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Ready-to-use Excel tool — walk into your ISO 13485 certification audit knowing you’ll pass.
For medical-device organizations running a QMS to ISO 13485

ISO 13485 Certification Audit Checklist

Prepare for the ISO 13485:2016 certification audit before the auditor arrives — an Excel file that scores your readiness clause by clause.

  • Every requirement the certification auditor will check
  • Readiness scored automatically so you see your weak points
  • Gaps turned into a dated action plan before the audit
  • Instant download — a file you keep and reuse
$49$98−50%

One-time payment. Instant download. 30-day money-back guarantee.

Add to cart — $49
Dashboard
Detailed checklist
Summary
Action plan
ISO 13485
64%
Overall conformity
100%
Requirements covered
23
Open gaps
58%
18%
17%
Conform Partial Non-conform N/A
The starting point

The certification auditor has a checklist. Now so do you.

The ISO 13485:2016 certification audit tests your medical device quality management system against the full standard. Going in without a self-assessment means discovering gaps in front of the auditor. This file lets you audit yourself first, close the gaps, and walk in ready.

What you get

Exactly what’s inside

A sample of the “Detailed checklist” tab. Each row is a requirement the auditor checks, with what they look for.

ReferenceRequirement checkedWhat the auditor looks forReadinessStatus
Product realization
7.3Control design and development, including design transfer and files.Design & development files (DHF)R&DPartial
7.5.1Control production under defined and validated conditions.Device master record, process validationProductionNon-conform
Measurement & improvement
8.2.1Handle complaints and feedback from the market.Complaint handling recordsRegulatory affairsTo evaluate
8.3Control nonconforming product and apply CAPA.Nonconformity & CAPA recordsQuality managerPartial
Plus every other requirement across all clauses of ISO 13485:2016 — in the complete file.
File structure

Four tabs that work together

1

Dashboard

Overall conformity rate, number of open gaps, breakdown by status. Everything updates as you fill in the checklist.

2

Detailed checklist

One row per requirement: the point to check, the expected evidence, the owner and a status drop-down.

3

Summary

Charts generated from your entries: score by clause and status breakdown, ready to present to management.

4

Action plan

Each gap becomes a dated, assigned action, tracked to closure and ready for your audit.

Free vs complete

What the free list doesn’t give you

A free requirements list tells you what the standard asks. This checklist turns it into a working control tool.

FeatureFree requirements listCertification audit checklist
Requirements listYesYes
One detailed row per requirementNoYes
Point, evidence and owner per requirementNoYes
Conformity score calculated automaticallyNoYes
Dashboard and summary chartsNoYes
Corrective action plan includedNoYes
How it works

Three steps, from where you are to done

Step 1

You self-assess

You test your system against every requirement the auditor will check, and score your readiness.

Step 2

You close gaps

Each weak point becomes a dated, assigned action so nothing is open on audit day.

Step 3

You certify

You walk into the certification audit prepared, with the evidence organized and the gaps closed.

Self-assessment → Close gaps → Certification audit → Certificate

Coverage

The 5 core clauses of ISO 13485:2016, requirement by requirement

Nothing is left as a heading. Every clause is broken down into the requirements you check off — here is what each one covers.

4Quality management system
General & documentation requirementsQuality manualMedical device fileControl of documents & records
5Management responsibility
Management commitment & customer focusQuality policy & objectivesResponsibility & authorityManagement review
6Resource management
Human resources & competenceInfrastructureWork environment & contamination control
7Product realization
Planning & customer-related processesDesign & developmentPurchasingProduction & service provisionControl of monitoring & measuring equipment
8Measurement, analysis & improvement
Feedback & complaint handlingReporting to regulatory authoritiesInternal auditControl of nonconforming productCorrective & preventive action
30-day money-back guarantee

Your purchase is protected for 30 full days

Download the checklist, put it to work on your real project, and judge it against what you actually need. If it doesn’t fit — or you simply change your mind — email us any time within 30 days and we’ll refund you in full. No forms to fill in, no justification to give, no risk on your side. We’d rather earn a satisfied customer than keep an unhappy one, which is exactly why every QSE Academy download comes with this promise.

One standard, one checklist per need

Which ISO 13485 checklist do you need?

Each stage of your project has its checklist. You’re in the right place for this one.

Implementation
Build the system, requirement by requirement
Discover
Internal Audit
Run the internal audit the standard requires
Discover
Certification Audit
Prepare for the certification audit before the auditor
You are here

Going further: the complete ISO 13485 documentation kit.

FAQ

What to know before you buy

Does this checklist replace the ISO 13485 documentation kit?
No. The checklist diagnoses your gaps and structures your action plan. To provide the documents that close those gaps, the ISO 13485 documentation kit takes over.
What format is the checklist delivered in?
An Excel (.xlsx) file, downloadable immediately after purchase. It works offline; you keep it and reuse it as often as you need.
Does the conformity score calculate itself?
Yes. You pick a status per requirement from a drop-down, and the dashboard and charts update automatically.
Which version is it built on?
The version in force, ISO 13485:2016, shown on the cover.
Will this guarantee I pass the audit?
No tool can guarantee a result, but self-assessing against every requirement the auditor checks — and closing the gaps first — is the single best way to remove surprises on audit day.

Pass your ISO 13485 certification audit

Download the certification audit checklist and walk in ready, not hopeful.

$49$98−50%
Add to cart — $49
ISO 13485 Certification Audit Checklist — $49Add to cart