ISO 13485:2016 MDSAP Certification Fee Survey

#1
Hi folks,

How much are you guys being charged for ISO 13485:2016 MDSAP Certification Audits?

My company is being charged about $5,250 per audit day for 7.5 days for a total about $40k a year. The scope include CE Marking, ISO 13485:2016, MDSAP Audit. And there doesn't seem to be any difference between certification and surveillance audit. Both type of audits (surveillance & re-certification) require same number of audit days and fee. Is this also your experience with your notified body?

Pete
 
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Highground

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#4
Cost sounds about right.
We have been informed this year's audit will only give 1 year certification because it is not an onsite audit because of COVID.
I don't agree with this and it will create issues when registering and renewing registrations in other countries where they require a cert with more than 6 months expiry dates.

Anyone else with this issue?
 

levatorsuperioris

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#5
Who is your AO? Surveillance should cost significantly less than re-certification. If they are doing multiple re-cert it could be due to poor management at the NB, if the NB fails to perform audits in timely manner etc, it triggers all sort of requirements for them to do multiple re-certification audits Also how many people are in your organization?
 
Last edited:

twanmul

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#6
Who is your AO? Surveillance should cost significantly less than re-certification. If they are doing multiple re-cert it could be due to poor management at the NB, if the NB fails to perform audits in timely manner etc, it triggers all sort of requirements for them to do multiple re-certification audits Also how many people are in your organization?
I agree, our re-cert audit costs more than our surveillance audit. Mostly because they have performed across a different timespan (more auditor days).

Cost sounds about right.
We have been informed this year's audit will only give 1 year certification because it is not an onsite audit because of COVID.
I don't agree with this and it will create issues when registering and renewing registrations in other countries where they require a cert with more than 6 months expiry dates.

Anyone else with this issue?
We just had a remote surveillance audit which hasn't impacted on our certificate validity or expiry.

It's all inclusive.
If this includes the cost of the issue of the certificate, then I'd say this is very competitive. If the cost of the re-issued certificate is separate, then I'd say it's still about right as others have said.
 
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