Quality & Certifications
Built to ISO standard.
Quality isn't a department — it's the system. Our processes are certified to ISO 9001:2015 and, for medical work, ISO 13485:2016.
ISO 9001:2015
Quality Management System
The international standard for consistent, documented, continually-improving processes — applied across injection molding, thermoforming, fabrication, rotational molding, and extrusion.
ISO 13485:2016
Medical Device Quality
The quality standard for medical-device manufacturing — clean-room molding, documented process controls, traceability, and assembly for life-science applications.
What it means for you
Quality you can document.
- Repeatable processes. Documented work instructions and process controls on every job.
- Traceability. Material and production records for regulated programs.
- Clean-room medical molding. ISO 13485 controls for device components.
- Continual improvement. Audited systems that get better over time.
Made in the USA. Every part is produced through our U.S. manufacturing partner network and held to our ISO-certified quality systems — domestic accountability from first quote to final shipment.
Need a certified partner?
From commercial parts to ISO 13485 medical components, we'll quote your program with the right controls.