Learning Paths

ISO 13485:2016

This program will provide an understanding of which policies, procedures and systems need to be put in place to implement and maintain compliance with the 13485 standards and some of the key advantages to an ISO 13485 certification

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Total Time : 6 Hours

Learning Path Code : LP-020

Continuing Education Units : 0.8

#1

ISO 13485:2016 – Chapter 1-3: Introduction

Course Code: ELM-801

Course Duration: 45 mins

#2

ISO 13485:2016 – Chapter 4: The Quality Management System (QMS)

Course Code: ELM-802

Course Duration: 60 mins

#3

ISO 13485:2016 – Chapter 5: Management Responsibility

Course Code: ELM-803

Course Duration: 45 mins

#4

ISO 13485:2016 – Chapter 6: Resource Management

Course Code: ELM-804

Course Duration: 45 mins

#5

ISO 13485:2016 Product Realization (Chapter 7 – Part A)

Course Code: ELM-805

Course Duration: 60 mins

#6

ISO 13485:2016 – Product Realization (Chapter 7 – Part B)

Course Code: ELM-806

Course Duration: 45 mins

#7

ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part A)

Course Code: ELM-807

Course Duration: 45 mins

#8

ISO 13485:2016 – Measurement Analysis and Improvement (Chapter 8 – Part B)

Course Code: ELM-808

Course Duration: 45 mins

Congratulations

You are now certified in ISO 13485:2016

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