Harmonised Standards

Harmonised Standards are a special category of European standards developed by European Standardization Organizations (e.g., CEN, CENELEC) following a request from the European Commission. Their key feature is providing a 'presumption of conformity' with the essential requirements of specific EU legislation, such as the AI Act or GDPR, once their references are published in the Official Journal of the EU (OJEU). This means a company adhering to a harmonised standard is legally presumed to comply with the corresponding technical requirements of the law. Unlike general international standards like ISO/IEC 27001, which offer best-practice frameworks, harmonised standards provide a direct, legally-recognized route to compliance for products on the EU market. For high-risk AI, forthcoming harmonised standards will be crucial for demonstrating fulfillment of requirements like risk management (Art. 9) and data governance (Art. 10).

To apply Harmonised Standards in risk management, enterprises should follow three steps. First, conduct regulatory scoping to determine if a product, such as a high-risk AI system, falls under EU legislation that utilizes these standards. Second, identify the relevant harmonised standards for that law in the OJEU and perform a gap analysis, mapping the standard's technical clauses against the company's existing processes. Third, implement the required technical and organizational measures and create a comprehensive technical file to document conformity. For instance, a Taiwanese company developing AI-powered medical diagnostic software can use a future harmonised standard for the AI Act to structure its risk management system. This approach not only ensures compliance with the Act's specific articles but also standardizes evidence, potentially reducing Notified Body audit times by over 30% and significantly increasing the first-pass approval rate.

Taiwanese enterprises face three main challenges. 1) Information and Language Gaps: The complexity and frequent updates of EU regulations and draft standards are difficult to track for non-European companies. The solution is to establish a dedicated regulatory intelligence team or partner with expert consultants for timely updates and localized interpretation. 2) Technical Gaps: Existing R&D processes may not meet the stringent requirements for data governance, robustness, and cybersecurity detailed in the standards. The solution is to conduct a thorough gap analysis against the standard, adopt foundational frameworks like ISO/IEC 42001 (AIMS), and create a phased plan to upgrade technical capabilities. 3) High Compliance Costs: Implementation requires significant investment in training, process re-engineering, and potential product redesign. The solution is to adopt a risk-based approach, prioritizing the highest-risk products, and leverage integrated management systems to avoid redundant efforts, thereby optimizing resource allocation.

Winners Consulting specializes in Harmonised Standards for Taiwan enterprises, delivering compliant management systems within 90 days. Free consultation: https://winners.com.tw/contact