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This guidance has been superseded by ISO 9001:2015 Clause 8.3.6 Design and Development Changes.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.
Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement and document your organization's quality management system or integrated management system.
ISO 9001:2008: Design and development changes 7.3.7 (superseded)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.
Want to know more?
- Read our customer's feedback
- Client list - who's using our templates?
- How the templates are formatted and download examples
- Why we use turtle diagrams and process maps
- What's the difference between a process and a procedure?
- About documented information
SSL certification
A certificate guarantees the information your internet browser is receiving now originates from the expected domain - https://www.iso9001help.co.uk. It guarantees that when you make a purchase, sensitive data is encrypted and sent to the right place, and not to a malicious third-party.
Free PDCA guidance
ISO Navigator™ is our FREE online training tool that shows you how to apply the principles of PDCA to your operations. We also offer many helpful templates that get you on the road to documenting your management system, please visit the download page.