What the clause requires
Clause 10.1 opens the improvement section by requiring the organization to determine and select opportunities for improvement and to implement any necessary actions to meet customer requirements and enhance customer satisfaction. The clause then spells out what that includes: improving products and services to meet requirements as well as to address future needs and expectations; correcting, preventing or reducing undesired effects; and improving the performance and effectiveness of the quality management system itself.
The standard makes clear that improvement is not only corrective action. The examples it gives are correction, corrective action, continual improvement, breakthrough change, innovation and re-organization. An organization that only improves when something has gone wrong is meeting clause 10.2 reasonably well while leaving most of clause 10.1 untouched, and that gap is usually visible in the complete absence of any improvement project that was not triggered by a complaint or a finding.
The sources of improvement opportunities are spread right across the system: analysis of data in 9.1.3, internal audits in 9.2, the management review in 9.3, suggestions from the people doing the work, customer feedback, and the actions defined for risks and opportunities in 6.1. What the auditor looks for is a flow: an opportunity is identified, evaluated, selected or rejected with a reason, turned into an action or a project with an owner and a due date, and closed with a measured result.
To avoid losing ideas, many organizations keep a single register of improvement opportunities showing the origin, the person responsible for evaluating it and the decision taken. Reviewing that register during the management review demonstrates to the auditor that opportunities are genuinely handled rather than merely collected, and it gives top management a straightforward way to show they are leading improvement instead of just endorsing it.
What changes in ISO 9001:2026
In ISO 9001:2026 the role of leadership in continual improvement becomes more explicit in section 10. See everything that changed in the revision.
What the auditor asks to see
- Improvement opportunities recorded, evaluated and selected or rejected with a reason
- Improvement actions or projects with an owner, a due date and a measured result
- Improvements that go beyond corrective action, such as innovation, cost reduction or new services
- The result of each improvement measured against the situation before it started
Where companies most often get it wrong
- Improvement understood only as corrective action following a problem
- Suggestions from employees collected in a box and never evaluated
- Improvement projects closed with no measurement of the result achieved
- Opportunities raised during audits left without any decision or follow-up
Example of a nonconformity
- Requirement
- ISO 9001, 10.1: determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.
- Evidence
- The internal audits of 2025 and 2026 recorded 11 opportunities for improvement; none of them has an owner, an evaluation or a recorded decision.
- Finding
- The improvement opportunities identified are neither selected nor followed up.
How to comply using PrismaBiz
Ready-made templates for this clause
Frequently asked questions
Does an improvement opportunity raised in an audit have to be implemented?
No. The organization selects which ones it implements, but it has to evaluate each one and record the decision, including the decision not to proceed.
Is PDCA required?
The standard is built on the plan-do-check-act cycle, but it does not require any particular form or template for it.
What is the difference between 10.1 and 10.3?
Clause 10.1 deals with improvement in general, including breakthrough change and innovation. Clause 10.3 focuses on the continual improvement of the suitability, adequacy and effectiveness of the system.