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, E-beam and steam) 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 U.S. and Thailand sites by Det Norske Veritas (DNV), and currently conforms to ISO 9001:2000, ISO 13485:2003, ISO 11135, EN 550, ISO 11137 and EN 552. All European sites by are registered by BSI, and conform to ISO 9001:2000, ISO 13485:2003, ISO 11135, EN 550, ISO 11137 and EN 552.
• Because the Quality System is the same in all Sterigenics facilities, 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.

(The Sterigenics policy manual and ISO certificates are available for download at right.)