The STERIS Culture of Quality
Quality Systems and Regulatory Compliance Information
STERIS Isomedix Services operates under a quality system that is in compliance with 21 CFR Part 820 and applicable sections of 21 CFR Part 211. In addition, STERIS Isomedix Services is registered to the ISO 13485:2003 Quality Standard, and adheres to the requirements of ISO 11137-1:2006 (Gamma) and ISO 11135-1:2007 (EO).
To provide consistent quality service to our Customers, all 18 facilities belonging to the STERIS Isomedix Services business unit operate under a unified Quality Manual. Click here to learn more about our Quality manual.
Learn More About our 18 Facilities
Find more details about our gamma and ethylene oxide sterilization facilities by hovering over the locations in the map below.
Contact the Quality Team