Following the international trend NAH has started the preparation for biobank accreditation.
The activity of biobanks is the regulated and controlled - providing reproducible quality for usage - storage of biological materials of various origins (e.g.: human, animal, plant, bacteria, virus and fungi etc.).
The provisions and requirements for the accreditation of biobanks are laid down in MSZ EN ISO / IEC 17025: 2005 and / or in MSZ EN ISO 15189: 2013.
The activities of those biobanks providing the storage of the biological samples are accredited together with the laboratory methods.
1. Biobanks connected to testing laboratories are accredited in accordance with MSZ EN ISO / IEC 17025: 2005 standard.
2. In case of biobanks related to the activities of medical testing laboratories the accreditation happens according to MSZ EN ISO 15189: 2013 standard.
3. Biobanks linked to forensic laboratories could be accredited according to both (aforementioned) standards considering the professional specifications.
The mentioned standards could be purchased at the Hungarian Standards Institution: http://www.mszt.hu
We hereby inform our partners that their claims for biobank accreditation should be sent to the National Accreditation Authority until 15 October 2017 in which, please, specify the professional area regarding the usage of the stored biological samples.
Based on the incoming demand all the necessary preparations will be done by the Authority until 15 April 2018.
After that based on the already – until 15th October 2017 – submitted claims, the application document could be filled in. The needed templates and some further information could be downloaded from our website:
In case of any arising questions please, contact Ferencné Karsai (Head of Department) at firstname.lastname@example.org .
20 September 2017
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A hátralévő idő: