ISO 9001:2026 revision – what healthcare organizations need to know

Understanding ISO 9001:2026

What is ISO 9001:2026?

ISO 9001:2026 is the latest revision of the internationally recognized standard for quality management systems. It provides a framework for managing quality and sustainably improving operational performance.

Why was ISO 9001 updated?

Like other ISO standards, ISO 9001 is periodically reviewed and updated to ensure it remains relevant and responsive to evolving organizational needs, challenges, and risks across industries.

Does the update affect healthcare organizations?

Healthcare organizations that maintain ISO 9001 certification or participate in programs that incorporate ISO 9001 requirements may be affected. DNV will provide healthcare-specific guidance as implementation decisions are finalized.

Key changes for healthcare organizations

How does ISO 9001:2026 address environmental change and related risks?

The revised standard emphasizes the need for organizations to consider whether environmental change could affect their ability to achieve intended outcomes. It also encourages organizations to consider climate-related expectations from interested parties.

What changes have been made regarding leadership and organizational culture?

ISO 9001:2026 places greater emphasis on leadership's role in promoting ethical behavior, patient safety, and a strong quality culture. Employees are expected to understand the organization's quality objectives and ethical expectations.

What has changed regarding risk and opportunity management?

The updated standard separates risk and opportunity management into distinct requirements. This change is intended to help organizations address threats more effectively while also identifying opportunities to improve performance and outcomes.

How does ISO 9001:2026 address remote work, cybersecurity, and artificial intelligence?

The updated infrastructure requirements recognize modern work environments, including remote and hybrid work. New considerations include the protection of patient health information (PHI), cybersecurity, digital infrastructure, and the growing use of artificial intelligence in healthcare operations.

How do these changes support patient safety and quality care?

Many of the updates reinforce concepts already important to healthcare organizations, including patient safety, leadership accountability, risk management, ethical behavior, workforce awareness, information security, and continuous improvement.

Preparing for the transition

When do organizations need to transition?

ISO 9001:2026 was published on 16 September 2026. Organizations certified to ISO 9001:2015 have until September 30, 2029, to transition to the revised standard. After that date, ISO 9001:2015 certificates will no longer be valid.

Do I need to take action right now?

No action is required at this time. However, organizations should begin preparing for the transition and be ready to take action as DNV provides implementation timelines and next steps. Organizations should continue maintaining their current quality management systems and follow existing requirements.

Will my next audit be conducted to ISO 9001:2015 or ISO 9001:2026?

DNV will work with each organization to determine the appropriate timing for transition during the three-year transition period.  

How will I know what applies to my organization?

DNV will provide healthcare-specific information explaining how the update applies to healthcare accreditation, certification, and quality management programs.

DNV resources and support

Will DNV provide guidance and resources to help healthcare organizations navigate the transition?

Yes. DNV is developing healthcare-specific guidance and updated training resources to help organizations understand the revision and prepare for any future transition activities.

Where can I find the latest information?

DNV will provide updates as they are finalized through official client communications as additional information becomes available. You can also hear [this episode of the Rx for Hospital Quality podcast], in which we discuss the ISO 9001:2026 revision and what it means for healthcare organizations.

Will DNV’s training and education programs align with ISO 9001:2026?

Yes. DNV is updating its healthcare training curriculum to align with ISO 9001:2026. These updates are intended to help healthcare organizations better understand the revised standard, prepare for any applicable transition requirements, and continue strengthening their quality management systems.

Why am I receiving communications about ISO 9001:2026 that are relevant for other industries?

Because ISO 9001 is used across many industries, some DNV communications may address the standard from a broad, cross-industry perspective. While these communications are broadly informative, healthcare organizations should look for healthcare-specific communications that explain what the revision means for them. These communications will be clearly marked as being healthcare specific.

What is the most important thing healthcare organizations should know right now?

Be aware of the update, but don't be alarmed. No immediate action is required yet. DNV is actively preparing healthcare-specific guidance and will provide the information and support organizations need to prepare with confidence. The ISO 9001:2026 revision is designed to help organizations continue to operate effectively and remain resilient in today’s modern world.

For questions and concerns, please contact DNV's healthcare team by emailing support@dnvhealthcare.zendesk.com