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

07 DOCUMENTATION –
THE FOUNDATION FOR
LEGAL COMPLIANCE

Documentation is one of the most critical steps in the CE process and forms the basis for the Declaration of Conformity. In this phase, all relevant documents—such as risk assessments, validation reports, and technical specifications—are compiled, reviewed, and finalized. The goal is to create complete and consistent documentation that fully complies with all applicable standards and directives.

With Wieland as your partner, you can ensure that your documentation meets the highest legal and normative standards—leaving no gaps.

Objective:

To prepare and review complete documentation packages as the foundation for the EU Declaration of Conformity for each machine.

Description:

Documentation is a crucial component of the CE process. It includes all necessary records, such as the risk assessment, safety concept, test protocols, and validation results. Once compiled, the completeness of these documents is checked to ensure that all requirements are met. Opportunities for improvement are identified to raise the quality of the documentation.

⚙️ CHALLENGES & COMMON ISSUES

Incomplete or inconsistent documentation:
A systematic approach is often lacking, resulting in inconsistent or missing documents such as risk assessments, validation reports, or specifications.
Misapplication of standards and directives:
Correctly applying and documenting the relevant standards and directives requires in-depth regulatory knowledge. Misinterpretations or missing evidence can pose legal risks.
Lack of in-house expertise:
Teams are often not sufficiently trained to correctly interpret and apply legal and normative requirements such as the Machinery Directive or CE conformity. This leads to delays or errors in the process.

🔧 HOW WE SUPPORT YOU

Documentation review:
Our experts audit your documentation to ensure completeness and compliance with relevant standards and directives.
Optimization:
We provide actionable advice to help you streamline and standardize your documentation process.
Training and workshops:
Take advantage of our seminars covering topics like the Machinery Directive, CE compliance, liability issues, or retrofitting of existing machinery.

CONSULTING SERVICES

Expertise on demand – for a safe and compliant future.

Services	Audience	Description
CE documentation according to the machinery directive	Manufacturers and Operators	We create the required CE documentation for you to prove compliance with legal requirements.	Learn more
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
Checking the operating instructions for CE conformity	Manufacturers and Operators	We check the operating instructions of your machines for CE conformity and ensure that they contain all required safety information.	Learn more
CE conformity assessment according to machinery directives	Operators	Our check of the CE conformity of your machines provides the certainty that they meet requirements and your production is legally secure.	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
Verification of safety functions according to DIN EN ISO 13849-1	Manufacturers and Operators	Our verification of your safety concept according to EN ISO 13849-1 ensures that your safety measures meet applicable requirements and your production is safe.	Learn more
Validation of the safety functions according to EN ISO 13849-2	Manufacturers and Operators	Our validation of the safety functions of your machines according to EN ISO 13849-2 ensures that the technical safety measures defined in your safety concept are tested for effectiveness.	Learn more
Testing of safety devices and equipment on machinery	Operators	Our inspection of the safety devices on your machines ensures their functionality and compliance with legal requirements.	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
Validation of safety application software in machinery	This course covers the validation of safety software in mechanical engineering, including challenges in the application of safety controls.	✅ Wieland Training certificate	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
Design and validation of safety functions Sistema	In this course, you will learn how to model and evaluate the safety of your own machine according to EN ISO 13849-1 using SISTEMA.	✅ Wieland Training certificate	Learn more
Calculation of complex safety functions according to EN ISO 13849-1	The seminar deals with procedures for modeling and calculating safety functions according to EN ISO 13849-1, which deviate from the structures shown in the standard.	✅ 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!

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 07: Documentation.

In this step, the results of all preceding phases are compiled and reviewed to establish a solid foundation for a legally compliant CE Declaration of Conformity.

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