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Hello-
I am currently working on transitioning a mfg facility to become QSR compliant. I've done a lot of QMS work in the past and remember the differences between 13485 and the QSR and am trying to leverage the fact that our site was audited by BSI (and passed) to use as an interim strategy while our remediation is under way.
Essentially:
We passed a 13485 audit. We have gaps to the QSR. We have a resolution of those gaps on a quality plan. In the meantime, I'd like to have some FDA official guidance or indication that passing a 13485 audit or something similar is at least good thing. I'd like to use that as rationale for not having to shut down production and claim that it is low risk (compliance and safety wise).
I'm aware this probably doesnt exist but every so often, a weird clause here or there may find itself into a regulation or guidance document that we QEs can jump on
Thanks!
I am currently working on transitioning a mfg facility to become QSR compliant. I've done a lot of QMS work in the past and remember the differences between 13485 and the QSR and am trying to leverage the fact that our site was audited by BSI (and passed) to use as an interim strategy while our remediation is under way.
Essentially:
We passed a 13485 audit. We have gaps to the QSR. We have a resolution of those gaps on a quality plan. In the meantime, I'd like to have some FDA official guidance or indication that passing a 13485 audit or something similar is at least good thing. I'd like to use that as rationale for not having to shut down production and claim that it is low risk (compliance and safety wise).
I'm aware this probably doesnt exist but every so often, a weird clause here or there may find itself into a regulation or guidance document that we QEs can jump on
Thanks!