Are You Ready for the Transition to ISO 9001:2026?

Organizational context refers to the internal and external circumstances and conditions that may affect an organization’s strategic direction, operational capability and ability to achieve the intended outcomes of its quality management system.

The fundamental concepts established in ISO 9001:2015 continue to apply. However, the new edition places greater emphasis on climate change considerations, which were previously introduced through ISO 9001:2015/Amd 1:2024.

Organizations should therefore consider whether climate change is a relevant issue within their organizational context and whether interested parties have climate-related requirements or expectations.

Top management remains accountable for the overall performance and effectiveness of the quality management system. Leaders must integrate the quality management system into the organization’s business processes rather than treating it as a separate system disconnected from day-to-day operations.

Customer focus, engagement of people, relationship management, the process approach, evidence-based decision-making and improvement continue to be essential leadership responsibilities.

The new edition also places greater emphasis on quality culture and ethical behavior, both of which contribute to the long-term sustainability of quality throughout the organization.

Quality culture refers to an environment in which people at all levels share beliefs, values and behaviors that support compliance with requirements and the achievement of quality outcomes.

Examples of a strong quality culture include:

“Doing the right thing, even when no one is supervising.”

“When a problem is identified, people should have the confidence to report and address it rather than conceal it or misrepresent information. Results should be reported accurately and transparently.”

With quality culture receiving greater attention, organizations should assess whether the behaviors of employees and management genuinely reflect the commitments stated in their quality policy.

Under ISO 9001:2026, quality culture and ethical behavior cannot be evaluated solely through policies or documented information. They must also be demonstrated through leadership decisions, employee actions, data transparency and the willingness to report problems.

ISO 10010:2022 provides guidance that can support organizations in understanding, evaluating and improving quality culture.

A risk is an event or uncertainty that may affect an organization’s ability to achieve its intended outcomes.

An opportunity is a favorable circumstance that an organization can use to improve effectiveness, create value or enhance customer satisfaction.

The new edition provides a clearer and more systematic distinction between risks and opportunities. Organizations should be able to demonstrate appropriate criteria for their evaluation, as well as identify responsible owners, actions, resources, timelines and methods for evaluating effectiveness.

This approach ensures that organizations do not focus solely on preventing problems. It also enables them to identify and use opportunities to improve quality, increase customer satisfaction and enhance organizational performance systematically.

ISO 31000:2018 provides internationally recognized guidelines that can support effective risk management.

Changes to systems, processes, technologies, personnel or organizational structures can directly affect quality. Organizations should therefore evaluate the purpose of each change, its potential consequences, associated risks, required resources, responsibilities, communication needs and methods for monitoring results after implementation.

Change should not begin simply with the question:

“What needs to be done?”

Organizations should also consider:

• Why is the change necessary?
• What effects could the change have?
• What resources will be required?
• Who will be responsible?
• How will the change be controlled?
• How will the organization determine whether the change has been effective?

ISO 10020:2022 provides guidance that can support organizations in managing organizational change effectively.

Organizational knowledge includes the knowledge and experience that an organization possesses and requires for its operations. This encompasses both documented knowledge and knowledge held by its people.

Knowledge management under this edition of ISO 9001 does not necessarily mean creating more documents or establishing extensive databases. Instead, it means ensuring that the organization has accurate, sufficient and up-to-date knowledge that is readily available when needed.

An effective knowledge management system can support organizational change and improvement. It can also help reduce the risk of knowledge loss when key employees resign, retire or move to different positions.

ISO 30401:2018 is a management system standard specifically designed to support knowledge management.

Continual improvement is a systematic approach to enhancing the suitability, adequacy and effectiveness of a quality management system, or QMS. Its purpose is to continuously improve products, services, processes and organizational performance.

Continual improvement does not simply mean resolving immediate problems or increasing the number of improvement projects. An organization should be able to identify areas for development, prioritize the most important issues, implement improvements systematically and demonstrate that these actions have produced better and sustainable results.

Improvement may take several forms, including:

• Regular incremental changes
• Specific improvement projects
• Innovation
• Process redesign
• Significant changes to products or services

Continual improvement is not limited to addressing problems after a nonconformity has occurred. Organizations should clearly distinguish between the following concepts:

• Correction: Immediate action taken to eliminate a detected nonconformity
• Corrective action: Action taken to eliminate the cause of a nonconformity and prevent its recurrence
• Continual improvement: The ongoing enhancement of performance, processes or the QMS, even when no nonconformity has occurred

ISO 56001:2024 is a management system standard that can support innovation management and systematic improvement.