Management system guidance
10.0 Improvement
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10.1 Continual improvement
Clause 10.1 requires your organization to continually improve the suitability, adequacy and effectiveness of its quality management system. It must use the results of monitoring, measurement, analysis and evaluation, together with the results of management review, to identify opportunities, and then address those opportunities as part of its continual improvement. If you need a procedure and forms to help your business control its continual improvement process, click here.
What changed in ISO 9001:2026: in the 2015 edition, clause 10.1 ‘General’ dealt with selecting opportunities for improvement and clause 10.3 ‘Continual improvement’ dealt with continually improving the QMS using analysis, evaluation and management review outputs. ISO 9001:2026 merges the two into a single clause, 10.1 Continual improvement, and clause 10.3 no longer exists. The list of actions is now a) improving processes, products and services (processes are newly named); b) addressing future needs and expectations; and c) correcting, preventing or reducing undesired effects. The separate 2015 references to meeting customer requirements and enhancing customer satisfaction, and to improving QMS performance and effectiveness, are no longer stated in this clause, although they remain the purpose of the QMS. A note explains that improvement can come from incremental or breakthrough change, innovation or reorganization.
Your organization should actively seek out and realize improvement opportunities that will better enable it to achieve the intended outcomes of its quality management system. Potential sources of improvement opportunities include the results of analysis and evaluation of quality performance (9.1.3), customer feedback, internal and external audits (9.2) and management reviews (9.3).
Improvement often does not take place on a ‘continual’ basis. Sometimes improvement can be effected reactively through corrective actions, incrementally over time, by a step change or breakthrough, creatively through innovation or by re-organization and transformation.
Look out for objective evidence that improvement is taking place. Improvement does not need to be continuous, but it does need to be evidenced as an occurring process. Your organization should determine opportunities for improvement and implement the necessary actions, which must include:
- Improving processes, products and services – for example by acting on process performance results and audit findings, reducing waste, process re-engineering, improving reliability and yield, reducing cost and improving on-time delivery;
- Addressing future needs and expectations – by understanding contractual arrangements and implied customer expectations, tracking customer satisfaction information (refer to 9.1.2), and investing in the latest technology and innovation;
- Correcting, preventing or reducing undesired effects – by investigating root cause, preventing escapes to the customer, acting on customer feedback and/or in-service reports, and acting on the risks identified under 6.1.2.
Structural re-organization and breakthrough projects are equally valid routes to improvement, as are opportunities identified and pursued under 6.1.3.
Demonstrating continual improvement
Most auditors would expect you to revise the quality system documentation and processes as the quality management system matures or when a new process is implemented.
Determine whether your organization identifies improvement opportunities and management system underperformance using the data output from its processes, such as data analysis and evaluation, internal auditing, management review, and the use of appropriate tools and methodologies to validate findings. Ensure that your organization has implemented the identified opportunities for improvement in a controlled manner (see 6.3 Planning of changes).
You should seek objective evidence that your organization has implemented a process, with appropriate methods, techniques, and formats, for identifying areas of underperformance or opportunities for improvement, and has selected appropriate tools and techniques to investigate causes. The impetus for continual improvement should come from the use of (as a minimum):
- The quality policy;
- Risks and opportunities;
- Quality objectives;
- Analysis and evaluation of data;
- Audit results;
- Management review;
- Nonconformity and corrective action.
Processes can always be made more efficient and effective, even when they are producing conforming products. The aim of a continual improvement programme is to increase the odds of satisfying customers by identifying areas that need improvement. It requires the organization to plan improvement systems and to take into account many other activities that can be used in the improvement process.
To this end the continual improvement principle implies that you should adopt the attitude that improvement is always possible and your organization should develop the skills and tools necessary to drive improvement.
The PDCA cycle is a perfect way of introducing continual improvement to your organization’s activities. Each step to improvement can be defined by four sub steps, Plan, Do, Check and Act:
- Plan: Establish a timetable for internal audits and management reviews. Establish the objectives and processes necessary to deliver results in accordance with your customer’s requirements and your organization’s policies.
- Do: Implement changes designed to solve the problems on a small scale first to see the effect. This minimizes disruption to routine activity while testing whether the changes will work or not.
- Check: Monitor and measure processes and product against policies, objectives and requirements and report the results. Also check on key activities to ensure that the quality of the output is conforming and not influenced by the changes.
- Act: Take actions to continually improve process performance. Implement the changes on a larger scale, if the experimental changes have proven to be successful. This means making the changes a routine part of the activity.
Also act to involve other people, departments or suppliers affected by the changes and whose co-operation is needed to implement them on a larger scale. Make sure that changes are documented properly according to the documentation requirements.
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
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