Clause 7.3.7 Design and development changes
Stable designs are very rare. Most designs are subjected to frequent changes, sometimes even before the design process is finished. It is as important to control these changes as it is to control the original design and development process. It should be clear how these changes are handled and what effects they have on the product.
Most organizations choose to handle any changes to designs similar to the way new designs are handled.
When changes to design and development is needed, go back to design and development planning (7.3.1) to incorporate changes.
Records (4.2.4) of design and development changes and actions taken thereof shall be maintained.
External Document Reference: Documentation Kit
Methodology for Product Design and Development
Design and Development Plan/Review Record
