A quality system that follows the development work

Editorial draft · Sample article for design review

Start with how the team works

A useful quality system makes responsibilities, decisions, and records visible within the actual development process. The procedures need enough detail to guide the people doing the work.

Connect the records

Requirements, risk controls, design outputs, and verification evidence should tell a coherent product story. Traceability becomes more useful when those relationships are maintained during development.

Use the system to manage change

As the product and organization grow, review where the existing process no longer fits. Change control should help the team understand the affected work and evidence.