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Certifications, Registrations, and Affiliations

ISO 9001 Registration

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.

View our Fluke Biomedical ISO 9001:2008 Certificate »
View our Fluke Biomedical ISO 13485:2003 Certificate »

NVLAP Accreditation

Fluke Biomedical also received the prestigious NVLAP Lab Code 200566-0 accreditation in September 2003.

Administered by the Institute's National Voluntary Laboratory Accreditation Program, NVLAP provides Fluke Biomedical customers the added assurance that their radiation calibrations are being held to even higher standards.

Specifically, NVLAP accreditation means that Fluke Biomedical operates in accordance with NVLAP 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.

View our certificate »
Scope of Accreditation »

Additional Accreditations

In addition to NVLAP 200566-0:2006, Fluke Biomedical adheres to ISO 17025:2005, ANSI Z540, Mammography MQSA, and CNSC. Also, the laboratory is traceable to both the NIST & PTB. We also comply with Quality Programs ISO 9001:2008, ISO 13485:2003, FDA/QSR, and NRC/Part 50, Appendix B/Part 21.

Fluke Biomedical Certifications, Registrations, and Affiliations

American Association of Physicists in Medicine American College of Radiology Health Physics Society
American Association of Physicists in Medicine » American College of Radiology » Health Physics Society »
Center for Devices and Radiological Health Mammography Quality Standards Act Nuclear Regulatory Commission
Center for Devices and Radiological Health » Mammography Quality Standards Act » Nuclear Regulatory Commission »
U.S. Department of Transportation - Certified for Transportation of Hazardous Material International Organization for Standardization American National Standards Institute Z540
U.S. Department of Transportation - Certified for Transportation of Hazardous Material » ISO 9001:2000 »
ISO 13485:2003 »
ISO/IEC 17025:2005 »
American National Standards Institute Z540 »
Canadian Medical Devices Conformity Assessment System Medical Devices Directive European Conformity
Canadian Medical Devices Conformity Assessment System » Medical Devices Directive » European Conformity »
Canadian Nuclear Safety Commission National Electrical Manufacturer Association Deutsches Institut fur Normange e.V.
Canadian Nuclear Safety Commission » National Electrical Manufacturer Association » Deutsches Institut fur Normange e.V. »
Occupational Safety and Health Administration German National Standards Lab National Institute of Standards and Technology
Occupational Safety and Health Administration » German National
Standards Lab »
National Institute of Standards and Technology »
National Voluntary Laboratory Accreditation Program    
Scope of Accreditation Under NVLAP Lab Code
200566-0:2006 »
   
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Fluke Biomedical Registrations and Accrediation Certificates

ISO 9001 Registration

ISO 9001:2008 Certificate »
ISO 13485:2003 Cleveland Certificate »
ISO 13485:2003 Everett Certificate »

NVLAP

NVLAP Certificate »

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