OUR COMMITMENT TO QUALITY
In 2016, LSI’s Quality Management System became certified by NSAI in ISO 13485:2003 for the design, manufacture, installation and servicing of cardiopulmonary patient monitoring systems, including the central workstation, monitoring and diagnostic software, and wearable ECG transmitters. In 2018, LSI successfully upgraded it’s Quality Management System to the updated ISO 13485:2016 standard.
OUR QUALITY POLICY
LSI is committed to producing high quality, safe and effective products that meet regulatory requirements, the requirements of ISO 13485 and meet or exceed customer requirements through continuous improvement of our products, processes and relationships.
ABOUT ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device