Apply the ISO 12100 methodology to identify hazards across a machine's full life cycle.
Engineering & Maintenance
Machinery Safety Risk Assessment and CE Marking Under ISO 12100
Apply ISO 12100 machinery risk assessment methodology and the CE marking process to identify hazards, select protective measures and compile technical files for industrial machinery.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
Placing machinery on the market or substantially modifying existing equipment requires a documented risk assessment and a defensible conformity process, yet many engineering teams treat CE marking as paperwork completed after the design is finished rather than a process that should shape the design itself. This course teaches mechanical and safety engineers to apply the ISO 12100 risk assessment methodology from the earliest design stage: identifying hazards across the machine's life cycle, estimating risk using severity and probability criteria, and applying the three-step hierarchy of inherently safe design, safeguarding and information for use to reduce risk. Participants select protective measures, including guards, interlocks and safety-related control systems designed to the performance level required by ISO 13849-1, and practise documenting the rationale for each decision in a form supporting later audit or investigation. The course covers compiling the technical file required for CE marking, including the risk assessment record, drawings, verification evidence and the declaration of conformity, and addresses how substantial modification can trigger a fresh conformity obligation. By the end, participants can lead a risk assessment workshop and assemble a technical file that would withstand scrutiny from a notified body.
Expected Learning Outcomes
Estimate and evaluate risk using severity and probability criteria consistent with ISO 12100.
Apply the three-step hierarchy of inherently safe design, safeguarding and information for use to reduce risk.
Select protective measures, including guards, interlocks and safety-related control systems, to the required performance level.
Document risk reduction decisions in a form that withstands audit or incident investigation scrutiny.
Compile a technical file for CE marking, including risk assessment records and verification evidence.
Determine when substantial modification of existing machinery triggers a fresh conformity assessment obligation.
Who Should Attend
Mechanical engineers designing or modifying industrial machinery for the market.
Machinery safety engineers conducting risk assessments under ISO 12100.
Compliance specialists compiling technical files for CE marking submissions.
Maintenance engineers responsible for substantial modification of existing machinery.
Control systems engineers designing safety-related functions for machinery.
Quality assurance professionals reviewing conformity documentation before market release.
Course Modules
Select any module to see its sessions and points.
01Hazard Identification and Risk Estimation
2 sessions · 8 points
Session 1Identifying Hazards Across the Machine Life Cycle
- Identify mechanical, electrical, thermal and ergonomic hazards present across transport, installation, operation and decommissioning.
- Consider foreseeable misuse and reasonably foreseeable operator behaviour when identifying hazards.
- Involve operators and maintenance technicians in hazard identification to capture practical failure scenarios.
- Record identified hazards in a structured hazard log that feeds the subsequent risk estimation stage.
Session 2Estimating and Evaluating Risk Under ISO 12100
- Estimate risk for each identified hazard using severity of harm and probability of occurrence criteria.
- Account for frequency and duration of exposure when estimating probability of occurrence.
- Evaluate estimated risk against a defined tolerability criterion to determine whether reduction is required.
- Prioritise hazards for risk reduction based on the magnitude of estimated risk rather than ease of fixing.
02Applying the Risk Reduction Hierarchy
2 sessions · 8 points
Session 1Inherently Safe Design and Safeguarding Measures
- Apply inherently safe design measures that eliminate a hazard rather than merely guarding against it.
- Select guarding solutions, including fixed and interlocked guards, appropriate to access frequency and hazard severity.
- Specify safe distances and openings for guards using recognised anthropometric and reach data.
- Justify why safeguarding rather than inherently safe design was selected where elimination was not feasible.
Session 2Information for Use and Residual Risk
- Determine what residual risk must be communicated through warnings, signage and instructions for use.
- Draft instructions for use that address safe operation, foreseeable misuse and maintenance precautions.
- Distinguish residual risk that is acceptable from residual risk requiring further design iteration.
- Review information for use with intended operators to confirm warnings are understood and effective.
03Safety-Related Control Systems and Verification
2 sessions · 8 points
Session 1Designing Safety-Related Control Systems
- Determine required performance level for safety functions using the risk graph method under ISO 13849-1.
- Select architecture categories for safety-related control systems appropriate to the required performance level.
- Specify components, including safety relays and light curtains, that achieve the required performance level in combination.
- Coordinate safety-related control system design with the mechanical guarding solution it supports.
Session 2Verification and Validation of Risk Reduction Measures
- Verify that implemented protective measures achieve the risk reduction assumed during the design stage.
- Validate safety-related control system performance through testing against the specified performance level.
- Confirm guards and interlocks function correctly under normal and foreseeable fault conditions.
- Document verification and validation evidence for inclusion in the technical file.
04CE Marking, Technical Files and Modification
2 sessions · 8 points
Session 1Compiling the Technical File for CE Marking
- Assemble the risk assessment record, technical drawings and verification evidence into a coherent technical file.
- Draft the declaration of conformity referencing the applicable directives and harmonised standards used.
- Determine when a notified body assessment is required rather than self-certification of conformity.
- Organise the technical file so it can be produced promptly in response to a market surveillance request.
Session 2Managing Substantial Modification and Ongoing Compliance
- Assess whether a proposed machinery modification constitutes a substantial modification triggering new conformity obligations.
- Update the risk assessment and technical file to reflect substantial modifications made during the machine's service life.
- Coordinate with the original equipment manufacturer where modification affects warranty or manufacturer responsibility.
- Maintain technical file currency as standards referenced in the original declaration of conformity are revised.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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