ISO/DIS 9001:2025 – What Is It?

Draft ISO 9001:2025 – Evaluation of the New Revision

ISO 9001 is the most widely used management system standard in the world. Today, thousands of organizations are certified to this standard.

With the ISO 9001:2015 version, the most critical concept introduced was risk-based thinking. This shifted quality management from a narrow focus on product and process conformity to a proactive risk-oriented approach.

Ten years later, the draft of the upcoming revision (DIS ISO 9001:2025), expected to be published in 2026, has been released for public review. This draft does not represent a radical break from the past; rather, it deepens the existing framework and seeks to reduce interpretation gaps.

1. General Character of the Revision

The new draft does not bring a structural overhaul. The ISO 9001 framework remains aligned with Annex SL, so the backbone of the standard is unchanged. The content changes, however, serve three main purposes:

• Deepening the risk – opportunity approach,
• Making leadership, quality culture, and ethical behavior more tangible,
• Strengthening change management,
• Bringing digitalization, hybrid work, and sustainability into scope.

This is not a revolution but an evolution that makes quality management more measurable, contextual, and people-centered.

2. Needs and Expectations of Interested Parties (Clause 4.2)

Organizations are now expected not only to identify relevant interested parties and their expectations, but also to determine which of those expectations will be addressed within the QMS.

3. Operational Planning and Control (Clause 8.1)

In the 2015 version, operational planning referred back to Clause 4.4 (process approach). In the draft, this reference has been removed. Instead, Clause 8.1 is now explicitly linked to Clause 6 (risks, opportunities, objectives, change planning) and Clause 8.4 (externally provided processes, products, and services).

The implication: operations are no longer only about executing defined processes. They must be planned based on risk assessment and supplier performance criteria. This positions operational planning as a management tool for adapting to environmental changes and supply chain risks.

In other words, Clause 8.1 is no longer about managing operations, but about managing the dynamics of operations.

4. Risks and Opportunities (Clause 6.1)

Previously, risks and opportunities were described together in a single paragraph. Many organizations addressed risks but neglected opportunities. The draft changes this by:

• Splitting risks and opportunities into separate subclauses,
• Making opportunities a visible and measurable part of the system.

This means quality management becomes not only a defensive shield but also a driver of competitive advantage and innovation.

Example: In a food business, it’s not just about “reducing customer complaints,” but also about leveraging opportunities such as “innovating with sustainable packaging for multiple benefits.”

5. Leadership and Quality Culture (Clauses 5.1.1 and 7.3)

Leadership responsibilities have been expanded. Top management is now expected to:

• Promote ethical behavior,
• Develop and sustain a quality culture.

This brings new questions to the table:

• How do you build quality culture?
• How do you measure it?

At the same time, Clause 7.3 on awareness has been extended. Employees are now expected to be aware not only of the policy and objectives but also of quality culture and ethical behavior.

For the first time, ISO 9001 explicitly brings human behavior and organizational culture into the QMS. It is no longer just a system of processes and documents, but also a framework that shapes workplace values.

6. Maturity of Change Management (Clause 6.3)

In the 2015 version, change management was often reduced to updating documents. The draft now requires change planning to include:

• Availability of resources,
• Information flow and communication,
• Measurement of effectiveness,
• Review of results.

This transforms ISO 9001 into a system that enables adaptation and organizational learning – a step towards embedding business continuity within quality management.

7. Infrastructure and Work Environment (Clauses 7.1.3 – 7.1.4)

The draft includes hybrid and remote working arrangements within the QMS. The “work environment” is no longer just physical; it now includes digital infrastructure and remote access reliability.

This highlights risks around data integrity and secure access, encouraging organizations to address them systematically.

8. Improvement and Corrective Action (Clause 10)

In 2015, improvement and corrective action were grouped together. The draft separates them:

• Improvement now includes incremental changes as well as innovation and redesign,
• Corrective action is given a stricter framework for root cause analysis and effectiveness verification.

This separation clarifies the difference between solving today’s problems and shaping tomorrow’s progress.

9. Expansion of Annex A

Annex A has been significantly expanded. It now provides detailed guidance aligned with Clauses 4 – 10, making implementation more accessible, especially for SMEs.

10. Overall Assessment

DIS ISO 9001:2025 does not bring structural upheaval but introduces important clarifications and refinements.

Its defining features include:

• Integration of risks, opportunities, and the supply chain into operations,
• Elevating leadership through quality culture and ethics,
• Reframing change management as a tool for adaptation,
• Addressing hybrid work and digital environments,
• Clearer distinction between improvement and corrective action.

In short, the revision makes ISO 9001 more aligned with modern contexts, more measurable, and more human-centered.

Key Highlights of the Draft ISO 9001:2025

1. Opportunities, alongside risks, must now be tracked and monitored.
2. Leadership responsibilities now explicitly cover quality culture and ethical behavior.
3. Hybrid working and digital contexts are part of the system scope.
4. Change management is reframed as part of organizational adaptation and resilience.

Sectoral Impact Analysis

The draft revision of ISO 9001 does not only refine the standard – it also has practical consequences for different industries.

Manufacturing and Industrial Sectors

• Risk–opportunity separation means manufacturers will need to go beyond compliance. Instead of only reducing defects, they will be expected to track opportunities such as energy efficiency, sustainable materials, or digitalization.
• Change management maturity will force factories to move away from ad-hoc document updates and adopt structured change control with measurable outcomes.

Food Industry

• Opportunities in innovation: Food companies will be pushed to consider not just preventing complaints or recalls but also leveraging opportunities, such as sustainable packaging, alternative proteins, or waste reduction.
• Quality culture and ethics: In a highly regulated field, food businesses will now have to show how they foster a culture of safety, transparency, and ethical behavior. Auditors may ask: “How do you measure quality culture among employees?”
• Hybrid and digital work: Teams increasingly operate remotely (supplier audits, digital monitoring, HACCP reviews). ISO 9001 now recognizes these practices as part of the “work environment,” requiring robust data integrity and secure access.

Service and Technology Companies

• Hybrid work integration will be particularly critical for IT and service firms, where remote teams must maintain data reliability.
• Ethical behavior is now explicitly linked to organizational reputation. For customer-facing sectors, this will mean stronger governance around decision-making and client interaction.

SMEs (Small and Medium Enterprises)

• The expanded Annex A provides simpler guidance, lowering the barrier for SMEs. However, the new emphasis on culture, ethics, and opportunities may require capacity-building in areas traditionally outside their focus.

Final Thought

For organizations in all sectors, but especially in food and manufacturing, the new draft highlights that quality management is no longer only about conformance – it is about resilience, culture, ethics, and innovation. Those who embrace this shift early will be better positioned to meet regulatory expectations, earn customer trust, and remain competitive in a fast-changing environment.