What the standard requires
ISO 9001 requires, among other things, control of documented information and identification of products throughout realization, with traceability where it is required.
Brought by the ERP
- Dated records
- Lot and serial traceability
- Linked documents
Still human
- Quality policy
- Risk analysis
- Audit and management review
What the ERP brings
- Dated and attributed records: receipts, orders, deliveries.
- Traceability of lots and serial numbers.
- Documents attached to the right objects.
What it does not replace
The quality policy, risk analysis, internal audit and management review remain human processes. Badly configured software can even produce misleading records.
Limits
This text refers to ISO 9001:2015. Check the revision in force on the date of your audit; no certification is obtained by choosing software.