Machine Safety Assessment and CE Conformity Services
Professional Support in EN ISO 12100 | ISO 13849-1 | IEC 62061 Standards. As SWL, we are with you in your transition from the 2006/42/EC Machinery Directive to the new Machinery Regulation (EU) 2023/1230 with our over 10 years of field experience and our national and internationally qualified process partners.
⚠️ Big change is coming in 2027!
The new EU Machinery Safety Directive ((EU) 2023/1230), which will become mandatory as of January 20, 2027, aligns safety standards in industrial production with the digital age. Here are 10 key changes that manufacturers and users should be aware of:
- Updated High Risk Machinery List (Annex I)
- Safety Component Definition Expanded.
- Third-Party Approval Requirement Is Increasing.
- Special Emphasis on Human-Machine Collaboration (Cobots).
- The Declaration of Conformity and Technical File Contents Have Been Detailed.
- Digital Cyber Security is Now a Part of Security.
- Artificial Intelligence and Autonomous Systems are included.
- Digital Documentation Becomes Essential.
- Expanded and Clarified Chain of Responsibility.
- Anyone Making a “Significant Change” Will Now Be Considered a Manufacturer.
Our Areas of Expertise
Technical Security Standards
- Extensive expertise and hands-on experience in EN ISO 12100, ISO 13849-1 and IEC 62061 standards.
Legal Transition Process Management
- Professional guidance in the process of compliance from the Machinery Directive to the Machinery Regulation.
Integrated Solution Approach
- Comprehensive safety solutions together with our national and international partners.
Conformity Assessment Service Scope for New Machinery
How Do We Ensure Safety with Our Systematic Approach?
Machine safety is too serious a task to be left to chance. That’s why we offer a service process based on international standards, with every step meticulously planned:
- Risk Analysis and Assessment (EN ISO 12100):
In this first step, which forms the basis of the process, we systematically analyze and evaluate the potential hazards and all risks inherent in your machine in accordance with the EN ISO 12100 standard. - Safety Concept Development and Review: Using data obtained from the risk analysis, we create a “Safety Concept” that includes the most effective protective measures to eliminate risks or reduce them to acceptable levels, or we review your existing concept in detail.
- Safety Design Validation:
Translating theory into practice accurately and safely is critical. We meticulously verify the compliance of all your safety designs, especially control systems and protective equipment, with the established concept and relevant standards (e.g., ISO 13849, IEC 62061). - Manufacturing and Installation Control:
We verify on-site that approved designs are accurately reflected in manufacturing and installation processes. We ensure that safety functions are implemented correctly and that the installation adheres to the project. - Safety Verification and Validation:
As the final step in the entire process, we verify that the safety functions operate as designed by testing and checking the machine under actual operating conditions. This step is the final confirmation that the system is safe under real-world conditions. - Declaration of Conformity and CE Marking:
For your machines that have successfully completed all stages, we prepare the EU Declaration of Conformity in collaboration with our authorized process partners, helping you complete the entire process required to affix the CE marking, a legal guarantee, to your product.
Contact us today to prepare your machines for future standards and secure your production processes.
Scope of Conformity Assessment for Existing Machinery
Machinery currently in operation or those you’ve purchased secondhand can fall short of current safety standards over time due to changes, new equipment additions, or changing regulations. This not only creates a serious risk of workplace accidents but can also put you in a difficult position during legal audits. Our “Conformity Assessment Service” provides a safety and regulatory report card for your existing machinery and provides a clear roadmap for bringing it up to current standards.
Safety and Compliance Roadmap for Your Existing Machinery
Our experienced team of experts conducts a comprehensive assessment process that allows you to safely extend the life of your existing machinery:
- Current Situation Analysis and Identification of Non-Conformities:
We inspect your machinery on-site and analyze its current status within the framework of the current “Health and Safety Conditions in the Use of Work Equipment Regulation” and relevant standards. We identify all mechanical, electrical, and operational non-conformities in a detailed report. - Review of Modifications and Add-ons:
We periodically review the compatibility of new equipment, revised parts, or modified functions added to machines with safety systems. We carefully assess whether these add-ons pose new risks. - Assessment of Machinery According to Modern Standards Before CE Marking:
Even if your machine’s production date predates the CE marking requirement, we conduct a comprehensive risk assessment based on EN ISO 12100, the fundamental safety standard. We provide practical and applicable improvement recommendations for identified gaps and potential hazards. - Performans Seviyesi (PL) Tespiti ve Aksiyon Planı Oluşturma:
Makinelerinizin mevcut emniyet kontrol sistemlerinin performans seviyelerini (PL – Performance Level) ISO 13849-1 standardına göre belirliyoruz. Tespit edilen tüm eksiklikler için önceliklendirilmiş, net ve uygulanabilir bir aksiyon planı oluşturarak size sunuyoruz. - Post-Action Verification:
After you’ve made improvements based on the action plan, we re-inspect your machines. We complete the process by verifying that the measures taken have eliminated risks and achieved the targeted safety level. - Declaration of Conformity and Reporting:
We prepare the Declaration of Conformity for your machines that have successfully completed all stages, in collaboration with our authorized process partners.
Get expert support to manage the risks and ensure legal compliance of your existing machinery. Contact us to learn more about our assessment service.
Why SWL?
At SWL, we ensure your business’s compliance with both national and international standards with our expert team and process partners who deeply understand the complex requirements of machinery safety assessment and CE compliance processes. With our industry experience and independent technical perspective, we offer customized machinery safety assessment and CE compliance consulting services tailored to your facility, taking into account the unique safety and security needs of your production processes.
