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.










