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ISO 13485 Workbook Details

The workbook is divided into 3 sections which include:

Detailed task checklists Thorough explanations 28 Exercises

Section 1: Prepare Your Organization

Management must identify a steering team for the project. It should be made up of managers from different areas of the organization. The purpose of the team will be to assign resources and responsibilities for the project as well as providing leadership for the project.

Once the steering team has been identified, the team can work together to complete the assigned tasks for section 1 which helps you prepare for the project and put together the project plan and timeline.

This section breaks this down into 10 tasks and takes you through it step by step.

Task 1: Management Describe your company
Task 2: Management Choose your ISO Management System
Task 3: Management Obtain the latest ISO 13485 standard
Task 4: Management Select the Management Rep & Steering Team
Task 5: ISO Steering Team Prepare an Organizational Chart
Task 6: ISO Steering Team Establish the Quality Team
Task 7: Quality Team Conduct First Team Meeting
Task 8: ISO Steering Team Formulate the Quality Policy/Objectives
Task 9: ISO Steering Team State the scope of the QMS
Task 10: Quality Team/ Identify applicable regulations ISO Steering Team

Section 2: Develop Your ISO 13485 Quality Management System (QMS)

This section of the workbook includes a Gap Analysis to help you identify where you need to create or amend processes critical to meeting customer requirements, as well as helpful diagrams and Gantt charts.

Task 11: Quality Team Identify/Describe processes/Prepare process flow diagrams
Task 12: ISO Steering Team Provide Communication Tools
Task 13: Quality Team Conduct a Preliminary Assessment
Task 14: ISO Steering Team Assign Improvement Actions for QMS
Task 15: ISO Steering Team Provide ISO 13485 training-Exercises A-G
Task 16: ISO Steering Team Manage the Implementation Project
Task 17: ISO Steering Team Complete Project Timing Chart
Task 18: ISO Steering Team Collect Existing Documents
Task 19: ISO Steering Team Perform financial study of costs and benefits
Task 20: ISO Steering Team Reconfirm the ISO 13485 Decision
Task 21: ISO Steering Team Promote and practice teamwork

Section 3: Implementation and ISO 13485 Registration

This section of the workbook includes the steps to complete the design, implementation and documentation of your ISO 13485 QMS. The ISO Steering Team will assign responsibilities and timeline for tasks, including training, internal audits, management review and the final steps to implementation.

Task 22: ISO Steering Team Obtain and Review a Model for a QMS Manual
Task 23: ISO Steering Team Use the Model as a Template to generate QMS documentation
Task 24: ISO Steering Team Implement the Quality Management System
Task 25: ISO Steering Team Conduct Internal Audit of the QMS
Task 26: ISO Steering Team Conduct the Management Review
Task 27: Select a Certification Body to register the QMS
Task 28: Receive Certification and Celebrate!

Includes PowerPoint Training Presentations for each section.
This Product is an electronic document which you can immediately download upon completing your transaction.

We can also provide full color, professionally printed and bound copies of the workbook. To order these,, please select <Hard Copy> as an additional item during checkout and enter your desired quantity.. This adds $30/workbook + shipping.

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.