Carmo is ISO 13485 certified and offers full traceability

Quality Assurance

Carmo is ISO 13485 certified, which guarantees full control of all our processes. With our quality assurance, we provide our customers full material transparency, documentation, and traceability. With components from Carmo, our customers can be certain of COC/COA also on Additive Manufactured components. When working with project development, we have implemented a stage-gate review process to drive all new projects from idea to launch in a structured manner.

“Quality is essential for Carmo"

"Quality is essential for Carmo and we have integrated our quality management system in all our processes. This ensures that all processes in our project development and production are well documented. Therefore, we can meet the demands for consistent quality, which is vital in all industries from industrial to medical.”
Jeanett Thrane Gath, Quality Manager at Carmo

Carmo provides consistent quality

Carmo have always focused on delivering high quality products in a consistent quality and we have been ISO certified since 1993 and holds an ISO 13485 certification today. With full control of all our design and manufacturing processes, we have implemented strict procedures ensuring high standards for production planning and continuous quality control. All these steps are your guarantee that we deliver your products in a consistent high quality.

Complete documentation and compliance

We have full documentation of all our processes from raw material to shipment of finished components. Therefore, we have effective tracking and traceability, which enables us to adjust the production in a precise and structured way if necessary. All our production is in compliance with MDR.

Clean room class 8 and customized quality control

Carmo have clean room class 8 facilities meeting all industry standards. Our clean room facilities include assembly and packaging. We have also developed flexible production cells as their own modular clean rooms. These cells include injection moulding machines with 6 axis robots, and they handle part take out, QC sampling, packaging, surface treatment, and subassembly.
June 11, 2021
Two new strategic partners in the United Kingdom
Carmo has entered two new strategic partnerships in the United Kingdom. The new partners Connetika and Flexible Reinforcements will promote and sell Carmo components in...
May 19, 2021
Say hello to the newest addition to our production capacities
Carmo is expanding the production capacities again. This week a new injection moulding machine, an Arburg Allrounder 630 S 2500 – 800, arrived at our...
April 19, 2021
New 3D printed tools enables prototyping in half the time
By combining modern 3D print, traditional injection moulding and tool construction, Carmo can now develop functional prototypes with their customers in short time and at...