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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 9001:2000 and ISO 13485:2003.

View our Fluke Biomedical ISO 9001:2000 certificate.
View our Fluke Biomedical ISO 13485:2003 Cleveland certificate.
View our Fluke Biomedical ISO 13485:2003 Everett certificate.


NVLAP Accreditation
Fluke Biomedical also received the prestigious NVLAP 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.


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 9001:2000, ISO 13485:2003, FDA/QSR, and NRC/Part 50, Appendix B/Part 21.


Fluke Biomedical Certifications, Registrations, and Affiliations


AAPM - American Association of Physicists in Medicine

American Colleged of Radiology
ACR - American College of Radiology


HPS - Health Physics Society

Nuclear Regulatory Commission

NRC - Nuclear Regulatory Commission

US Department of Transporation

DOT – U.S. Department of Transportation - Certified for Transportation of
Hazardous Material

International Organization for Standardization
ISO 9001:2000,
ISO 13485:2003,
ISO/IEC 17025:2005

American National Standards Institute ANSI Z540
American National Standards Institute
ANSI Z540

Canadian Medical Devices Conformity Assessment System
CMDCAS - Canadian Medical Devices Conformity Assessment System

Medical Devices Directive
EU-MDD
Medical Devices Directive


European
Conformity

Canadian Nuclear Safety Commission
CNSC - Canadian Nuclear Safety Commission

National Electrical Manufacturer Association
National Electrical Manufacturer Association

Deutsches Institut fur Normange eV
DIN -
Deutsches Institut fur Normange e.V.

Occupational Safety and Health Administration
Occupational Safety and Health Administration

German National Standards Lab
PTB - German National
Standards Lab

National Institute of Standards and Technology
National Institute of Standards and Technology


Scope of accreditation under NVLAP Lab Code 200566-0:2006

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