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.
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.
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