ISO 13485:2016 – Chapter 1-3: Introduction

Description:

The learning objectives of this program are to understand what ISO 13485 is, and what some of the key advantages to an ISO 13485 certification can provide. This program will also provide an in depth understanding of which policies, procedures and systems need to be put in place to be able to implement and maintain compliance with the 13485 standards.

Curriculum for this course:
Module 1: Introduction
Overview 45 secs
Course introduction 1 min 31 secs
CFR, ICH and The FDA 1 min 21 secs
Challenges facing the medical device industry 1 min 10 secs
Single user license 58 secs
Course objectives 1 min 09 secs
Module 2: About ISO
Background & history 1 min 32 secs
Mission statement 1 min 16 secs
The difference between ISO 13485 and ISO 9001 1 min 29 secs
Updates every five years 1 min 31 secs
ISO certification 1 min 45 secs
Advantages of ISO certification 1 min 09 secs
European Union – Part 1 1 min 16 secs
European Union – Part 2 1 min 19 secs
The United States 1 min 38 secs
ISO inspections – Part 1 1 min 42 secs
ISO inspections – Part 2 1 min 49 secs
Module 3: Medical Devices – Quality Management System
Scope 1 min 20 secs
Definitions 1 min 32 secs
Definition example 1 min 40 secs
Conclusion
Final Assessment
Certification
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