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.
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