Record each analyser, ECG unit and probe from board build to calibrated handover.

A haematology analyser or an ECG recorder is a small system of its own, and the factory must treat it like one. It might hold a main board, a medical-grade power supply, a photometer lamp or a transducer, tubing, pumps, a display and a firmware image. Each part has a lot, a revision and a supplier. Nothing is anonymous.

Buyers include pathology laboratories, clinics and imaging centres. They ask for calibration certificates, installation reports and spare lamps for a unit that left the factory years ago, and they expect an answer on the same call. A manufacturer that keeps these in separate files spends hours finding what was fitted to one console. Slow.

Production starts with a bill of materials for the model. Boards are assembled in house or by a contract assembler, and each board lot is logged. Technicians build the unit, fit the flow cell, optics or probe, flash a firmware image and run burn-in. Calibration uses reference standards, and readings are saved with the instrument serial, the standard used and the person who signed the sheet at the end of the run.

Finished units pass a final test, including electrical safety checks such as leakage current, and are packed with a manual, accessories and a calibration certificate. Field engineers travel to the laboratory or clinic, install the unit and run the site checks. The handover report names the serial, the bench conditions and whoever accepted the unit on site. Later visits cover preventive maintenance, reagent supply and pump or lamp replacement. A design change to a board or its startup code must reach every unit still on the shop floor. Otherwise old parts keep shipping.