Blog › Quality Series › Chapter 8
◆ Quality Series · Part 8
In short: if something ever needs investigating, you should be able to trace it — and trust the instruments that measured it.
Traceability
Batch records link raw-material lots → production batch → finished lot → shipment. Any unit can be traced back to its materials, and a recall can be scoped precisely if it is ever needed. UDI is applied per the applicable requirements.
Calibration
- Balances, alcohol meters, UV lamps and other measuring instruments are under internal calibration on a schedule.
- An instrument that is out of calibration can not be used to release product.
The compliance backbone
- ISO 13485:2016 quality management system.
- China Class II manufacturing registration.
- EU Declaration of Conformity.
- EUDAMED registration with an EU Authorised Representative.
For buyers — what to ask for: a traceability demonstration on one lot (release record back to raw-material lots), calibration records for the test instruments, and the system certificates above. That closes the loop on the whole series.
