Management system guidance
6.0 Planning
ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret and better implement the requirements of ISO 9001:2026, ISO 14001:2026 and ISO 45001:2018.
Our range of ISO templates cover the requirements of ISO 9001:2026, ISO 14001:2026 and ISO 45001:2018, and offer an easy way to implement your next management system.
6.3 Planning of changes
When your organization determines that changes to its quality management system are needed, those changes must be carried out in a planned manner. Once your processes are determined (Clause 4.4), your organization should identify the risks and opportunities associated with them, and many of the actions taken to address those risks and opportunities will themselves lead to changes to the QMS.
What changed in ISO 9001:2026: Clause 6.3, now titled “Planning of changes”, has been strengthened. The matters to be considered when planning changes now include the availability of information as well as resources, and three new items: how the changes will be communicated, how their effectiveness will be monitored and evaluated, and how the results of the changes will be reviewed.
In order to realize the benefits associated with the identified risks and opportunities, subsequent changes to the management system may be needed. These changes could relate to any aspect of any process, such as its; inputs, resources, suppliers, personnel, activities, controls, measurements, and outputs.
Changes are intended to be beneficial but they need to be carried out when determined by your organization as relevant and achievable. In addition, consideration of newly introduced risks and opportunities should also be taken into account.
To achieve the benefits associated with changes, your organization should consider all types of change that may occur. These changes may be generated, for example, in:
- Processes and procedures;
- Quality manual (where used);
- Documented information;
- Need to revise infrastructure;
- New tooling;
- Process equipment;
- Adoption of climate change requirements;
- Employee training;
- Contractual requirements;
- Supplier evaluation;
- Stakeholder management;
- Interested party requirements, including those related to climate change.
Whenever quality management system changes are planned, Top management should ensure that all personnel are made aware of any changes which affect their process, and that subsequent monitoring is undertaken to ensure that QMS changes are effectively implemented. Requirements for change management are present in the following sections of ISO 9001:2026:
- 4.4 QMS and its processes;
- 5.3 Roles, responsibilities and authorities (5.3 f) integrity of the QMS when changes are planned and implemented);
- 7.5 Control of documented information;
- 8.1 Operational planning and control;
- 8.2.4 Changes to the requirements of products and services;
- 8.3.6 Design and development changes;
- 8.5.6 Control of changes.
Clause 6.3 does not specifically require documented information, but you should seek and record evidence of how changes that impact upon the management system were planned and implemented, for example a change request or change plan, meeting minutes or project records.
Check that organizational knowledge is reviewed before changes to the QMS are made when responding to any change. Ensure that your organization has planned how to integrate and implement the changes into its QMS processes, so that the integrity of the QMS is maintained while the change takes place. To ensure changes are implemented effectively and achieve their intended results, check that your organization has considered:
- The purpose of the changes and their potential consequences (risks and opportunities);
- The potential impact on the integrity of the management system (how does the change affect current processes?);
- The availability of resources and information (are resources and the necessary information available to effect the change?);
- The allocation or reallocation of responsibilities and authorities (are the right staff allocated?);
- How the changes will be communicated (who needs to know, what, when and how?);
- How the effectiveness of the changes will be monitored and evaluated (what indicators or checks will show the change is working?);
- How the results of the changes will be reviewed (for example at a post-implementation review or at management review).
The approach to planning can differ depending on the reason for the change, its complexity and the significance of its potential impacts – a minor procedural update needs far less planning than relocating a site or replacing a core IT system. Changes can arise from external or internal issues, from decisions taken by your organization or from changes in other management systems. ISO/TS 10020 provides guidance on managing change.
More information on PDCA
Planning
Context
Planning
Support
Doing
Support
Operations
Checking
Monitoring, measurement, analysis and evaluation
Acting
Improvement
Want to know more?
- Read our customer's feedback
- Client list - who's using our templates?
- How the templates are formatted and download examples
- Why we use turtle diagrams and process maps
- What's the difference between a process and a procedure?
- About documented information
SSL certification
A certificate guarantees the information your internet browser is receiving now originates from the expected domain - https://www.iso9001help.co.uk. It guarantees that when you make a purchase, sensitive data is encrypted and sent to the right place, and not to a malicious third-party.
Free PDCA guidance
ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.