ISO 13485 Internal Auditor Training
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June 26 • 8:00 AM - 4:00 PM
June 27 • 8:00 AM - 4:00 PM
Online
Cost
$625; after June 12th, 2024, the price increases to $645
Contact
317-275-6810
mepsupport@purdue.edu
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