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I've got a question about the type/level of quality systems usually used for IVD systems classed as "General", following the Annex III conformity route (e.g. not devices for self-test, or Annex II).
As I read the IVD, Annex III requires that the quality system used for a product be documented and recorded in the technical documentation. However, there doesn't seem to be any guidance on the type or level of quality system that would be expected. So, it seems that several approaches are possible -- what is the usual and customary industry practice?
By way of example, do manufacturers of General/Annex III IVDs typically employ a...
1. Certified ISO 13485 quality system
2. 13485 'like' (but not certified) quality system
3. Certified ISO 9001 quality system
4. 9001 'like' (but not certified) quality system
5. Home grown quality system
6. Other?
Perhaps this is argumentum ad absurdum, but if you meet all the Annex I essential requirements, would anything more than the procedures relevant to meeting those requirements be required or expected?
Thanks in advance for examples, experience and any guidance on how best to think about this issue.
As I read the IVD, Annex III requires that the quality system used for a product be documented and recorded in the technical documentation. However, there doesn't seem to be any guidance on the type or level of quality system that would be expected. So, it seems that several approaches are possible -- what is the usual and customary industry practice?
By way of example, do manufacturers of General/Annex III IVDs typically employ a...
1. Certified ISO 13485 quality system
2. 13485 'like' (but not certified) quality system
3. Certified ISO 9001 quality system
4. 9001 'like' (but not certified) quality system
5. Home grown quality system
6. Other?
Perhaps this is argumentum ad absurdum, but if you meet all the Annex I essential requirements, would anything more than the procedures relevant to meeting those requirements be required or expected?
Thanks in advance for examples, experience and any guidance on how best to think about this issue.