Free DHF Audit Checklist & Index Template
Free DHF Audit Checklist & Index Template
Instant download. Editable files. One-organization licence. 30-day money-back guarantee.
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Train your team on this
Make sure the whole team understands the requirement behind these records. The ISO 13485 Foundations Course is online and self-paced.
ISO 13485:2016 Foundations Course (Online, Self-Paced, Certificate of Completion), $99Certificate of Completion issued by ISO Cloud Consulting. It is not an accredited or third-party qualification.
Also see: ISO 13485:2016 Lead Implementer Course (Online, Certificate of Completion), $399. Browse the Academy.
Get the complete version
The free template is one piece of the system. The ISO 13485 Starter Kit gives you the six core kits: gap assessment, quality manual, document control, CAPA, internal audit and training.
See the ISO 13485 Starter Kit for $249Prefer to learn it properly? ISO 13485:2016 Foundations Course (Online, Self-Paced, Certificate of Completion), with unlimited access and a certificate of completion, for $99.
Check a design history file before an auditor does. This free workbook indexes 19 design history file elements (plan, inputs, outputs, reviews, verification, validation, transfer, changes and more) and gives you 20 audit questions with the evidence to look for.
What you get
- DHF Audit Checklist and Index (Excel): instructions, DHF index and audit checklist.
Want the full system?
The ISO 13485 Design Controls & DHF template kit adds the plan, inputs, outputs, reviews, V&V, transfer and change templates, trace matrices and a fully worked example.
Three ways to buy ISO 13485 templates
Start with the gap assessment, build the core system with the Starter Kit, or get every kit at once. Upgrade credits mean you never pay twice for the same kit.
| What is included | Gap Assessment Workbook See where you stand before you commit $49View Gap Assessment Workbook | Starter Kit
Core system: 6 kits for clauses 4 to 6 and 8
$249 | Best valueComplete QMS Kit
All 15 kits, including design, risk and production
$449 |
|---|---|---|---|
| Gap assessment, 71 requirement areas with action plan | Included | Included | Included |
| Quality manual and management review kit | Not included | Included | Included |
| Document control and records kit | Not included | Included | Included |
| CAPA and nonconformance kit | Not included | Included | Included |
| Internal audit kit | Not included | Included | Included |
| Training and competence kit (8 modules) | Not included | Included | Included |
| Design controls and DHF kit, ISO 14971 risk management file kit | Not included | Not included | Included |
| Supplier control, production and traceability, equipment and calibration kits | Not included | Not included | Included |
| Software validation, medical device file and labelling kits | Not included | Not included | Included |
| Complaint handling, PMS and vigilance kit, plus the process validation IQ/OQ/PQ pack | Not included | Not included | Included |
| Start-here roadmap to certification | Not included | Not included | Included |
| Optional 60-minute onboarding call with the author | Not included | Included | Included |
| 30-day money-back guarantee, instant download, one-organization licence, free updates for this edition | Included | Included | Included |
Prices in USD. Crossed-out prices are the combined price of the included items bought separately. Own a smaller kit already? Upgrade credits are listed on each product page. Still unsure? Which kit is right for me?
What every download includes
Templates refer to clause numbers and describe requirements in our own words. They do not reproduce the text of any ISO standard, so you need your own licensed copy. Templates support your system; they do not guarantee certification. Licence, updates and refunds in one place: purchase terms. Sold by ISO Cloud Consulting LLC.
Questions about Free DHF Audit Checklist & Index Template
How will I receive the files?
A download button appears on the order confirmation page and the same link is emailed to you within a few minutes. Bundles arrive as one ZIP file.
Can I get a refund?
Yes. With our 30-day money-back guarantee, if the files do not fit your quality management system you can ask for a full refund within 30 days of your order. It applies once per customer and organization, covers the whole product, and requires you to confirm you have deleted the files. We also refund non-delivery, defective files, wrong items and duplicate purchases within 30 days. Read the full refund policy.
Can I see the files before I buy?
Yes. The images above show real pages from the files, and most kits have free sample pages you can download with your email address. You can also see a fully worked example of a procedure and its linked records.
Will I get updates?
Yes, for the edition of the standard this product covers. Corrections, amendments and guidance changes for that edition are sent to you free, by email, for as long as we sell the product. If the standard is replaced by a new edition, the new kit is a separate product and existing buyers get an upgrade discount. See the version history.
Can I use the templates with more than one company?
Each purchase is licensed to one organization (one legal entity). Consultants can use one product with up to 10 client organizations with the Consultant Multi-Client Licence, including applying their own or the client's branding. See consultant rights and the licence agreement.
Who wrote these templates
Ishan Maharaj
Founder and Principal Consultant
BSc Engineering (Industrial) Honours and MSc Engineering Management
An industrial engineer who has worked in regulated medical device manufacturing throughout his career, in senior operations and quality leadership roles since 2019. Every template on this site was written and checked by him against the published standard, and the same person answers your questions.