Applicability first. Documents second.
Every requirement marked applies or doesn't, with the reason and the clause next to it, so you can check each call yourself. Then templates you adapt for the ones that apply.
ISO 13485 Applicability Kit
- Applicability list, clause cited on every line
- Editable templates for the requirements that apply
- U.S. (QMSR) and EU notes
- 12 months of corrections and edition updates included
- $150 credit toward a QMS Roadmap Session
ISO 13485 Kit + Review
- Everything in the kit
- 1-hour call with Joshua
- Review of two documents you've completed
- 12 months of updates included
ISO 9001:2026 Applicability Kit
- Built on the edition published September 16, 2026
- Applicability list and templates to adapt
- The 2015 → 2026 changes summary is free: get it here
Check the citations before you pay.
Try the free sample first. If the kit isn't what this page describes, or a requirement is missing its clause, you get a full refund within 30 days.
No update subscription. Corrections and edition updates for 12 months are included in the price.
Get the free sampleAbout the kits.
Will a kit get us certified?
No kit can. These are templates you adapt to your company and processes. Your auditor still decides.
Can I share the files?
Each kit is licensed to one company. Downloads are personalised.
What about ISO 9001:2015 → 2026 changes?
The summary of what changed is free. The kit is for building or rebuilding your system on the 2026 edition.
Start with your device's case.
A 90-minute Roadmap Session and a one-page standards matrix you keep, whatever you decide next.