• 01 Research ▸ 02 Risk Assessment • 03 Safety Concept • 04 Safety Engineering • 05 Verification
• 06 Validation • 07 Documentation • 08 Evaluation & Final Report • 09 Inspection

02 RISK ASSESSMENT –
THE FOUNDATION FOR SAFETY AND COMPLIANCE

Risk assessment is a critical step in the CE process, where all potential hazards associated with a machine are systematically analyzed and evaluated. Risks are identified, prioritized, and corresponding mitigation measures are defined. This step lays the groundwork for developing a standards-compliant safety concept and ensures the long-term safety and efficiency of your machine.

With Wieland at your side, you can be confident that this process is carried out precisely and thoroughly.

Goal:

Identify, assess, and document all potential hazards related to the machine in accordance with EN ISO 12100. This forms the basis for the development of a compliant safety concept.

Description:

This step involves identifying all hazards that may occur throughout the entire machine lifecycle – from assembly and operation to maintenance. Based on this analysis, mitigation measures are defined to reduce risks to an acceptable level. The results directly influence machine design and the safety concept.

⚙️ CHALLENGES & COMMON ISSUES

Complexity of Hazard Analysis:
Many companies struggle to systematically identify all relevant hazards and fully meet the requirements of EN ISO 12100. Critical hazards—especially those across different machine lifecycle phases—are often overlooked.
Uncertainty in Risk Evaluation:
Assessing risks using the principle “Risk = Severity × Frequency × Possibility of Avoidance” requires solid expertise. Lack of experience may lead to misjudgments and insufficient protective measures.
Incomplete Documentation:
The results of the risk assessment, including defined mitigation measures, are often not fully documented. This can lead to delays or rework later in the CE process, as this documentation is a key part of the CE Declaration of Conformity.

🔧 HOW WE SUPPORT YOU

Detailed Risk Analysis:
We identify and assess hazards, and work with you to define effective risk reduction measures.
EN ISO 12100 Training:
We train your team on the requirements of the standard and provide hands-on knowledge for practical risk assessment.

CONSULTING SERVICES

Expertise on demand – for a safe and compliant future.

Services	Audience	Description
Machine safety consultation day on-site	Manufacturers and Operators	Our experts visit your site and provide advice on optimizing the safety of your machines and facilities to ensure safe and reliable production.	Learn more
Risk assessment of machinery according to DIN EN ISO 12100	Manufacturers and Operators	Conducting a risk assessment according to DIN EN ISO 12100 provides an overview of the risks of your machines and enables targeted measures to be taken to reduce these risks.	Learn more
Effects of substantial modifications to machinery for CE marking	Operators	We regularly check your machines for significant changes to ensure that they continue to meet applicable safety standards and do not affect your operational processes.	Learn More
Hazard and risk analysis of machinery for operators	Operators	Our comprehensive risk assessment provides valuable recommendations for improving the safety of your machines and reducing the risk of accidents.	Learn more

TRAININGS

Strengthen your independence and build long-term expertise.

Course	Description	Certification
Certified Electrical Safety Engineer	The 3-day course focuses on the electrical section, providing you with a complete overview of the CE process with a final examination for TÜV certification.	✅ TÜV-certified	Learn more
Refresher Seminar – Certified Safety Engineer	Our course offers you the opportunity to renew your certification and be well-prepared for the future.	✅ TÜV-certified	Learn more
Certified Functional Safety Expert (CFSE) for Electrical and Fluid Power Systems	Comprehensive training for electrical & fluid safety systems.	✅ International certification	Learn more
Fundamentals of functional safety	The course provides legal and normative foundations for assessing the functional safety of a machine.	✅ Wieland Training certificate	Learn more
Retrofit of used machinery and the significant modification	In this course, you will learn how to carry out the conversion of old machines in the existing machine park.	✅ Wieland Training certificate	Learn more

DOWNLOADS

PRACTICAL MANUAL
FOR FUNCTIONAL SAFETY

Experience knowledge at your fingertips. Our functional safety practical handbook offers simple guidance and easy-to-understand examples for designing safety solutions. Experienced practitioners and standards experts provide a comprehensive insight into the most important topics relating to functional safety. Application examples of safety circuits and Sistema calculations help maintain the longevity of your machine’s operating lifecycle.

Get your DOWNLOAD

CONTACT

Get support for your CE process

Whether you need help with a single step or full end-to-end support – with Wieland at your side, you'll successfully master the entire CE marking process. Contact us for individual consulting!

Contact us

CALLBACK SERVICE

Skip the waiting line.
Our experts will call you back.

Fill out the form
Specify your preferred time
Receive a call from our experts

Callback-Service

YOUR ORIENTATION
IN THE CE PROCESS

You are currently at Step 02: Risk Assessment.

Building on the research, this is the next key step to analyze hazards and systematically assess risks. This phase is essential for developing a safety concept and ensuring your machine is implemented in compliance with applicable standards.

To keep an overview of the entire CE process, you’ll find the summary here:

CE-Marking
CE-Process	CE-Services
Research Risk Assessment Safety Concept Safety Engineering Verification Validation Documentation Evaluation & Final Report Inspection	On-Site Consulting Day Risk Assessment for Machines Development of Safety Concept Software Development Validation of Safety Functions Verification of Safety Functions Commissioning Inspection Operating Manual Review CE Documentation Inspection and Overrun Measurement CE Conformity Assessment Review of Significant Modifications Safety-related Inspections Hazard Assessment

01 Research

Identify all applicable standards, directives, and legal requirements for your machine type – the foundation for a legally secure and smooth CE process.

Learn more