Pick a sample, get the PDF
Before you buy a kit, see what the files look like. Each sample is a PDF of real, unedited pages from the paid kit: the procedure, the protocol or the register itself, not a brochure. Enter your email once and you can download all of them.
Before you buy a template kit, see what the files look like. Each free sample is a PDF of real pages from the paid kit: the procedure, the protocol or the register itself. Pick the sample that matches your work, enter your email, and download it straight away.
ISO 13485 samples: which kit each one comes from
Seven of the samples above come from our ISO 13485 kits. Here is what each full kit contains and what it costs, so you can go straight from the sample to the files you need.
| Sample | Full kit | Price |
|---|---|---|
| IQ protocol pages and the validation master plan | Process Validation IQ/OQ/PQ Pack (clause 7.5.6) | US$99 |
| Design review pack and DHF index | Design Controls & DHF Kit (clause 7.3) | US$149 |
| Document Control SOP and master document list | Document Control & Records Kit (clause 4.2) | US$79 |
| CAPA SOP and 8D form | CAPA & Nonconformance Kit (clauses 8.3 and 8.5.2) | US$79 |
| Audit checklist and audit report template | Internal Audit Kit (clause 8.2.4) | US$79 |
| Risk management plan and hazard catalogue | ISO 14971 Risk Management File Kit | US$129 |
| Quality manual, gap assessment and Document Control SOP | ISO 13485 Starter Kit (six core kits) | US$249 |
Building a whole ISO 13485 system?
The Starter Kit bundles the six kits most companies need first: quality manual and management review, document control, CAPA, internal audit, training with eight ready modules, and a gap assessment. Bought separately they cost about twice as much. The Complete QMS Kit adds every other kit we make, including design controls, the ISO 14971 risk file, process validation, supplier control, complaints and vigilance, and the medical device file.
ISO 13485 Starter Kit, US$249Complete QMS Kit, US$449
Instant download. Editable Word and Excel. One-organization licence. 30-day money-back guarantee.
Free ISO 13485 tools you can use today, no sample form needed: the ISO 13485 Gap Assessment Lite, the DHF Audit Checklist and Index and the Master Document List template. All ISO 13485 kits are in the ISO 13485 templates collection.
ISO 9001:2026: see real pages now, no email needed
Three pages straight from the ISO 9001:2026 Complete QMS Documentation Kit, exactly as they open in Word: the Quality Manual cover with its document-control block, the approval page with its guidance notes, and the first page of the corrective action procedure. Highlighted fields are the ones you replace; blue guidance notes are deleted before issue.
The manual on its own is the ISO 9001:2026 Quality Manual Template (US$79).
ISO 9001:2026 Gap Analysis Workbook: a three-page extract
Three pages from the ISO 9001:2026 Gap Analysis Workbook, shown as images: the Instructions sheet, the first lines of the Gap Analysis sheet (clauses 4.1 to 4.3, with the 2026 change flag and typical evidence to look for), and the Dashboard sheet as it opens, before any assessment is entered. Select an image to enlarge it. The complete workbook, with all 178 requirement lines, the Action Plan and the Evidence Log, is the paid download.
