Structured Testing and Evaluation Process for Machinery - STEP4M

The STEP4M Program follows a defined process that provides consistent quality across all projects. This standardization eliminates guesswork and provides manufacturers with clear expectations and deliverables at each stage of the compliance journey.

Recognizing that different manufacturers have varying needs and project stages, the program offers unprecedented flexibility. Clients can select one or two steps to start with or engage for the complete end-to-end process – all based on their current project status and requirements.

Each step is managed by designated experts who bring deep knowledge of machinery regulatory requirements, industry best practices, and technical standards. This ensures that all assessments are conducted with the highest level of expertise and accuracy.

The program generates thorough documentation at each step, providing manufacturers with clear records of compliance activities, findings, and recommendations. This documentation serves as valuable evidence for regulatory submissions and internal quality assurance processes.

This step establishes the regulatory baseline for your machinery by identifying all applicable legislation, standards, and fundamental safety requirements at the earliest concept stage. 

Scope  

• Early identification of applicable EU/UK directives, regulations, and standards.  
• High-level design appraisal to spot fundamental compliance gaps before detailed engineering or manufacturing begins.  

Typical Activities  

• Confirm product category and intended markets.  
• Map mandatory legislation (e.g., EU Machinery Regulation (EU) 2023/1230Machinery Directive 2006/42/EC, EMC, RoHS).  
• Initial hazard identification and concept risk log.  
• Feasibility check of design concept against essential health-and-safety requirements.  

Key Deliverables  

• Regulatory applicability matrix.  
• Conceptual risk register.  
• Gap analysis summary and high-level action plan. 

This step evaluates whether the detailed mechanical, electrical, and software design complies with ISO 12100 and applicable harmonized standards, and whether identified risks have been adequately reduced. 

Scope

• Deep-dive into drawings, bills of materials, and safety-related control functions.  
• Formalize risk assessment in accordance with ISO 12100 methodology.  

Typical Activities

• Review of detailed mechanical, electrical, and software designs.  
• Verification that chosen components meet harmonized standards.  
• Draft Functional Safety assessments (e.g., EN ISO 13849-1, IEC 62061).  
• Develop validation & test plans aligned to identified hazards and regulatory needs.  

Key Deliverables

• Updated risk assessment with reduction measures.  
• Validation test matrix and acceptance criteria.  
• Design change recommendations and compliance checkpoints.

This step verifies, through testing and inspection, that the risk reduction measures defined during design validation are effective and correctly implemented in the prototype. 

Scope

• Demonstrates that mitigations defined in STEP 2 are effective.  

Typical Activities

• Safety, EMC, and environmental testing (e.g., IP rating, vibration).  
• Functional safety verification (hardware & software).  
• Usability and maintenance assessments.  
• Generation of raw test data and preliminary findings.  

Key Deliverables

• Complete test reports traceable to validation plan.  
• Non-conformance log with corrective-action guidance.  
• Revised technical file evidence (e.g., schematics, software revision records). 

This step confirms that all regulatory requirements have been met and that the machinery is ready for CE marking, UKCA marking, or other applicable conformity procedures.

Scope 

• Final gate confirming product readiness for CE marking, UKCA marking, or other certification marks. 

Typical Activities  

• Review and approval of the full Technical Documentation.
• Audit of residual risks and verification that corrective actions are closed.
• Issuance of non-accredited Verification of Conformity (VoC), Attestation of Conformity (AoC) or other agreed deliverables.

Key Deliverables  

• Conformity Assessment Report summarizing evidence package. 
• Signed VoC and declaration templates. 
• Final project dossier ready for market surveillance authorities.

Manufacturers can engage with our experts all the way from step 1 to 4, receiving comprehensive support throughout the entire development and compliance process. This approach provides maximum value through continuous expert guidance and systematic risk management.

Manufacturers can choose to engage for specific steps based on their current project status. I.e., a manufacturer with an established design and prototype might begin directly with STEP 1 until final reporting. This flexibility allows for cost-effective service delivery tailored to specific needs.

Quotations are provided based on the selected entry point and scope of engagement. Each quotation includes clear breakdowns for each requested STEP, allowing manufacturers to understand exactly what services are included and the associated costs.

Manufacturers can initially engage for specific STEPs and later request additional services as their projects evolve. This progressive approach allows for budget management and ensures that services are aligned with project timelines and requirements.

Comprehensive guidance on CE marking obligations, including technical documentation requirements, conformity assessment procedures, and declaration of conformity preparation.

Preparation for the upcoming Machinery Regulation, including understanding of new requirements, transition planning, and compliance readiness strategies.

Guidance on the application of relevant harmonized standards, including standard selection, compliance demonstration, and documentation requirements.

Expert support for compliance with UL, NFPA, and CSA standards, ensuring machinery meets safety and electrical requirements for both the US and Canadian markets. Our services include guidance on certification pathways, documentation, and testing for general and hazardous location equipment.

Specialized support for machinery intended for hazardous environments, including compliance with the ATEX Directive, IECEx, US and Canada requirements. We provide a full range of services from training to certification. Learn more about our Hazardous Locations testing and certification services.