Worked Example: Supplier Evaluation From Selection to Annual Re-evaluation
By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 26 October 2026.
Short answer: a supplier evaluation is a chain of records: a risk classification that sets how much control the supplier needs, scored evaluation against criteria you defined in advance, an approval decision with conditions, incoming checks, and a planned re-evaluation that uses real performance data. This example follows one foam supplier from selection to the annual review.
What the standard expects. ISO 13485 clause 7.4.1 requires criteria for the evaluation, selection, monitoring and re-evaluation of suppliers, control in proportion to the effect on the finished device, planned monitoring and re-evaluation, and records of the results and any actions (summary of clause 7.4). ISO 9001 clause 8.4 asks for similar control of externally provided processes, products and services. Check the wording in your licensed copy.
The situation
Northbay Wound Products (fictional) needs a second source for the foam used in its wound dressings. It evaluates Harbourline Foams (fictional).
1. Risk classification (SUP-2026-007)
| Item supplied | Polyurethane foam sheet, a direct component of the finished dressing (Example). |
|---|---|
| Effect on the finished device | High: the foam is in contact with the wound and affects performance. Classification: critical supplier. |
| Control required | Full evaluation including a quality system review, quality agreement, incoming inspection of every lot and annual re-evaluation. |
2. Evaluation scorecard
Criteria and weights were set in the Supplier Control procedure before any supplier was scored. Each criterion is scored 0 to 5. The weighted total is out of 100: 75 or more approved, 60 to 74 conditional, below 60 not approved (Example thresholds).
| Criterion (Example) | Weight | Score (0 to 5) | Evidence |
|---|---|---|---|
| Quality system and certification | 20 | 5 | Valid ISO 13485 certificate seen; scope covers foam conversion |
| Product quality (samples) | 40 | 4 | 3 sample lots met specification; one cell-size value close to the limit |
| Delivery capability | 20 | 3 | Lead time 6 weeks; no history yet |
| Responsiveness and change control | 10 | 4 | Written change notification process shown |
| Commercial terms | 10 | 3 | Price competitive; minimum order quantity high |
Weighted score (Example): (5×20 + 4×40 + 3×20 + 4×10 + 3×10) ÷ 5 = 390 ÷ 5 = 78 out of 100.
3. Remote audit finding (SAUD-2026-003)
| Method | Document review and video walk-through of goods-in, cutting and packing, using the Supplier Audit Checklist. |
|---|---|
| Finding | Minor: the supplier's cutting records did not state the foam lot number. Supplier corrective action requested within 30 days. |
| Closure | Corrective action accepted 12 days later with a revised cutting record. Verified at the first incoming lot. |
4. Approval and approved supplier list entry
| Decision | Approved with conditions, by the quality manager on 14 July. Score 78 (Example). |
|---|---|
| Conditions | Quality agreement signed before first order. First three lots at 100% incoming inspection on the critical dimensions. Re-evaluation due July the following year. |
| Approved scope | Polyurethane foam sheet, specification FS-02 only. Any other material requires a new evaluation. |
5. Quality agreement (key clauses)
| Change notification | Harbourline must notify Northbay in writing before any change to formulation, raw material source, process or site, and may not ship changed product until Northbay has agreed (Example). |
|---|---|
| Records and access | Batch records kept for the retention period; Northbay may audit with notice. |
| Nonconformity | Supplier notifies Northbay of any nonconforming lot already shipped and responds to a supplier corrective action request within 30 days. |
6. Incoming inspection record (IIR-2026-118)
| Lot | HF-4471 received 2 September (Example). |
|---|---|
| Checks | Certificate of conformance present; thickness, density and cell size measured on a sample drawn per the sampling plan; packaging and labelling intact. |
| Result | Accepted. Recorded against the supplier in the scorecard data. |
7. Annual re-evaluation (SREV-2027-002, the following July)
The performance data for the year comes from incoming inspection and goods-in records (Example): 12 lots received, 11 accepted and 1 rejected for out-of-limit cell size; 10 of 12 delivered on time.
| Criterion (Example) | Weight | Original score | New score | Reason |
|---|---|---|---|---|
| Quality system and certification | 20 | 5 | 5 | Certificate renewed |
| Product quality | 40 | 4 | 3 | One rejected lot; supplier corrective action opened |
| Delivery | 20 | 3 | 3 | 10 of 12 lots on time |
| Responsiveness and change control | 10 | 4 | 4 | One notified change handled correctly |
| Commercial terms | 10 | 3 | 3 | No change |
New weighted score (Example): (5×20 + 3×40 + 3×20 + 4×10 + 3×10) ÷ 5 = 350 ÷ 5 = 70, which falls in the conditional band.
Decision: keep the supplier on the list as conditional. Complete the supplier corrective action, return to 100% inspection of critical dimensions for the next three lots, and re-evaluate in six months. Result reported at management review.
What this shows
- The level of control follows the risk classification, not the supplier's size or price.
- Criteria, weights and thresholds are set before scoring, so the score cannot be adjusted to fit the outcome.
- Re-evaluation uses real incoming data, and the outcome changes what happens next.
- Every decision is traceable from the approved supplier list back to the evidence.
The templates behind it
The Supplier Control SOP, Supplier Evaluation Scorecard, Approved Supplier List, Supplier Audit Checklist, three quality agreement templates and Incoming Inspection record are in the ISO 13485 Supplier Control Kit, and all of them are in the ISO 13485 Complete QMS Kit. For ISO 9001, supplier evaluation records are part of the ISO 9001:2026 Complete QMS Documentation Kit.