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