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Understanding and Documenting ISO 13485:2003

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Seminar Content

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD Competency Units. This seminar fully covers the ISO 13485:2003 requirements.ISO 13485 is a Quality Management Standard for Medical Devices. Many medical device companies are utilizing ISO 13485:2003 as a platform to build their business management systems because of its benefits or because it is a necessary step to market their products and services in certain regions. For many companies, registration to ISO 13485 is a key to securing and maintaining global business. Other topics include the documentation process, and implementing or upgrading a management system to meet the requirements of ISO 13485:2003 and the operational objectives of the company.

This class also covers the FDA 21 CFR 82030 for design control guidance for Medical Device Manufacturers, the section of the Food, Drug and Cosmetic Act relating to Medical Devices, Labeling for Medical Devices, US FDA QSR regulations and Good Manufacturing Practices (GMP), Post Market Surveillance, and Human Factors in Medical Device Design.

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

  • Exemplar Global-MD

Who Should Attend

This seminar is designed for Quality Assurance Managers, ISO 13485:2003 Implementation Team Members, and Management Representatives.

Recommended Training and/or Experience

A general understanding of ISO 13485:2003 is recommended.

Seminar Materials

Each participant will receive a seminar manual.

Seminar Goals

  • Understand the application of Quality Management Principles in the context of ISO 13485:2003.
  • Relate the quality management system to the organization’s medical devices, and provision of related services.

Seminar Outline

Day One

  • Introduction and Welcome
  • The Challenge for Top Management
  • Eight Quality Management Principles
  • The ISO 13485:2003 Standard Explained
  • Overview of ISO 13485:2003 Requirements
    • Breakout Exercise 1: Exclusions
  • Overview of ISO 13485:2003 Requirements – Clause 4
  • Overview of ISO 13485:2003 Requirements – Clause 5
  • Overview of ISO 13485:2003 Requirements – Clause 6
  • Overview of ISO 13485:2003 Requirements – Clause 7

Day Two

  • Overview of ISO 13485:2003 Requirements – Clause 8
  • Introduction to ISO 13485:2003 Audit Trails
    • Breakout Exercise 2: Documentation Review


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