ISO 9001:2026 – What Has Changed?
An overview of the key changes from ISO 9001:2015
ISO 9001:2026 was published on 16 September 2026, replacing ISO 9001:2015.
For organisations already certified to ISO 9001:2015, the transition to the new edition is not intended to require a complete rebuild of an existing Quality Management System (QMS).
The changes to ISO 9001:2026 are relatively limited. However, organisations will need to consider how the revised requirements apply to their own context and management system and determine whether any changes are necessary.
The key changes are outlined below.
Alignment with the Harmonized Structure
ISO 9001:2026 has been updated to further align with the Harmonized Structure used for ISO management system standards.
This provides greater consistency in the structure and terminology used across management system standards.
Changes to Terms and Definitions
Changes have been made to the terms and definitions used within the standard to align with the Harmonized Structure.
New quality-specific terms have also been included for:
Quality management system
Quality policy
Quality objectives
ISO 9000 remains the normative reference for quality management terms and definitions.
Documented Information
ISO 9001:2026 introduces changes relating to documented information.
The wording has been updated and clarification has been provided regarding the requirement for documented information to be available.
Organisations should therefore review how documented information is maintained, controlled and made available within their QMS.
Greater Emphasis on Quality Culture and Ethical Behaviour
Changes have been made to the requirements relating to leadership and organisational culture.
Clause 5.1 has been reorganised and now includes a specific requirement concerning the promotion of quality culture and ethical behaviour.
A new note explains that an organisation's quality culture and ethical behaviour are reflected in its shared values, attitudes and established practices.
Related changes have also been made to Clause 7.3 – Awareness, which now includes organisational quality culture and ethical behaviour.
Organisations should consider how quality culture and ethical behaviour are reflected within their existing management system and organisational practices.
Changes to Risk and Opportunity Management
Clause 6.1 has been reorganised.
The requirements are now structured around:
6.1.1 – Determining risks and opportunities
6.1.2 – Actions to address risk
6.1.3 – Actions to address opportunities
Organisations should review their existing approach to risks and opportunities and consider whether any changes are necessary to reflect the revised structure and requirements.
Changes to Planning of Changes
Clause 6.3, relating to planning of changes, has been expanded.
The revised requirements include consideration of:
How the effectiveness of changes will be monitored and evaluated
Communication of changes
How the results of changes will be reviewed
Organisations should consider these aspects when planning changes that could affect their Quality Management System.
Changes to Management Review
Changes have also been made to Clause 9.3.2 – Management Review Inputs.
The revised requirements include consideration of changes in the needs and expectations of interested parties that are relevant to the Quality Management System.
The management review requirements have also been reorganised.
Organisations should therefore review their existing management review arrangements against the revised requirements.
Annex A Updated
Annex A has been revised to provide additional clarification regarding the requirements of ISO 9001:2026.
Annex A remains informative and is intended to assist organisations in understanding the requirements of the standard.
Annex B has been removed from the new edition.
What Does This Mean for Your Organisation?
The overall changes to ISO 9001:2026 are considered to be relatively limited.
However, the impact of the changes will vary between organisations depending on their context, objectives, processes and existing Quality Management System.
There is therefore no single set of changes that every organisation will need to make.
Each certified organisation is responsible for determining how ISO 9001:2026 applies to its own QMS and identifying any changes that may be required.
For most organisations, the transition should be approached as a structured review of the existing QMS rather than starting again from the beginning.
What Should You Do Now?
If your organisation is currently certified to ISO 9001:2015, you can begin preparing for the transition by:
1. Obtain ISO 9001:2026
Review the new edition and become familiar with the revised requirements.
2. Review your existing QMS
Consider how the changes apply to your organisation and its existing processes.
3. Complete a gap analysis
Identify any areas where your existing arrangements may need to be updated.
4. Plan any necessary changes
Determine what needs to be changed, who is responsible and when the changes will be implemented.
5. Allow time for implementation
Ensure that any necessary changes are implemented and operating effectively before your transition assessment.
IPC will provide certified clients with further information on the transition process, including arrangements for completing the transition assessment and the timing of the transition within your certification cycle.
The final deadline for existing ISO 9001:2015 certified organisations to complete their transition is 30 September 2029.
