Hello,
We are a ISO 13485 certified company and are working with own production facilities as well as ISO 13485 certified sub-contractors.
Processes (primarily welding and injection moulding) are validated in our own facilities.
Our auditor requires us to perform process validations according to IQ/OQ/PQ also at the sub-contractors.
We argue that since they are ISO 13485 certified, it is covered in their QMS.
Any thoughts, remarks, guidance would be helpful.
Kind Regards,
T Verm
We are a ISO 13485 certified company and are working with own production facilities as well as ISO 13485 certified sub-contractors.
Processes (primarily welding and injection moulding) are validated in our own facilities.
Our auditor requires us to perform process validations according to IQ/OQ/PQ also at the sub-contractors.
We argue that since they are ISO 13485 certified, it is covered in their QMS.
Any thoughts, remarks, guidance would be helpful.
Kind Regards,
T Verm