ISO 13485:2016 Certified
ISO 9001 / AS 9100:2016 Certified
Machine Validation: Conforms to FDA 21 CFR 820.75
Process Validation: Conforms to ISO 13485:2016 section 7.5.2 validation of processes for production
Raw Material Controls: In addition to Mill Certifications, all raw material is analyzed with a Thermo Scientific Niton XL2 Elemental Analyzer – Critical safeguards for critical products and systems.
Product validation performed to customer requirements or we default to PFEMA’S, CPK and Process Control Plans.
Full traceability is maintained for all product manufactured.
The quality department and personnel are supported with SmartScope Vision Systems, Keyence Vision System and Zeiss Programmable CMM.
Personnel participate in continuous education as to remain current on all systems and metrology.
- KEYENCE IM Series Optical Gaging System
- Smart Scope Flash 20 Optical Gaging System
- ONYX RAM Optical Gaging System
- ZEISS Contura G2 Programmable CMM
with Articulating Head
- Brown and Sharp Gage 2000 Manual CMM
- Thermo Scientific NITON XL2 Elemental Alloy Analyzer