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ISO 13485 GAP CHECKLIST 2008 Edition, 2008
Complete Document
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ISO 13485 GAP CHECKLIST
Additional Comments: ISO DOCUMENT NOT INCLUDED * SEE ISO 13485
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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.

Features/Benefits:
  • A detailed Gap Checklist used to compare an organization’s current quality 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.
  • Provides information to determine the necessary resources and timeline for the implementation project.


Contents:
  • 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