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

M.R.Falco

Starting to get Involved
#1
Hello everyone! Made an account here as we've run into an issue and I'm wondering if others are experiencing the same. Mid-2018 we recertified our medical device manufacturing facility to ISO 13485 under the MDSAP certification plan. We completed the audit with a few minor NC's and were recommended for re-certification. To this date, we still have not received our certificate due to a 'backlog' with our auditing body. We have pressed them repeatedly on this and have mostly been given the runaround for the past 7 months or so.

Is anyone else experiencing this issue with their auditing body? Is it worth investigating other auditing bodies to see if we can get better service elsewhere? From what I'm reading, it looks like this might be a problem with multiple firms now. This has gone on long enough to potentially be a breach of contract on the auditor's part and is beginning to impact our business operations.

I'm curious if others are having the same issue and how you plan to handle it!
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#3
To this date, we still have not received our certificate due to a 'backlog' with our auditing body. We have pressed them repeatedly on this and have mostly been given the runaround for the past 7 months or so.

I'm curious if others are having the same issue and how you plan to handle it!
While delays in technical reviews (a step in the certificate issuance process) is relatively normal in times of transition, 7 months is utterly unacceptable and indicates (to me) there is an issue with the CB that they won't make it transparent for you. Other than naming and shaming the CB here, Yelp and in the BBB, you should be DEMANDING the HIGHEST UP manager at the CB to contact you. As long as you keep talking to "account managers", certificate issuance specialists, technical reviewers, etc, you will be getting the run around.

Very likely, the CB has something in their website to the effect of keeping customers happy, commitment to customer satisfaction, bla bla bla...Make them accountable to their promises.

Good luck
 
Y

Yukon

#4
Hello everyone! Made an account here as we've run into an issue and I'm wondering if others are experiencing the same....
Contact ANAB via e-nail and lodge a formal complaint. Make sure you cc your CB auditor and your CB sales rep. I have worked for a CB for 18 years and that old saying "the squeaky wheel gets the grease" works just fine.
 

M.R.Falco

Starting to get Involved
#5
Appreciate the feedback! I thought this was an unusually long stretch of time, even for a transition period like this. We will press them more forcefully and file complaints. Thanks everyone!
 
Y

Yukon

#6
I'm an auditor with SAI Global and I also do Technical Reviews when we are backlogged. Our objective is to get the certificate to the client within 7 days after submission of the auditors' completed audit-package (Audit Plan, Audit Report, Cleared NCRs, etc). We have a metric and senior management monitor this quality objective.
In the event of urgency on the part of the client (needs the cert for contract purposes) we will provide the registration certificate within 24 hrs. It has been done many times.
 

RickRay

Registered Visitor
#7
Hello everyone! Made an account here as we've run into an issue and I'm wondering if others are experiencing the same. Mid-2018 we recertified our medical device manufacturing facility to ISO 13485 under the MDSAP certification plan. We completed the audit with a few minor NC's and were recommended for re-certification. To this date, we still have not received our certificate due to a 'backlog' with our auditing body. We have pressed them repeatedly on this and have mostly been given the runaround for the past 7 months or so.

Is anyone else experiencing this issue with their auditing body? Is it worth investigating other auditing bodies to see if we can get better service elsewhere? From what I'm reading, it looks like this might be a problem with multiple firms now. This has gone on long enough to potentially be a breach of contract on the auditor's part and is beginning to impact our business operations.

I'm curious if others are having the same issue and how you plan to handle it!
Hi,

I wanted to say that we are going through the same issue. We had our transition audit last August and passed with one minor NC. We have paid the bill, and here it is March 13 and have yet to receive the new cert. I have contacted our auditing body many times, they finally issued us a letter saying that they are backlogged and we are in their review cycle.

Very frustrating.
 

DannyK

Trusted Information Resource
#8
I am not sure that complaining to the AB will help since the MDSAP certificate is not accredited. I have been involved with many MDSAP audits and there are huge delays for at least one of the largest auditing organizations (not CB). One of my clients did not get his certificate until his next year audit was held.

I would speak to the account manager of the auditing organization and ask them for the reason for the delay. You can also send feedback/complaint to the regulators such as FDA and Health Canada since they created the process and can also be partially accountable.
 

M.R.Falco

Starting to get Involved
#9
Thanks for the further follow-up! Not happy to see that others are in the same boat but at least we know it's not just us. We consider them in breach of contract since they have accepted payment for services they have not rendered. It looks like our lead auditor from last year left their employment and they simply lost track of our auditing project. After we mentioned potential litigation we finally got a response although still no certificate. If we had failed our audit that would be one thing but given our recommended recertification they appear to not be compliant with their own general terms and conditions.

Hopefully anyone else suffering through this type of backlog is able to get movement on their own projects. At this point I'm going to have to speak with Health Canada to at least get them to keep our licenses active past the April 1st deadline so we don't suffer loss of business. Looks like this MDSAP situation is just a general mess all-around.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
It looks like our lead auditor from last year left their employment and they simply lost track of our auditing project.
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.
 
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