ISO 13485 Gap Analysis Toolkit

A detailed ISO 13485 GAP Analysis checklist (MS Word) with guidance on what to look for to evaluate your current processes and their compliance to the ISO 13485 Requirements.
Price: US$59.00

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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 therequirements 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

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