Preparing the published article.
Compliance Documentation: The Technical File
The file is the evidence that the design meets the claimed requirements.
What the file usually contains
| Content | Purpose |
|---|---|
| Description | What the machine is and how it works |
| Risk assessment | Hazards, measures and residual risk |
| Standards applied | Number, edition and how each was addressed |
| Test records | Measurements and validation results |
| Drawings and diagrams | Layout, electrical and safety schematics |
| Instructions | Operating and maintenance documentation |
Keeping it usable
- Update the file whenever the machine changes.
- Keep a change log so the current revision is obvious.
- Store a controlled copy with the machine documentation.
Required content varies by market and directive. Confirm the applicable list with a specialist.