Documentation & Compliance Consulting
Risk Assessment (ISO 12100)
Structured hazard identification and risk evaluation following the international reference methodology.
Overview
What this service is
ISO 12100 is the methodology EU directives — and most national authorities — expect to see behind a risk assessment. It walks through the product's full life cycle, identifies hazards, estimates the associated risks, and documents the measures applied to reduce them.
We perform the assessment with your engineering team, produce the documentation that goes into the technical file, and (importantly) tie the residual risks back to the warnings printed on the product and in the manual.
Scope
What's included
- Hazard identification across transport, installation, use, maintenance, and end-of-life
- Risk estimation per ISO 12100 methodology (severity × probability)
- Risk reduction measures: inherent design, safeguards, information for use
- Residual risk documentation and traceability to warnings
- Integration into the technical file
Deliverables
What you receive
Why it matters
The cost of skipping it
ISO 12100 risk assessment is mandatory under the Machinery Directive and treated as best practice across EU product law. A missing or superficial risk assessment is one of the first things auditors flag.
Who it's for
Typical clients
Manufacturers of machinery, electrical equipment, and consumer products who need a defensible risk assessment before CE marking or before a contractual audit.
Process
How we work
- 01IntakeBrief call to scope the product, the market, and the documentation that already exists.
- 02AnalysisGap assessment against the applicable EU directives and harmonised standards.
- 03DeliveryFinished file, report, or test results — with a walkthrough call for your team.
- 04Follow-upCorrections and support during external audits or market surveillance.
FAQ
Common questions
Not sure where to start?
Book a 15-minute intro call to discuss your compliance needs.