How does ISO 9001:2026 Affect ISO 13485 Certification?

Will ISO 9001:2026 impact ISO 13485 compliance for medical device manufacturers? ISO 13485 remains the dedicated quality management system (QMS) standard for medical devices, but upcoming ISO 9001 revisions could affect organizations maintaining both certifications. In this video, we break down the key differences between ISO 9001 and ISO 13485, where their requirements overlap, and why medical device manufacturers must continue meeting industry-specific requirements for risk management, document control, traceability, and regulatory compliance. Key points: How ISO 9001:2026 relates to ISO 13485 Key similarities and differences between the two standards What dual-certified medical device manufacturers should consider How an electronic QMS helps streamline quality management and compliance processes Simplify ISO 13485 compliance with QT9 QMS. Centralize document control, risk management, quality processes, and compliance tracking in one cloud-based solution. Explore QT9 QMS: https://qt9software.com/go/youtube