Manual of Biobank Quality Management

This pioneering handbook serves as an essential tool for any biobanking entity to create, implement and continuously improve their Quality Management System (QMS). Written in a concise and highly readable manner all biobanking related QMS aspects, ranging from legal aspects to safety matters, are addressed according to the best knowledge in compliance with the dedicated Biobanks ISO standards. Following a practical approach by making use of FAQ and common practice sections this book guides the readers through this complex field in an easy-to understand way.

The guidelines are convergent not only with ISO 20387:2018 Biotechnology - Biobanking - General requirements for biobanking but also with ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible, among others with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices.

Aimed at both biobank employees and other stakeholders (e.g. public bodies, political bodies, hospitals, pharmaceutical industry, funders) at any level of experience the book serves as valuable source for self-education and teaching. The manual complies to the principles of responsibility, openness, and transparency and can be used by any biobanking unit regardless of the biological material the biobank operates with and independent of their associated biobank network.

On behalf of a group of specialists and experts in the area of biobanking, regarding Quality Management Systems (QMS), Ethical, Legal and Societal Issues (ELSI) and IT solutions, the authors present with this book a significant achievement based on activities within the project, European Research Infrastructure BBMRI-ERIC "Quality Standards for Polish Biobanks" Handbook (QSPB).

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 Gleńska-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 Witoń 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 Zagórska: A graduate of Medical Analytics, Certified Laboratory Diagnostician, post-graduatestudies 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".

Blażej Marciniak: Information technology expert, gained experience in the startup environment, since 2009 associated with the University of Lódź, 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 - Lódź project.; He is ISO 9001 and ISO 27001 lead auditor.