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

Training to Understand and Document ISO 13485:2016 for Medical Devices QMS

Course Duration: 2 Days - 8 Hours/day

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.

Attendees who successfully demonstrate competence during this course will achieve a Certificate of Attainment for the following competency units:

  • Exemplar Global-MD

*FOR PUBLIC TRAINING ONLY - The requirements portion of this training is conducted online prior to the in-classroom or virtual course. The seated or virtual classroom portion of the class will begin on Tuesday morning with a review and testing. The Monday of that training week will be offline and for finishing the e-learning or contacting the instructor with questions. The auditor portions (AU and TL) will continue as appropriate according to the dates scheduled.

Learning Objectives

  • Understand the application of Quality Management Principles in the context of ISO 13485:2016.
  • Relate the quality management system to the organization’s medical devices, and provision of related services.

Course Outline

Each participant will receive a seminar manual.

Who Should Attend

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

Course Materials

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)

Note: Omnex does not provide copies of standard(s) during training courses, but clients are encouraged to have their own copy.


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

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