Unannounced Audit Results?

Ed Panek

QA RA Small Med Dev Company
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Super Moderator
I was curious if there are statistics on ISO 13485 unannounced audit results. We have a board meeting and I am trying to compare our (good) results with industry results
 

Sidney Vianna

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Admin
Who performed the unannounced audit? The CB? Unannounced/short-notice audits are very rare and, normally, would only be triggered if a stakeholder has valid reasons to doubt the validity of a management system certification.

As for public information on such audit results, why would anyone disclose sensitive information?

Add in edit https://lne-gmed.com/wp-content/uploads/2020/09/faq-unannounced-audits-GMED.pdf
 
Last edited:

Jean_B

Trusted Information Resource
ISO 13485 typically does not have unannounced audits. It is a hallmark of CE certification audits, where they are often merged into a single audit.

I do not recall a central repository of outcome information, companies generally do not taut dirty laundry so it would be a biased sample from other sources.
My personal experience is that while they feel more exciting (though not necessarily more tense), the results are usually lower in grade and less in amount compared to the regular scheduled audits. It would be a lower bar of things to expect.
Won't go into further specifics for obvious reasons.
 
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