Change Management Procedure & Log (ISO 9001:2026 Clause 6.3)
Change Management Procedure & Log (ISO 9001:2026 Clause 6.3)
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Clause 6.3 (Planning of changes) lists seven considerations in ISO 9001:2026, including how changes are communicated, how their effectiveness is monitored and evaluated, and how results are reviewed. This procedure, form and log cover the full loop.
What you get
- Change management procedure (Word, 8 pages) covering purpose and consequences of the change, QMS integrity, resources and information, responsibilities, communication, monitoring and review of results.
- Change request and impact assessment form with approval block.
- Change log (Excel) with status dashboard, overdue flags and a field for the post-change effectiveness review.
- Post-implementation review form.
- Three worked examples: new ERP system, relocation of a production line and a change of key supplier.
Who it is for
Companies that handle change informally today, or whose procedure stops at approval.
How to use it
- Adopt the procedure and brief process owners.
- Log your ISO 9001:2026 transition itself as the first change.
- Close each change with a review of results.
3 questions your auditor will ask about planned changes
- Show me the last change you made to the QMS. How did you tell the people affected? Have ready: the change request and the communication record.
- How did you know the change was working, and who reviewed the results? Have ready: monitoring data and the post-implementation review.
- How does top management see planned changes and their results? Have ready: the change log and management review minutes.
These are examples. Questions vary by auditor and organisation. The change form, log and review form in this product give you the records to answer them.
The procedure's steps (C1 to C11) are our own template design, not clauses of the standard.
Template version 1.1 (October 2026), checked line by line against ISO 9001:2026 as published on 16 September 2026.
Watch: how this works in practice
Watch: Managing change the way the 2026 edition expects: a worked example.

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The three planning tools, for a quick first pass
$99 | Transition Toolkit
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A full QMS: manual, procedures, forms and all 11 tools
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|---|---|---|---|
| ISO 9001:2015 to 2026 Change Matrix | Included | Included | Included |
| Gap Analysis Workbook (178 lines) | Included | Included | Included |
| Transition Plan Template with Gantt chart | Included | Included | Included |
| Internal Audit Checklist (253 questions) | Not included | Included | Included |
| Risk and Opportunity Register, and Change Management Procedure and Log | Not included | Included | Included |
| Context, Interested Parties and Climate Change Pack, and Organizational Knowledge Register | Not included | Included | Included |
| Management Review Pack, and Quality Culture and Ethical Behavior Pack | Not included | Included | Included |
| Awareness Training Kit (train unlimited staff) | Not included | Included | Included |
| Start-here guide sequencing a 20-week transition | Not included | Included | Included |
| 33-page Quality Manual and 20 procedures (QP-01 to QP-20) | Not included | Not included | Included |
| 43 forms and registers, with a pre-filled Master Document List | Not included | Not included | Included |
| 24-week implementation roadmap for first-time certification | Not included | Not included | Included |
| Optional 60-minute onboarding call with the author | Not included | Included | Included |
| 30-day money-back guarantee, instant download, one-organization licence, free updates for this edition | Included | Included | Included |
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Templates refer to clause numbers and describe requirements in our own words. They do not reproduce the text of any ISO standard, so you need your own licensed copy. Templates support your system; they do not guarantee certification. Licence, updates and refunds in one place: purchase terms. Sold by ISO Cloud Consulting LLC.
Questions about Change Management Procedure & Log (ISO 9001:2026 Clause 6.3)
What does clause 6.3 of ISO 9001:2026 say about planned changes?
When the need for changes to the QMS is determined, they are carried out in a planned manner. The clause lists seven considerations: purpose and potential consequences, impact on QMS integrity, availability of resources and information, allocation or reallocation of responsibilities and authorities, communication of the changes, how their effectiveness will be monitored and evaluated, and how the results will be reviewed. The 2015 edition listed four.
Is a documented change procedure mandatory?
The standard requires changes to be carried out in a planned manner. It does not mandate a procedure or form. This procedure and log are a practical way to show consistent planning.
Does this cover engineering or design changes?
It covers changes to the quality management system. Design changes are controlled under clause 8.3.6 and production changes under 8.5.6, and the procedure explains how they link.
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Who wrote these templates
Ishan Maharaj
Founder and Principal Consultant
BSc Engineering (Industrial) Honours and MSc Engineering Management
An industrial engineer who has worked in regulated medical device manufacturing throughout his career, in senior operations and quality leadership roles since 2019. Every template on this site was written and checked by him against the published standard, and the same person answers your questions.
Working in medical devices too?
If your organization is also ISO 13485 certified, these templates apply the same requirement to a medical device quality system.

