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Supplier Qualification
Qualify suppliers, keep an approved-supplier list, and re-evaluate on schedule.
ISO 13485 §7.4 (21 CFR Part 820, QMSR)
What it does
Move suppliers through qualification (Pending → Under Evaluation → Approved → On Hold / Disqualified), maintain a live approved-supplier list, and track periodic re-evaluation so approvals don't silently go stale.
How Indelio handles it
Supplier approval, holds and disqualification are electronic-signature events that bind the evaluation. Approval sets the next re-evaluation date automatically, and the list flags overdue re-evaluations. A hold takes a supplier off the approved list while a problem is investigated, without discarding the qualification. Supplier audits feed the supplier file.
Key capabilities
- ✓ Approved-supplier list with overdue re-evaluation flags
- ✓ E-signed approval, hold, and disqualification
- ✓ Reversible On Hold — off the approved list, qualification kept
- ✓ Linkage to supplier audits
The whole quality system shares one audit trail.
Supplier Qualification plus thirteen more modules — connected, Part 11, validation included.
Explore the rest of the suite