Library
sterilization, sterilize, sterilisation, medical device sterilization, contract sterilization

Quality Policy Manual and ISO Certificates

A four-tiered Quality System administered by Corporate Quality Assurance, provides the quality management structure for each technology (EO, gamma and E-beam) offered by Sterigenics.

All test methodologies and procedures are executed in accordance with AAMI, ISO, ASTM, FDA and/or specific customer supplied requirements.

The Quality System is registered in all global locations by BSI and currently conforms to ISO 9001:2008, ISO 13485:2003, EN ISO 11135-1:2007 and EN ISO 11137-1:2006.

Through the centralized Quality System, we can assure that a consistent quality process, coupled with exceptional customer service, will be delivered to every customer whether a single site or multiple facilities are utilized.

Of special interest to customers in the food products industry: Sterigenics will assist with all regulatory compliances including USDA (United States Department of Agriculture) and the FDA (Food and Drug Administration), as well as state and international laws.

Quality Policy Manual

Sterigenics Quality Policy

ISO 9001

ISO 13485

Belgium

Canada

China

Denmark

France

Germany

Mexico

Thailand

United Kingdom

USA