ISO 13485 medical device manufacturing — pilot
The QMOS ISO 13485 module is a manufacturing-focused pilot. It connects device files and batch evidence to authorised release decisions using the shared document and approval foundation.
Device files and traceability
Record the device, model, intended use and markets. Link controlled documents to device file sections and follow production evidence through UDI and component lot records.
DHR and release evidence
Link approved inspection records, label checks and relevant sterilisation loads to the batch. Process validation records support evidence continuity; an authorised person makes the release decision.
- Device file and UDI
- DHR and batch disposition
- Process/sterilisation validation
- Regulatory reporting assessment for complaints
Agree pilot boundaries before rollout
The module does not provide automatic regulatory reporting, product approval or a validation guarantee. In this version, audits, management review, training, equipment and supplier screens also depend on ISO 9001 or 14001/45001 access; a standalone 13485 setup needs separate review.
QMOS supports records and workflows; it is neither an ISO certificate nor a certification guarantee. In-app approvals are not qualified electronic signatures. The ISO 13485 module is in pilot; authorised people remain responsible for regulatory, conformity and release decisions.
Frequently asked questions
Does the module prove a device is legally compliant?
No. Product conformity, evaluation of the software for its intended use and applicable regulatory duties remain the responsibility of your authorised team.
Can the evidence contributor release the same batch?
No. The pilot applies separation of duties to prevent someone who added DHR evidence from releasing that batch.