IngMar Medical is proud to announce that our Quality Management System has been successfully re-certified to ISO 9001 compliance by TÜV Rheinland (Registration Nr. 74 300 3727). Certification is to the newest version of the standard, ISO 9001:2015.
The scope of registration is the “Design, Manufacture, Calibration, System Training, Consulting and Worldwide Distribution of Respiratory Simulation Devices and Systems.”
“Our certification to the new ISO 9001:2015 means that our customers can rely on our commitment to quality,” said Dr.-Ing Stefan Frembgen, President of IngMar Medical. “We are proud to have reached this milestone a year ahead of required compliance.”
ISO 9001:2015 is an internationally recognized standard for quality management. Complying with the rigor of this standard helps ensure that customers get consistent, high quality products and services. Annual audits are required to maintain certification.
ISO Standards and Requirements for Test Lungs
IngMar Medical’s high-fidelity ASL 5000 Breathing Simulator meets or exceeds the requirements for test lungs used for volume testing as specified in the following standards:
- ISO 80601-2-12:2011 (Critical Care Ventilators)
- ISO 80601-2-13:2011 (Anesthetic Workstations)
- ISO 10651-6:2004 (Home Care Ventilatory Support Devices)
- ISO 10651-3:1997 (Emergency and Transport Ventilators)