We still have not received our certificate due to a 'backlog' with our auditing body

[JoshuaFroud]

That is exactly the kind of event that I mentioned not being made transparent to you.

Don’t be surprised if they tell you they will have to perform another audit of your system, but free of charge to you.

Which is of course only free if you do not count the man hours to support said audit before, during and after.

 

[Sidney Vianna]

And, even worse, with potentially very different audit results; after all, audit results are much more auditor-dependent than system-dependent...

 

[M.R.Falco]

Ugh, let's hope that doesn't happen. Right now it looks like they are picking up our project and finishing it (and of course re-requesting documents we sent them 7 months ago because they are lost). Whether or not that will be before the April 1st deadline for Health Canada is another matter. We told them we will not pay them any additional fees until the services we originally paid for have been completed; maybe that will provide additional motivation to complete the work.

 

[Ronen E]

And, even worse, with potentially very different audit results; after all, audit results are much more auditor-dependent than system-dependent...

That's why it's called "a standard".

 

[Ellison]

We received our 13485 cert the day before it expired from both of our NB and that was no easy feat. we still have not received our reports or our MDSAP certificates. I would say the current response rate from the NBs Is about zero which is not to surprising with the one but very surprising with the other.

I dont imagine its going to get any better in the near future.

Thanks Ellison

 

[pkost]

the number of letters I get forwarded by suppliers from their NB saying an audit was conducted and was acceptable in lieu of a certificate quite frankly disturbs me. Sure an auditor can leave and things can get misplaced, but I would expect that to be a rarity and exceptional; auditors move regularly, they must have processes in place to hand over information. It should not be something I experence on an annual basis from at least one of my suppliers.

 

[StephanieT]

Same experience here during the same time frame. It took us 8 months to receive our certificates - our certs expired during that time frame and they left us hanging. The issues and lack of service have been so bad, we've decided to transfer to another CB. The transfer process so far has been a breeze compared to what we were dealing with. Don't hesitate to start looking around!

 

[J0anne]

Yes this is a common issue and many CBs are noncompliant - Resources

I think more manufacturers should be auditing their CBs (if any do at all) as they are critical suppliers.

 

[pkost]

Yes this is a common issue and many CBs are noncompliant - Resources

I think more manufacturers should be auditing their CBs (if any do at all) as they are critical suppliers.

Haha, I'd love to see their response to this, and their faces when you started issuing them with non conformances

 

[Ronen E]

What would be their incentive? Not losing the business?... Doesn't look like they care... or maybe they know that manufacturers don't really have options? No, that would be too cynical.