PRIMUS recently completed a comprehensive four-day audit by two external auditors to certify that the PRIMUS Quality System remains in full compliance with the following requirements:
- ISO 9001:2008 – Quality Management Systems
- ISO 13485:2003 – Medical Device – Quality Management Systems
- Canadian Medical Device Regulations SOR/98-282 (CMDR)
Note
Please see Did You Know? # 72 – International Organization for
Standardization for a detailed discussion of the ISO system
The new registration certificates are posted on the PRIMUS website.
Based on the audit results, PRIMUS made improvements to its internal Quality Manual. Many of the improvements were made to reflect recent changes to the Canadian Medical Device Regulations (CMDR). Some of these changes require a greater degree of involvement and accountability by PRIMUS’ Canadian dealers in the management of the PRIMUS Quality System.
PRIMUS must undergo a comprehensive audit every three years and a surveillance audit every year in the two years between comprehensive audits. The entire PRIMUS Quality System at both the Omaha and Great Bend locations is audited during the three-year comprehensive audit. Select areas are reviewed during the shorter surveillance audits. PRIMUS has contracted with Intertek to conduct the audits. The Intertek auditors are highly experienced experts in the standards listed above.
The standards are periodically updated to reflect the best industry practices and technology changes. Because of this, PRIMUS has to be vigilant in constantly reviewing its Quality System to ensure the company remains fully compliant with the various standards.
In order to comply with the regulations and requirements, PRIMUS is required to maintain current location and end user contact information for all PRIMUS steam sterilizers. PRIMUS needs the help and full cooperation of its Dealer/Independent Sales Representatives/Authorized Service Agencies to fulfill this obligation.
Have a question or having difficulties? Talk to Dave Schall, our PRIMUS sterilizer expert who is here to assist you anytime at 877.679.7800 extension 1212 or email at dschall@spire-is.com.
Visit us at spire-is.com