ImageVision’s primary manufacturing facility in Houston, TX is registered to ISO 9001:2008, Certificate Number 2006-OSL-AQ-7875 and to ISO 13485:2008, Certificate Number 2006-OSL-AQ-0650.
In addition, this facility maintains both the Texas Department of Health (Cert # 30003848601) as well as FDA registration (FDA# 0033199) which requires compliance and being independently audited to the FDA's GMP Quality System, Regulation 21 CFR 820.
Our secondary fabrication facility, located in Magnolia, TX has completed extensive training and evaluation of ISO 9000 certification, and elected to implement disciplines learned into their manufacturing processes without completing the certification process.
These disciplines, coupled with our own "closed loop" Customer Satisfaction Reporting System, insure that any problems that occur are fully addressed and are resolved in a manner that they do not repeat themselves in the future.