Stage 1 of 12
We're too early for a QMS.
A beautiful stage. The demo works, the roadmap is exciting, and nobody has yet said the words document control out loud.
The actual problem
The team is already making design decisions, selecting tools, changing software, and generating evidence - even if nobody is calling it that yet.
The saner move
Start tiny. Define intended use assumptions, decision logs, version control, basic design inputs, and who approves what.
BBT translation
The goal is not a full enterprise QMS on day one. It is enough structure to stop early decisions becoming archaeological mysteries later.