ISO 13485 Internal Auditor Training

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 to 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.

Cost of a public workshop includes one copy of the ISO 13485:2016 standard for each participant.

Objectives:

• 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.

Intended audience: Personnel involved in conducting or supporting ISO internal audits.

Workshop length: 16 hours/2 days