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Catalog · Checklists

Internal Audit Checklist

Process-based audit prompts for ISO 13485 / QMSR audits — understanding, performance, risk and prior findings — with an evidence column that records what you actually sampled.

DOCX templateProcess-basedEvidence-sampling discipline built in
  • Audit processes, not paragraphs — the checklist follows how work flows, the approach auditors are trained to use
  • Record what you sampled (IDs, dates, quantities), so findings survive challenge
  • Walk in with prior findings loaded — follow-up verification is a section, not a memory
What's inside

Built like the working documents we write about

  • Checklist details block

    Audit scope, criteria, date and auditor — the identity fields your audit record needs.

  • Process understanding

    Prompts that establish inputs, outputs, owners and interactions before any conformity question is asked.

  • Process performance

    Objective-evidence prompts against the process's own metrics and the applicable clauses.

  • Risk and change

    What changed since last audit, and whether risk controls moved with it.

  • Prior findings

    Verification prompts for earlier nonconformities — §8.2.4's follow-up requirement as a section.

  • Summary of findings

    Classified findings with evidence references, ready to route into reporting and CAPA.

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
Process understandingISO 13485 §4.1.2 · processes, their sequence and interaction — the process approach the audit follows
Process performanceISO 13485 §8.2.4 · conformity to planned arrangements, judged on objective evidence
Risk and changeISO 13485 §4.1.2(b) · risk-based control of QMS processes, re-checked when they change
Prior findingsISO 13485 §8.2.4 · follow-up verification of actions from previous audits
Summary of findingsISO 13485 §8.2.4, §4.2.5 · results recorded and reported; the record is controlled
Whole documentFDA QMSR (21 CFR 820, eff. 2026-02-02) · incorporates ISO 13485:2016 by reference
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
5 checklist sections · evidence and findings columns throughout
Mapped to
ISO 13485:2016 §8.2.4 and the §4.1.2 process approach
Works with
RT-SOP-005 Internal Audit Procedure — this is the checklist its §6.3 preparation step expects
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

A checklist that only asks "is there a procedure?" audits paper. This one follows the process and demands sampled evidence — IDs, dates, quantities. Read the craft behind it: what an internal audit plan has to decide and what makes a checklist worth trusting.

Take the checklist template to work today.

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

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