Management system guidance
8.5 Production and service provision
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8.5.6 Control of changes
This requirement is unchanged in ISO 9001:2026 (it first appeared as a separate clause in ISO 9001:2015). It requires the organization to review and control changes affecting production or service provision, whether planned or unplanned, to the extent needed to make sure that products and services continue to conform to requirements.
Keep documented information as evidence of the outcome of each change review, who authorized the change, and any actions the review identified. ISO 9001:2008 had no direct equivalent; the nearest was Clause 7.3.7 Control of Design and Development Changes.
The clause requires an organization to make changes in a thoughtful manner and to consider the potential impact to other processes, products and possibly the customer. Key items to consider are:
- Is the impact of the change evaluated to determine its effects on work in process or products already delivered?
- What process control documentation (procedures, travellers, forms, etc.) will need updating as the result of change to be implemented?
- Was the change approved prior to implementation including, where applicable, approval by the customer, statutory or regulatory authority?
- Does the documented information kept as evidence indicate the source of change and information on necessary actions and approvals?
You should seek objective evidence that your organization has implemented a process to review and control changes in accordance with the requirements set out above. If you need a procedure and forms to help control your business's product and service provision process, click here.
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