Quality Management

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FDA 21 CFR 820 Auditing

Internal FDA 21 CFR 820 audits 
Supplier audits
Internal auditor training
System optimization audits
Value-added audits
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FDA 21 CFR 820 Audits

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

  • No time for supplier audits?

  • Corrective actions are still open from the previous audit?

  • Wish your auditors had better training?

  • Little added value from your FDA 21 CFR 820 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 complete our Request for a Quote form.

Call us today to discuss your specific ISO management system needs!

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