Course Description

ISO 13485:2003 Foundation and Basic Principles(old Version)

Course Description:

Note: This is only for users who want to knowledge the previous version of ISO 13485


This course covers the following topics:

  • Basic principles of ISO 13485:2003
  • A step-by-step guide of ISO 13485:2003 requirements
  • Detailed explanations of each requirement and quality system links between the requirements

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Build a strong foundation of the basic principles of ISO 13485 before moving on to the applicable guidance document ISO/TR 14969: “Medical Devices - Quality Management Systems - Guidance on the Application of ISO 13485”
  • Participate in the process of implementing a quality system

Who Should Enroll:

Quality management staff who are new to medical devices, regulatory staff seeking a refresher in quality system requirements, and management staff not directly in charge of compliance issues but wanting an overview are all encouraged to take this course. 

Prerequisite Knowledge/Requirements:

The following material is required:

  • Familiarity with other quality system standards or regulations, such as ISO 9001
  • A copy of the ISO 13485:2003 standard
  • A copy of the current version of the ISO/TR 14969 guidance

Subject Matter Expert:
Carole Stamp
Maria Cianciotto

183 min

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Basic Account: € 349.00
Premium Account: € 261.00

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