A complete, editable ISO 13485:2016 documentation toolkit: a clause-by-clause manual, 19 procedures and 61 ready-to-use forms in Word and Excel, with sample filled examples.
Preparing the documentation is the slowest and most confusing part of getting certified to ISO 13485:2016. You have to work out what the standard asks for, decide what to write, and turn it into a manual, procedures and records that an auditor will accept. Done from a blank page it takes months, and paying a consultant to do it can cost thousands.
The ISO 13485:2016 Documentation Toolkit gives you that whole system, already written and ready to edit. It is built by practitioners around the exact structure of the standard, so nothing an auditor expects is missing. You add your company details, adapt anything specific to your operation, and you have a complete, consistent medical devices qms system that is ready for audit. Every single document you receive is listed and explained further down this page, so you know precisely what you are buying before you spend anything.
Every kit follows the same proven structure, so it is easy to understand and easy to implement.
The top level document. It answers ISO 13485:2016 clause by clause and sets out the scope of your system, your policy, the context of your organisation, and how your processes connect. This is the document an auditor opens first.
19 procedures that describe how you actually meet each requirement, from managing documents and training to internal audit and corrective action. They turn the manual into day-to-day practice.
61 ready-to-use forms and registers that capture the evidence an auditor wants to see. Sample filled forms are included so you can see exactly how each one is meant to be used.
No hidden contents and no vague claims. Here is the complete document set, with a short description of what each file is for and the clause it helps you meet.
A complete document set, fully editable in Microsoft Office.
The top level document of the system, written clause by clause to match ISO 13485:2016. It states the scope, the policy, the context of the organisation, and how each requirement of the standard is met.
The writing is done. You edit instead of authoring from a blank page.
Get a professional system for a fraction of the cost of hiring one.
Mapped clause by clause so every requirement is covered.
Easy to read, easy to adapt, no jargon you have to decode.
Forms and registers capture exactly what an auditor asks to see.
A perpetual licence for your whole team, with free updates.
The full set arrives by email in minutes, in Word and Excel.
Swap the highlighted placeholders for your own company details.
Roll out the procedures and capture evidence on the forms.
Use the internal audit checklist and management review templates.
Face the auditor with a complete, consistent system.
Files sent securely within 24 working hours of payment.
Microsoft Word and Excel, with placeholders to fill in.
If the standard is revised, you get the update free.
One organisation, unlimited internal users, perpetual.
| What matters | From scratch | Hire a consultant | isofolder kit |
|---|---|---|---|
| Time to a full document set | Months | Weeks | The same day |
| Typical cost | Your time | Thousands | $149 once |
| Written by experts | No | Yes | Yes |
| Mapped to every clause | Risky | Usually | Yes |
| You keep full control | Yes | Limited | Yes, fully editable |
| Free updates on revision | No | Extra fee | Included |
isofolder is a team of auditing and consulting professionals with more than 80 years of combined experience. Our kits are written by practitioners and reviewed by working auditors, then refined across many real certification projects. When you buy from us, you are buying a system that has already helped companies pass their audits.
If you ever need a document that is specific to your operation and not already in the kit, our team will prepare it for you.
The documents were well structured and easy to adapt. We cleared our certification audit with no major findings.
Saved us weeks of writing. Everything was mapped to the clauses, so we knew nothing was missing.
Clear, professional and fully editable. Far better value than the consultant quotes we received.
Download a free sample document from the ISO 13485:2016 toolkit and judge the quality and writing style for yourself. No risk, no obligation.
Download the complete, editable toolkit and start building an audit ready system in minutes, with a free sample available before you buy.