Earn your Certificate with Quiz 1 when you score 85% or higher
Click to see picture of certificate
- Created by: Rai Chowdhary – QMS Lead Auditor | CMQ/OE | CQE | Six Sigma Black Belt
- Focus: Terms and Concepts in QMSR and ISO 13485:2016
- Time required: 10 minutes or less
- Questions: Up to 15 randomly drawn from a bank of 100; check your answers as you go
- Unlimited practice: Practice and improve your score at your pace, at your convenience
- Fees: None for practice – learn for free, small processing fee ($29.95) for certificate (click to preview) with comments from the author.
Validate your understanding of QMSR and ISO 13485 essentials.
QMSR and ISO 13485 Essentials Knowledge Assessment
Created by Rai Chowdhary - QMS Lead Auditor | CMQ/OE | CQE | Six Sigma Black Belt
The QMSR is in effect as of February 2, 2026!
The transition from the legacy 21 CFR 820 (QSR) to QMSR alters how requirements are interpreted and inspected. The FDA now applies Compliance Program 7382.850 in place of the prior QSIT approach. This knowledge assessment helps ensure that foundational concepts are understood precisely before inspection pressure exposes gaps in understanding and interpretation.
Utility For Individual Professionals
Use this assessment to validate and refine your understanding of QMSR and ISO 13485 essentials. Demonstrate conceptual proficiency through a performance-based Certificate of Achievement (85% or higher).Advantage For Leadership Teams
Use this assessment to gauge whether foundational knowledge across your organization aligns with current regulations.
FAQs
1 Q: How does the QMSR transition affect ISO 13485:2016 compliance?
A: The QMSR incorporates ISO 13485:2016 by reference, meaning the FDA now accepts the international standard as the foundation for U.S. QMS requirements, with some additional FDA-specific constraints.
2 Q: What replaced the FDA QSIT inspection technique?
A: As of February 2, 2026, the FDA uses Compliance Program 7382.850 (not the previous QSIT) for inspections, which aligns with the new QMSR framework.
3 Q: Is a certificate required to prove QMSR knowledge?
A: While not a regulatory requirement, it has two benefits: (a) proof of training and an asset for your career, (b) a Certificate of Achievement with a score of 85% or higher from a Lead Auditor validates that essentials are understood.
