Understanding and Documenting AS9120B Aerospace Quality Management Systems (AQMS)

Training overview
Professional Course
Virtual Classroom
2 day(s)
From 795 USD

Start dates
795 USD
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Course description

Understanding and Documenting ISO 13485:2016 for Medical Devices Quality Management Systems

Omnex is an Exemplar Global certified training provider and offers this 1.5 day course under the TPECS scheme meeting the knowledge competency requirements for Medical Devices Management Systems that can be applied to all auditor grades. This seminar fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector.

Many medical device companies are utilizing ISO 13485 as a platform to build their business management systems because of its value or because third-party certification is a specified requirement by customers and/or regulators.

This class also covers the comparable 21 CFR 820 content for additional guidance for organizations in the Medical Device sector.

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Who should attend?


A general understanding of quality management systems and a minimum of 3 months of relevant experience is recommended.

Who Should Attend

This seminar is designed for Quality Assurance Practitioners, Managers, ISO 13485:2016 Implementation Team Members, and Management Representatives.

Training content

Day One

  • Introduction and Welcome
  • Chapter 1 - Introduction to ISO 13485
  • Chapter 2 - The ISO 13485 Standard Explained
  • MD Written Exercise 1 (individual)
  • Chapter 3 - Overview of ISO 13485:2016 Requirements
  • MD Written Exercises 2a, 2b (Audit Scenarios)

Day Two

  • Overview of ISO 13485:2016 Requirements (cont’d)
  • Breakout Exercise 2c (Audit Scenarios)
  • MD Written Exercise 3 (individual)

Course delivery details

Course Duration: 2 Days - 8 Hours/day

About Omnex

Omnex, International Consulting, Training and Software Development Organization

Omnex is an international consulting, training and software development organization specializing in management system solutions that elevate the performance of client organizations. Omnex provides consulting and training services in Quality, Environmental, and Health and Safety standards-based management systems. Omnex also...

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