ISO 9001:2026 Clause 6.3 Planning of Changes: Requirements, Procedure and Examples
ISO Cloud Consulting editorial team
Clause 6.3 of ISO 9001:2026 still requires changes to the quality management system to be carried out in a planned manner, but it adds three considerations to the four in the 2015 edition: how the change is communicated, how it is monitored, and how the results are reviewed. A change process that ends at approval no longer covers the clause.
What are the seven considerations?
| Consideration | Edition | Question to answer |
|---|---|---|
| Purpose and potential consequences | 2015 | Why are we changing, and what could go wrong? |
| Integrity of the QMS | 2015 | Which processes, documents and records are affected? |
| Availability of resources | 2015 | Do we have the people, budget and time? |
| Responsibilities and authorities | 2015 | Who owns the change, and do roles need to change? |
| Communication | 2026 | Who needs to know, when, and how will we tell them? |
| Monitoring | 2026 | How will we know the change is going to plan? |
| Review of results | 2026 | Did the change achieve its purpose, and what did we learn? |
This table summarises the clause in our own words. Check the exact wording in your copy of the standard.
Which changes does this apply to?
Clause 6.3 is about changes to the management system: introducing an ERP or eQMS, moving site, restructuring departments, outsourcing a process, changing a critical supplier, extending the certification scope. Design and development changes fall under 8.3.6 and production or service provision changes under 8.5.6. A good procedure explains the boundary so people know which route to use.
A simple change procedure
- Request. Anyone can raise a change request describing the change and its purpose.
- Assess. The process owner completes an impact assessment against the seven considerations.
- Approve. Top management or a delegated authority approves significant changes.
- Communicate. Issue the communication plan before implementation starts.
- Implement and monitor. Track actions in a change log with status and dates.
- Review. At a set point after go-live, review results against the purpose and record lessons learned.
- Report. Summarise open and closed changes at management review.
Worked examples
New ERP system
Consequences include data migration errors and loss of traceability. Monitoring is a weekly cutover checklist. The review of results, three months after go-live, checks order accuracy and on-time delivery against the period before the change.
Relocating a production line
QMS integrity items include revalidation, calibration after the move and updated work instructions. Communication covers customers who require notification of a site change. The review confirms first-pass yield has returned to the previous level.
Changing a key supplier
The assessment links to supplier evaluation under 8.4. Monitoring is incoming inspection results for the first ten deliveries. The review decides whether to reduce inspection to normal levels.
How to update your system
- Add communication, monitoring and review fields to your change form.
- Add a review date and review outcome to the change log.
- Add planned changes and their results to the management review agenda.
- Log the ISO 9001:2026 transition as change number one.
The Change Management Procedure and Log includes the 8-page procedure, form, log, review form and these three examples in editable Word and Excel.
