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Hi,
I am new to a regulatory position although I have a QA background - . The company I work for has design and business overseas but manufactures in the US. They are working toward ISO 13485:2016 certification.
Will the audit for ISO 13485 cover both locations?
They also produce a device for which each individual device is custom made and is non invasive, transient in use and not for diagnostic purposes. They have been led to believe that this device is not in scope for the ISO audit and therefore they do not have to demonstrate various control procedures relate to this device. I think there might be a disconnect here. Surely purchasing controls, inventory control, supplier controls and so on will be looked at for this device in an audit?
Is there a recommended source of information for these scenarios?
Thank you