DANSK DSF/ISO/FDIS 20387 PDF

1.1 This document specifies general requirements including quality control requirements for the competence, impartiality and consistent operation of biobanks to ensure biological material and data collections of appropriate quality. 1.2 This document is applicable to all organizations performing biobanking activities, including biobanking of human, animal, plant and microorganism resources for research and development. 1.3 Biobank users, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks. 1.4 This document does not apply to biological material intended for food production or therapeutic use. NOTE 1 – International, national or regional regulations or requirements can also apply to specific topics covered in this document. NOTE 2 – For entities handling human materials procured and used solely for diagnostic and treatment purposes ISO 15189 and other clinical standards apply first and foremost.