ISO requires new and revised management-system standards to use a common Harmonized Structure (HS) — the same clause numbers and titles, plus shared core text and definitions. Clauses 1–3 are scope, normative references and terms; the requirements live in clauses 4 to 10. The headings below are as used in ISO 9001:2026.
4 Context of the organisation
What is the organisation, what affects it, who cares about it and what does the system cover?
- 4.1 Understanding the organisation and its context — internal and external issues (since the 2024 amendments, including whether climate change is relevant)
- 4.2 Needs and expectations of interested parties
- 4.3 Scope of the management system
- 4.4 The management system and its processes
5 Leadership
- 5.1 Leadership and commitment — top management is accountable
- 5.2 Policy
- 5.3 Roles, responsibilities and authorities
6 Planning
- 6.1 Actions to address risks and opportunities
- 6.2 Objectives and planning to achieve them
- 6.3 Planning of changes
7 Support
- 7.1 Resources · 7.2 Competence · 7.3 Awareness · 7.4 Communication · 7.5 Documented information
8 Operation
- 8.1 Operational planning and control — then each standard adds its own technical requirements (design and production for ISO 9001, hazard control for ISO 22000, risk treatment for ISO/IEC 27001…)
9 Performance evaluation
- 9.1 Monitoring, measurement, analysis and evaluation
- 9.2 Internal audit
- 9.3 Management review
10 Improvement
- 10.1 Continual improvement
- 10.2 Nonconformity and corrective action
11 How the clauses map to Plan-Do-Check-Act
| PDCA | Clauses |
|---|---|
| Plan | 4 Context, 5 Leadership, 6 Planning, 7 Support |
| Do | 8 Operation |
| Check | 9 Performance evaluation |
| Act | 10 Improvement |
12 Watch out for older numbering
Standards published before the 2021 update to the structure (for example ISO 45001:2018, ISO 22301:2019, ISO 50001:2018) put Nonconformity and corrective action at 10.2 and Continual improvement at 10.3, and do not all have 6.3 Planning of changes. ISO 13485:2016 does not use the structure at all.