Manual of Biobank Quality Management

Agnieszka Matera-Witkiewicz: PhD Pharmacy, Biotechnologist, Clinical Trials Management, R&D Project Manager; Wroclaw Medical University Biobank concept creator-first Integrated Biobank in Poland with ISO9001 Quality Certificate; BBMRI.pl Quality Manager; BBMRI-ERIC Quality Expert/Auditor; ISO9001 Lead Auditor, Polish Committee for Standardization TC 287 Biotechnology expert; ISO Expert TC 276 Biotechnology WG2 Biobanks and Bioresources; ESBB member; Co-author and concept creator of "Quality Standards for Polish Biobanks Handbook"; she prepared first biobank in Poland to accreditation according to ISO 20387-2021-01. Joanna Glenska-Olender: PhD in biological sciences; QMS Expert, Lead Auditor and Trainer in BBMRI.pl; Polish Committee for Standardization TC 287 Biotechnology expert; ISO Expert TC 276 Biotechnology WG2 Biobanks and Bioresources; Co-author of "Quality Standards for Polish Biobanks Handbook"; biobanking experience from 2014. Izabela Uhrynowska-Tyszkiewicz: Physician, Doctor of Medicine, academic teacher; area of interest in terms of quality and safety of human somatic tissues and cells intended for human application, application of computer systems in the practice of tissue and cell banking, coding of tissues and cells, legal aspects of tissue and cell banking. Co-author of "Quality Standards for Polish Biobanks Handbook". Malgorzata Witon: Biotechnologist and scientist with special interest in Quality Management and biobanking as well as digital pathology; started professional career as a clinical embryologist and academic teacher; several years of experience in the application and implementation of R&D projects and in working on the QMS implementation and maintenance; co-author of "Quality Standards for Polish Biobanks Handbook". Karolina Zagorska: A graduate of Medical Analytics, Certified Laboratory Diagnostician, post-graduate studies Microbiology, Hygiene and Quality in Industry. Technical expert in the BBMRI.QM Services. A member at the Polish Committee for Standardization (PKN) at KT 287 for Biotechnology and Expert at ISO TC 276 Biotechnology, WG 2 Biobanking and Bioresources; co-author of "Quality Standards for Polish Biobanks Handbook". Katarzyna Ferdyn: From 2004 is working in the biotechnological area; experience in biobanking processes mapping, processes implementation including tissue and cell banking; Polish Committee for Standardization TC 287 Biotechnology expert; co-author of "Quality Standards for Polish Biobanks Handbook"; QMS Expert, Lead Auditor and Trainer in BBMRI.pl in 2017-2019. Michal Laskowski: M.Sc. of Medical Diagnostic, Medical University of Lublin, Poland. In biobanking area from 2014. From 2017 biobanking specialist at Wroclaw Medical University Biobank; responsible for development of technological and procedural solutions regarding the collection of biological material and data. Representative in Polish Committee for Standardization and ISO Working Groups; co-author of "Quality Standards for Polish Biobanks Handbook"; he prepared first biobank in Poland to accreditation according to ISO 20387-2021-01. Patrycja Sitek: MSC of Biotechnology, MSC of Chemistry, 14 years of experience in the field of GMP and Tissue Banking industry. From 2019 IRCA ISO 9001 Lead auditor with experience in biobanking. BBMRI pl and BBMRI ERIC auditor, trainer and consultant; co-author of "Quality Standards for Polish Biobanks Handbook". Blazej Marciniak: Information technology expert, gained experience in the startup environment, since 2009 associated with the University of Lodz, and since 2014 with the Biobank Laboratory. In Biobank, he manages IT resources, coordinates IT projects in the field of digitization of science resources and data sharing infrastructure. Co-organizer of bioinformatics hackathons; co-author of "Quality Standards for Polish Biobanks Handbook". Jakub Pawlikowski: M.D., Ph.D., J.D., M.A.: graduated in medicine, law and philosophy. Professor at Department of Humanities and Social Medicine at Medical University of Lublin (Poland). His research interests focuses on research ethics, medical law and public health. He is a member of international ELSI expert groups in BBMRI.ERIC and a coordinator of ELSI area in BBMRI.pl; co-author of "Quality Standards for Polish Biobanks Handbook". Dominik Strapagiel: Biobank Lab Head at the University of Lodz. He leads development of the integrated database which consists of genomic, health and phenotypic data collected in POPULOUS cohort study of the Biobank - Lodz project.; He is ISO 9001 and ISO 27001 lead auditor.

Chapter 1. Management of Biobanks.- Chapter 2. Quality Management.- Chapter 3. Documentation and Records.- Chapter 4. Human Resources Management.- Chapter 5. Ethical and Legal Aspects.- Chapter 6. Supplies, Materials Management.- Chapter 7. Equipment.- Chapter 8. Traceability.- Chapter 9. Environmental and Staff Hygiene.- Chapter 10. Biobanking Processes and Quality Control.- Chapter 11. Deviations, Nonconforming Product/Data or Service.- Chapter 12. Audits.- Chapter 13. Improvement.- Chapter 14. Biobank Cooperation in the Scientific, Research and Development Area.- Chapter 15. Safety and Security.