakelands
Publication by BBMRI.at partner Alpen Adria University
NEU: ISO 20387 Biobanking Standard nun auf Deutsch
.. verfügbar bei Austrian Standards Institute
Presentations from Regulatory Conference “MD & IVD”
… available for download - Oct 2020
Discounted pre-analytical ISO standards until 20 November 2020
...benefit from up to 50% discount and ORDER NOW
SAVE-THE-NEW DATES - IVDR & analytical performance testing requirements
... jointly organized by LISAvienna & BBMRI.at | 20 Oct 2020 | Vienna
BBMRI.at as example of QM in biobanking
Letter to the editor of CCLM Journal - June 2019
Special Edition in New Biotechnology
.. on sample quality - with contribution from BBMRI.at
Download publication on sample pre-analytics standards & IVDR
With contribution of BBMRI
New publication by BBMRI.at
Book chapter in "Handbook of Biomarkers and Precision Medicine" (published May, 2019)
REGISTER NOW for the course "CEN and ISO Standards for Pre-analytical Processes"
May 16, 2018 | Medical University of Graz, Austria
SAVE-THE-DATE – “Biomedical Research Workshop”
... at/by BBMRI.at Partner, Medical University of Graz, Austria - May 11-15, 2020
Dr. Uwe Oelmueller awarded for pre-analytics work
CEN-CENELEC, Brussels, Feb 17, 2020
"Data Quality for Biobanks" (webinar)
by BBMRI.at expert JE (Jan, 2019)
Watch the e-lecture: Enhance the reliability of diagnostics with the support of standards
Video by Dr. Uwe Oelmueller (Feb 2020)
ISO 15189 accreditation in pathology
QM event at BBMRI.at partner Med Uni Graz – 28 Feb 2020
Guidelines & publications for SARS-Cov-2 containing biospecimens
a current summary - 1 April 2020
Why are Quality Standards important?
watch the video and explore .... Feb 2020