M
Mor628
Hi guys,
If one of our Class I (self declare) products has a significant complaint (patient at risk, national authority is notified), is there auditor then allowed to question us on it even though it is not on our ISO 13485 scope and therefore not one of the products on their sampling list.
How much can the auditor be involved in those products that are self declare? Are self declare products subject to the same audit procedure as Class Is?
If one of our Class I (self declare) products has a significant complaint (patient at risk, national authority is notified), is there auditor then allowed to question us on it even though it is not on our ISO 13485 scope and therefore not one of the products on their sampling list.
How much can the auditor be involved in those products that are self declare? Are self declare products subject to the same audit procedure as Class Is?