Internal Audit SOP + 3 Templates — ISO 13485 & MDSAP Compliant

Process Package — Internal Audit

A complete internal audit system covering ISO 13485:2016 §8.2.4 and MDSAP Chapter 1 audit-readiness expectations. Risk-based programme planning, structured audits, and findings management with linkage to CAPA.

What’s included:

• SOP-CORE-03 Internal Audit — full procedure including risk-based programme rationale, audit team competence, planning, conduct, reporting, NC grading methodology (5-tier per Annex A), follow-up and effectiveness verification.
• F-CORE-03.1 Annual Audit Programme (Excel) — programme planning workbook with risk scoring, MDSAP coverage tracker (5 chapters mapped to processes), conditional formatting for status and risk level, and statistics block with auto-counting formulas.
• F-CORE-03.2 Audit Plan (Word) — single-audit planning template with scope, criteria, team, process owner contacts, sample selection plan, and logistics.
• F-CORE-03.3 Audit Report (Word) — final report template with executive summary, findings count, detailed findings with grading, CAPA linkage, positive observations, closing meeting attendance, and sign-off block.

Why this package: Internal audit is one of the four corners of an effective QMS. This package gives you a programme that is risk-based, MDSAP-coverage-mapped, and produces evidence auditors recognize and accept.

Format: Microsoft Word + Microsoft Excel
Updated: May 2026
Delivery: Instant download after purchase