Clause 6.3 of ISO 9001:2026 still says that changes to the quality management system shall be carried out in a planned manner, but it now lists seven things the organisation shall consider instead of four. The three additions are the communication of the changes (6.3 e)), how the effectiveness of the changes will be monitored and evaluated (6.3 f)) and how the results of the changes will be reviewed (6.3 g)); the fourth consideration now covers the availability of information as well as resources (6.3 c)). ISO’s Foreword calls this “strengthened management of change”. In audit terms it means that any change an auditor picks, from a new ERP module to a new shift pattern, can now generate three questions that most organisations cannot answer from records: who was told, how did you know it worked, and who reviewed the result.
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The seven considerations, side by side with 2015
| 6.3 item | ISO 9001:2015 | ISO 9001:2026 | Status |
|---|---|---|---|
| a) | The purpose of the changes and their potential consequences | Unchanged | Same |
| b) | The integrity of the QMS | The potential impact on the integrity of the QMS | Same in substance |
| c) | The availability of resources | The availability of resources and information | Changed |
| d) | The allocation or reallocation of responsibilities and authorities | Unchanged | Same |
| e) | — | The communication of the changes | New |
| f) | — | How the effectiveness of the changes will be monitored and evaluated | New |
| g) | — | How the results of the changes will be reviewed | New |
The lead-in also changed: 2026 says the organisation shall consider these items “to ensure changes are implemented effectively to achieve intended results”, which ties 6.3 to the same language of intended results used in 4.4.1 h), 5.1.1 e) and 6.1.2.
Which changes does 6.3 apply to?
Clause 6.3 applies to changes to the quality management system. Annex A.6.3 widens the lens: changes to the organisation, including changes to its QMS, can arise from external or internal issues, from decisions the organisation takes, or from changes in other management systems, and some of them adversely affect the ability to achieve objectives while others open an opportunity. Three other clauses deal with specific kinds of change and keep their own requirements: 8.1 (control of planned changes and review of the consequences of unintended changes in operational planning), 8.3.6 (design and development changes, with records) and 8.5.6 (changes for production or service provision, with records of the review, the person authorising and the actions). 6.3 is the general method that sits above them.
In practice the changes that reach 6.3 are the ones that alter how the system works: a new site or the closure of one, a new product line, outsourcing a process, a new software platform, a restructure that moves responsibilities, a change of certification scope, a merger, and the transition to ISO 9001:2026 itself.
A change plan that answers all seven
The standard does not require a documented procedure for 6.3 and does not require a record of the plan; the requirement is to consider the seven items. Because the three new ones are questions about the future (how will you communicate, monitor, review), the only way to show they were considered before the change is to have written them down before the change. A one-page change plan does it.
| Field on the plan | Satisfies |
|---|---|
| What is changing, why, and what could happen as a result (good and bad), including effects on customers | 6.3 a) |
| Which processes, controls, documents and records are affected; whether any certificate scope, customer commitment or legal requirement is touched | 6.3 b) |
| People, money, equipment, systems, data and information needed, and confirmation they are available before the start date | 6.3 c) |
| Who owns the change, who does what, and which responsibilities move permanently | 6.3 d) |
| Who needs to know (staff, customers, suppliers, the certification body), what they will be told, when and by whom | 6.3 e) |
| What “worked” looks like, which measures will show it, who monitors them and until when | 6.3 f) |
| When and by whom the results will be reviewed, and where the review will be recorded (a management review input under 9.3.2 b) is the natural home for significant changes) | 6.3 g) |
Keep the plan proportionate. A change of label printer needs three lines; a new plant needs a project. The 6.3 items are considerations, and Annex A.2 b) makes the point that “consider” means the organisation thinks about a topic to determine whether it will be included in decisions or actions, whereas “take into account” means it must be included.
The transition to ISO 9001:2026 as the worked example
The transition is a change to the QMS, so 6.3 applies to it, and auditors have already begun asking to see the transition planned under 6.3. Purpose: certification to the 2026 edition before the transition deadline, with the new requirements met in substance. Consequences: revised policy, split risk and opportunity registers, revised change-planning template, culture and ethics expectations communicated, revised internal audit checklist and management review agenda. Integrity: the 2015 system continues to operate and its certificate remains valid throughout. Resources and information: the standard itself, the clause-by-clause register, consultant or internal time, training. Responsibilities: a transition owner, plus process owners for each revised element. Communication: leadership briefing, staff briefing on culture and ethics, a note to the certification body requesting its accreditation date and audit arrangements. Monitoring and evaluation: gap closure tracked to zero; one internal audit and one management review completed against the 2026 edition. Review: transition audit findings and their closure, reviewed at the following management review. Written on one page, that plan is evidence for 6.3 a) to g) and a credible answer to the first question a transition auditor will ask.
What an auditor will ask
Auditors rarely audit 6.3 in the abstract. They pick a change they can see (a new machine, a new customer portal, a new supervisor) and trace it. Under the 2026 edition expect: what was the purpose and what did you think could go wrong; who was told and how; how did you know it worked; where was the result reviewed. A change that was managed well but never written down will produce a finding under 6.3 e) to g), because the consideration cannot be demonstrated. That is the reason to introduce the plan template now, before the first change of the transition period.
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Frequently asked questions
Is a change management procedure mandatory in ISO 9001:2026? No. Clause 6.3 requires changes to be planned and seven items to be considered; it does not require a documented procedure or a record. A short change plan is the practical way to show the seven items were considered.
What is new in clause 6.3 of ISO 9001:2026? Three considerations: the communication of the changes (e)), how their effectiveness will be monitored and evaluated (f)) and how their results will be reviewed (g)). Item c) now covers the availability of information as well as resources.
Does 6.3 apply to every change? It applies to changes to the quality management system. Operational changes are controlled under 8.1, design changes under 8.3.6 and production or service changes under 8.5.6, each with its own requirements and records.
Does the transition to ISO 9001:2026 count as a change under 6.3? Yes. It changes the QMS, so it should be planned with the seven considerations, and auditors have started to ask for exactly that.
How is the effectiveness of a change monitored? By defining, before the change, what result it is meant to achieve and which measure will show it, then checking that measure for an agreed period. The result is reviewed under 6.3 g) and, for significant changes, reported to management review under 9.3.2 b).
Where does ISO/TS 10020 fit? ISO/TS 10020 gives guidance on organisational change management processes and is cited in Annex A.6.3. It is guidance, not a requirement.
Read next
The clause-by-clause register; risks and opportunities in ISO 9001:2026; the transition checklist; the ISO 9001:2026 playbook; and ISO 9001:2026 transition consulting from Sterling.
Sources
ISO 9001:2026, Quality management systems — Requirements, sixth edition (published 16 September 2026): 6.3, 8.1, 8.3.6, 8.5.6, 9.3.2 b), Annex A.2 b) and A.6.3. ISO 9001:2015, 6.3, for the comparison. ISO/TS 10020, Quality management systems — Organizational change management — Processes (Bibliography reference).
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