Plan medical device audits around process risk.
Guides medical device quality audits from risk-based planning through evidence collection, finding classification, and corrective-action verification.
When to use it
Use when planning or conducting internal audits, classifying findings, preparing for external audits, or managing an audit program.
Give it an audit request and relevant quality-system documents and records; it guides the audit and produces evidence-backed findings and a report.
What you provide
No setup requirements listed.
No additional actions listed.