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Manual of Biobank Quality Management
Agnieszka Matera-Witkiewicz , Błażej Marciniak , Dominik Strapagiel , Izabela Uhrynowska-Tyszkiewicz , Jakub Pawlikowski , Joanna Gleńska-Olender , Karolina Zagórska , Katarzyna Ferdyn , Małgorzata Witoń , Michał Laskowski , Patrycja Sitek
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).
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