Manual of Biobank Quality Management (Hardcover, 1st ed. 2023)

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).

General

Imprint:	Springer International Publishing AG
Country of origin:	Switzerland
Release date:	February 2023
First published:	2023
Authors:	Agnieszka Matera-Witkiewicz • Joanna Glenska-Olender • Izabela Uhrynowska-Tyszkiewicz • Malgorzata Witon • Karolina Zagorska • Katarzyna Ferdyn • Michal Laskowski • Patrycja Sitek • Blazej Marciniak • Jakub Pawlikowski
Dimensions:	235 x 155mm (L x W)
Format:	Hardcover
Pages:	152
Edition:	1st ed. 2023
ISBN-13:	978-3-03-112558-4
Languages:	English
Subtitles:	Polish
Categories:	Books > Science & Mathematics > Biology, life sciences > General Books > Medicine > General issues > Medical equipment & techniques > Medical research Books > Professional & Technical > Biochemical engineering > Biotechnology > General
LSN:	3-03-112558-4
Barcode:	9783031125584

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