ISO 13485 clause 7.3.8 asks for a documented transfer of the design to production. Its point is simple: the design outputs must be shown to be suitable for manufacturing before they become the specifications production works from. In practice that is a sequence of steps, each of which can send the design back.
Pilot builds
A pilot build makes units the way production will make them: with the real parts, the real tools and the people who will do the work. It answers the question the prototype could not: can this be built, as drawn, at the rate and the yield the business needs? Tolerances that stack up, parts that need an extra hand and steps that only an engineer can do all surface here.
Process validation
Where the output of a process cannot be fully checked afterwards, ISO 13485 clause 7.5.6 asks for the process itself to be validated. A seal, a bond or a moulded part can look right and still be weak. Validation is usually done in three stages:
| Stage | Question it answers |
|---|---|
| IQ, installation qualification | Is the equipment installed and set up as specified? |
| OQ, operational qualification | Does the process hold its output across the full range of settings? |
| PQ, performance qualification | Does it make good product, run after run, in normal production? |
Work instructions and inspection
Every unit has to be made the same way by whoever is on shift. That needs work instructions written for the line rather than for the design team, inspection points with clear acceptance criteria, and controls on the suppliers of every critical part (clause 7.4). Each batch then leaves a record that ties the unit to the materials, the equipment and the people that made it.
Common mistakes
- Transferring a design that is still changing. Freeze it first, or every change repeats the transfer work.
- Treating the pilot build as a demo. Its job is to find the problems, and it should be planned to.
- Validating a process at one setting. OQ exists to prove the edges of the window, not the middle.
- Keeping knowledge in people's heads. If a step needs the engineer who designed it, it is not transferred yet.