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ISO9001 - 1st Surveillance less than 6 months after registration

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
There's a very good reason for it... our PED Module D expires at the end of April and our PED Notified Body is also our ISO Registrar. The whole reason we chose them for ISO was to combine our PED and ISO audits.

So it's working out that our 1st ISO surveillance will be 6 months earlier than anticipated.

Can anyone think of any pitfalls to look out for by having the surveillance so close to the registration audit?
I have handful of observations (no NC's) from the registration audit that have been addressed in our CAPA system already - so that's covered.
We haven't made any significant changes.
We're keeping up with our audit schedule.

One thing I'm having troubling thoughts about is Management Review. We're not due to complete our next management review until October... Think I should rush that or just explain to the auditor that I don't have new management review minutes to show you because we're not due to have one for 4 more months?
Or maybe do a brief management review in the next couple of weeks to get the 2008 ball rolling? I could break the management review process into multiple meetings between now and August. My procedure is flexible enough to allow for that.
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
One thing I'm having troubling thoughts about is Management Review. We're not due to complete our next management review until October... Think I should rush that or just explain to the auditor that I don't have new management review minutes to show you because we're not due to have one for 4 more months?
Or maybe do a brief management review in the next couple of weeks to get the 2008 ball rolling? I could break the management review process into multiple meetings between now and August. My procedure is flexible enough to allow for that.
Scott,

As for your question: Your system reflects intervals of the Management Review meeting, therefore to have one before (unless there are some issues regarding the System's health) the scheduled meeting would be, in my opinion, an overkill and would come across as doing something outside the documented system to satisfy the Auditor (CB).

Having a surveillance audit 6 months after the Registration audit seems pretty normal to me (which this depends on how the Contract for Services with the CB, was written and accepted).

In my opinion, don't do anything outside the documented and approved system, unless there are factors that cause the change.

That is why ISO9001:2000 was written to provide consistency with the company's business processes.
 

SteelMaiden

Super Moderator
Super Moderator
#3
We did surveillance audits every six months for the first 3 years, moved to nine months for the second three year period. If I had my druthers, I'd go back to the 6 month schedule. I will never suggest that we go to a yearly surveillance.
 

Paul Simpson

Trusted Information Resource
#4
Scott I agree with all the other posts.
Can anyone think of any pitfalls to look out for by having the surveillance so close to the registration audit?
Nope. It may even be fresher in people's minds! ;)
I have handful of observations (no NC's) from the registration audit that have been addressed in our CAPA system already - so that's covered.
We haven't made any significant changes.
We're keeping up with our audit schedule.
Again all ok.

One thing I'm having troubling thoughts about is Management Review. We're not due to complete our next management review until October... Think I should rush that or just explain to the auditor that I don't have new management review minutes to show you because we're not due to have one for 4 more months?
No need to add or bring forward the review. Your schedule is your schedule and will be acceptable to your registrar - or else point him this way! :lol:
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
Scott I agree with all the other posts.
Nope. It may even be fresher in people's minds! ;)
Again all ok.

No need to add or bring forward the review. Your schedule is your schedule and will be acceptable to your registrar - or else point him this way! :lol:
I'd love to point him this way... but then he'd see all the nasty things I wrote about his firm back last summer and fall. :mg:

To All - you know, it just occurred to me that I'm so used to thinking of it as an annual audit (because our registrar/NOBO is in Europe and more than that is cost prohibitive) that a lot of people do a 6 month schedule coving about 1/2 the standard in each one. Duh.
 

SteelMaiden

Super Moderator
Super Moderator
#6
To All - you know, it just occurred to me that I'm so used to thinking of it as an annual audit (because our registrar/NOBO is in Europe and more than that is cost prohibitive) that a lot of people do a 6 month schedule coving about 1/2 the standard in each one. Duh.
Hey, it's Friday, the week is winding down, and we give special dispensation to our friends in Joisey. :notme:
 

SteelMaiden

Super Moderator
Super Moderator
#8
yep, all those exhaust fumes can be hazardous.:biglaugh:

Actually, we will find ourselves in the yearly thing for our CE certification, I cannot afford to bring those boys over too often, especially at the exchange rate now!
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#9
yep, all those exhaust fumes can be hazardous.:biglaugh:

Actually, we will find ourselves in the yearly thing for our CE certification, I cannot afford to bring those boys over too often, especially at the exchange rate now!
you're not kidding. I have an alternate quote from another NOBO with offices in the US for future consideration, but the politics are hard... it's a small niche with the PED and we don't want to burn any bridges and suddenly be in an adversarial relationship with our many of our customers' NOBO.
Ah well.
 
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