Required evidence for ISO 26262 safety audit

The documents required for an ISO 26262 safety audit may vary depending on the specific context and the scope of the audit. However, here’s a general list of documents commonly requested during an ISO 26262 safety audit:

  1. Functional Safety Management (FSM) documentation:
    • Safety plan
    • Safety manual
    • Safety case
    • Safety management system procedures
    • Safety requirements specification
  2. Hazard Analysis and Risk Assessment (HARA) documentation:
    • Hazard analysis report
    • Risk assessment report
    • Safety goals and requirements
  3. Functional Safety Concept (FSC) documentation:
    • Functional safety concept report
    • Technical safety concept
    • Architectural design specifications
    • Item definition
  4. Technical Safety Concept (TSC) documentation:
    • Safety requirements allocation
    • System architecture
    • Technical safety requirements specification
    • Safety architecture documentation
  5. Software and Hardware Requirements Documentation:
    • Software requirements specification (SRS)
    • Hardware requirements specification (HRS)
    • Interface requirements specification
  6. Functional Safety Verification and Validation Documentation:
    • Verification and validation plans
    • Test specifications
    • Test reports
    • Verification and validation results
  7. Safety Element out of Context (SEooC) Documentation:
    • SEooC specification
    • SEooC assessment report
  8. Safety-related Component Documentation:
    • Component safety plan
    • Component safety case
    • Component technical safety requirements
  9. Safety Assessment Documentation:
    • Safety assessment plan
    • Safety assessment report
  10. Safety-related Software and Hardware Documentation:
    • Software safety requirements specification
    • Hardware safety requirements specification
    • Safety-related software and hardware design documents
  11. Documentation on Safety Measures:
    • Safety analysis reports
    • Safety mechanisms and features documentation
    • Safety validation and verification reports
  12. Change Management Documentation:
    • Change management procedures
    • Change history documentation
    • Impact analysis reports
  13. Documentation on Safety Processes and Procedures:
    • Safety process descriptions
    • Safety review meeting minutes
    • Safety audit reports
  14. Training Documentation:
    • Training plans
    • Training materials
    • Training records
  15. Other Documentation:
    • Any other documents relevant to the safety of the product or system being audited, as per the requirements of ISO 26262 and the organization’s safety practices.

This list is not exhaustive, and the specific documents required for an ISO 26262 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