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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

 


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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


Quality management for biobanks

a series of BBMRI.at publications


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