Required evidence for IEC 61508 safety audit

An IEC 61508 safety audit typically involves a comprehensive review of documentation related to functional safety practices and processes. Here’s a list of documents commonly requested during an IEC 61508 safety audit:

  1. Safety Management Documentation:
    • Safety plan
    • Safety manual
    • Safety policy
    • Safety management system procedures
    • Safety requirements specification
  2. Safety Lifecycle Documentation:
    • Safety lifecycle plan
    • Safety lifecycle model
    • Safety lifecycle documentation for each phase (e.g., concept phase, system design phase, software design phase, etc.)
  3. Hazard and Risk Assessment Documentation:
    • Hazard analysis report
    • Risk assessment report
    • Safety integrity level (SIL) determination report
    • Safety requirements derived from hazard analysis
  4. Safety Requirements Documentation:
    • Safety requirements specification
    • Safety requirement allocation to hardware and software components
  5. Functional Safety Concept Documentation:
    • Functional safety concept report
    • Architectural design specifications
    • Safety requirements allocation to system components
    • Functional safety concept verification and validation documentation
  6. Hardware and Software Design Documentation:
    • Hardware design specification
    • Software design specification
    • Safety-related hardware and software architecture documentation
    • Safety-related design verification and validation documentation
  7. Verification and Validation Documentation:
    • Verification and validation plans
    • Test specifications and procedures
    • Test reports
    • Traceability matrices linking requirements to verification and validation activities
  8. Safety Integrity Level (SIL) Verification Documentation:
    • SIL verification plan
    • SIL verification calculations and analyses
    • SIL verification reports
  9. Safety-related Component Documentation:
    • Safety-related component specifications
    • Component verification and validation documentation
    • Component failure rate data and reliability information
  10. Safety Assessment Documentation:
    • Safety assessment plan
    • Safety assessment reports
    • Safety audit reports
  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 functional safety
  14. Documentation on Safety Measures:
    • Safety analysis reports
    • Safety mechanisms and features documentation
    • Safety validation and verification reports
  15. Documentation on Functional Safety Management during Operation and Maintenance:
    • Procedures for operation and maintenance related to functional safety
    • Records of incidents, near misses, and safety-related maintenance activities
  16. Other Documentation:
    • Any other documents relevant to the functional safety of the product or system being audited, as per the requirements of IEC 61508 and the organization’s safety practices.

This list is comprehensive but not exhaustive, and the specific documents required for an IEC 61508 safety audit may vary based on factors such as the development phase, the complexity of the system, and the requirements of the auditing organization or regulatory body.

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Philipp Hofmann
Head of Safety Management