Is there a formalized Design & Development procedure defining how you plan, manage and control a new design project?
Evidence of the following being carried out consistently is required.
a Conceptual meeting to define project, goals and key stages
b Documented Design FMEA study with agreed outcomes
c Design for Manufacture study with agreed outcomes
d Design freeze and approval for each key stage, including production approval
Auditor to sample 3 recent projects, 1 point for each category to comply"