3. Set up design reviews

The aim of a design review is to assess the ability of the design solutions to satisfy the input data. These represent all the requirements formalized as part of the design project: functional requirements, regulatory and legal requirements, etc.

A design review brings together the players involved in the stage(s) defined in the meeting agenda.

This is very important, as multi-disciplinary skills will bring complementary points of view.

Paragraph 8.3.4 of ISO 9001 version 2015 sets out the conditions for good development control.

During a design review, you will identify problems and prioritize actions.

The management review minutes will contain the decisions made.

We recommend that any proposed actions be taken into account, as this type...