ISO 13485 Templates: Free Preview and What's Included

By Ishan Maharaj, Founder and Principal Consultant. Last reviewed 2 November 2026.

Last updated: November 2026

Short answer: our ISO 13485 templates are editable Word and Excel kits, one per area of the standard, so you buy only the clauses you need. You can see sample pages and download a free gap assessment before you pay for anything. Each kit is a starting point that you adapt to your devices, processes and regulatory market; it does not replace your own judgement or your auditor's decision.

Not sure where to start? Begin with the ISO 13485 Gap Assessment Workbook (US$49), or jump to the kit for each clause.

Preview before you buy

Free ISO 13485 Gap Assessment Lite: a quick self-check to see where your QMS stands against the standard.
Free template samples: real pages from the paid kits, as they open in Word and Excel. Some are viewable without an email.
All free ISO 13485 resources.

Which kit covers which clause?

ISO 13485:2016 area	Kit	Price (USD)
All clauses: where do we stand?	ISO 13485 Gap Assessment Workbook	49
4.2.2 Quality manual and management system	Quality Manual and Management System Kit	99
4.2.4 and 4.2.5 Document and record control	Document Control and Records Kit	79
7.3 Design and development	Design Controls and DHF Kit	149
7.4 Purchasing	Supplier Control Kit	79
7.5.6 Process validation	Process Validation IQ/OQ/PQ Pack	99
8.2.1 to 8.2.3 Feedback, complaints and reporting	Complaint Handling, PMS and Vigilance Kit	99
8.2.4 Internal audit	Internal Audit Kit	79
8.3 and 8.5.2 Nonconforming product and corrective action	CAPA and Nonconformance Kit	79

More kits and bundles are in the full ISO 13485 templates collection. The clause references above are the main clauses each kit supports.

How to choose

Start with the free gap assessment or the paid workbook to list your gaps, so you do not buy kits you do not need.
Fix the areas auditors check first: document control, CAPA and internal audit are usual starting points for a first certification or a surveillance audit.
Add the product-specific kits (design controls, process validation, complaint handling) for the devices you actually make.

Your next step

Building a medical device QMS from scratch: start with the Gap Assessment Workbook (US$49), then the Quality Manual and Management System Kit (US$99) and the Document Control and Records Kit (US$79). Fixing one weak area before an audit: pick the single kit from the table above. 30-day money-back guarantee if a template doesn't fit your QMS.

Start with the Gap Assessment Workbook Browse all ISO 13485 templates

Training and expert help

Training your team on the standard? The ISO 13485:2016 Foundations Course (US$99, online, self-paced) covers the basics, and the ISO 13485:2016 Complete Training Track (US$599, 3 courses) goes further. Course certificates are certificates of completion. If you want a specialist to review your system before an audit, see our ISO 13485 consulting services. If you also hold or want ISO 9001, read ISO 9001 vs ISO 13485.

Frequently asked questions

Are there free ISO 13485 templates?

Yes. There is a free gap assessment and a set of free samples you can open before buying. The full kits are paid, instant downloads.

What file formats are the templates in?

Editable Word and Excel files, so you can put your own company name, device details and numbering into them.

Do the templates guarantee ISO 13485 certification?

No. They give you a structured starting point. Certification is decided by your certification body based on your implemented system and its records.

Which ISO 13485 template should I buy first?

Run a gap assessment first. If you are starting from nothing, document control and the quality manual are the usual first steps.

Online course

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