ISO 13485 Checklist: Step-by-Step Workbook and Presentations

ISO 13485 Workbook Contents

The workbook is divided into 3 sections and includes detailed task checklists, explanations and 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.

There is a PowerPoint Training Presentation for this process.

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.

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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.
Includes a PowerPoint Training Presentation.

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