General requirements clauses address is a very broad way all aspects of biobank management and activities, such as the general principles of quality documentation, impartiality and confidentiality. Structural requirements [...]
ISO defines uses specific language to address this. (see https://www.iso.org/foreword-supplementary-information.html) "shall" indicates a requirement "should" indicates a recommendation "may" is used to indicate that something is permitted "can" is [...]
The cost of a pre-assessment audit is included in B3-ISO budget for 20 biobanks. A pre-assessment audit is not mandatory and can be skipped. Contact B3-ISO@kankerregister.be if you wish [...]
Funding is only provided for BBMRI.be members. If additional biobanks become BBMRI.be members over time, they too will have access to support for reaching levels Q2 to Q4. Certain [...]
Yes, because adherence to the applicable laws is a prerequisite for BBMRI.be membership, and BBMRI.be membership is a prerequisite for funded participation in the B3-ISO project.
The B3-ISO scheduled external audits can be in the language of your choice: English, French or Dutch. This choice is to be agreed upon with the external auditor. We [...]
Yes, the Quality Manual, SOP or other documented information that you use in your biobank can be in the language of your choice. Having this information available in the [...]
All BELAC prices are published in BELAC 7-01: BELAC: General and practical information (https://economie.fgov.be/en/publication/series-belac-7-xx-information). Dossier cost: non-recurrent, to be payed upon submission of accreditation-request Yearly fee during accreditation Audits: [...]
The central BBMRI.be support in the B3-ISO project to reach levels Q1, Q2, and Q3 are financed in the project, the initial assessment form Belac to reach Q4 is [...]
Within the B3-ISO project, we will support the biobanks in the road towards ISO 20387 accreditation by providing: templates/ guidelines & webinars to facilitate obtaining the different Quality levels [...]
