ISO 13485:2016 / MDSAP Surveillance 2 Audit Delay Consequences

Whirlyball

Registered
We are being scheduled for our Surveillance 2 audit. Our RA/QA Director recently left the company. I am about to hire a replacement but it will take some time for her to come up to speed to support an audit.

The agreement from the auditor says that surveillance audits "shall be conducted at least once a calendar year, except in recertification years"

They are putting pressure on me to do it within 12 months of Surveillance 1 (in June) but doesn't the above indicate that I can do it anytime in 2024? We are staying compliant regardless (I built the QMS) but I would really like to get a more fully qualified RA/QA up to speed before the audit.

Thank you all for your input.
 
Last edited:

DannyK

Trusted Information Resource
I have had several customers that had a gap of 5-6 months between surveillance 2 and recertification audits due to lack of resources at the MDSAP Auditing Organization. It is critical for the Auditing Organization to conduct the recertification audit 3 months before the certificate expires. The auditing organizations use the flexibility for their benefit. They usually do not bend for the customer's benefit. Perhaps escalating your issues to the Auditing Organization's management may allow for more flexibility.
Good luck!
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
This may be a substantial QMS change depending on how serious this managers change actually is. If his departure puts your QMS MDSAP readiness in question it may be a substantive change
 

lgoryoka

Registered
We are being scheduled for our Surveillance 2 audit. Our RA/QA Director recently left the company. I am about to hire a replacement, but it will take some time for her to come up to speed to support an audit.

The agreement from the auditor says that surveillance audits "shall be conducted at least once a calendar year, except in recertification years"

They are putting pressure on me to do it within 12 months of Surveillance 1 (in June) but doesn't the above indicate that I can do it anytime in 2024? We are staying compliant regardless (I built the QMS) but I would really like to get a more fully qualified RA/QA up to speed before the audit.

Thank you all for your input.
Your NB audit team should be able to delay your audit if they know your situation. I highly recommend speaking to the Lead Auditor or the scheduler. Most of my clients are in your situation, and NB understands it. Depending on their opening schedule, they can delay it for 3 or 4 months. Typically, the NB is busy in Q3 and Q4. Who is your NB?
 

Whirlyball

Registered
Thank you for your note. Our NB is Intertek and they are working with us on the schedule. We are in touch with our scheduled lead auditor, who is also very supportive.
 
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