[Code of Federal Regulations]
[Title 15, Volume 1, Parts 0 to 299]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 15CFR285.5]

[Page 411-412]
 
                  TITLE 15--COMMERCE AND FOREIGN TRADE
 
 CHAPTER II--NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY, DEPARTMENT 
                               OF COMMERCE
 
PART 285--NATIONAL VOLUNTARY LABORATORY ACCREDITATION PROGRAM--Table of Contents
 
                     Subpart A--General Information
 
Sec. 285.5  Definitions.

    Accreditation (of a laboratory): A formal recognition that a 
laboratory is competent to carry out specific tests or calibrations or 
types of test or calibrations.
    Accreditation criteria: A set of requirements used by an accrediting 
body which a laboratory must meet in order to be accredited.
    Approved Signatory (of an accredited laboratory): An individual who 
is recognized by NVLAP as competent to sign accredited laboratory 
calibration or test reports.
    Assessment (of a laboratory): The on-site examination of a testing 
or calibration laboratory to evaluate its compliance with the conditions 
and criteria for accreditation.
    Authorized Representative (of an accredited laboratory): An 
individual who is authorized by the laboratory or the parent 
organization to sign the NVLAP application form and commit the 
laboratory to fulfill the NVLAP requirements (The Authorized 
Representative may also be recommended by the laboratory as an Approved 
Signatory).
    Calibration: A set of operations which establish, under specified 
conditions, the relationship between values indicated by a measuring 
instrument or system, or values represented by a material measure, and 
the corresponding known values of a measurand.
    Calibration method: A defined technical procedure for performing a 
calibration.
    Certificate of Accreditation: A document issued by NVLAP to a 
laboratory that has met the criteria and conditions for accreditation. 
The Certificate of Accreditation may be used as proof of accredited 
status. A Certificate of Accreditation is always accompanied with a 
Scope of Accreditation.
    Competence: The ability of a laboratory to meet the NVLAP conditions 
and to conform to the criteria in NVLAP publications for specific 
calibration and test methods.
    Deficiency: The non-fulfillment of NVLAP conditions and/or criteria 
for accreditation.
    Director of NIST: The Director of the National Institute of 
Standards and Technology or designate.
    Laboratory: An organization that performs calibrations and/or tests. 
When a laboratory is part of an organization that carries out activities 
additional to calibration and testing, the term ``laboratory'' refers 
only to those parts of that organization that are involved in the 
calibration and testing process. The laboratory activities may be 
carried out at or from a permanent location, at or from a temporary 
facility, or in or from a mobile facility.
    LAP: A laboratory accreditation program established and administered 
under NVLAP, consisting of test methods or calibrations relating to 
specific products or fields of testing or calibration.
    NIST: The National Institute of Standards and Technology.
    NVLAP: The National Voluntary Laboratory Accreditation Program. 
NVLAP is an Office within the National Institute of Standards and 
Technology.
    Person: Associations, companies, corporations, educational 
institutions, firms, government agencies at the federal, state and local 
level, partnerships, and societies--as well as divisions thereof--and 
individuals.
    Product: A type or a category of manufactured goods, constructions, 
installations, and natural and processed materials, or those associated 
services whose characterization, classification, or functional 
performance is specified by standards or test methods.
    Proficiency testing: The determination of laboratory performance by 
means of

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comparing and evaluating calibrations or tests on the same or similar 
items or materials by two or more laboratories in accordance with 
predetermined conditions.
    Quality manual: A document stating the quality policy, quality 
system, and quality practices of an organization. The quality manual may 
reference other laboratory documentation.
    Quality system: The organizational structure, responsibilities, 
procedures, processes, and resources for implementing quality 
management.
    Reference material: A material or substance one or more properties 
of which are sufficiently well established to be used for the 
calibration of an apparatus, the assessment of a measurement method, or 
for assigning values to materials. A ``certified reference material'' 
means that one or more of the property values of the reference material 
are certified by a technically valid procedure, accompanied by or 
traceable to a certificate or other documentation which is issued by a 
certifying body.
    Reference standard: A standard, generally of the highest 
metrological quality available at a given location, from which 
measurements made at that location are derived.
    Scope of accreditation: A document issued by NVLAP which lists the 
test methods or services, or calibration services for which the 
laboratory is accredited.
    Sub-facility: A laboratory operating under the technical direction 
and quality system of a main facility that is accredited.
    Test: A technical operation that consists of the determination of 
one or more characteristics or performance of a given product, material, 
equipment, organism, physical phenomenon, process or service according 
to a specified procedure.
    Test method: A defined technical procedure for performing a test.
    Testing laboratory: A laboratory which measures, examines, tests, 
calibrates or otherwise determines the characteristics or performance of 
products or materials.
    Traceability of the accuracy of measuring instruments: A documented 
chain of comparison connecting the accuracy of a measuring instrument to 
other measuring instruments of higher accuracy and ultimately to a 
primary standard.