Module18 April 20264 min read
Module spotlight: Work Orders & Manufacturing Records
The device history record is proof a product was built the way it was meant to be. Work orders and manufacturing records capture production as it happens.
By MoniDoseQMS Team
When a product is built, you need a record that it was built correctly — the right materials, the right steps, the right checks. Work orders drive production, and manufacturing records capture what actually happened, forming the device history record regulators expect.
What you can do
- Issue and track work orders for production
- Capture manufacturing records as work is performed
- Tie records to batches, materials, and equipment
- Feed into product release with the evidence already assembled
Why it matters
Production and process controls under ISO 13485 §7.5 and the device history record under FDA rules depend on contemporaneous manufacturing records. Capturing them in the system makes release decisions faster and recalls more precise.