North America Office
8757 West Cornell Avenue Suite 4
Lakewood, CO 80227 USA
+1 (720) 635-5563

Mexico Office:
Calle Arthur Ashe No. 40
Raquet Club
San Juan Cosala
Jalisco C.P. 45820 Mexico
+1 (720) 635-5563

FDA 21 CFR 820 Auditing

Internal FDA 21 CFR 820 audits 
Supplier audits
Internal auditor training
System optimization audits
Value-added audits
ISO 13485 Auditing


FDA 21 CFR 820 Quality System Audits

  • Behind the schedule with your ISO and QSR internal audits?

  • No time for supplier audits?

  • Corrective actions are still open from the previous audits?

  • Wish your auditors had better QSR FDA 21 CFR 820 training?

  • Little added value from your quality system audits?

We can help! Quality Works assisted dozens of companies in auditing their FDA 21 CFR 820 compliant quality management systems. Our certified Quality Management System auditors have worked for and with leading registrars around the world. We focus on effectiveness and compliance of your Quality Management system to optimize your documentation, increase repeatability of your processes and identify opportunities for improvement. You do not have to do it all by yourself! Our contract auditing service will help you stay on schedule and get a professional external assessment of your FDA 21 CFR 820 compliant quality management system. For a free no obligation proposal, Call us today to discuss your specific ISO management system needs!

© Copyright 1996 - 2016 Quality Works