IngMar Medical’s Quality Management System has been recertified to ISO 9001:2008 compliance by TÜV Rheinland (Registration Nr. 74 300 3727).
The scope of registration is the “Design, Manufacture, Calibration, System Training, Consulting and Worldwide Distribution of Respiratory Simulation Devices and Systems.”
“Customer satisfaction and continuous improvement are key principles for our company. This recertification validates our progress,” said Dr.-Ing Stefan Frembgen, President of IngMar Medical. “We are proud of our entire team’s commitment to the Quality Management System.”
Planning is already underway to transition to the ISO 9001:2015 standard well before the 2018 deadline.
ISO 9001:2008 is an internationally recognized standard for quality management, designed to help organizations ensure that they meet the needs of customers and other stakeholders. Over one million organizations worldwide are certified to ISO 9001:2008.
Annual audits are required to maintain ISO 9001:2008 certification, which is based on eight quality management principles to help improve organizational performance including customer focus, leadership, involvement of people, process approach, system approach to management, continual improvement, fact-based decision-making, and mutually beneficial supplier relationships.
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)