The Gap Analysis is one of the most important steps in your project. It helps you determine your path:

• You know where you are.

• The ISO 13485 Standard tells you where you need to be

• Anytime they differ you need to change your processes to bridge the gap

The purpose of the Gap Analysis Toolkit is to:

• Provide the tools and checklist you need to conduct your Gap Analysis

• Provide a detailed checklist to use to compare your current systems to the requirements of ISO 13485

• Help you identify the requirements that your organization is already meeting, and those that need to be addressed

• Give you the information you need to determine resources and a timeline for your project.

This Gap Analysis Checklist Toolkit includes:

• A detailed 40 page checklist which you can customize to fit your needs. (MS Word)

• Includes guidance to evaluate your current processes and their compliance to the ISO 13485 Requirements.

• Space for notes and observations

• Instruction Guide: What is an ISO 13485 Gap Analysis?

• Project Plan Template

• Project Plan