Medical Device Supplier Evaluation Scoring Worksheet
ISO 13485 requires you to evaluate and select suppliers based on their ability to supply product meeting your requirements, with controls proportionate to risk. This worksheet gives you a weighted score and a recorded decision per supplier.
| Supplier | Supplied item | Criticality | Quality score (0-100) | Delivery score (0-100) | Regulatory score (0-100) | Weighted score | Decision | Next audit | |
|---|---|---|---|---|---|---|---|---|---|
90 | |||||||||
88.1 | |||||||||
74.4 | |||||||||
81.3 | |||||||||
64.5 |
Weights are 50% quality, 20% delivery, 30% regulatory. Change the expression to suit your procedure. Critical suppliers normally also need a quality agreement and audit regardless of score.
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How to use the worksheet
Add a row per supplier and set criticality first, because it drives how much evidence you need. Enter quality, delivery and regulatory scores from audit results, incoming inspection data, on-time delivery and certificate status. The worksheet calculates a weighted score, which supports but does not replace judgement. Record the decision and the next audit date, and export to Excel for your approved supplier list.
Scoring and weighting
The default weighting favours quality at 50%, with regulatory standing at 30% and delivery at 20%. Raise regulatory weight for sterilization or contract manufacturing, where certification and audit history matter most. Set a minimum threshold, for example 80 for critical suppliers, and treat any single criterion below a floor as a trigger regardless of the average.
- Quality from incoming inspection and SCAR history
- Delivery from on-time in-full rate
- Regulatory from ISO 13485 or MDSAP certificate and audit findings
- Criticality drives audit frequency
Common mistakes
Treating a certificate as the whole evaluation is common. A valid ISO 13485 certificate does not tell you about your specific part or process. Others re-evaluate only at onboarding and never feed back performance data. Set a review frequency and link it to nonconformance and CAPA trends.
Frequently Asked Questions
What does ISO 13485 require for suppliers?
Clause 7.4 requires documented criteria for evaluation, selection, monitoring and re-evaluation, controls proportionate to the effect on product and risk, and records of results and any actions arising.
How often should suppliers be re-evaluated?
Set it by criticality. Many companies review critical suppliers at least annually and others every two or three years, and sooner after a significant nonconformance.
Is a quality agreement required?
Not by name in every case, but written agreements on change notification and quality responsibilities are expected for critical suppliers, and FDA and notified bodies look for them.
What score should disqualify a supplier?
Your procedure decides. Many use a threshold such as under 60 for disqualification and a conditional band with a corrective action plan in between.
If supplier performance data sits in your ERP, Netray can help pull it into scoring automatically. Ask for a short review.
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