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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 procedures we need to provide to our personnel members, or does it also concern communication to other stakeholders such as donors?
The biobank has to document all relevant processes and their interdependencies. (adapted from the German Quality Manual)
What is relevant are the critical biobanking activities, and that is something that the biobank can decide themselves. ISO20387 annex A needs to be implmented for the critical activities of the biobank, and annex B can provide guidance.
- 4.1.5 The documentation shall include relevant information generated from procedures pertaining to the quality management system (see Clause 8) as well as the management of facilities/dedicated areas. What does this actually mean? It’s very vague to me.
Does this adress procedures we need to provide to our personnel members, or does it also concern communication to other stakeholders such as donors?
The biobank has to document all relevant processes and their interdependencies, including how you manage the rooms used in biobanking activities (adapted from the German Quality Manual)
What is relevant are the critical biobanking activities, and that is something that the biobank can decide themselves. ISO20387 annex A needs to be implmented for the critical activities of the biobank, and annex B can provide guidance.
- 4.1.7 The biobank should document the identity of personnel performing activities encompassing procedures as referred to in 4.1.1 Is this applicable to all processes performed; should we register who’s handling the sample at each seperate step in the biobanking process?
The biobank has to document the tasks and responsibilities of internal staff and external users regarding all critical biobanking activities.
The instructions are binding for all biobank employees. The requirements for externally provided services also need to be described, but as the biobank doesn’t have them under direct control, the instructions are not binding for external personnel. (adapted from the German Quality Manual)
- On page 32 an annex B: B.2 are listed: Acquisition, collection method, method of sampling.
What does method of sampling mean here? Is this the same as the ‘type of collection’ data field in SPREC? It’s also not entirely clear to me why this data field is improtant.
‘Specific properties’ is added to Annex A (A2g) because specific extra information can be relevant for specific sample types. It’s added there as a reminder: if there would be relevant info with regards to specific properties, then you need to record that info.
- On page 32 an annex B: B.2 are listed: Acquisition, specific properties – infectiousness — biosafety information radioactivity/radiation – transgenic, chimera, genetically modified etc
Do we need to define this of each study where this is applicable? Are there other things to keep in mind that could fall in the categogy ‘specific properties’?
‘Specific properties’ is added to Annex A (A2g) because specific extra information can be relevant for specific sample types. It’s added there as a reminder: if there would be relevant info with regards to specific properties, then you need to record that info.
Annelies Debucquoy2024-06-11T14:38:51+02:00
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