NVLAP Dosimetry Accreditation Organization of Agreement States – August 2012.

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NVLAP Dosimetry Accreditation Organization of Agreement States – August 2012

National Voluntary Laboratory Accreditation Program (NVLAP)• NVLAP is:

• A system for accrediting laboratories found competent to perform specific tests or calibrations

• NVLAP is not :• An operator of a certification program• A certifier of products or personnel• A certifier of test data

NVLAP – Regulatory Requirement

15 CFR Part 285 – NVLAP• Department of Commerce regulation

• NIST administers NVLAP

• Established in 1976

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NVLAP Accreditation Programs

TESTING - Ionizing Radiation Dosimetry - Radiation Detection Instrument Testing Carpet/Electric Motors/

Lighting/Thermal Insulation/ Fasteners-Metals/EMC-Telecommunications/IT Security/ Asbestos/Acoustics/Construction/ Biometrics/Health IT

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NVLAP Accreditation

•Applicant laboratories – any testing laboratory

• Government/national testing laboratories • Manufacturer’s testing laboratories• Independent testing laboratories• Domestic testing laboratories• Foreign testing laboratories

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NVLAP Accreditation • Accrediting body - ISO/IEC 17011,

Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies

• Accredited laboratories - ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories

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General Accreditation Criteria• NIST Handbook 150, NVLAP Procedures

and General Requirements

• Ensures consistency with international standards and guidelines, specifically ISO/IEC 17025.

• Chapter 4, Management Requirements, and Chapter 5, Technical Requirements, are verbatim with ISO/IEC 17025.

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Program-specific Requirements

• Program-specific Handbooks

• NIST Handbook 150-4, Ionizing Radiation Dosimetry

• Consensus standards

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Dosimetry Standards

•Consensus standards

• ANSI N13.11-2009, Personnel dosimetry Performance – Criteria for Testing (whole body)

• ANSI N13.32-2008, Performance Testing of Extremity Dosimeters (extremity)

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Dosimetry Proficiency Testing

•Different radiation categories (see ANSI N13.11 and ANSI N13.32)

• Accident photons• Photons/photon mixture• Beta• Photon/beta mixtures • Neutron/photon mixtures

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Dosimetry Proficiency Testing

•Proficiency testing (ANSI N13.11 and ANSI N13.32)

• Submit dosimeters for proficiency testing – every 2 years

• Test in categories that best represent the services provided

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NVLAP Accreditation

• On-site assessment every two years• Quality management system• Technical capabilities

• NVLAP Assessors• Technical experts (industry, government,

academia)• Trained in assessment techniques

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NVLAP On-site Assessment

•Assessor resources are on NVLAP website

• publically available • no surprises for lab

•Laboratories resolve all nonconformities to maintain accreditation

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Dosimetry Accreditation

• Dosimeters are NOT accredited• NVLAP does not certify any product

• Dosimetry processors are accredited • Scope of accreditation lists the processing

equipment, dosimeters, holders and radiation categories

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Dosimeters

• Film• TLDs (thermoluminescent dosimeters)• OSLs (optically-stimulated luminescence)• EPDs (electronic personal dosimeters)• Instadose (built-in memory chip)

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Dosimetry Processing

• Some dosimeters are not “processed”, but are electronically “read”

• Processed Film / TLDs / OSLs

• Not processed EPDs / Instadose

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NVLAP Accreditation

• All dosimeters types (processed and not processed) have to be submitted for proficiency testing

• Dosimeters are pulled from existing inventory and not specially selected

• Dosimeter has to “pass” PT in the radiation categories for which lab seeks accreditation

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NVLAP Accreditation

• Accredited laboratory has to have control over data obtained from dosimeter• Clients cannot manipulate/change data used

to report dose

• Instadose data goes directly to accredited laboratory• Fully automated transfer of data

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Summary –Dosimetry Processing Accreditation

• Any laboratory may apply

• Government/national testing laboratories • Manufacturer’s testing laboratories• Independent testing laboratories• Domestic testing laboratories• Foreign testing laboratories

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Summary –Dosimetry Processing Accreditation • Scope of Accreditation

• Dosimetry system• Dosimeter, badge holder, readers

• Radiation categories for which the lab seeks accreditation

• ANSI N13.11(whole body)• ANSI N13.32 (extremity)

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Summary –Dosimetry Processing Accreditation

PLEASE REMEMBER

•Dosimeters are not accredited.

•Laboratories are accredited.

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Betty Ann Sandoval

NIST/NVLAPhttp:www.nist.gov/nvlap

301-975-8446betty.sandoval@nist.gov

Contact Info –

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