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The FDA’s QMSR is now in effect, shifting medical device manufacturers from transition planning to compliance verification. Organizations should review their QMS, confirm alignment with ISO 13485:2016, close gaps, strengthen risk management, and prepare objective evidence for future FDA inspections.

ISO/IEC 42001 provides a framework for organizations to govern artificial intelligence responsibly. This lesson explains why AI governance matters, the risks organizations should manage, key ISO 42001 requirements, and how businesses can prepare for responsible AI implementation, compliance, and continual improvement.

As ISO 9001:2026 approaches, organizations should focus on strengthening the Quality Management System they have today rather than reacting to speculation. Accurate documentation, effective internal audits, engaged leadership, meaningful management reviews, and timely corrective actions will put certified organizations in a stronger position when official transition guidance is released.