T
Tiffany
Dear all,
As required by the standard ISO 13485, it is required to establish documented procedure for traceability.
To fulfill this requirement, our system actually have this SOP which also describe the extent of the product traceability.
The auditor have issued us a NCR for having this SOP which did not descibe the extent of the traceability!
Can anyone there can help me how to describe it? or perhaps can share a comprehensive SOP with me here?
Tiff
As required by the standard ISO 13485, it is required to establish documented procedure for traceability.
To fulfill this requirement, our system actually have this SOP which also describe the extent of the product traceability.
The auditor have issued us a NCR for having this SOP which did not descibe the extent of the traceability!
Can anyone there can help me how to describe it? or perhaps can share a comprehensive SOP with me here?
Tiff