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United StatesISO 13485 and FDA QSR 21 CFR Part 820 Foundation for Practitioners and Auditors
ISO 13485 and FDA QSR 21 CFR Part 820 Foundation Training is for Practitioners & Auditors who want to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (QSR 21 CFR Part 820).
Important Note: This course is based on the current FDA Quality System Regulation (QSR 21 CFR Part 820) that is being replaced by the new QMSR in February 2026. If you want to master the requirements of the new FDA QMSR, you should visit this course page.
Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
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Course Overview
ISO 13485 and FDA QSR 21 CFR Part 820 Foundation
Identify and comprehend the basics of the FDA QSR structure, its provisions, and content
Discern the similarities and key differences between the FDA QSR and ISO 13485
Practical application of Quality Management System Requirements as required under the FDA QSR and ISO 13485 requirements
An Insight into the auditor’s approach during Quality Management System audits
During the eLearning modules, each Learner will cover the following:
- Module 1 – Introduction to ISO 13485 & the FDA QSR
- Module 2 – Quality Management System
- Module 3 – Management Responsibility
- Module 4 – Resource Management
- Module 5 – Product Realization, Part 1
- Module 6 – Product Realization, Part 2
- Module 7 – Measurement, Analysis, and Improvement
This course would be targeted at:
- Quality Engineers
- Quality Specialists
- Internal Auditors
- Quality Managers
- Regulatory Professionals
CQI & IRCA certify this course (No. 2589). Upon successful completion, each Learner shall receive a digital Certificate of Completion within 1 business day.
It is recommended that each Learner should have the following prior knowledge before completing this course:
- The Plan, Do, Check, Act (PDCA) cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
- The fundamental concepts and commonly used quality management terms and definitions
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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