Required evidence for DIN EN 50126 safety audit

EN 50126 is a standard that pertains to the railway sector and focuses on the specification and demonstration of reliability, availability, maintainability, and safety (RAMS). During a safety audit conducted according to DIN EN 50126, a variety of documents are typically required for review. Here’s a comprehensive list:

  1. RAMS Management Documentation:
    • RAMS plan
    • RAMS policy
    • RAMS manual
    • RAMS management system procedures
  2. Safety Management Documentation:
    • Safety plan
    • Safety case
    • Safety management system procedures
    • Safety requirements specification
  3. RAMS Lifecycle Documentation:
    • RAMS lifecycle plan
    • RAMS lifecycle model
    • Documentation for each lifecycle phase (e.g., concept, system definition, design, development, testing, integration, operation, maintenance, and decommissioning)
  4. Hazard and Risk Assessment Documentation:
    • Hazard analysis report
    • Risk assessment report
    • Safety integrity level (SIL) determination report
    • Safety requirements derived from hazard analysis
  5. Safety Requirements Documentation:
    • Safety requirements specification
    • Safety requirement allocation to system components
  6. System Safety Assessment Documentation:
    • System safety assessment plan
    • System safety assessment reports
    • System safety audit reports
  7. Functional Safety Concept Documentation:
    • Functional safety concept report
    • Architectural design specifications
    • Safety requirements allocation to system components
    • Functional safety concept verification and validation documentation
  8. Verification and Validation Documentation:
    • Verification and validation plans
    • Test specifications and procedures
    • Test reports
    • Traceability matrices linking requirements to verification and validation activities
  9. Safety Integrity Level (SIL) Verification Documentation:
    • SIL verification plan
    • SIL verification calculations and analyses
    • SIL verification reports
  10. Safety-related Component Documentation:
    • Safety-related component specifications
    • Component verification and validation documentation
    • Component failure rate data and reliability information
  11. Change Management Documentation:
    • Change management procedures
    • Change history documentation
    • Impact analysis reports
  12. Documentation on Safety Processes and Procedures:
    • Safety process descriptions
    • Safety review meeting minutes
    • Safety audit reports
  13. Training Documentation:
    • Training plans
    • Training materials
    • Training records related to RAMS and functional safety
  14. Documentation on Safety Measures:
    • Safety analysis reports
    • Safety mechanisms and features documentation
    • Safety validation and verification reports
  15. Documentation on RAMS Management during Operation and Maintenance:
    • Procedures for operation and maintenance related to RAMS
    • Records of incidents, near misses, and safety-related maintenance activities
  16. Other Documentation:
    • Any other documents relevant to RAMS and functional safety of the railway system being audited, as per the requirements of EN 50126 and the organization’s safety practices.

This list encompasses the key documentation typically required for an EN 50126 safety audit. However, the specific documents may vary based on the context, the phase of the project, and the requirements of the auditing organization or regulatory body.

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Philipp Hofmann
Head of Safety Management