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ISO 13485 Gap Analysis Checklist
The Gap Analysis is one of the most important steps in your project. It outlines what areas of your current Quality System need improvement to meet ISO 13485:
- You know where you are (Current Quality Management System).
- You want to be ISO 13485 Compliant
- The difference between these is your gap. Anytime they differ you need to change your processes to bridge the gap.
This Gap Analysis Checklist Toolkit includes:
 A detailed 40 page checklist covering every section ISO 13485. Includes guidance on what to look for to evaluate your current processes and their compliance to ISO 13485 and space for notes. - ISO 13485 Gap Checklist Sample
- Project Plan
- Project Plan Template
- Sample Gap Schedule
- Instruction Guide: What is an ISO 13485 Gap Analysis?
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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 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.
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.
All for only
! That's like getting an electronic GPS for the price of a paper map!
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