Certifications, Accreditations, and Affiliations

Fluke Biomedical shows its ongoing commitment to quality through the continuous improvement process required by the internationally recognized ISO 9001 Quality System registration. Fluke Biomedical complies with Quality Programs ISO 9001:2008 and ISO 13485:2003.

Learn more about the International Organization for Standardization.

ISO 9001: 2015 Certification 

ISO 13485: 2016 Certification

As part of Fluke Biomedical, the Ionizing Radiation Calibration Facility at Landauer ensures the delivery of quality irradiation calibration activities through the American Association for Laboratory Accreditation (A2LA) – an independent, internationally-recognized accrediting body for ISO/IEC 17025 Testing/Calibration Laboratories. 

This accreditation provides both Fluke Biomedical and Landauer customers confidence that their radiation calibrations are being held to high standards. 

Specifically, A2LA accreditation means that Landauer Calibration Facility at Fluke Biomedical executes procedures in accordance with A2LA management and technical requirements pertaining to quality systems, personnel, accommodation and environment, test and calibration methods, equipment, measurement traceability, sampling, handling of test and calibration items and test and calibration reports.

Learn more about the American Association for Laboratory Accreditation (A2LA).

A2LA certification

In addition to our NVLAP Accreditation, Fluke Biomedical adheres to ISO 17025:2017, ANSI Z540, Mammography MQSA, and CNSC. 

The laboratory is traceable to both the NIST & PTB. 

We also comply with Quality Programs ISO 9001:2015, ISO 13485:2016, FDA/QSR, and NRC/Part 50, Appendix B/Part 21.