PRIMUS Sterilizer
PRIMUS Completes ISO 9001:2008, ISO 13485:2003, and CMDR Surveillance Audit

PRIMUS successfully completed a weeklong ISO 9001:2008, ISO 13485, and CMDR Surveillance Audit on July 26, 2013. 

The audit was done by Intertek, a global services firm with over 35,000 people in 1,000 locations in over 100 countries. Intertek is headquartered in England. PRIMUS has contracted with Intertek to be its ISO registration body since 2004.

One Intertek auditor spent two days in Great Bend, Kansas and the lead auditor evaluated the Omaha headquarters for three days.

PRIMUS registration certificates can be found and downloaded from the bottom of the first page of the PRIMUS website.  Simply click on one or both of the Intertek logos.

For additional information on PRIMUS' regulatory and standards compliance efforts, please review the following Did You Know? bulletins on the PRIMUS website:

             DYK #6 - ASME and Pressure Vessel Safety

             DYK #9 - UL Certification

             DYK#22 - cGMP Overview

             DYK#72 - International Organization for Standardization (ISO)

             DYK #145 - ISO 9001:2008 and ISO 13485:2003 Regulations

             DYK #188 - FDA Regulations - Refurbished and Remanufactured Steam Sterilizers

             DYK #213 - FDA Audit Results