Verify
Confirm legitimacy, ownership, operating history, registration, licenses, financials, and manufacturing footprint.
IMPACT SCM / SUPPLIER INTELLIGENCE
Supplier & Factory Qualification
Effective global sourcing starts with the right manufacturing partners. Our qualification framework evaluates manufacturing capabilities, product quality, regulatory readiness, operational reliability, and commercial competitiveness — using a structured, risk-based approach to supplier evaluation.
Manufacturing capabilityProduct qualityRegulatory readinessOperational reliabilityCommercial competitiveness
QUALIFICATION FRAMEWORK 01 — 06 REVIEW FRAMEWORKIMPACT / SCM
A structured, risk-based approach
Our Supplier Qualification Framework
Six evaluation disciplines, assessed against your business requirements — from manufacturing legitimacy through to ongoing supplier performance.
01Manufacturer Verification+
Establishing supplier legitimacy and operational credibility.
- Business registration and manufacturing license verification
- Factory ownership and operating history
- Manufacturing location and production capabilities
- Export experience and customer references
- Financial and operational stability assessment
02Quality & Regulatory Compliance+
Evaluating product quality and readiness for the U.S. market.
- ISO 13485 and ISO 9001 certifications, where applicable
- FDA establishment registration and device listing verification, where required
- Product-specific regulatory requirements
- ASTM and other applicable industry standards
- Product testing, inspection, and quality documentation
- Corrective and preventive action (CAPA) processes
- FDA registration or device listing does not constitute FDA approval.
03Factory Capability Assessment+
Understanding manufacturing capacity and consistency.
- Production capacity and equipment capabilities
- Manufacturing process controls
- Quality management systems
- Raw material sourcing and traceability
- Production lead times and scalability
- Maintenance, calibration, and workforce capabilities
04Product Qualification & Testing+
Verifying products against customer specifications.
- Product specifications and technical documentation
- Samples and product evaluations
- Independent laboratory testing, when appropriate
- Packaging and labeling requirements
- Lot traceability and shelf-life documentation
- Pre-shipment quality inspections
05Commercial & Supply Chain Evaluation+
Balancing quality, reliability, and total landed cost.
- Competitive manufacturer-direct pricing
- Minimum order quantities (MOQ)
- Production and delivery lead times
- Freight, duties, and landed cost analysis
- Supply continuity and contingency planning
- Payment terms and commercial risk assessment
06Ongoing Supplier Performance+
Building long-term supplier relationships through measurable performance.
- Product quality and defect rates
- On-time delivery performance
- Pricing competitiveness
- Customer complaints and corrective actions
- Regulatory and certification changes
- Supplier responsiveness and continuous improvement
From due diligence to ongoing confidence
A risk-based qualification process
Inspect
Assess quality systems, certifications, regulatory readiness, equipment, capacity, process controls, and workforce capability.
Validate
Evaluate product specifications, samples, testing, documentation, packaging, labeling, lot traceability, and shelf life.
Compare
Review MOQ, lead times, freight and duties, continuity planning, payment terms, and commercial risk against your targets.
Monitor
Track quality, on-time delivery, pricing, complaints, regulatory changes, and continuous improvement across the relationship.