The International Standard for Quality Management Systems (QMS) has taken a step forward with the official publication of ISO 9001:2026.
This revised standard replaces the 2015 version, ensuring that quality management systems remain relevant in evolving global conditions. The new edition introduces targeted updates to improve clarity, usability and relevance while building on the familiar framework organisations already use. It places greater emphasis on leadership, a culture of quality and ethical behaviour, while providing greater clarity on the consideration of risks and opportunities to support better strategic decision-making. A new section also helps users better understand the intent of the requirements and apply them consistently.
Organisations already certified to ISO 9001:2015 should find the transition manageable without the need for major changes to their existing systems. See below for a summary of the changes.
Summary of Changes
Clause 4 – Context of the organisation
Clause 4.1 – Understanding the organisation and its context. The climate action changes introduced through ISO 9001:2015/Amd 1:2024 have been incorporated into ISO 9001:2026 and are now within the relevant clauses of the standard.
Note 2 now identifies the political environment as an additional potential consideration when seeking to understand external context.
Note 3 now adds strategic identifiers, resources and knowledge as areas for consideration when attempting to understand internal context.
4.2 – Understanding the needs and expectations of interested parties has undergone minor rewording and a new bullet c) was added. The organisation needs to determine which of these requirements will be addressed through the quality management system.
Clause 5 – Leadership and commitment
5.1.1 General
The 2026 update revises and expands the list of expectations for top management in relation to leadership and commitment. The ISO 9001:2015 bullet list has been reordered and several items have been reworded.
The most significant change to this clause is the new text within bullet i) in the 2026 edition, requiring top management to promote quality culture and ethical behaviour. This is not an action that can be delegated.
The 2015 edition bullet d) ‘promoting the use of the process approach and risk-based thinking’ is split in the 2026 edition into bullet j) ‘promoting the use of the process approach’ and bullet k) ‘promoting risk-based thinking and opportunities-based thinking’.
The 2015 edition bullet i) ‘promoting improvement’ becomes the 2026 edition bullet g) ‘promoting continual improvement’.
The addition of a new NOTE 2 reminds users of the standard that an organisation’s quality culture and ethical behaviour will be reflected in its shared values, attitudes, practices and actions.
Clause 6 – Planning
6.1
There has been a structural change to clause 6.1 which is designed to make the distinction between risks and opportunities clearer. Clause 6.1.1 was previously titled ‘Actions to address risks and opportunities’ and Clause 6.1.2 was untitled but required organisations to plan to address these risks and opportunities.
In the 2026 edition, clause 6.1.1 becomes ‘Determining risks and opportunities’, 6.1.2 becomes ‘Actions to address risks’ and a new subclause, 6.1.3, becomes ‘Actions to address opportunities’.
6.3
Existing requirements related to the enacting of changes to the QMS have been supplemented with additional requirements relating to communicating QMS change(s), the monitoring and evaluation of QMS changes to determine their effectiveness, and consideration as to how the results of QMS changes will be reviewed.
Clause 7 – Support
7.1.3
Remains largely unchanged, however the note has been expanded to clarify across different working locations. Text reads as “For all types of work (e.g. on site, remote or a combination thereof) infrastructure can include:
a) buildings and associated utilities.
b) equipment, including hardware and software.
c) transportation resources.
d) information and communication technology.
7.1.4
The note in this clause ‘Environment for the operation of processes’, has been amended to account for differences in an organisation’s quality culture. The following has been added “Some factors can be influenced by the organisational quality culture and ethical behaviour”
7.2 Competence
The clause remains substantively unchanged, except for minor changes to bullet a) and d):
a) Becomes ‘that affects its QMS performance’
d) Replaced with ‘appropriate documented information shall be available as evidence of competence’, and now forms a new paragraph instead of a bullet
7.3 Awareness
In the 2026 update, there’s one new bullet added to the existing four: e) is ‘the organisational quality culture and ethical behavior’.
7.4 Communication
Clause 7.4 Communication, which sets out requirements for both external and internal QMS related communications, remains unchanged but its relevance is reinforced through linkage to change management communication.
Clause 8.1 Operational Planning and Control
There has been reformatting of bullet points and changes in terminology from ‘retaining and maintaining documented information’ to ‘documented information shall be available’ and ‘documented information shall be available as evidence of’.
Clause 8.2 Requirements for Products and Services
Communication requirements now include:
- Providing information relating to contingency actions when relevant.
- Information provided to customers should include any related disruptions to the provision of goods and services.
- A new note provides examples of potential communication channels.
Clause 8.3 Design and Development
8.3.1 – This continues to require organisations to establish, implement and maintain a design and development process where applicable. A new note has been added confirming that the design and development process can include cycles of review, verification, validation and feedback.
8.3.2 – The design and development planning, wording has been expanded to include customers and other relevant interested parties, rather than referring only to customers and users.
8.3.3 – Rewording in Clause 8.3.3 Design and development inputs, reinforces that design inputs should reflect a wider range of needs and expectations, based on what is relevant to the organisation’s context.
8.3.4 – Design and development controls, remains substantively unchanged with only minor rewording.
8.3.5 – Design and development outputs – outputs must now explicitly include the characteristics of products and services, and the information on products and services that are essential for their intended purpose and their safe and proper use.
8.3.6 – Design and development changes, emphasis has shifted from identifying changes to determining their impact.
Clause 8.4 Externally provided processes, products and services
8.4.1 – The organisation must ensure that externally provided processes, products and services conform to requirements. There are minor wording changes but no change to substantive requirements.
Clause 8.5 / 8.7 Production, release and nonconformity control
The requirements relating to production and service provision, release and control of nonconforming outputs remain substantively unchanged. Updates primarily relate to wording, restructuring and terminology alignment, including the consistent use of ‘documented information shall be available as evidence of’. These changes improve clarity and consistency, but do not alter the intent of the requirements or the way operational controls are applied within the QMS.
Clause 8.5.1
In this section, Bullet a) 1) is divided into a) 1) and a) 2), and the 2015 a) 2) now appears as a) 3)
Clause 8.7.2
This section has been reworked. The intent is unchanged and introduces bullets a) to d), with revised bullet wording.
9.1 Monitoring, measurement, analysis and evaluation
Clause 9.1.1 b) of the 2026 edition, ‘as applicable’ has been added into bullet b), now reading as ‘the organisation shall determine the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results’.
Clause 9.1.2 In the 2015 edition the organisation was required to monitor customers’ perceptions of the degree to which their needs and expectations had been fulfilled. In the 2026 edition the organisation must monitor customer satisfaction.
Clause 9.1.3 sets out requirements relating to how relevant data and information arising from monitoring and measurement is to be utilised by the organisation. There has been a minor rewording of this clause.
9.2 Internal Audit
9.2.1 – Apart from minor word changes to align with the Harmonised Structure (HS), Clause 9.2.1 and its intent remains unchanged.
9.2.2 – Wording and structural changes were made to this clause, but of more significance is the new requirement that audit objectives be defined for each audit.
9.3.2 Management Review
This is further reinforced in clause 9.3.2, where the 2015 edition bullet e) ‘the effectiveness of actions to address risks and opportunities’ has been split into two bullets in the 2026 edition, one focused on risk and the other focused on opportunities.
Clause 10 – Improvement
The clause has been restructured, with the previous clause 10.3 and elements of clause 10.1 combined into a revised Clause 10.1 Continual improvement. While wording and structure have been refined, including clearer references to monitoring, measurement and data, the substantive requirements for both clauses 10.1 and 10.2 remain largely unchanged.
Guidance – Annex A – Informative
There has been an extensive revision of the contents of Annex A. This now provides enhanced clarification of the structure of ISO 9001, its terminology and the intent of the standard’s requirements. Whilst the current Annex A only covers a handful of specific topics, the revised Annex addresses each clause. Annex A remains informative and as such does not add to, modify or remove any ISO 9001:2026 requirements.
Both auditors and quality professionals implementing a QMS are advised to use Annex A as guidance to support their understanding of the intent and direction of the requirements set out in the standard. However, it is important that this guidance is not treated as mandatory or as auditable criteria.
Removal of Annex B
The previous Annex B listed ISO references and titles of other TC 176 standards considered relevant to users of ISO 9001. These included the core standards ISO 9000 and ISO 9004, as well as guidance standards in the ISO 10000 series and ISO 19011 Guidelines for auditing management systems. In ISO 9001:2026, this annex has been removed. Instead, references to these standards are incorporated, where relevant, within the notes to each section of the revised Annex A.
Normative Documents
ISO 9000:2026 has been issued to support the changes.
ISO 9000:2026, which is a normative reference to ISO 9001:2026, defines quality culture as a ‘culture supporting the achievement of a quality policy and objectives, and the delivery of products and services that meet the needs and expectations of customers and other interested parties’. Both auditors and quality professionals should be aware of this definition and consider the explanatory material provided in Annex A when interpreting and evaluating this requirement.
What about the transition to ISO 9001:2026 from ISO 9001:2015?
Organisations have three years to transition to the new standard. The new standard was released on the 16th September 2026, and all WCS ISO 9001:2015 certificates will expire on the 30th September 2029.
WCS will be able to transition its certified clients by three methods:
- By completing a short transition “special” audit.
- During surveillance audits with additional time added to cover the changes.
- During a recertification audit with additional time added to cover the changes.
Existing clients wishing to start the transition process should complete the online application form below.
If you need more information contact your local WCS representative.
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