Introduction to ISO 13485 (Clause by Clause)

The aims and learning outcomes of this course are:

• To understand the requirements of ISO 13485:2016.
• To appreciate the requirements of a quality management system.

Following completion of this course, participants should:

• Understand the requirements of ISO 13485:2016.
• Be able to actively participate in preparing documentation for their quality management system.
• All participants should have a working knowledge of a quality management system.

This course is held live in an online lecture theatre and delivered with a PowerPoint presentation.  All participants will fully engage with the lecturer through both group and individual exercises and direct participation throughout the course.  There are exercises included in order to ensure the course contents are fully understood and the opportunity is always available for participants to ask questions.

This three module course works through the ISO 13485:2016 quality management system standard and is broken down into 3 modules.

1. Introduction to the ISO 13485 standard.
2. Plan & Do clauses of the standard.
3. Check and Act clauses of the standard.