Systemic Standards – 专业产品安全服务。卓越合规。

ISO 12100 Pre-Audit & Gap Analysis

(Review of Risk Assessment & Machinery Safety)

Are you planning the market approval of a machine or plant in the EU? To ensure that your design and documentation meet the strict requirements of ISO 12100 (Safety of machinery — General principles for design — Risk assessment and risk reduction), we conduct a structured Pre-Audit beforehand.

We analyze your existing documentation and engineering approaches for potential liability risks and gaps in the safety concept. Please fill out the following form so we can calculate the exact analysis scope for your machinery.

1. Company Details & Corporate Role

2. Technical Details of the Machinery / Plant

3. Documents & Technical Documentation

Please upload all available documents for your machinery below. The more detailed the specifications, the more precise our gap analysis will be.

Tip: You can select multiple files at once or upload a compressed ZIP archive.

Excerpts or drafts of a risk analysis according to ISO 12100 (e.g., from software like Safexpert, SISTEMA, or Excel).

No files selected

General arrangement drawings, dimension sheets, pneumatic/hydraulic plans, or electrical circuit diagrams.

No files selected

Draft or finished user handbook including maintenance, troubleshooting, and emergency instructions.

No files selected

Data sheets for safety components (e.g., emergency stop switches, light curtains, interlocking guards, safety controllers).

No files selected

Overall views of the machinery as well as detailed close-ups of hazard zones and protective installations.

No files selected

4. Process and Next Steps

1. Quotation & Commissioning: You will receive a tailor-made quotation from us for conducting the ISO 12100 gap analysis (based on the complexity of your machinery/plant). Upon your approval, we will send you the order invoice.
2. Payment Receipt & Audit Launch: Following payment receipt and delivery of your technical documentation, we will immediately begin the document review and the software-supported analysis.
3. Technical Review & Assessment: We analyze your engineering data and risk assessments in deep detail and discuss critical parameters in a collaborative technical review meeting.
4. Evaluation Report (Action Catalog & Control Safety): You will receive a detailed evaluation report. This maps out exactly where gaps regarding ISO 12100 still exist (e.g., insufficient risk reduction or errors in safety distances). Concurrently, we evaluate whether a validation of the safety-related parts of your control systems (Performance Level according to ISO 13849-1, e.g., via SISTEMA) is required or already sufficiently documented.
5. Compliance Support & Performance Level Calculation (Optional): Upon request, we actively support you in revising the risk assessment. In doing so, we also handle the standard-compliant calculation and verification of the Performance Level (PL) according to ISO 13849-1 for your safety control systems, all the way to the final CE declaration of the machinery.