# Medical Device Supplier Evaluation Scoring Worksheet

> Source: https://netray.co/tools/medical-device-supplier-evaluation-scoring-worksheet
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

Weighted scoring of critical and non-critical suppliers with approval status, for ISO 13485 clause 7.4 purchasing controls.

## Category

quality

## Industry

Medical Devices

## Audience

- Supplier quality
- Purchasing
- Quality manager

## Tool

**Kind:** worksheet

**Mode:** editable

**Columns:**

#### Supplier

**Key:** supplier

**Type:** text

#### Supplied item

**Key:** category

**Type:** select

**Options:**

- Component
- Raw material
- Sterilization service
- Calibration service
- Contract manufacturer
- Packaging

#### Criticality

**Key:** criticality

**Type:** select

**Options:**

- Critical
- Major
- Minor

#### Quality score (0-100)

**Key:** quality

**Type:** number

#### Delivery score (0-100)

**Key:** delivery

**Type:** number

#### Regulatory score (0-100)

**Key:** regulatory

**Type:** number

#### Weighted score

**Key:** weighted

**Type:** number

**Expr:** quality * 0.5 + delivery * 0.2 + regulatory * 0.3

**Format:** decimal

#### Decision

**Key:** decision

**Type:** select

**Options:**

- Approved
- Conditional
- Disqualified
- Under review

#### Next audit

**Key:** next_audit

**Type:** date

**Rows:**

**Supplier:** PolyTube Extrusions

**Category:** Component

**Criticality:** Critical

**Quality:** 92

**Delivery:** 85

**Regulatory:** 90

**Decision:** Approved

**Next audit:** 2027-03-15

**Supplier:** SteriServe Contract EO

**Category:** Sterilization service

**Criticality:** Critical

**Quality:** 88

**Delivery:** 78

**Regulatory:** 95

**Decision:** Approved

**Next audit:** 2027-01-20

**Supplier:** Precision Molds Ltd

**Category:** Component

**Criticality:** Major

**Quality:** 74

**Delivery:** 82

**Regulatory:** 70

**Decision:** Conditional

**Next audit:** 2026-12-10

**Supplier:** PackRight Films

**Category:** Packaging

**Criticality:** Major

**Quality:** 81

**Delivery:** 90

**Regulatory:** 76

**Decision:** Approved

**Next audit:** 2027-05-05

**Supplier:** CalLab Services

**Category:** Calibration service

**Criticality:** Minor

**Quality:** 65

**Delivery:** 70

**Regulatory:** 60

**Decision:** Under review

**Next audit:** 2026-11-30

**Summary:**

#### Average weighted score

**Key:** avg_score

**Expr:** avg_weighted

**Format:** decimal

**Primary:** true

#### Lowest weighted score

**Key:** lowest

**Expr:** min_weighted

**Format:** decimal

**Totals:**

#### Suppliers evaluated

**Key:** supplier

**Agg:** count

**Notes:** 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.

## Content

**Intro:** 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.

**Sections:**

#### How to use the worksheet

**Body:** 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

**Body:** 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.

**Bullets:**

- 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

**Body:** 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.

**Cta:** If supplier performance data sits in your ERP, Netray can help pull it into scoring automatically. Ask for a short review.

**Faq:**

#### What does ISO 13485 require for suppliers?

**Answer:** 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?

**Answer:** 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?

**Answer:** 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?

**Answer:** Your procedure decides. Many use a threshold such as under 60 for disqualification and a conditional band with a corrective action plan in between.

## Search terms

supplier evaluation form ISO 13485, medical device supplier qualification worksheet, approved supplier list scoring excel, supplier evaluation matrix, ISO 13485 purchasing controls template, supplier risk scoring medical device

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