Quality Management at BBMRI.at is a 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
- Free access to the online Self-Assessment Surveys for testing the state-of-the-art of pre-analytical processes
Several BBMRI.at partners have QM systems in place and are ISO certifications. All BBMRI.at partner biobanks have committed themselves to handle biological samples from patients according to state-of-the-art procedures, i.e. CEN/TS and ISO standards for pre-examination processes.
Latest ISO and CEN standards relevant for biobankers and researchers
Standard series "Molecular in vitro diagnostics – specifications for pre-examination processes"
The European Committee for Standardization (CEN) and the international Standard Organisation (ISO) published standards for the pre-analytics of biospecimens that are intended for molecular analysis. They describe requirements for the pre-analytical phase and are considered as state-of-the-art for pre-analytical workflows.
Quality Management System Standards
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>
EN ISO 15189:2014 Medizinische Laboratorien - Anforderungen an die Qualität und Kompetenz (ISO 15189:2012, korrigierte Fassung 2014-08-15) ...order>
EN ISO 15189:2012 11 01 Medical laboratories - Requirements for quality and competence (Corrected version 2014-08-15) ...order>
ISO and CEN standards - state-of-the-art and good scientific practise
Pre-analytical sample quality - a pre-requisite for reliable and reproducible analyses results
The pre-analytical phase is a very critical phase o analysis workflow. It is extremely error-prone. Pre-analytical errors have turned out to be a major cause why promising results in biomarker research fail in the process of validation, as data were not reproducible in a large scale. Also in diagnostics pre-analytical variables can lead to unreliable or wrong test results.
See video "Misstand bei Bluttests" (Deutsches Fernsehen (SWR), by now, German version only)
ISO and CEN standards
The European Committee for Standardization (CEN) and the international Standard Organisation (ISO) have taken up this issue and published standards for the pre-analytics of biospecimens that are intended for molecular analysis. They describe requirements are considered as state-of-the-art for pre-analytical workflows.
Evaluate your pre-analytical sample handling processes
Does your lab meet the pre-analytical CEN/TS & ISO Standards' requirements?
To find out use the BBMRI Self-Assessment Surveys for
- General Requirements for Biobanking; ISO 20387:2018
- Frozen tissue - Part 1: Isolated RNA; ISO 20184-1:2018
- Frozen tissue - Part 2: Isolated proteins; ISO 20184-2:2018
- FFPE tissue - Part 1: Isolated RNA; ISO 20166-1:2018
- FFPE tissue - Part 2: Isolated proteins; ISO 20166-2:2018
- FFPE tissue - Part 3: Isolated DNA; ISO 20166-3:2018
- Venous whole blood - Part 1: Isolated cellular RNA; ISO 20186-1:2019
- Venous whole blood - Part 2: Isolated genomic DNA; ISO 20186-2:2019
- Venous whole blood - Part 3: Isolated ccfDNA from plasma; ISO 20186-3:2019
- Metabolomics in urine; CEN/TS 16945:2016
Software template for documentation of pre-analytical data
Documentation of pre-analytical data is state-of-the-art and good scientific practice
Several CEN/TS and ISO standards for pre-examination processes exist that require the documentation of pre-analytical data from human specimens and samples. Also the In Vitro Diagnostics Regulation explicitly mentions pre-analytics and requires pre-analytical data in the technical documentation for in vitro diagnostic devices.
In order to support researchers in their efforts to optimize their pre-analytical workflows, BBMRI.at in collaboration with SPIDIA4P (H2020, grant no. 222916), Biobank Graz, and CyBiobank (H2020 grant no. 8571222) developed a software template for the documentation of pre-analytical data. It is based on REDCap as IT framework and on the ISO Standards (ISO 20184-1:2018; ISO 20184-2:2018) as source for pre-analytical requirements.
Download free software template for pre-analytical frozen tissue
The software can be downloaded as file and shall serve as a template that can be adapted by the users (familiar with REDCap) to local / individual needs. How the installed software and data entry mask for frozen tissue looks like is to be seen here as pdf (or under this link>>).
Trainings on QM topics
Trainings on QM topics offered by BBMRI partners are listed under News/courses>>
Precision Diagnostics Europe 2021
LAST CHANCE TO REGISTER until 15 May 2021
New pre-analytics ISO standards published
ISO 20166-4 FFPE tissue – in situ detection & ISO 23118 metabolomics in urine, blood, serum
Newsletter August 2021
Neue Qualitätsstandards für Präanalytik / New pre-analytics quality standards
Federführend von BBMRI.at mitentwickelt / co-developed by BBMRI.at
REGISTER: LISAvienna Regulatory Conference for Medical Devices and In-Vitro Diagnostics
… with contribution from BBMRI.at – 12 Oct 2021
NEU: ISO 20387 Biobanking Standard nun auf Deutsch
.. verfügbar bei Austrian Standards Institute
Biobanking Courses - Register now!
... by BBMRI.at partner Med Uni Graz (Int. Biobanking & Education), Sep 16-17, 2021
Quality management for biobanks
a series of BBMRI.at publications
Data Quality for Medical Data Lakelands
Publication by BBMRI.at partner Alpen Adria University
Biobanks, specimens, IVDR & standards
Video by K. Zatloukal (BBMRI.at) – May 2021
Watch the e-lecture: Enhance the reliability of diagnostics with the support of standards
Video by Dr. Uwe Oelmueller (Feb 2020)
Biological Samples in Biobanks – Types, Quality, Management and Gains for your Business/Research
Free webinar - 9 March 2021
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)
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