Home » ISO 13485 Gap Analysis Checklist
ISO 13485 Gap Analysis Checklist
 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 Standard tells you where you need to be
- Anytime they differ you need to change your processes to bridge the gap
We've developed the Gap Analysis Checklist to help you map your path. The Gap Analysis
Toolkit will:
- 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 checklist (MS Word) with guidance on what to look for to evaluate your
current processes and their compliance to the ISO 13485 Requirements. view screenshot
- Space for notes and observations
- Project Plan
- Project Plan Template
Only $59! That's like getting an electronic GPS for the price of a paper map!
When traveling to unknown areas, a map is a necessity. Likewise, a Gap Analysis will
provide you with valuable information to help you plan your Implementation Project.
Our Checklist will give you the information you need to bridge the Gap.
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