Manual of Biobank Quality Management

The book provides a comprehensive guide to creating, implementing, and improving Quality Management Systems (QMS) for biobanking entities, covering legal, safety, and quality aspects. It follows ISO standards and is compatible with other guidelines, making it a valuable resource for self-education and teaching. The manual is based on the project "Quality Standards for Polish Biobanks" and aims to promote responsibility, openness, and transparency in biobanking.

Format: Paperback / softback
Length: 152 pages
Publication date: 15 February 2024
Publisher: Springer International Publishing AG

The pioneering handbook "Quality Management System for Biobanking: A Practical Guide" is a vital resource for biobanking entities seeking to establish, implement, and enhance their Quality Management System (QMS). Written in a concise and accessible style, it covers all aspects of QMS related to biobanking, including legal, safety, and ethical considerations. The book follows a practical approach, utilizing FAQ and common practice sections, to guide readers through the complex field. It aligns with various international standards, including ISO 20387:2018 (Biotechnology - Biobanking - General requirements for biobanking), ISO 9001:2015 (Quality Management Systems), ISO 19011:2018 (Guidelines for Quality and/or Environmental Management Auditing), ISO 27000:2014 (Information Security Management), and ISO 27002:2013 (Code of Practice for Information Security Management). Additionally, it adheres to recommendations from organizations such as the Organization for Economic Cooperation and Development (OECD), the International Agency for Research on Cancer (IARC), and the International Society for Biological and Environmental Repositories (ISBER). Designed for both biobank employees and stakeholders, the handbook serves as a valuable self-education and teaching tool. It promotes responsibility, openness, and transparency and can be utilized by any biobanking unit, regardless of the biological material it handles and its associated biobank network. The book is a result of collaborative efforts within the project, "European Research Infrastructure BBMRI-ERIC "Quality Standards for Polish Biobanks" Handbook (QSPB)." The authors, a group of specialists and experts in the field of biobanking, have successfully achieved their goal of providing a comprehensive and practical guide to QMS for biobanking.

Weight: 272g
Dimension: 235 x 155 (mm)
ISBN-13: 9783031125614
Edition number: 1st ed. 2023