News from the BBMRI.pl QM expert working group

The activities of BBMRI.pl QM Expert Working Group include a wide range of initiatives arising from BBMRI-ERIC membership. Biobanks associated in Polish Biobanking Network (PBN) receive an expert support in implementation and development of quality systems. Each biobank cooperates with dedicated consultant preparing templates of procedures, forms and instructions. Within the Knowledge Hub trainings, workshops and QM Caffee are organized, where not only new quality topics are presented but also current issues regarding routine work are discussed. Thus, each biobank is prepared to three rounds of audit programme, where the final compliance with the requirements of Quality Standards for Polish Biobank is confirmed and the medal of recognition is awarded. From 2017 over 80 audits have been performed in Polish Biobanking Network. Simultaneously, biobanks from PBN with the help of BBMRI.pl QM Expert Group, can be audited for compliance with the BBMRI-ERIC Checklist and apply for Q-mark in the BBMRI-ERIC Directory. So far 3 biobanks have undergone the audit, 6 biobanks have completed the QMS-SAS and two more are in audit process.

Polish BBMRI.pl Experts are involved in BBMRI-ERIC WGs and create solutions for all infrastructure. Moreover, they are active members of ISO TC Biotechnology WG2 Biobanks and Bioresources and WG4 Bioprocessing. They cooperate with Polish Centre for Accreditationin implementing national settlements for the conformity assessment process for ISO 20387:2018. Also cooperation with Polish Committee for Standardization in providing opinions and translations of normative standards related to biobanking.

Consequence of action and continuous improvement resulted also the publication of the 2nd version of the Quality Standards for Polish Biobanks-QSBP in 2021 – a manual strictly addressed to the requirements for biobanks, including ISO 9001: 2015 and ISO 20387:2018, as well as ISO 19011:2018, ISO 27001:2014 and ISO 27002:2013 and legal and ethical guidelines applicable to the biobanking process. A new published book Internal Auditor in Biobank – a practical guide is a completion of the QSPB. It helps biobanks to prepare for audits and to conduct internal audits in the biobank. The effect of the BBMRI.pl QM Expert Group’s work is the second Biobank in Poland-Polish Stem Cells Bank in Warsaw (thus the second at BBMRI-ERIC) with a positive external evaluation by BBMRI-ERIC of QMS-SAS for compliance with ISO 20387. Together with the Wroclaw Medical University Biobank, it is one of two biobanks with the Q-mark for the compliance the requirements for ISO 20387:2018 across the BBMRI-ERIC infrastructure.