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We were talking about FAI and a person brought up we need a SOP and point me to a website.
On the site it has the following-
The ISO 13485 First Article Inspection (FAI) Procedure provides instruction on conducting first article inspections and generating a first article inspection report.
I checked ISO 13485 and no where does it call out anything for a FAI. It does call out inspections and records. Is there anything under the FDA QSR that calls out FAI? Just looking for any feedback people have on FAI and where if any place in the Reg it calls out FAI's.
Thank you
On the site it has the following-
The ISO 13485 First Article Inspection (FAI) Procedure provides instruction on conducting first article inspections and generating a first article inspection report.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
I checked ISO 13485 and no where does it call out anything for a FAI. It does call out inspections and records. Is there anything under the FDA QSR that calls out FAI? Just looking for any feedback people have on FAI and where if any place in the Reg it calls out FAI's.
Thank you