MDSAP Training: Internal Auditor Training Based on ISO 13485:2016 & International MDSAP Audit Model Exemplar Global Certified (4-Day)
The ISO 13485:2016 and international Medical Device Single Audit Program (MDSAP) four-day training is focused on international MDSAP and ISO 13485 compliant medical device requirements and auditing methods. This training is taught in conjunction with Omnex, who is an Exemplar Global Certified provider.
Medical device auditing requires technical knowledge as well as a deep understanding of international medical device regulations. Students participating in this course will gain knowledge and skills to conduct audits of ISO13485: 2016 management system requirements in accordance with the new MDSAP Audit Model.
The Internal Auditor Training course will teach students to plan, conduct, report and follow-up on QMS audits in accordance with ISO 13485:2016 and MDSAP. Auditing standards include MDSAP requirements, ISO 19011 and ISO 17021 (MDSAP auditors need to follow ISO 17021).
- Prepare and conduct a solo internal audit
- Understand the MDSAP audit model.
- Understand and interpret the ISO 13485 and MDSAP requirements.
- Apply the proper interpretation of the standard in actual audit situations.
- Understand process auditing tools
- Conduct audits that result in real improvements to the quality system
- Plan and execute the entire audit process
The course is designed for:
- Quality directors
- Managers
- Engineers
- Auditors
- ISO coordinators
- Laboratory Quality professionals
Day One
- Introduction and Welcome
- MDSAP background and Acceptability
- Written Exercise 1: Risk Assessment
- Chapter 1: Management Processes
- Chapter 2. Device Marketing Processes Overview of ISO 13485:2016 Requirements
Written Exercise 2: Audit Scenarios Management Process and DMAFR - Chapter 3: Measurement, Analysis and
Improvement (MAI) processes - Chapter 4: Adverse Event and Advisory Notices Requirements (AEANR) Processes
- Written Exercises 3: Audit Scenarios Measurement Analysis and Improvement and
AEANR
Day Two
- Chapter 5: Design & Development Processes
- Written Exercise 4: Audit Scenarios – Design
& Development - Chapter 6: Production and Service Controls
- Chapter 7: Purchasing Process
- Written Exercise 5: Production and Service
Control and Purchasing - Understanding MDSAP Audit Model Final Exam
Day Three
- Chapter 8: Planning for the MDSAP Audit
- Breakout Exercise 1: Calculating Audit
Duration - Breakout Exercise 2: Audit Objectives and
Scope - Breakout Exercise 3: Preparing an Audit
Plan - Breakout Exercise 4: Documentation
Review
Day Four
- Chapter 8: Planning for the MDSAP Audit (cont’d)
- Chapter 9: Conduct an Audit Using the MDSAP Approach
- Breakout Exercise 5: Raising and Grading
Nonconformities - MDSAP Auditing Final Exam