Qualifications
HONDVO operates a triple-certified quality management system and a validated cleanroom production environment, supported by equipment and metrology capabilities.
Certifications
- ISO 13485 — medical device quality management system.
- IATF 16949 — automotive quality management system.
- ISO 9001 — general quality management system.
Production Environment
- Two Class-100,000 cleanrooms for injection moulding.
- Controlled material handling and traceability.
Validation & Inspection
- IQ / OQ / PQ qualification documentation available for customer review.
- Sampling inspection plan aligned to customer specification before shipment.