ISO 9001:2026 planning of changes to the QMS

What 6.3 now requires

Since 2015, organizations have had to carry out changes to the QMS in a planned manner, considering purpose and potential consequences, the integrity of the system, the availability of resources and the allocation of responsibilities. The 2026 edition adds four points:

This is about changes to the QMS itself, such as a new organisational structure, a new site, merged processes or new software. Changes to products and services are still covered by 8.3.6 and 8.5.6.

A practical example

A machinery manufacturer merges goods receipt and dispatch into one logistics department. Under 2015 it would have defined the new responsibilities, updated process descriptions and planned staff. Under 2026 it also needs:

• Information: the new inspection instructions and customer specifications are available to staff before the cut-over date, not after it.
• Communication: staff, purchasing, sales and key customers learn in time what changes and whom to contact.
• Effectiveness: it is defined in advance how success is measured, for example by lead time, booking errors and complaints.
• Review of results: three months later the indicators are reviewed and the insights recorded.

A lean change procedure

1. 1

   Describe the change

   Record purpose, scope, affected processes and documents in a short change request.

2. 2

   Assess consequences and risks

   Assess possible effects on customers, products and other processes. Transfer larger risks to the register under 6.1.

3. 3

   Make a plan

   Define resources, owners, required information, communication channel and dates.

4. 4

   Set effectiveness criteria

   Decide in advance how you will recognise success and when you will check.

5. 5

   Implement and communicate

   Change documents through the approval process, inform the people affected and make sure they acknowledge it.

6. 6

   Review the result

   At the agreed time, evaluate the criteria, record the insights and adjust where necessary.

When a change falls under 6.3

Not every adjustment is a change to the QMS. Typical triggers for 6.3 are new sites or business units, merged or outsourced processes, new software for core workflows, changed responsibilities in management and new standards or customer requirements that affect several processes. A single revised work instruction, by contrast, falls under the control of documented information in 7.5.

A short list of triggers in your manual or process description helps. It defines who decides whether a change goes through the procedure. That way, big changes do not happen on the side and small ones do not drown in forms.

Evidence for the audit

• a rule stating which changes must be planned,
• change requests or project plans covering the eight planning points,
• approvals of the changed documents and evidence of communication,
• a documented review of results against the criteria defined in advance.

Common mistakes

• Limiting communication to a circular email without checking whether it arrived.
• Defining effectiveness only after implementation, when the result is already known.
• Forgetting the review of results because the project is formally closed.
• Mixing product changes and system changes in one procedure without respecting the differences.

Implementation in docxpert

For changed documents you use change control with change suggestions followed by review through approval workflows. You evidence communication with read acknowledgements: you see who has confirmed the new version and who has not yet.

docxpert keeps the transition plan itself with the “changes” step. There you attach owners, due dates and linked documents. For actions with an effectiveness check, the CAPA module is a good fit. The transition check shows where you stand on all changes.