ISO 21448

ISO 21448, or Safety of the Intended Functionality (SOTIF), is an international standard addressing safety risks arising from functional limitations or foreseeable misuse in autonomous vehicles, rather than component failures. Unlike ISO 26262, which focuses on hardware/software malfunctions, SOTIF manages risks where the system operates as designed but fails to handle complex real-world scenarios. This standard is critical for compliance with UNECE WP.2 regulations and is a prerequisite for AI-driven automotive products entering the European and North American markets. It requires a systematic approach to identify unknown hazardous scenarios and mitigate them through design improvements or operational constraints.

Implementation typically follows three phases: Scenario Identification, Risk Assessment, and Risk Mitigation. Companies first build a comprehensive scenario library using simulation, road testing, and real-world data. Risk-adjusted scenarios are then evaluated using SOTIF-specific risk-ranking methods to prioritize mitigation efforts. Mitigation strategies include enhancing sensor-fusion algorithms, updating software via Over-the-Air (OTA) updates, or restricting the Operational Design Domain (ODD). For example, a Taiwanese ADAS supplier implemented SOTIF-based scenario-based testing, reducing critical edge-case incidents by 35% within 12 months, while improving-turnaround time for regulatory compliance by 20%.

Taiwanese enterprises face three primary challenges: Data Scarcity, Cross-functional Silos, and Regulatory Complexity. Data scarcity can be addressed by investing in high-fidelity simulation platforms like NVIDIA DRIVE Sim or Ansys ADTF. Cross-functional silos require the establishment of a unified Safety-Security-AI task force to ensure alignment between functional safety, cybersecurity (ISO 21434), and AI governance (ISO 42001). Regulatory complexity can be managed by partnering with consultants who specialize in both European (UNECE) and Asian automotive standards. A phased approach—starting with ODD definition, followed by scenario-based validation—is recommended for sustainable compliance.

Winners Consulting Services Co., Ltd. specializes in ISO 21448 for Taiwan enterprises, delivering compliant management systems within 90 days. Free consultation: https://winners.com.tw/contact