Scope of Audit

Vignesh M

Hello everyone, I'm Vignesh, a QA & RA engineer at Cureous Labs in Bangalore. I have a question: Can batch production, specifically vacuum casting for medical devices, be classified as manufacturing? Can it be included in the scope of an audit for ISO 13485, which pertains to medical device manufacturers?


Quite Involved in Discussions
I don't see why not. Typically ISO 13485 certificate scopes identify the various processes performed. Ultimately, your notified body or registrar will make the call as to what can be in the scope of the certificate. There are various guidances on certificate scope that they have to comply with.
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