About Course
Course Duration: 5 Days – 8 Hours/day
This 5-Day ISO 13485 training course fully covers the ISO 13485:2016 requirements. Other topics include audit systems, the auditing process and audit instruments; the documentation process, conducting an audit, writing the audit report and evaluating corrective actions. Auditing case studies will be used to develop the required auditing skills based on ISO 19011.
This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.
Course Outline
Day One
- Introduction and Welcome
- Chapter 1 – Introduction to ISO 13485
- Chapter 2 – The ISO 13485 Standard Explained
- MD Written Exercise 1 (individual)
- Chapter 3 – Overview of ISO 13485:2016 Requirements
- MD Written Exercises 2a, 2b (Audit Scenarios)
Day Two
- Overview of ISO 13485:2016 Requirements (cont’d)
- Breakout Exercise 2c (Audit Scenarios)
- MD Written Exercise (individual)
- Introduction to Management System Audit Trails
- AU Breakout Exercise 1: Scope and Objectives
- Management of Audit Programs
- Management System Audit Planning and Preparation
- AU Breakout Exercise 2: Documentation Review
- AU Breakout Exercise 3: Audit Plan
Day Three
- Performing the Audit
- AU Breakout Exercise 4: Conducting the Audit
- Writing Nonconformity Statements
- AU Breakout Exercise 5: Writing Nonconformities
- Closing Meeting
- Completing the Audit Report
- Corrective Action and Closeout
- AU Written Exercise (individual)
Day Four
- Review of Audit Process and Audit Management Strategies
- Case Study Mock Audit
Day Five
- Instructor Interviews as needed
- TL Written Exercise (individual)
