Quality management · QMS
ISO 9001:2026
The most widely used management-system standard: requirements for a quality management system that consistently meets customer and regulatory requirements and keeps improving. The 2026 edition puts more weight on leadership, quality culture and ethical behaviour, and separates risks from opportunities.
1 What it covers
ISO 9001 sets out what an organisation must do to plan, run, check and improve the way it delivers products and services so that they meet customer requirements and applicable legal requirements. It does not tell you how to run your business — it asks you to understand your context, set a quality policy and objectives, manage your processes and their interactions, address risks and opportunities, and keep improving.
The standard is built on ISO's seven quality management principles: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management.
What changed in 2026
ISO describes the 2026 edition as an evolution rather than a rewrite. According to ISO, the main changes are:
- a stronger leadership role, with more emphasis on quality culture and ethical behaviour (clause 5.1)
- a quality policy linked more explicitly to the organisation's context and strategic direction (5.2)
- a clearer distinction between actions to address risks and actions to address opportunities (6.1)
- new awareness requirements about quality culture and ethical behaviour (7.3)
- a new informative Annex A explaining concepts, terminology and the intent of the requirements
The climate-change consideration added to ISO 9001:2015 by its 2024 amendment is carried forward. UKAS's high-level gap analysis rates the changes at 4.2, 5.1.1, 6.1.2, 6.1.3, 6.3, 7.3 and 9.3.2 as significant.
2 Who uses it
Organisations of every size and sector — manufacturers, service companies, construction firms, software houses, hospitals, universities, public bodies and charities. Many UK public-sector and supply-chain tenders ask for ISO 9001 certification, and the standard is often the first one people train in.
3 Structure and key clauses
ISO 9001:2026 follows the Harmonized Structure. Clause headings below are as listed in UKAS's 2026 gap analysis.
4 Context of the organisation
- 4.1 Understanding the organisation and its context
- 4.2 Understanding the needs and expectations of interested parties
- 4.3 Determining the scope of the quality management system
- 4.4 Quality management system (and its processes)
5 Leadership
- 5.1 Leadership — 5.1.1 General, 5.1.2 Customer focus
- 5.2 Quality policy
- 5.3 Roles, responsibilities and authorities
6 Planning
- 6.1 Actions to address risks and opportunities — 6.1.1 Determining risks and opportunities, 6.1.2 Actions to address risks, 6.1.3 Actions to address opportunities
- 6.2 Quality objectives and planning to achieve them
- 6.3 Planning of changes
7 Support
- 7.1 Resources (people, infrastructure, environment for operation of processes, monitoring and measuring resources, organisational knowledge)
- 7.2 Competence · 7.3 Awareness · 7.4 Communication · 7.5 Documented information
8 Operation
- 8.1 Operational planning and control
- 8.2 Requirements for products and services
- 8.3 Design and development of products and services
- 8.4 Control of externally provided processes, products and services
- 8.5 Production and service provision
- 8.6 Release of products and services
- 8.7 Control of nonconforming outputs
9 Performance evaluation
- 9.1 Monitoring, measurement, analysis and evaluation (incl. 9.1.2 Customer satisfaction)
- 9.2 Internal audit
- 9.3 Management review
10 Improvement
- 10.1 Continual improvement
- 10.2 Nonconformity and corrective action
4 Key facts for courses and exams
- Current edition: ISO 9001:2026 (published 16 September 2026). Courses titled “ISO 9001:2015” teach the previous edition — ask the provider whether materials have been updated.
- Clause 8 is where ISO 9001 adds most of its own requirements on top of the Harmonized Structure (customer requirements, design, external providers, production, release, nonconforming outputs).
- In the 2026 edition, the old clause 10.3 has gone and 10.1 is now Continual improvement (UKAS gap analysis).
- The seven quality management principles are described in ISO 9000 and in ISO's free Quality management principles booklet.
5 ISO 9001 qualifications
6 Prepare
S Sources
Facts on this page last checked 3 October 2026.
- ISO news release, 16 September 2026 — https://www.iso.org/news/2026/09/ISO9001-2026
- ISO, “ISO 9001:2026: What businesses need to know” — https://www.iso.org/quality-management/iso-9001-2026
- UKAS Technical Bulletin, High-Level Gap Analysis ISO 9001:2015 and ISO 9001:2026 (V1.0, September 2026)
- LRQA, ISO 9001 publication date confirmed — https://www.lrqa.com/en/latest-news/iso-9001-publication-date-confirmed/
- ISO, Quality management principles — https://www.iso.org/quality-management/principles