ISO 13485 and FDA QSR 21 CFR Part 820 Foundation for Practitioners and Auditors

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.