ISO 13485 Workbook and Training Package

The first step in your ISO 13485 project is to define and build a Quality Management System (QMS) according to the requirements of the ISO 13485 standard.

 

This workbook guides you by providing:

• Checklists and Exercises
  The ISO 13485 Workbook is a series of detailed checklists, exercises and instructions that take you through 28 systematic tasks for your organization to consider and complete.
  
• View list of workbook contents
  
• Training Presentations
  

The Workbook includes a set of 3 ISO 13485 PowerPoint training presentations designed to be a companion to the Workbook. Use these to train everyone in the organization on the ISO 13485 implementation and system.

Think of it as your own personal seminar on implementation for your organization. Your business is unique in its approach, execution, and commitment to customers. You can design your QMS to work for your particular business (instead of a generic approach) while ensuring that you meet the requirements of ISO 13485.

The Workbook is part of our do-it-yourself-workshop approach along with the ISO 13485 Documentation Package, and will save you time and money by guiding you through the necessary steps.

These products are all integrated to work together to help you achieve certification. This is an effective method that is well suited to small and medium size organizations.

The identified workbook provides a very “hands-on” approach and the work can be systematically and successfully completed with a small multi-tasking staff.

This workbook has been used successfully around the world in a variety of industries.
US$299

Additional Workbooks

 

If you would like additional workbooks for your team members or if you are a very small company and don't need to train others, you can purchase the workbook on its own, without the presentations.
US$226