Basic↦Biobanking↦Biobanking Standards↦ISO Biobanking
What is it? Why is it important?
ISOs (International Standards Organisation) are international standards developed by experts using internationally recognised processes.
The objective of the ISO 20387 for Biobanking is to promote confidence in the set-up and management of a biobank. This is achieved by:
- Setting standards supporting competent biobanking operations
- Ensure that researchers are provided with Biological Material (BM) and associated data of quality
- General and structural aspects
- Resources for the set-up of a biobank (e.g. infrastructure, equipment, personnel, competence, training)
- Processes for handling BM and associate data (e.g. collection, reception, transport, preparation, storage, documentation, traceability, sharing)
- QMS processes (e.g. risk assessment, audit, CAPAs, quality reviews)
ISO standards have been approved by the CEN and the SNV
What do I need to do?
The ISO 20387 is liable to cost.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking