Recommended for anyone who wants/needs to learn about ISO 13485, trainers who want a simple, effective method of explaining ISO 13485 to employees, potential internal auditors, and risk and quality managers.

• Apply invaluable insights into the benefits the process approach of ISO 13485:2003 can deliver to any business management system.
• Assimilate purpose and intent of the ISO 13485 standard
• Define the process approach and how it impacts the use of ISO 13485:2003.
• Identify and understand the process within your organization.
• Apply the 8 quality management principles upon which the ISO 9000 family of standards were based.
• Define Terminology and exclusion requirements in ISO 13485:2003
• Apply the standard's clauses and relate 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.
• Use "Reflect and Connect" exercises and 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 each clause is applied to your own company.