Internal Audit Prep Kit – ISO 13485 & FDA 21 CFR 820 Ready

Complete 8-document toolkit to plan, conduct, and report internal audits. Includes SOP, checklists, report templates, and 50+ auditor questions with best practice answers.

What's included:

✅ Audit SOP – Complete procedure for internal audits (ISO 13485:2016 Section 8.2.4)

✅ Audit Plan Template – Document scope, objectives, criteria, and schedule

✅ Audit Checklist (Excel) – Comprehensive checklist for all QMS processes

✅ Annual Audit Schedule (Excel) – Plan your full audit program with risk-based frequency

✅ Audit Report Template – Professional format with finding classification

✅ Pre-Audit Readiness Checklist – Prepare your team 1-2 weeks before any audit

✅ Interview Guide – 50+ typical auditor questions with best practice answers

✅ Quick Reference Card – One-page audit process summary

Compliance: ISO 13485:2016 | FDA 21 CFR 820.22 | ISO 19011:2018

Format: Editable .docx and .xlsx files