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Catalog · Procedures

Internal Audit Procedure Template

Planning, conducting, reporting and following up internal QMS audits — a six-step procedure whose structure answers ISO 13485 §8.2.4's requirements one by one, independence rules included.

DOCX template6 procedure stepsMapped to ISO 13485:2016 §8.2.4
  • Run an audit program that covers criteria, scope, frequency and methods — the four things §8.2.4 says you must define
  • Keep auditor independence defensible: the qualification section bars auditing your own work by design
  • Close the loop — findings route into corrective action with follow-up verification, not into a drawer
What's inside

Built like the working documents we write about

  • Ready-to-adopt document shell

    Document-control header, approvals block and revision history table, wired for your document control.

  • Audit program

    A risk-informed annual program defining criteria, scope, frequency and methods across the QMS.

  • Auditor qualification and independence

    Competence requirements plus the impartiality rule — no one audits their own work.

  • Preparation and conduct

    Per-audit scope, checklist discipline, and evidence sampling that records what was sampled.

  • Reporting

    Findings classified and reported with objective evidence, on a defined timeline.

  • Corrective action and follow-up

    Nonconformities route into the CAPA system; verification closes the audit, not the report.

The source map

Why each section exists

Bundle shops sell you a zip and a wish. Every section of this document states the clause it was written to satisfy — the same map is printed inside the document, where your auditor can read it.

Document sectionSatisfies
6.1 Audit programISO 13485 §8.2.4 · audits at planned intervals; criteria, scope, interval and methods defined and recorded
6.2 Auditor qualification and independenceISO 13485 §8.2.4 · objectivity and impartiality; auditors do not audit their own work
6.3 PreparationISO 13485 §8.2.4 · criteria and scope defined for each audit
6.4 ConductISO 13485 §8.2.4 · audit methods executed against objective evidence
6.5 ReportingISO 13485 §8.2.4, §4.2.5 · records of audits and their results maintained
6.6 Corrective action and follow-upISO 13485 §8.2.4 · corrections and corrective actions without undue delay; follow-up includes verification and reporting
Program output over timeISO 13485 §5.6.2(c) · audit results are a required management-review input
Whole documentFDA QMSR (21 CFR 820, eff. 2026-02-02) · incorporates ISO 13485:2016 by reference — and under QMSR, audit reports are no longer exempt from FDA review
The details

Exactly what you get

No surprises at download time — the format, the scope, and the license, stated up front.

Format
Microsoft Word (.docx) — no macros, works in Google Docs
Length
9 sections · 6 procedure steps · approvals and revision-history tables included
Mapped to
ISO 13485:2016 §8.2.4 and FDA QMSR (21 CFR 820), section by section
Works with
RT-CHK-001 Internal Audit Checklist and RT-SOP-007 CAPA Procedure (findings route there)
Delivery
Instant download after checkout, with a re-download link on your receipt
Updates
Revised when the source moves; buyers get the new revision by email, free
License
One purchase covers your team at one company site

Check our work

Under the QMSR, internal audit reports lost their FDA-inspection exemption — the program you run is now part of the record an investigator can read. Read the craft behind it: what an internal audit plan has to decide and what makes a checklist worth trusting.

Take the sop template to work today.

One purchase, yours immediately at launch — and revised for free when the source moves.

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