Functional Safety (ISO 26262) Certification

ISO 26262 is the functional safety standard for managing hazards that could arise from failures of electrical/electronic systems in road vehicles. It is the automotive adaptation of IEC 61508. At its centre is the concept of the ASIL (Automotive Safety Integrity Level): a hazard analysis and risk assessment (HARA) assigns each safety goal a level from A to D, and this level determines the rigour of the methods to be applied.

• Vehicle electronics and ECU developers
• Manufacturers of brake, steering and driver-assistance systems
• Developers of electric-vehicle powertrain and battery management systems
• Automotive software and hardware component suppliers
• Semiconductor manufacturers (with the SEooC approach)

The standard itself is not directly a legal requirement, but it is regarded as 'accepted engineering practice' in relation to product-liability and general vehicle-safety legislation. OEM contracts make it effectively mandatory: business is not awarded for an ASIL-assigned component without demonstrated ISO 26262 compliance. The assessment produces a product/project-level conformity assessment report and a safety case, not a management-system certificate.

• Part 2 — Functional safety management: safety culture, roles, the safety plan
• Part 3 — Concept phase: item definition, hazard analysis and risk assessment (HARA), ASIL determination, the functional safety concept
• Part 4 — Product development at the system level: the technical safety concept, system integration and verification
• Part 5 — Product development at the hardware level: hardware architectural metrics, random hardware failure targets (SPFM, LFM, PMHF)
• Part 6 — Product development at the software level: architectural design, unit design, verification and test methods
• Part 7 — Production, operation, service and decommissioning
• Part 8 — Supporting processes: change and configuration management, verification, documentation, tool qualification, proven in use
• Part 9 — ASIL-oriented analyses: ASIL decomposition, dependent failure analysis
• Part 11 — Guidance on application to semiconductors
• Part 12 — Adaptation for motorcycles

1. 1ApplicationThe organisation's field of activity, headcount, number of sites and scope boundaries are determined. The number of audit days is calculated from this information.
2. 2Document Review (Stage 1)The management system documentation, scope definition, risk assessment and internal-audit/management-review records are examined; readiness for the on-site audit is assessed.
3. 3Certification Audit (Stage 2)It is verified on site that the system is implemented and effective. Findings are classified as major/minor nonconformity or observation.
4. 4Closing NonconformitiesThe organisation submits a root-cause analysis and corrective action plan. The certificate is not issued until major nonconformities are closed.
5. 5Issuing the CertificateThe certificate is issued after review by an independent decision-maker. The audit team cannot make the certification decision.
6. 6Surveillance AuditsA surveillance audit is carried out at least once a year during the certificate's validity. The first surveillance cannot exceed 12 months from the last day of Stage 2.
7. 7RecertificationAt the end of three years, the entire system is re-audited; it must be completed before the certificate expires.

Management system certificates are valid for three years. At least one surveillance audit is carried out per year during this period; the certificate is suspended if surveillance is not carried out. A recertification audit is completed at the end of the third year.

• Trade registry record and operating licence
• The organisation's organisation chart and headcount
• The list of sites/branches within scope
• The management system manual or process documentation
• Internal audit and management review records
• Legal permits, licences and operating documents, if any
• The item definition and system boundaries
• The hazard analysis and risk assessment (HARA) and ASIL assignments
• The functional and technical safety concept
• The safety plan and the verification plan
• Hardware metric calculations and the FMEDA
• Software architecture, unit test and coverage records
• Tool qualification records
• The safety case and the assessment report

There is no fixed list price; the cost is calculated based on the following variables and provided in writing in the quote.

• The headcount within scope (directly determines the number of audit days)
• The number of sites and branches; whether multi-site sampling applies
• The activity's risk level and process complexity
• The number of standards to be certified — an integrated audit reduces the number of days
• The three-year cycle: certification + two surveillance audits

Management system certification is carried out within the scope of ISO/IEC 17021-1. The certification body is accredited by an accreditation body party to the IAF multilateral recognition agreement (IAF MLA); This agreement establishes a chain of international recognition that ensures that a document issued in one country is accepted in other countries. EUROLAB has internationally recognized accreditation from IAF member accreditation bodies within the scope of ISO/IEC 17021-1.

The scope under which this scheme can be offered varies according to your product and activity; it is confirmed in writing at the quote stage.

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