To improve patient safety, the notify body has published The European Commission Recommendation 2013/473/EU relating to audits and assessments.
There was a remarkable point in this publication. UNANNOUNCED AUDIT of medical device manufacturers.
Manufacturers do not know about the audit, which is why it is called an unannounced audit. The audit is made by a subcontractor or a supplier who has an appropriate contract with the manufacturer. These types of audits are focused on a particular product. The reason is to verify if the product meets with the technical file, document compliance or compliance with the audit scope.
The duration is in total around 4-5 days.
In the attached image, you can see the frequency of unannounced visits.
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- WHAT IS AN UNANNOUNCED AUDIT?
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