Each device, identified and with history
Manufacturer, model and serial number, its location in the site and the full intervention history, with QR label.
ISO 13485 · Medical devices
CMMS for ISO 13485: medical equipment service
Whoever maintains medical devices must be able to show what was done, by whom and with what result. GMAO CLOUD gathers the asset history and the record of every intervention.
ISO 13485
ISO 13485 is the international quality management standard for organisations across the medical device life cycle. It expressly includes installation and servicing, and asks for records that make it possible to verify the activities performed, identify products and trace their interventions. The organisation meets it with its procedures; the CMMS gives it the support to record and retrieve them.
What ISO 13485 asks of service
The clauses where the service team’s daily work leaves evidence.
Control of documents and records (4.2.4 and 4.2.5)
Controlled documents and records that are kept and retrievable.
Servicing activities (7.5.4)
Procedures and records of the servicing activities carried out.
Identification and traceability (7.5.8 and 7.5.9)
Be able to identify the product and reconstruct what was done on it.
Complaints and improvement (8.2.2 and 8.5)
Handle complaints and non-conformities and act to prevent recurrence.
How GMAO CLOUD helps with ISO 13485
Each device with its whole story, ready for an audit or a complaint.
A record of every service
Request, order, service type (workshop, on site, installation, review), technician, technician and customer signature and PDF report.
Checks recorded
The checks for each device type, with measured values, ranges, photographs and signature.
Parts with lot
The materials used in each intervention, with lot and expiry.
Controlled documentation
Manuals, certificates and reports linked to the asset and order. We are adding version control to the document manager.
Non-conformity handling
Three entry points: the customer marks an incident as KO from their app, the technician records an anomaly on the asset during the order, and the satisfaction surveys linked to each order capture the rating. Everything is logged and resolved with its corrective order.
Shall we look at it with your way of working?
Leave your details and we will get in touch to see whether we fit. No commitment, no lock-in period.
Evidence left for the audit
What you can reconstruct for any device in minutes.
- Full device history: requests, orders, technicians, materials and documents.
- Report of each intervention with technician and customer signature.
- Completed checklists with values and photographs.
- Parts used with their lot.
- Change log and status history of each order.
Who it is for
For medical equipment service teams, distributors with technical support and installers serving hospitals, clinics or manufacturers who must document every intervention.
Frequently asked questions
Must every service provider be ISO 13485 certified?
Not automatically: it depends on their activity, regulation and contracts. A manufacturer-authorised service provider usually follows that manufacturer’s procedures, certified or not.
What records does a service audit ask for?
Which device was serviced, when, by whom, what was checked and with what result, which materials were replaced and which documents accompany the work, plus the device history.
How is each device identified?
With its asset record — manufacturer, model and serial number — and a QR label the technician scans from the app to see its history.
Can the hospital see what was done?
Yes. With the customer portal they see their assets, orders, reports and documents, and can rate the service.
How would ISO 13485 look in your operations?
In a demo we go through the records your ISO 13485 audit asks for and how they come out of daily work in GMAO CLOUD.