Bioequivalence and Bioavailability Forum

Hi Auditor,

❝ In clinical trial is there any role of ISO?

In my opinion no and yes.
No, because you generally do not get a deficiency letter asking questions around ISO compliance. I think it could happen in relation to med. devices / 13485 in some territories but not in BE as far as I am aware. The quality standards are GMP, GLP and GCP (much to the regret of those who want to protect the rain forest).

Yes, because your company may be 9001 certified or 17025 or sumfin, or a CRO you are using for some part of the clinical operations is. Let's for example say you are ISO9001 certified and you are using a lab that's 17025; your own QMS might, depending on the specifics, require or suggest you to do a supplier audit at the CRO, in which case you could use the 17025 as criterion. The relevance of this would depend on the reason you have chosen that lab and the relative importance of it for your own opeations.