Summary: what changed in Clauses 0 to 3 of ISO 9001:2026
ISO 9001:2026 is a technical revision, not a rewrite. The foreword names six changes: terms and definitions are now included in Clause 3; quality culture and ethical behaviour are introduced; risks and opportunities are separated; management of change is strengthened; Annex A is expanded; Annex B is removed. In the front matter, subclause 0.3.3 on risk-based thinking is deleted and its guidance moves to Annex A.6.1.2, ISO 9000:2026 replaces ISO 9000:2015 as the normative reference, and more than twenty terms are set out inside ISO 9001 for the first time.
State the changes named in the foreword of the 2026 edition, and explain what the inclusion of terms and definitions in Clause 3 means for your QMS documentation.
AWhat’s changed
ISO classifies the 2026 edition as a technical revision. In practice it is a measured revision rather than a rebuild. The clause structure is unchanged, the harmonised structure still underpins it, and the intent of the standard is the same. Someone who knows ISO 9001:2015 will find the 2026 edition immediately familiar.
That said, the changes are not cosmetic. The foreword names six of them.
| CHANGE NAMED IN THE FOREWORD | COVERED IN |
|---|---|
| Core management system terms and definitions are now included in the standard | This module |
| Quality culture and ethical behaviour are introduced, with associated requirements | Modules 4 and 7 |
| Risks and opportunities are more clearly separated | Module 5 |
| The management of change is strengthened | Module 6 |
| Annex A is substantially expanded | Module 10 |
| Annex B is removed | Module 10 |
Of these, only the introduction of quality culture and ethical behaviour places a genuinely new obligation on an organization. The rest clarify, restructure or relocate what was already there. Organizations that already run a healthy quality culture will find the transition straightforward; those that do not will find this the demanding part of the revision.
The front matter – where several changes hide
Clauses 0 to 3 are easily skipped. In the 2026 edition they carry three changes worth knowing.
Clause 0 Introduction. Subclause 0.3.3 Risk-based thinking has been deleted. The concept has not been abandoned – guidance on it now appears in Annex A at A.6.1.2, with new guidance on opportunity-based thinking at A.6.1.3. Figures 1 and 2 have both been redrawn. In Figure 1, the inputs now include decisions; in Figure 2, hexagons replace circles and the Plan, Do, Check and Act labels have moved from beside the arrows into the relevant shapes, with the relationship between the clauses and the scope of the QMS now shown. The description of the PDCA stages in 0.3.2 now comes before the figure rather than after it. The explanation of the verbal forms ‘shall’, ‘should’, ‘may’ and ‘can’ has been removed from 0.1.
Clause 1 Scope. The purpose of the standard is unchanged. It still specifies requirements for a QMS where an organization needs to demonstrate that it can consistently provide products and services meeting customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.
Clause 2 Normative references. ISO 9000:2026 replaces ISO 9000:2015 as the normative reference. A normative reference is not optional background reading – it is the document you need in order to apply ISO 9001 correctly.
Clause 3 Terms and definitions. This is the substantive front-matter change. ISO 9001:2015 contained no terms at all; it simply pointed the reader to ISO 9000:2015. The 2026 edition sets out more than twenty terms in the body of the standard – core management system terms taken from the harmonised structure, and quality management terms drawn from ISO 9000:2026, some with additional notes or examples.
organization interested party top management management system quality management system policy quality policy objective quality objective risk process competence documented information performance continual improvement effectiveness requirement conformity nonconformity corrective action audit measurement monitoring
Users are also directed to the ISO Online Browsing Platform and IEC Electropedia to search for terms.
Finally, one change runs through the whole document: ISO 9001 no longer calls itself ‘this International Standard’. It is now ‘this document’, in line with the harmonised structure.
BAffected clauses
| ISO 9001:2015 | ISO 9001:2026 | TYPE OF CHANGE | IN SHORT |
|---|---|---|---|
| 0.1 General | 0.1 General | Wording only | Text on the process approach, PDCA, risk-based thinking and the verbal forms removed |
| 0.2 Quality management principles | 0.2 | Wording only | Still the seven principles; ‘typical actions’ becomes ‘actions’ |
| 0.3.1 General (process approach) | 0.3.1 | Wording only | Processes now considered in terms of risk, opportunity and added value; Figure 1 redrawn |
| 0.3.2 Plan-Do-Check-Act cycle | 0.3.2 | Restructure | PDCA stages described before Figure 2; figure restyled and relabelled |
| 0.3.3 Risk-based thinking | Deleted → Annex A.6.1.2 | Restructure | Guidance relocated; opportunity-based thinking added at A.6.1.3 |
| 0.4 Relationship with other MSS | 0.4 | Wording only | The framework is named as ISO’s harmonised approach; relationship with ISO 9002 added; Annex B reference removed |
| 1 Scope | 1 Scope | Wording only | Substantively unchanged |
| 2 Normative references | 2 Normative references | Updated reference | ISO 9000:2026 replaces ISO 9000:2015 |
| 3 Terms and definitions | 3 Terms and definitions | New content | More than twenty terms now set out in ISO 9001 itself |
| Throughout | Throughout | Wording only | ‘This International Standard’ becomes ‘this document’ |
Shaded rows are the three front-matter changes with a practical consequence.
CInterpretation and implications
Relocation is not removal
The deletion of 0.3.3 does not reduce the standing of risk-based thinking. Risk-based thinking remains fundamental to the standard and its requirements sit, as before, in Clause 6.1. What has moved is the explanatory material, which now lives in Annex A alongside new guidance on opportunity-based thinking. This is consistent with the wider aim of the revision: keep requirements in the clauses and explanation in the annex.
Terms in Clause 3 – a review, not a relabelling exercise
Having the terms inside ISO 9001 is a convenience, not a trap. Most of them will already be familiar because they appeared in ISO 9000:2015, which was the normative reference. But some definitions, and more often their notes and examples, have been revised.
Watch the notes
Notes in Clause 3 are not decoration. They supplement the terminology and can carry requirements about how a term is to be used. Read them rather than skimming to the next definition.
The sensible response is a systematic review of your documented QMS to check that the terms you use still line up with the revised definitions – and to change something only where the revised meaning actually affects how a part of your QMS is understood. There is no requirement to adopt the standard’s vocabulary. If your organization prefers ‘records’ to ‘documented information’, or ‘supplier’ to ‘external provider’, that remains perfectly acceptable.
The normative reference has real weight
Changing the normative reference to ISO 9000:2026 is not an administrative detail. It is the document that gives the definitions you must apply. Internal guidance, procedures and – importantly – training material that still relies on ISO 9000:2015 terminology should be reviewed.
‘This document’
This affects nothing in your QMS except your own cross-references. It is worth knowing only so that a change of phrasing is not mistaken for a change of requirement.
DWhat you do about it
If you implement or manage the QMS
| If you audit the QMS
|
ESample questions and answers
Two sample questions with worked answers, so you can check your understanding before moving on. These are not scored and do not affect your final result.
Question 1. Subclause 0.3.3 Risk-based thinking has been deleted from the Introduction. What does this mean?
- Risk-based thinking is no longer part of ISO 9001.
- Risk-based thinking is now optional for organizations with a mature QMS.
- The explanatory material has moved to Annex A.6.1.2; the requirements remain in Clause 6.1.
- Risk-based thinking has been replaced by opportunity-based thinking.
Answer: c. Explanation has been relocated to the annex, and new guidance on opportunity-based thinking added at A.6.1.3. The requirements themselves are unaffected and still sit in Clause 6.1.
a – incorrect; the concept is unchanged in standing.
b – incorrect; nothing in the standard makes risk-based thinking optional.
d – incorrect; opportunity-based thinking has been added alongside risk-based thinking, not in place of it.
Question 2. Clause 3 now sets out terms and definitions inside ISO 9001. What does this require an organization to do?
- Adopt the standard’s vocabulary throughout the QMS, replacing terms such as ‘records’ and ‘supplier’.
- Review the documented QMS to check alignment with the revised terms and their notes, changing wording only where meaning is affected.
- Nothing – the terms were already available in ISO 9000:2015.
- Renumber QMS documentation to match the numbering of the terms in Clause 3.
Answer: b. A proportionate review, not a relabelling programme.
a – incorrect; organizations remain free to use their own terminology.
c – incorrect; some definitions and, more often, their notes and examples have been revised.
d – incorrect; nothing in ISO 9001 requires documentation to follow its numbering.
- The 2026 edition is a measured revision. The structure and intent are familiar; only quality culture and ethical behaviour are genuinely new obligations.
- The foreword names six changes: terms and definitions, quality culture and ethical behaviour, separation of risks and opportunities, strengthened management of change, expanded Annex A, removal of Annex B.
- Risk-based thinking guidance has moved from 0.3.3 to Annex A.6.1.2; the requirements remain in Clause 6.1.
- ISO 9000:2026 is now the normative reference and should be obtained.
- Clause 3 contains terms for the first time – review your QMS terminology against them, but do not treat it as a relabelling exercise.