What is a lead auditor? What is a technical auditor?
A lead auditor focuses on general aspects of the overarching QMS (CA, personnel,…). A technical auditor focuses on very specific tasks (e.g., tests in ISO17025). The specifics are not [...]
In what language will the BELAC pre-assessment and assessment be performed?
The audit is performed by default in your own language (French, Dutch, German). This can differ from the language of your documented information. It can also be requested to [...]
Specific questions related to the ISO 20387 norm
4.1.4 Information relevant to biobank activities, processes and procedures shall be documented in a comprehensible format. What does this actually mean? It’s very vague to me. Does this adress [...]
Is it possible to include only storage of HBM in the scope of my ISO20387 accreditation?
Acquisition, storage and distribution are all obligatory activities in the BELAC ISO20387 accreditation scope. Therefore it's not possible to receive an ISO20387 accreditation if your biobank only includes storage [...]
I’m interested in technical guidance on pre-analytical protocols. Where can I find the relevant ISO documents?
ISO TC212 (Clinical laboratory and IVD test systems) published Technical Specifications for pre-examination processes for a broad range of matrices and uses. The most recent versions can be found [...]
What is the difference between ISBER BAT and BBMRI-ERIC SAS?
These are two separate tools The BBMRI-ERIC Self-Assessment Survey (SAS) is developed by BBMRI-ERIC. This tool is available to members of BBMRI-ERIC for free, and non BBMRI-ERIC members can [...]
Do I need to include all of my biobank collections and processes in the scope of my ISO 20387 accreditation, including satellite collections?
It’s up to the biobank to define the scope of their activities and quality objectives. If you exclude certain activities or collections out of your scope of accreditation, you [...]
We’re trying to reduce our energy costs. Would changing the storage temprature from -80°C to -70°C have a concequence on the quality of our samples?
This could be, and you could do a validation study for this. We refer to the following sources: Review on long-term storage temperatures: https://www.liebertpub.com/doi/10.1089/bio.2013.0084 Lukasz Kozera BBMRI-ERIC webinar series [...]
Is it obligatory to have a Quality Manual, Standard Operation Procedures and Working Descriptions?
Biobanks don't have to use a quality manual, SOPS or WDs. They can structure their documented information as is most convenient for them. When they wish to attain ISO20387 [...]
Is there an obligatory use of the B3-ISO documents?
The B3-ISO ISO20387 Workbook and associated documents are only guidance for you information. Their use is not mandatory.