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What Does ISO 9001 Clause 8.5.6 Control of Changes Mean?



ISO 9001 Clause 8.5.6, "Control of changes," emphasizes the importance of managing changes within the organization to ensure that they do not adversely affect the quality of products and services.


Explanation of Clause 8.5.6


  1. Review and Approval of Changes: The organization is required to review and approve changes before they are implemented. This ensures that changes are carefully considered, and potential impacts on product or service quality are assessed.

  2. Review of Consequences: When changes are proposed, the organization should assess the potential consequences, both intended and unintended, on product or service conformity. This includes considering the impact on safety, performance, and compliance with requirements.

  3. Availability of Information: Documented information regarding reviews of the nature of the change, who authorized the change, and any actions resulting from the review of the change should be retained. This helps in maintaining transparency and traceability of changes.

  4. Communication: Relevant personnel, including those affected by the change, should be informed about the changes and, if necessary, trained to implement them effectively.


Clause 8.5.6 Software Development Example


  • Change in Software Code: If there's a proposed change in the software code of a product, the organization reviews the proposed modifications. The review involves assessing whether the change might introduce new bugs or affect the functionality of the software.

  • Consequence Analysis: The organization considers the consequences of the code change on the overall performance, security, and quality of the user experience. This includes anticipating any potential risks or unintended side effects.

  • Documented Information: All details related to the change, including the nature of the change, reasons for the change, and authorization details, are documented. This documentation serves as a record for future reference and audits.

  • Communication and Training: Relevant members of the development team are informed about the change, and if necessary, training sessions are conducted to ensure that everyone understands how to implement the change correctly.


By following Clause 8.5.6, the organization ensures that changes are managed in a controlled manner, preventing unintended consequences and maintaining the integrity of its quality management system.


ISO 9001:2015 Clause 8.5.6 Control of Changes


The significance of controlling changes within the organization is emphasized in ISO 9001 Clause 8.5.6 Control of changes, to make sure they don't negatively impact the caliber of goods and services.

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