ISO 13485:2016 / MDSAP Surveillance 2 Audit Delay Consequences

[Whirlyball]

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.

 

[DannyK]

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]

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