Guidance
Design and development
The ISO Navigator™ database hyperlinks the ISO 9000:2005 principles and the ISO 9001:2008 requirements; and explains them in plain English with practical guidance.
This guidance has been superseded by ISO 9001:2026 Clause 8.3.6 Design and Development Changes. If you want to see a comparison matrix that correlates the requirements of ISO 9001:2008 to the revised requirements of ISO 9001:2015, please click here to begin comparing.
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ISO 9001:2008: Design and development changes 7.3.7 (superseded)
It is as important to control design changes throughout the design and development process and it should be clear how these changes are handled and what effects they have on the product. Ensure control over design and development changes, design changes must be:
- Identified
- Recorded
- Reviewed
- Verified
- Validated
- Approved
Design and development changes (after the original verification and validation) have to be verified and validated as appropriate (as well as reviewed) and to 'include evaluation of the effect of changes on constituent parts and products already delivered'.
If the organization chooses not to perform re-verification and re-validation on every design change, then the auditor should expect to see some very well defined criteria as to when the activity needs to occur.
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