Clause 10 of ISO 9001:2026 has two sub-clauses where the 2015 edition had three. The former 10.1 (General) and 10.3 (Continual improvement) are merged into a single 10.1, now titled Continual improvement, and 10.2 (Nonconformity and corrective action) keeps its number and its content. The merged 10.1 is more directive than either of its parents: it names the two sources the organisation shall use to find improvement opportunities, requires those opportunities to be addressed, and lists three kinds of action that improvement shall include, one of which, improving processes, and one of which, addressing future needs and expectations, are now explicit. If any of your procedures, checklists or audit reports cite “10.3”, they now point at a sub-clause that does not exist.
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10.1 Continual improvement: what the merged text requires
The requirement has three parts. The organisation shall continually improve the suitability, adequacy and effectiveness of the QMS; that sentence came from the 2015 10.3. The organisation shall consider the results of monitoring, measurement, analysis and evaluation of data and information, and the results of management review, to determine opportunities, and shall address those opportunities as part of continual improvement; that is the 2015 10.3 second sentence, now tightened from “consider… to determine if there are needs or opportunities” to a requirement to determine and address them. And actions shall include: a) improving processes, products and services; b) addressing future needs and expectations; c) correcting, preventing or reducing undesired effects. The 2015 10.1 listed a) improving products and services to meet requirements as well as to address future needs and expectations, b) correcting, preventing or reducing undesired effects, and c) improving the performance and effectiveness of the QMS. The 2026 list therefore adds “processes” to the first item, makes future needs and expectations an item of its own, and folds QMS performance into the opening sentence. The NOTE, that improvement can be incremental or breakthrough change, innovation or reorganisation, is retained.
| Element | ISO 9001:2015 | ISO 9001:2026 |
|---|---|---|
| Sub-clauses | 10.1 General; 10.2 Nonconformity and corrective action; 10.3 Continual improvement | 10.1 Continual improvement; 10.2 Nonconformity and corrective action |
| Sources of improvement opportunities | 10.3: consider the results of analysis and evaluation and the outputs of management review to determine if there are needs or opportunities | 10.1: consider those results to determine opportunities, and address them |
| Actions shall include | Improving products and services (incl. future needs); correcting, preventing or reducing undesired effects; improving QMS performance and effectiveness | Improving processes, products and services; addressing future needs and expectations; correcting, preventing or reducing undesired effects |
| NOTE | Incremental or breakthrough change, innovation, reorganisation | Retained |
Annex A.10.1 gives the intent: improvement aims to enhance performance and QMS effectiveness; it can result from changes in context, risks or opportunities, or the adoption of technologies; its nature and extent can be influenced by increased reliance on data and the integration of technologies within and between organisations; and improvement activities can involve adapting processes, knowledge and resources in response to internal and external changes.
What “addressing future needs and expectations” asks of you
This item connects Clause 10 to 4.1 and 4.2 (context and interested parties, both of which must be monitored and reviewed), to 6.1.3 (opportunities, whose NOTE cites the current and changing needs of customers and interested parties) and to 9.3.2 c) (changes in interested-party needs as a management review input). The practical test is whether at least some of the organisation’s improvement work is forward-looking: a capacity increase ahead of demand, a competence built for a product not yet launched, a control introduced for a regulation not yet in force, a service adapted for a customer requirement that is emerging rather than current. An organisation whose only improvements are fixes to past nonconformities meets 10.1 c) but not 10.1 b).
10.2 Nonconformity and corrective action: unchanged, with one new NOTE
The six-step method is the same as in 2015. When a nonconformity occurs, the organisation shall a) react to it by controlling and correcting it and dealing with the consequences; b) evaluate the need for action to eliminate the cause so that it does not recur or occur elsewhere, by reviewing the nonconformity, determining its causes and determining whether similar nonconformities exist or could occur; c) implement any action needed; d) review the effectiveness of the corrective action; e) update the risks and opportunities determined during planning, if necessary; f) make changes to the QMS, if necessary. Corrective actions shall be appropriate to the effects of the nonconformities encountered. The records required by 10.2.2 are the same: the nature of the nonconformities and subsequent actions, and the results of corrective action.
The one addition is a NOTE: customer complaints can be a source of nonconformities. It states what competent systems already did, and it closes a gap auditors see often, where complaints are logged in a customer-service tool and never enter the nonconformity and corrective-action process. Annex A.10.2 adds that the organisation determines the approach, including the extent of investigation and the methods used, based on its context and needs, and considers the risk of recurrence, the potential or actual impact, and the requirements of customers and other interested parties when deciding whether corrective action will be applied. In other words, not every nonconformity needs a root-cause investigation, but the decision not to investigate should be a decision.
Where Clause 10 connects to the 2026 changes elsewhere
Improvement now has explicit feeders in three changed clauses. 5.3 e) assigns responsibility for reporting opportunities for improvement to top management. 9.1.3 h) evaluates the need for improvements to the QMS from analysed data. 9.3.2 e) makes opportunities for improvement a management review input and 9.3.3 makes decisions on them a required output. An auditor tracing improvement in 2026 will follow that chain: who reported the opportunity, what data supported it, what management decided, what was done under 10.1, and whether the improvement covered a process or a future need rather than only a past defect.
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Frequently asked questions
Is there a clause 10.3 in ISO 9001:2026? No. The 2015 sub-clause 10.3 (Continual improvement) has been merged into 10.1, which is now titled Continual improvement. Clause 10 has two sub-clauses: 10.1 and 10.2.
What changed in continual improvement under ISO 9001:2026? The requirement to consider analysis results and management review results now leads to determining and addressing opportunities, and the actions shall include improving processes as well as products and services, and addressing future needs and expectations as an item of its own.
Did 10.2 nonconformity and corrective action change? The requirements and records are unchanged. A NOTE was added stating that customer complaints can be a source of nonconformities.
Does every nonconformity need corrective action? No. 10.2.1 b) requires the organisation to evaluate the need for action to eliminate the cause; Annex A.10.2 confirms the organisation decides the extent of investigation based on recurrence risk, impact and interested-party requirements. The evaluation, not the investigation, is mandatory.
Does ISO 9001:2026 require an improvement programme or Kaizen system? No. It requires continual improvement of the QMS’s suitability, adequacy and effectiveness, with the three kinds of action listed in 10.1. How you organise it is your choice.
What should we update in our documents? Any reference to 10.3; any procedure that describes improvement without processes or future needs; the link between complaints handling and the nonconformity process; and the management review agenda so that improvement opportunities produce decisions.
Read next
Management review inputs in ISO 9001:2026; risks and opportunities; the clause-by-clause register; the ISO 9001:2026 playbook; and ISO 9001:2026 transition consulting from Sterling.
Sources
ISO 9001:2026, Quality management systems — Requirements, sixth edition (published 16 September 2026): 5.3 e), 9.1.3 h), 9.3.2 e), 9.3.3, 10.1, 10.2.1, 10.2.2, Annex A.10.1 and A.10.2. ISO 9001:2015, 10.1, 10.2 and 10.3, for the comparison. ISO 10002, Quality management — Customer satisfaction — Guidelines for complaints handling in organizations (Bibliography reference).
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