Quality Management (QM) at BBMRI.at is a key competence

Activities of BBMRI.at and its partners include:

• Development of ISO standards and CEN Technical Specifications for sample-pre-analytics and overview on latest standards of this series

• Implementation of these standards

• Contribution to the development of a BBMRI Self-Assessment-Tool for pre-analytical processes

• Free access to the online Self-Assessment Surveys for testing the state-of-the-art of pre-analytical processes Self-evaluate your pre-analytical processes >>

• Quality Management cross audits in BBMRI.at partner biobanks

• Quality Management trainings

• Videos & presentations about the relevance of pre-analytics and ISO/CEN standards with respect to IVDR and reproducibility/reliability of research results .. examples of videos>

• Publications about the relevance of pre-analytics and ISO and CEN standards with respect to IVDR and reproducibility/reliability of research ... examples of publications>

• Information why sample quality and respective standards are essential for research and development

  • Importance of sample quality>

  • How R&D can benefit from sample pre-analytic standards>

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.

These standards can be purchased at Standards Institutes like the Austrian Standards Insitute (ASI)>

(search with ISO or CEN/TS number).

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>

Relevance of ample quality and quality standards for research

ISO and CEN standards are considerted state-of-the-art and good scientific practise for basic and translational research.

Particularly the pre-analytical phase is a very critical phase of the analysis workflow.  Errors can easily occur during all preanalytical steps like labelling, sample collection, transport, processing, storage, DNA/RNA isolation aso. 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.

Therefore, pre-analytical sample quality - a pre-requisite for reliable and reproducible analyses results.

See video on relevance of sample pre-analytics and ISO standards (German) >

See video "Misstand bei Bluttests" (Deutsches Fernsehen (SWR), by now, German version only)

https://www.swr.de/wissen/odysso/aexavarticle-swr-77780.html

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.

Learn why standards are in general important

Watch video>

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

Self-evaluate your pre-analytial processes >>

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>>).

Download free software template for pre-analytical data documentation>> (frozen tissue)

Trainings on QM topics

Trainings on QM topics offered by BBMRI partners are listed under News/courses>>