Understanding ISO 13485

Learn the concepts of ISO 13485 and how the standard can become a valuable part of your business management system. Participants engage in activities that create an understanding of each standard element and the benefits of each element for their organization and for them as participants in a business management system.

Length:  2 days     Prerequisites:  None

Learning Objectives

  • Identify the benefits the process approach of ISO 13485 can deliver to any business management system.
  • Demonstrate an understanding of the purpose and intent of the ISO 13485 standard
  • Demonstrate an understanding of the process approach and relate how it impacts the use of ISO 13485.
  • Identify and understand the process within your organization.
  • Identify 8 quality management principles upon which the ISO 9000 family of standards were based.
  • Demonstrate an understanding of the purpose of ISO 14971 and ISO/TR 14969 and their relationship with ISO 13485
  • Define terminology and exclusion requirements in ISO 13485
  • Apply of each of the standard’s clauses and relates the clauses to the intent of the standard
  • Create a basic business model for elements of the standard – with inputs, transformations, and outputs as any business would have.
  • Compare the model to your organization’s model — and confirm insights gained into the process.
  • Relate key elements of the standard to your own company. Clause-by-clause review of the standard ensures understanding — and how each clause is applied to your own company.

Plexus Learning Model

Learning is maximized through participation. That is why Plexus training avoids lecture-based teaching and focuses on group activities, case studies and hands-on applications. Learn by doing.

Who Should Attend

  • Any memeber of an ISO 13485 implementation team
  • Risk managers
  • Quality managers
  • New internal auditors and experienced auditors that have not attended training in over three years
  • Representatives from key functional groups involved in an organization’s quality management system


Plexus Master Trainers. Plexus Master Trainers train and evaluate:

  • ISO 9001:2008, ISO/TS 16949:2009, AS9100, ISO 14001:2004 Environmental Management Systems, FSSC 22000:2005 Food Safety, ISO 9001:2008 for Healthcare and ISO 13485:2003 for Medical Devices.
  • Plexus trains 3rd party auditors and wrote the materials used to certify all of them


Day 1

  • Purpose and Objectives
  • Process Approach and Impacts
  • Clause by clause of ISO 13485

Day 2

  • Clause by clause review of ISO 13485 (continued)
  • Quality Management Principles
  • Closure and Planning: Opportunities, roadblocks and implementation planning