Home » ISO 9001 and ISO 13485 Gap Analysis Checklist

ISO 9001 to 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 9001 and ISO 13485.

This Gap Checklist will help you create an ISO 13485 and ISO 9001 compliant Quality Management System, regardless of your current system.

• You know where you are (Current Quality Management System).
• You want to be ISO 9001 and ISO 13485 Compliant
• The difference between these is your gap. Anytime they differ you need to change your processes to bridge the gap.

ISO 9001 to ISO 13485 (complete standard with changes highlighted)

This Gap Analysis Checklist Toolkit includes:

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 9001 and ISO 13485.
• Highlight the differences between ISO 9001 and 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!