Supplier Assessment & Qualification
Know your suppliers before you depend on them. We design and run structured evaluation programs that give you a defensible basis for every approved vendor decision.
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Qualify suppliers before risk reaches your production line
Supplier qualification is the process of systematically evaluating whether a supplier can consistently meet your quality, regulatory, and business requirements — before you add them to your approved vendor list and before you place a purchase order.
Regulated industries require it. ISO 9001 Clause 8.4, ISO 13485 supplier controls, and CMMC supply chain requirements all mandate documented supplier evaluation. But qualification done well is also a business asset: it reduces incoming inspection costs, prevents escapes, and gives you leverage when a supplier relationship needs to change.
What we assess
Quality system capability
- ISO 9001, ISO 13485, or AS9100 certification status and scope
- Internal audit program maturity and CAPA effectiveness
- Document control, change management, and records integrity
Process and product controls
- Manufacturing process capability and statistical controls
- Inspection and testing methods for your specific product types
- Traceability from raw material to finished output
Regulatory and compliance fit
- FDA registration, CE marking, or industry-specific certifications
- Cybersecurity controls where data or IP flows to the supplier
- Environmental, health, and safety compliance relevant to your product
Our qualification process
Consistent, documented, and defensible — designed to satisfy auditors and actually reduce your supply chain risk.
- 1
Supplier survey & document review
Questionnaire tailored to your product risk level. We review quality manuals, certifications, customer scorecards, and past CAPA history.
- 2
On-site or remote assessment
Structured evaluation of the supplier’s facilities, processes, and quality system against your defined criteria and applicable standards.
- 3
Risk scoring & recommendation
Weighted risk score across quality, regulatory, financial, and strategic dimensions. Clear approve / conditional / disqualify recommendation with rationale.
- 4
AVL onboarding & conditions
For conditional approvals, we define specific improvement conditions, timelines, and re-assessment triggers before full AVL status is granted.
What you get
Qualification report
Documented assessment results, scoring rationale, and a clear recommendation — ready to attach to your AVL records.
Risk scorecard
Multi-dimensional supplier risk score you can use for ongoing monitoring and re-qualification scheduling.
AVL process design
If you don’t have one: a documented approved vendor list process tailored to your industry requirements and audit exposure.
Supplier questionnaire template
Reusable qualification questionnaire built for your product types and applicable standards — yours to run on future suppliers.
Conditional approval plan
For suppliers who don’t fully qualify: a structured improvement plan with milestones and re-assessment criteria.
Re-qualification schedule
Risk-based re-qualification frequency recommendations so your AVL stays current without unnecessary audit burden.
Related services
2nd Party Audits
On-site and remote supplier audits to verify ongoing compliance — the natural follow-on to initial qualification.
Learn moreSupplier Escalations
Structured escalation process when a supplier’s performance falls below acceptable thresholds.
Learn moreGap Analysis
Identify compliance gaps in your own quality system before your next certification audit.
Learn moreReady to qualify your supply chain?
Tell us about your supplier landscape and we’ll scope a qualification program that fits your risk profile and audit requirements.
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