An engineer tweaks a component after launch to save cost. Six months later, returns start rolling…
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An engineer tweaks a component after launch to save cost. Six months later, returns start rolling in. Who checked that change? Clause 8.3.6 of ISO 9001 covers design and development changes, both during design and after the design is released. Changes must be determined, reviewed and controlled so they do not hurt the ability to meet requirements. Here is the 2026 hint. The 2015 edition said identify changes. The 2026 revision says determine, which implies a discovery process that builds real knowledge about the change. That was always the intent. Documented information must be available on four things: the design changes, the results of reviews, who authorised the changes, and the actions taken to prevent adverse impacts. A software team logs a change request, checks its impact on other features, gets approval and retests before release. A restaurant chain changing a recipe ingredient checks allergens, cost and taste first. Every change is a small new design. Treat it with the same care. Watch the full clause explained in plain words. Exemplar Global certified ISO 9001 training online, Foundation through to Lead Auditor, discounted at auditworkshop.com. #ISO9001 #ChangeManagement #DesignAndDevelopment #ISO9001Revision #AuditWorkshop
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