IngMar Medical ISO 9001:2015 Certified

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.”

Stefan Frembgen, Dr.-Ing, President, IngMar Medical proudly announces ISO 9001:2015 certification.
Stefan Frembgen, Dr.-Ing, President, IngMar Medical

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.

IngMar Medical’s Calibration Lab is accredited by A2LA to ISO/IEC 17025:2005 (Certificate Nr. 4172.01). To learn more about calibration, click here.

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)

IngMar Medical 17025 Accredited

IngMar Medical is proud to announce that our calibration lab has been accredited by A2LA to ISO/IEC 17025:2005 (Certificate Nr. 4172.01). This accreditation demonstrates technical competence for a defined scope and for the operation of a laboratory quality management system.ilac-mra-a2la-accredited-symbol-4172-01

Confidence in Testing

Accreditation to 17025 provides third-party confirmation that you can be confident in your results when using IngMar Medical’s ASL 5000 Breathing Simulator for your critical research, development, and quality testing.

Laboratories that are accredited to this international standard have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data. In fact, ISO/IEC 17025 is the single most important standard for calibration and testing laboratories around the world.

Moreover, as part of accreditation, our laboratory’s quality management system is thoroughly evaluated on a regular basis by A2LA, a highly respected third-party accreditation body. This ensures continued technical competence and compliance with ISO/IEC 17025.

Other Relevant ISO Standards

IngMar Medical is ISO 9001:2015 Certified (Registration Nr. (74 300 3727).

The 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)