Audit Protocol? Simultaneous surveillance and recertification audits.

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
We have a surveillance audit due in December this year and then another recert audit due prior to Sept 2023. Our NB just old me they would be performing BOTH at the same time in December. One Auditor doing the surveillance audit and a second is in the same room at the same time doing our recertification audit. I have not seen this done before and I feel there is a lot of redundancy and this is a $$ grab.

Has anyone else experienced this? It seems a colossal waste of money and if we need one it's the recert audit only; not both?
 
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ScottK

Not out of the crisis
Leader
Super Moderator
#2
that's weird. I'd go back to the contract you have with them and see what that says.
That should be dictating how often they come.... 10 months early for a recert doesn't feel right.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#3
10 months early for a recert doesn't feel right.
I agree that this is highly unusual, but, as long as the new certificate is extended for a new 3-year period, counting from the existing certificate expiry date (and not from the recert audit audit date), the organization will have no audit in 2023, I suppose. ISO 17021-1 is mute about timing of surveillance and recertification audits, ditto for the IAF MD-9 document.

This whole thing might be associated with the relative shortage of ISO 13485 qualified auditors.
 

Ron Rompen

Trusted Information Resource
#5
it doesnt sound right to me.....but I have very little knowledge of that standard or the auditing and certification requirements.
 

mihzago

Trusted Information Resource
#6
I would definitely push back. I would understand that they want to combine both and just do the re-cert early, but doing two audits separately at the same time? Doesn't make any sense.
Doing a re-cert early is a bit of a disadvantage too because now your next re-cert will be sooner.
 

mihzago

Trusted Information Resource
#8
Why? The early recert audit should not impact the date of the new certificate: 3 years from the expiry date of current certificate.
I think you're right, for some reason I thought it may affect the certificate date if it's done almost a year sooner.

Still it may mess up the audit cycle since the surveillance/re-rect audit must be performed within 12 months (or maybe that's not a rule?), so they still have to audit next year.
What's not clear to me is why is the surveillance audit scheduled for December if a certificate was issued in September, unless there are two different certificates involved (e.g., ISO13485 and EC) that are on different cycles.
 

Randy

Super Moderator
#10
Pretty dumb, it's just a matter of adding the required days together, justifying the reasons why and issue a single report. When audits got missed or abbreviated in 2020-2021 this is how I had to take care of the exact same problem more than once.

But 2 separate audits by 2 different audit teams? Totally stupid.
 
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