ISO 9001:2026 Is on the Horizon

Key Changes & How to Prepare Early

ISO 9001:2015 is entering its next revision cycle, with ISO 9001:2026 targeted for publication around September 2026. As with prior updates, organizations can expect a three-year transition period before ISO 9001:2015 is formally withdrawn. While the upcoming revision is not expected to fundamentally overhaul the standard, it will continue to reshape how quality management systems (QMS) are evaluated, audited, and sustained.

For medical device manufacturers and the suppliers that support them, ISO 9001 plays a critical role in supplier qualification, oversight, and operational maturity, even when ISO 13485 governs regulatory compliance. Early awareness and preparation for the 2026 revision will be essential.

Why ISO 9001 Is Being Updated

The ISO 9001 standard continues to evolve alongside global business, technology, and regulatory expectations. The 2026 revision is expected to place stronger emphasis on:

- Risk-based thinking and organizational resilience
- Leadership accountability for quality culture and ethical behavior
- Digital technologies, data integrity, and system integration
- Sustainability, climate considerations, and stakeholder engagement
- Improved alignment with other ISO management system standards

For organizations already compliant with ISO 9001:2015, these changes should feel incremental rather than disruptive. However, they are likely to influence audit focus areas, supplier qualification criteria, and management review expectations, particularly in regulated supply chains.

ISO 9001:2026 — Clauses Most Likely to Be Impacted

Clause 3 — Terms and Definitions

Key definitions are expected to be incorporated directly into the standard, reducing dependence on ISO 9000 and improving clarity during implementation and audits.

Clause 4 — Context of the Organization

Minor refinements are anticipated. Climate change considerations are now formally embedded following the 2024 ISO amendment, reinforcing expectations around external risk and organizational resilience.

Clause 5 — Leadership and Commitment

This clause is expected to more explicitly emphasize top management’s role in promoting quality culture, ethical behavior, and alignment between quality objectives and strategic direction. Auditors may increasingly look beyond policies to leadership behavior and decision-making.

Clause 6 — Planning

Risk and opportunity management may be reorganized into clearer sub-clauses, improving distinction between risk mitigation and opportunity-driven improvement. Organizations should be prepared to demonstrate intentional planning and follow-through.

Clause 7 — Support

While major new requirements are unlikely, restructuring and expanding awareness expectations—particularly around quality culture and ethics—may increase scrutiny of training effectiveness and communication.

Clause 8 — Operation

This clause is expected to remain largely stable, with only minor terminology or layout refinements anticipated.

Clause 9 — Performance Evaluation

Requirements will remain largely consistent, though expectations around performance monitoring and trend analysis may be clarified, reinforcing data-driven decision-making.

Clause 10 — Improvement

Continual improvement remains central, with additional guidance expected to link improvement activities more clearly to leadership engagement and systemic learning.

Why This Matters for Medical Device Manufacturers and Suppliers

As ISO 9001 evolves, supplier evaluations are increasingly moving beyond documentation to assess how effectively quality systems support risk management, resilience, and ethical operations. For medical device companies, this directly impacts supplier oversight, audit outcomes, and overall supply chain confidence.

How to Prepare Now

Although ISO 9001:2026 has not yet been published, organizations can take proactive steps today:

Reassess risk management and resilience planning
Strengthen leadership engagement in quality activities
Review how quality culture and ethics are communicated and reinforced
Ensure performance metrics support meaningful trend analysis
Begin evaluating supplier readiness for evolving expectations

Early preparation reduces transition risk, minimizes audit disruption, and positions organizations for smoother surveillance and recertification audits.

Final Thought

ISO 9001:2026 isn’t about reinventing your quality system; it’s about ensuring it remains effective in increasingly complex, regulated, and digitally driven environments. Organizations that prepare early will not only ease the transition, but also strengthen the long-term value of their QMS.

If you’d like support assessing readiness, aligning ISO 9001 with ISO 13485 expectations, or evaluating supplier impacts, Rook Quality Systems can help you prepare with clarity and confidence.

RQS Blog