QMSR and MDSAP

[dr1vn]

So we recently had an audit and the auditor commented that we do not have a plan in place to address the QMSR transition as we distribute in the US. We have ISO 13485 certification under the MDSAP (US/Brazil/Aus/Jap/Can) and so it was my understanding that as long as we meet those requirements we should be good. Am I missing something?

 

[shimonv]

Makes perfect sense.
The only way the makes sense is if QMSR introduces some new requirements.

Shimon

 

[yodon]

It's probably CRITICALLY IMPORTANT to that auditor that you have a plan to do a string replace of "QSR" with "QMSR." Seriously, there probably is a bit of tidying up to do, but from a compliance perspective, it sounds like you're ok.

 

[dr1vn]

It's probably CRITICALLY IMPORTANT to that auditor that you have a plan to do a string replace of "QSR" with "QMSR." Seriously, there probably is a bit of tidying up to do, but from a compliance perspective, it sounds like you're ok.

I explained to the auditor that we're MDSAP so we're in good shape. That really seemed to set the auditor off. So, I figured if he was that upset, then perhaps I missed a QMSR requirement? But, a plan to discuss how we mention QSR and it's to be replaced with QMSR in our documents is an excellent suggestion and something I'll do. Thanks!

 

[Tidge]

May I ask what the nature/mandate of this auditor was?(*1)

I suppose there is supposed to be transition period ("Effective date of 2 years", response to comment 75) for "21 CFR 820" to "MDSAP", but my thinking had been that (per my reading of the published rule thanks @Ed Panek ) that there won't be a gap in a company's "QSMR" if they are compliant to 13485.... see the response to comment 77:

FDA recognizes that it is important for manufacturers to prepare to align their practices with the QMSR as soon as practical, and some manufacturers may choose to begin complying with the QMSR before the effective date.

(*1) I'm genuinely curious, and partially suspicious. My suspicion is born of my personal interactions with '3rd parties' who have been "looking for solutions" to problems they (or their clients) face. I can imagine some 3rd parties are seeing euro/dollar signs with the prospect of being able to market their services as helping "QMS customers" transition to "QMSR customers."