ISO 13485 Gap Checklist

A detailed ISO 13485 Gap Checklist (MS Word) with guidance on what to look for to evaluate current processes and compliance to the ISO 13485 Requirements.

File Size: 0.99 MB
Format: ZIP
Language: English
Product Type: Checklist
Provider: 13485 Store

Price: $59.00
Product Details


  • Provides a detailed checklist and tools to compare an organization's current quality management system to the requirements of ISO 13485.
  • Identifies the requirements the organization is already meeting, and those that need to be addressed to meet the standard.
  • Includes information to determine the necessary resources and timeline for the implementation project.


  • 40 page checklist ISO 13485 Gap Checklist (MS Word)
  • Instruction Guide: What is an ISO 13485 Gap Analysis?
  • Project Plan Template
  • Project Plan
  • Sample Employee Newsletter

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed