CE-Conformity Assessment Procedure
Systematic evaluation of your machine to ensure compliance with all relevant standards.
Risk Assessment & Technical Documentation
Identification, evaluation, and documentation of all hazards — as the basis for standards-compliant and legally secure machine certification.
Why Risk Assessment & Documentation Are Important
Legal Certainty:
The risk assessment is a mandatory component of CE conformity and provides reliable evidence.
Safety in Operation:
Systematic hazard analysis reduces accidents and downtime — throughout the entire life cycle.
Sustainable Maintainability:
Good documentation facilitates modifications, maintenance, and future expansions.
What for & When Required?
- New development or commissioning of machines/systems
- Modifications and extensions — evaluation of “substantial modification”
- Machine interconnections and production lines
- In-house developments and special machines
- Proof for audits, authorities, and insurance companies
Standards and Directives
- EN ISO 12100 — Risk Assessment
- EN ISO 13849-1/-2 — Functional Safety (PL, SISTEMA)
- EN 60204-1 — Electrical Equipment of Machines
- Additional requirements depending on the application: EMC, Low Voltage, ATEX, Pressure Equipment requirements.
We translate regulatory requirements pragmatically into practice.
Note:
Not every technical change is substantial — we professionally classify modifications and document the decision.Procedure – Step by Step
System Limits & Intended Use
Definition of boundaries, operating modes, interfaces, and target groups.
Hazard Identification
Identification of all hazards (mechanical, electrical, control-related, etc.).
Risk Estimation
Evaluation of severity, frequency, and the possibility of avoidance.
Protective Measures
Three-step method:
- Inherently safe technical design
- Technical protective measures
- User information
Definition of PLr/SIL targets.
Verification and Validation
Proof (e.g., SISTEMA), test protocols, measurements (e.g., run-down times).
Documentation
Risk assessment, circuit diagrams, operating instructions, conformity documentation.
Our Scope and Service
Hazard Analysis
Risk assessment according to EN ISO 12100 including a catalog of measures.
PL/SIL-Verification
Design and validation of safety-related components (SISTEMA, ISO 13849).
Operating Instructions
Creation and review including residual risk information, warning notices, and maintenance instructions.
Circuit Diagrams & Parts Lists
Complete, audit-proof documentation for audits and service.
Test & Acceptance Protocols
Functional tests, electrical tests (e.g., EN 60204-1), and run-down time measurements.
Documentation & Templates
Clean documentation structure, versioning, and handover checklists.
Our Service
Run-Down Time Measurement
Precise determination of the run-down distances and times of your machines — for correctly dimensioned safety distances and maximum workplace safety.
Risk Assessment & Technical Documentation
Identification, evaluation, and documentation of all hazards — as the basis for standards-compliant and legally secure machine certification.
Recurring Inspections according to DGUV & VDE
Regular safety and functional inspections in accordance with DGUV and VDE requirements — for maximum operational safety and legal certainty.
OT security
We carry out comprehensive IT security analyses of your industrial plants and systems.