Slide 81 of 262
7.3.7 Control of Design and Development Changes
NOTE: There are no new requirements in Design and Development Changes from the 1994 version.
The ISO 9001:2000 standard states that all design and/or development changes must be identified, documented and controlled. This should not be an issue. Any basic design system should address documentation and tracking of changes. In the extreme, there is configuration management.
Potential Audit Questions:
1. Does your company document ALL design/ development changes? If you document some, but not all, what characteristics qualify a change for documentation?
2. If your company does document your changes, are these documents controlled in your QMS document control system? If not, why?