Quality Management

Clear processes. Reliable services. Continuous improvement.

We have implemented a Quality Management System in accordance with ISO 9001:2015. The principles of the standard provide a structured foundation for our processes, responsibilities and commitment to continuous improvement.

As part of this commitment, ELLECOM voluntarily maintained an independently certified Quality Management System in accordance with ISO 9001:2015. This voluntary certification reflected our commitment to structured processes, reliable services and the continuous development of our organization.

During a surveillance audit, the certified scope was extended to include:

“Services for the support and assessment of regulatory requirements for in vitro diagnostics and medical devices.”

This represented an important development for ELLECOM and reflected the growing focus of our organization on Regulatory Affairs and services for medical device and IVD manufacturers.

The principles behind quality management continue to form an important part of the way we work today. We focus on structured processes, clearly defined responsibilities, professional competence and the continuous development of our regulatory and quality services.

Regular training and knowledge development within our team support our ability to respond to evolving regulatory requirements and the needs of the manufacturers we work with.

Quality. Reliability. Continuous Improvement.