What is biobanking?
Biobanking involves the systematic management and preservation of biological material and associated data so that they can be used for research and development.
Quality and traceability are important aspects of the entire process.
The standard for biobanking
The standard SS-EN ISO 20387:2021, Biotechnology – Biobanking – General requirements for biobanking, sets requirements for, among other things, competence, impartiality and quality management.
The standard is intended to help build confidence that biological material and associated data are of the quality required for their intended purpose in research and development.
Swedac accredits biobanks in accordance with SS-EN ISO 20387:2021.
As part of the accreditation process, Swedac assesses whether the biobank has the competence and capability required to meet the requirements of the standard.
Currently, Swedac offers accreditation for biobanking activities involving human material. Accreditation in additional areas may be considered based on needs and demand.
Information for organisations seeking accreditation
Biobanks handling human material are accredited against SS-EN ISO 20387:2021 and Swedac’s applicable regulations on accreditation.
The standard includes requirements for, among other things, how biological material and associated data are to be managed, stored and traced. It also includes requirements for quality control.
Requirements and guidance documents
Specific documents for the accreditation scheme
Requirements to be fulfilled for accreditation to be granted
SS-EN ISO 20387:2021
Biotechnology – Biobanking – General requirements for biobanking
STAFS 2020:1
Swedac’s regulations and general guidance on accreditation
Instructions and guidance for meeting accreditation requirements
ILAC G24:2022 | Guidelines for the determination of recalibration intervals of measuring equipment
SWEDAC DOC 05:6 | Internal audits – Guidance for biobanks, laboratories and inspection bodies
SWEDAC DOC 06:9 | Swedac’s policy on accredited bodies’ participation in proficiency testing and/or other comparisons
SWEDAC DOC 04:2 | Swedac’s policy on metrological traceability, calibration and measurement uncertainty
SWEDAC DOC 10:5 | Guidance for information security management
SWEDAC DOC 20:1 | Swedac’s policy on references to accreditation – YES