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.
- 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
- Provides 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