Manual of Biobank Quality Management

This handbook is a vital resource for biobanking entities to develop, implement, and enhance their Quality Management System (QMS) in compliance with ISO standards. It is written in a concise and readable manner, with a practical approach using FAQ and common practice sections. It is aimed at biobank employees and other stakeholders, providing valuable information for self-education and teaching. The manual is compatible with other international standards and recommendations, and can be used by any biobanking unit regardless of the biological material they operate with.

Format: Hardback
Length: 152 pages
Publication date: 15 February 2023
Publisher: Springer International Publishing AG

This groundbreaking handbook is a vital resource for any biobanking entity seeking to establish, implement, and continually enhance their Quality Management System (QMS). Written in a concise and highly accessible style, it comprehensively covers all aspects of biobanking, ranging from legal considerations to safety protocols, in strict adherence to the dedicated Biobanks ISO standards. By employing a practical approach, the book guides readers through this complex field in a user-friendly manner, utilizing Frequently Asked Questions (FAQs) and common practice sections. The guidelines are aligned with ISO 20387:2018, Biotechnology - Biobanking - General requirements for biobanking, as well as ISO 9001:2015, ISO 19011:2018, ISO 27000:2014, and ISO 27002:2013. Furthermore, they are compatible with the recommendations of the Organization for Economic Cooperation and Development (OECD), IARC, and ISBER Best Practices.

Designed with the needs of biobank employees and other stakeholders, including public bodies, political bodies, hospitals, pharmaceutical companies, and funders, regardless of their level of experience, this manual serves as an invaluable tool for self-education and teaching. It adheres to the principles of responsibility, openness, and transparency and can be utilized by any biobanking unit, regardless of the biological material they handle or their affiliation with any associated biobank network.

On behalf of a collective of specialists and experts in the fields of biobanking, Ethical, Legal and Societal Issues (ELSI), and IT solutions, the authors present this book as a remarkable accomplishment stemming from their activities within the project, European Research Infrastructure BBMRI-ERIC "Quality Standards for Polish Biobanks" Handbook (QSPB).

Weight: 430g
Dimension: 235 x 155 (mm)
ISBN-13: 9783031125584
Edition number: 1st ed. 2023