Planning and Controlling Changes to the Quality Management System
ISO 9001 Clause 6.3
This clause requires the organisation to carry out changes in a planned manner, when it has identified a need to do so.
What Does ISO 9001 Clause 6.3 Require?
Clause 6.3 of ISO 9001:2015 requires that when the organisation determines a need to change the quality management system, those changes are carried out in a planned manner. Four factors must be considered: the purpose of the change and its potential consequences, the continued integrity of the QMS, the availability of resources, and the allocation or reallocation of responsibilities and authorities.
The clause does not define what constitutes a significant change - that is left to the organisation to determine. Changes to documented procedures, the scope of the QMS, key personnel, processes, or the products and services covered by the system would typically fall within the scope of this clause.
How to Manage Changes in Practice
The simplest approach is a change review process - a structured way of considering the four required factors before a change is implemented. This can be as simple as a change review form that captures the nature of the change, its potential impact on the QMS, who is responsible, and what resources are needed.
For changes to documented information - updated procedures, revised policies, new forms - the document control process under Clause 7.5 handles most of what is needed. For larger organisational changes, a change review form provides a more comprehensive record. Minor changes can often be captured within the management review process or on an issues and actions register.
The key principle is that changes are considered before they are implemented, not documented after the fact. An auditor will look for evidence that the QMS integrity has been maintained through change - that procedures still reflect current practice, that responsibilities remain clear, and that any quality implications of the change have been thought through.
Changes to the QMS are where things most commonly go wrong between certification audits. An organisation might restructure, change a key process, or start offering a new service - and the management system documentation simply doesn't keep pace. When I audit against Clause 6.3, I'm looking for evidence that changes have been managed in a controlled way and that the QMS still accurately reflects how the business operates. Where I find procedures that are out of date or where responsibilities have shifted but haven't been updated, that tells me changes haven't been managed as the standard requires.
The practical challenge with Clause 6.3 is building the habit of considering the QMS impact whenever a significant change happens in the business. A change review form helps because it creates a trigger - before a change goes ahead, someone completes the form. Linking this to the document control process means that any required updates to procedures or records are captured and actioned as part of the change rather than left to drift.
Clause 6.3 is just asking you to think before you change things. If you're changing a process, updating a procedure, bringing in new equipment, or restructuring responsibilities - consider what the impact is on the QMS before you do it. A simple change review form or a note in your issues register is usually enough. The main risk is not having a process at all, which means changes happen and the management system quietly becomes out of date without anyone noticing until the next audit.
Practical Compliance Guidance
To comply with Clause 6.3, the organisation needs a defined approach to managing planned changes to the QMS - one that considers the purpose and consequences of the change, maintains system integrity, confirms resources are available, and clarifies responsibilities before changes are implemented.
The alphaZ documents below support compliance with Clause 6.3. The F-Q23 Change Review Form provides a structured record of change considerations, and the ER1 Issues and Actions Register provides a lighter-touch way to track changes and their follow-up actions.
| alphaZ document | How it supports Clause 6.3 |
|---|---|
| ISO 9001 Management System Toolkit | The complete toolkit for implementing an ISO 9001 compliant management system. Includes the change review form, document register and all supporting documents. |
| F-Q23 Change Review Form | A structured form for documenting planned changes to the QMS, capturing purpose, consequences, resources, responsibilities and approval - directly addressing all four considerations required by Clause 6.3. |
| ER1 Issues and Actions Register | Can be used to log and track changes and their associated actions, particularly for smaller changes that do not require a full change review form. |
Note - all the above files can be downloaded with an alphaZ subscription
