ISO 13485:2016 Internal Auditor Training

Course Benefits

This course is intended to help you to understand ISO 13485:2016 and to conduct internal audits. Through examples, exercises, and a final exam, you will be familiar how this standard applies to the life-cycle of a medical device. The course covers the entire standard ISO13485:2016, and participants will learn about audit techniques, including behavior as well as questions and approaches for different clauses and requirements. Explanations of the necessary audit tasks and appropriate treatment of the nonconformities are an integral part of the training.

Who Will Benefit?

This course is designed for every employee who can perform internal audits under the scope of ISO 13485:2016.

Course Agenda

• Day 1: Management, Quality Documents, Training, Infrastructure
• Day 2: Design & development and Production
• Day 3: Indicators and controls, statistics and practical class for auditing skills

Duration

3 Days

Day 1: 10:00 AM – 05:00 PM
Day 2: 09:00 AM – 04:30 PM
Day 3: 09:00 AM – 04:30 PM

FAQs

We can also offer this training as in-house training courses on site in your company.

Timing

09:00 AM – 05:00 PM

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