In this two-day workshop, you’ll gain the knowledge and skills you need to audit your quality system to the ISO 13485:2016 standard. Course topics include updates the ISO 13485 standard, ISO 13485:2016 requirements, auditing principles, and techniques for conducting effective audits. You'll also get hands-on practice using auditing tools and techniques and have ample opportunities to get answers to questions you have about conducting ISO audits.
MEP provides participants a copy of the standard
Personnel involved in conducting or supporting ISO internal audits.
You Will Learn
- Explain the purposes of the ISO 13485 standard.
- Describe the structure and elements of ISO 13485:2016.
- Describe the changes included in ISO 13485:2016.
- Explain what is meant by a "process approach" and what the strategy of a process approach means for organizations.
- Explain basic principles, techniques, and steps for auditing to ISO 13485.
- Describe techniques for effectively working with others when conducting audits.