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Introduction to ISO 13485 (Clause by Clause)

This course takes you step by step through the standard. By the end of this course, participants will have a strong foundational knowledge of the Quality Management System requirements.

Course Details

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 is a one day course in which participants will fully engage with the lecturer through group and individual exercises and debate.  There are plenty of opportunities to ask questions and the course can be fully tailored to the company’s products and internal structure. 

This 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.