ISO 9001:2015 vs ISO 9001:2026 – Clause-by-Clause Comparison (Clauses 4 to 10)

Introduction: ISO 9001:2026 introduces updates to the Quality Management System requirements while retaining the familiar high-level structure of ISO 9001:2015. This comparison provides a practical overview of the changes from Clauses 4 to 10 and highlights areas that organizations may need to review during transition.

Important Note for Readers:

This article is intended for educational and implementation guidance. It is not a substitute for reading the official ISO 9001:2026 standard. Organizations should refer to the officially published standard and applicable certification-body guidance when planning their transition.

ISO 9001:2015 vs ISO 9001:2026 – Clause-by-Clause Comparison

ISO 9001:2026 is the latest edition of the ISO 9001 Quality Management System standard. It replaces ISO 9001:2015 and provides updated requirements and guidance for organizations implementing a Quality Management System (QMS).

The 2026 edition keeps the familiar structure of ISO 9001, so organizations already certified to ISO 9001:2015 do not necessarily need to create a completely new QMS. Instead, they should review their existing system and make changes where required.

This article provides a simple clause-by-clause comparison from Clause 4 to Clause 10.

ISO 9001:2015 vs ISO 9001:2026

Clause	ISO 9001:2015	ISO 9001:2026 – What to Review
4.1 Context of the organization	Identify internal and external issues affecting the QMS.	Review organizational context and relevant changes, including relevant climate-change considerations.
4.2 Interested parties	Identify relevant interested parties and their requirements.	Review interested parties and their requirements, including relevant climate-related requirements.
4.3 QMS Scope	Determine the scope of the QMS.	Review whether the existing QMS scope is still appropriate.
4.4 QMS and processes	Establish, implement and maintain QMS processes.	Process approach remains important. Review process interactions and controls.
5.1 Leadership	Top management demonstrates leadership and commitment.	Greater emphasis on leadership, quality culture and ethical behaviour.
5.2 Quality Policy	Establish and communicate the Quality Policy.	Review alignment of the Quality Policy with organizational direction and strategy.
5.3 Roles and responsibilities	Define responsibilities and authorities.	Review responsibilities and ensure they are understood and implemented.
6.1 Risks and opportunities	Determine risks and opportunities and plan actions.	Clearer consideration of risks and opportunities. Review the existing risk-management approach.
6.2 Quality objectives	Establish measurable quality objectives.	Continue monitoring measurable objectives and their effectiveness.
6.3 Planning of changes	Plan changes to the QMS.	Review how changes are planned, implemented and evaluated.
7.1 Resources	Determine and provide necessary resources.	Review resources required for effective QMS operation.
7.2 Competence	Determine competence and provide training where required.	Continue to demonstrate competence through appropriate evidence.
7.3 Awareness	Employees must be aware of the Quality Policy, objectives and their contribution.	Greater emphasis on quality culture and ethical behaviour.
7.4 Communication	Determine internal and external communication arrangements.	Review communication processes and their effectiveness.
7.5 Documented information	Control required documented information.	Review documents and records and update obsolete clause references.
8.1 Operational planning and control	Plan and control operational processes.	Review operational controls and evidence of implementation.
8.2 Customer requirements	Determine and review requirements for products and services.	Continue focusing on customer requirements and effective communication.
8.3 Design and development	Control design and development where applicable.	Existing design controls can generally continue, subject to review against the revised requirements.
8.4 External providers	Control suppliers and externally provided processes.	Review supplier selection, evaluation, monitoring and controls.
8.5 Production/service provision	Control production and service activities.	Review operational controls, identification, traceability and change control where applicable.
8.6 Release	Verify requirements before release.	Continue maintaining evidence that products/services meet acceptance requirements.
8.7 Nonconforming outputs	Control nonconforming products/services.	Continue control, correction, disposition and records of nonconformities.
9.1 Performance evaluation	Monitor, measure, analyze and evaluate QMS performance.	Review whether performance information supports effective management decisions.
9.2 Internal audit	Conduct internal audits at planned intervals.	Review audit programme, criteria, scope, auditor competence, reporting and follow-up.
9.3 Management review	Top management reviews the QMS at planned intervals.	Review management-review inputs, outputs, decisions, actions and improvement opportunities.
10.1 Improvement	Identify opportunities for improvement.	Continue identifying and implementing improvement opportunities.
10.2 Nonconformity & corrective action	Correct nonconformities and eliminate causes.	Existing corrective-action process can generally continue, with review against the revised requirements.
10.3 Continual improvement	Continually improve the QMS.	Review the revised clause structure and update internal references where necessary.

What Are the Main Changes?

The most important areas for organizations to review are:

1. Leadership and Quality Culture

ISO 9001:2026 places greater emphasis on the role of leadership in developing a quality culture and supporting ethical behaviour.

Organizations should be able to demonstrate that quality is not only the responsibility of the Quality Department but is supported throughout the organization.

2. Risks and Opportunities

Organizations should review their existing risk-management process.

The revised approach provides clearer consideration of both:

• Risks – things that may negatively affect intended results.
• Opportunities – circumstances that can help improve performance or achieve better results.

3. Quality Policy and Strategy

The Quality Policy should be relevant to the organization's purpose, context and strategic direction.

Top management should be able to explain how quality objectives and the QMS support the organization's overall direction.

4. Awareness and Quality Culture

Employees should understand:

• The Quality Policy
• Relevant quality objectives
• Their contribution to the QMS
• The importance of quality
• Their responsibilities
• The importance of appropriate and ethical behaviour

5. Climate Change

Organizations should consider climate change as part of their organizational context and interested-party considerations where it is relevant to the QMS.

For example, an organization may need to consider:

• Extreme weather
• Supply-chain disruption
• Energy availability
• Customer requirements
• Regulatory requirements
• Infrastructure risks

The organization should determine relevance based on its own circumstances.

ISO 9001:2026 Transition Checklist

Organizations currently certified to ISO 9001:2015 can use the following simple checklist:

☐ Review Clause 4.1 – Context of the organization

☐ Review Clause 4.2 – Interested parties

☐ Review QMS scope

☐ Review Quality Policy

☐ Review leadership and quality culture

☐ Review risks and opportunities

☐ Review quality objectives

☐ Review change-management arrangements

☐ Review competency and awareness

☐ Review documented information

☐ Review supplier controls

☐ Review operational controls

☐ Update internal audit checklist

☐ Update management review checklist

☐ Conduct a gap assessment against ISO 9001:2026

☐ Train relevant employees and internal auditors

☐ Discuss transition arrangements with the certification body

Conclusion

ISO 9001:2026 is an important update, but organizations using ISO 9001:2015 do not necessarily need to completely redesign their Quality Management System.

The practical approach is to understand the changes, conduct a gap analysis, update the QMS where necessary, implement the changes and verify their effectiveness through internal audit and management review.

The areas receiving particular attention include leadership, quality culture, ethical behaviour, strategic alignment, risks and opportunities, awareness and QMS performance.

Organizations should always refer to the official ISO 9001:2026 standard and their certification body's requirements when planning their transition.

Disclaimer

This article is provided for educational and general guidance. It is not a substitute for the official ISO 9001:2026 standard or certification-body requirements.