Driving Continual Improvement in an ISO 9001 Quality Management System
ISO 9001 Clause 10.1
This clause requires that the organisation makes continual improvements to the management system over time.
What Does ISO 9001 Clause 10.1 Require?
Clause 10.1 of ISO 9001:2026 requires the organisation to continually improve the suitability, adequacy and effectiveness of the QMS. The outputs of analysis and evaluation, internal audits and the management review, can be used to determine whether there are needs or opportunities that should be addressed as part of continual improvement.
The clause also carries the requirement to determine and select opportunities for improvement and to implement any action needed to meet customer requirements and enhance customer satisfaction. Those improvements must address three areas: improving products and services to meet requirements and to address future needs and expectations; correcting, preventing or reducing undesired effects; and improving the performance and effectiveness of the quality management system. In the 2015 edition that sat in a general improvement clause of its own, and the 2026 edition brings it together with continual improvement in one place.
Continual improvement is not a separate activity bolted onto the QMS - it is the result of running all the other elements of the system effectively. When performance evaluation under Clause 9 generates data, when the management review under Clause 9.3 uses that data to make decisions, and when those decisions are implemented and verified, that is continual improvement in practice.
What Continual Improvement Looks Like
Evidence of continual improvement typically comes from quality objectives that have been set and achieved, process improvements implemented following audit findings or nonconformity analysis, training or procedure changes following identified gaps, customer satisfaction trends that show improvement or active management, and resource decisions made as a result of management review. Reductions in nonconformance rates over time are another clear indicator.
The standard does not require a formal improvement programme or breakthrough projects. What it requires is a demonstrable commitment to making the QMS better over time - that the system today is more effective than it was at the last certification audit, and that there is a clear process driving that improvement.
For Clause 10.1 I'm looking at the QMS as a whole and asking whether it's getting better. Are this year's audit findings less significant than last year's? Are the objectives showing a track record of achievement and progression? Are the actions from management reviews being completed? That trajectory is what continual improvement looks like in practice. An organisation that can show a clear improvement story between audits is in a much stronger position than one with a perfect system on paper that hasn't actually changed.
If your audits are finding things and you're fixing them, your management review is producing actions and you're completing them, and your nonconformances are resulting in actual process changes rather than one-off fixes - you're satisfying Clause 10.1. Keep a record of what's improved so you can tell the story at your external audit.
If you are still working to ISO 9001:2015
ISO 9001:2026 was published on 16 September 2026 and replaces ISO 9001:2015. Continual improvement was numbered Clause 10.3 in the 2015 edition, with a separate general improvement clause at 10.1, and the 2026 edition merges the two and numbers the result Clause 10.1.
The changes between the 2015 and 2026 editions are covered clause by clause.
Practical Compliance Guidance
To comply with Clause 10.1, the organisation needs a demonstrable track record of identifying and acting on improvement opportunities, with evidence that actions are completed and their effectiveness evaluated.
An individual issues-actions register can be used to show individual improvements throughout the organisation, over time. Managment reviews completed frequently can also be used as a reference point for ongoing improvements.
The alphaZ documents below support compliance with Clause 10.1.
| alphaZ document | How it supports Clause 10.1 |
|---|---|
| ISO 9001 Management System Toolkit | The complete toolkit provides the full framework - from audit checklists to management review to issues registers - that generates and tracks improvement activity across the QMS. |
| ER1 Issues and Actions Register | Provides a central record of all improvement actions arising from audits, management reviews, nonconformities and other sources - enabling a clear improvement audit trail. |
| F-Q16 Improvement Request Form | Allows staff to formally raise improvement suggestions, providing a structured route for bottom-up improvement ideas and evidence that improvement opportunities are being captured across the organisation. |
Note - all the above files can be downloaded with an alphaZ subscription
