A2LA - P102 Politicas
A2LA - P102 Politicas
A2LA - P102 Politicas
Document Revised:
P102 – A2LA Policy on Metrological Traceability June 9, 2016
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June 2016
© 2016 by A2LA
All rights reserved. No part of this document may be reproduced in any form or by any
means without the prior written permission of A2LA.
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TABLE OF CONTENTS
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A2LA NOTE 3: Separate documents (P905 - A2LA Metrological Traceability Policy for
ISO 15189 Laboratory Testing and P705 – A2LA Metrological Traceability Policy for
CLIA/ISO 15189 Laboratory Testing) have been developed as A2LA’s official
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interpretation of P102 in the clinical laboratory testing (ISO 15189 and CLIA) area. P905
and P705 serve as the primary measurement traceability policies for clinical testing
laboratories (replacing P102 – A2LA Policy on Metrological Traceability).
Definition of terms:
Accreditation Body (AB) (ISO/IEC 17000 clause 2.6): Authoritative body that
performs accreditation.
The BIPM carries out measurement-related research. It takes part in, and organizes,
international comparisons of national measurement standards, and it carries out
calibrations for Member States.
Calibration (VIM3 clause 2.39): Operation that, under specified conditions, in a first
step, establishes a relation between the quantity values with measurement uncertainties
provided by measurement standards and corresponding indications with associated
measurement uncertainties and, in a second step, uses this information to establish a
relation for obtaining a measurement result from an indication.
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VIM NOTE 2 Calibration should not be confused with adjustment of a measuring system,
often mistakenly called “self-calibration”, nor with verification of calibration.
VIM NOTE 3: Often, the first step alone in the above definition is perceived as being
calibration.
Calibration and Measurement Capability (CMC): A CMC per the CIPM MRA-D-04,
Calibration and Measurement Capabilities in the context of the CIPM MRA is a
calibration and measurement capability available to customers under normal conditions:
b) as published in the BIPM key comparison database (KCDB) of the CIPM MRA.
At a meeting held in Paris on 14 October 1999, the directors of the national metrology
institutes (NMIs) of thirty-eight Member States of the BIPM and representatives of two
international organizations signed a Mutual Recognition Arrangement (CIPM MRA) for
national measurement standards and for calibration and measurement certificates issued
by NMIs. A number of other institutes have signed since then.
This MRA is a response to a growing need for an open, transparent and comprehensive
scheme to give users reliable quantitative information on the comparability of national
metrology services and to provide the technical basis for wider agreements negotiated for
international trade, commerce and regulatory affairs.
NMIs who sign an MRA with the CIPM participate in the measurement comparison
activities of the BIPM.
1http://www.bipm.org/en/cipm-mra/ Services covered by the CIPM MRA can be viewed in Appendix C of the
BIPM KCDB which includes the range and uncertainty of each listed service (http://kcdb.bipm.org/).
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The results of over 200 world-wide participants in key comparisons, such as length, mass,
thermometry, electricity, magnetism, ionizing radiation etc., are published in the KCDB
and is the basis of traceability of the SI conferred to an NMI from the BIPM.
Note 1: For these measurements to be traceable (T1) and (T5) of this document applies.
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VIM Note: The expression of “traceability to the SI” means ‘metrological traceability to a
measurement unit of the International System of Units’.
National Metrology Institute (NMI) (Derived from Joint BIPM, OIML, ILAC and ISO
Declaration on Metrological Traceability: 11/09/2011): A national laboratory that is
tasked with the realization, maintenance, improvement and dissemination of the SI units
via traceable calibration and measurement services based on their Calibration and
Measurement Capabilities (CMCs) for the metrology activities (ex. fundamental
metrology, applied, technical or industrial metrology and legal metrology) within a
particular country. This includes designated institutes that are empowered by an NMI for
specified functions.
Reference Standard (ISO Guide 30:1992): Standard, generally having the highest
metrological quality available at a given location or in a given organization, from which
subsequent measurements are derived.
Traceability (VIM3 clause 2.41): Property of a measurement result whereby the result
can be related to a reference through documented unbroken chain of calibrations, each
contributing to the measurement uncertainty.
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For equipment and reference standards that must be calibrated the calibration shall be
conducted by:
3. A U.S. State Weights and Measures facility with a current certificate of measurement
traceability. Please see http:/www.NIST.gov for a copy of current certificates.
1. For cases where the National Institute of Standards and Technology (NIST) service is
suitable for the intended need but is not covered by the CIPM MRA, A2LA will accept
services covered under the NIST SP 250 Series on NIST Measurement Services
2. A CAB may use a calibration laboratory whose service is suitable for the intended
need, but is not covered by the ILAC MRA under the following conditions:
b) The CAB maintains evidence of a calibration certificate that contains all of the
following
c) The CAB maintains evidence that the reference standard(s) noted on the
calibration certificate are traceable to the SI through NIST (or equivalent) or an
accredited laboratory;
d) The CAB maintains evidence of the calibration interval 4 for the measuring and
test equipment (M&TE) or reference standard.
3 Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which
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A2LA recognizes that there are circumstances where a non-accredited laboratory must be
used even when an accredited laboratory is available to perform the calibration. An
exception to (T1) is allowed under the following special circumstances:
1. Cases where the reference standard or M&TE warranty from the Original Equipment
Manufacturer (OEM) will be deemed null and void should another calibration provider
other than the OEM be used. Evidence of the warranty shall be maintained by the
CAB. In this case (T2.2) still applies.
2. Cases where the calibration must be performed by the OEM since proprietary
software is needed to perform the calibration which is not made available by the OEM
to the public through policy or pricing. Evidence that use of such software is required
for the performance of the calibration shall be maintained by the CAB. In this case
(T2.2) still applies.
Exceptions to A2LA (T1) are valid for the length of the calibration interval. After the
interval is complete another search for an accredited provider shall be conducted and
documented.
In cases where the calibration interval of the reference standard or M&TE is set at
greater than two years, and it exceeds the manufacturer’s recommended interval,
documented evidence (e.g. records of intermediate checks) indicating that the reference
standard or M&TE continues to remain within the manufacturer (or applicable)
specification is also required.
Note: this does not apply for reference standards or M&TE where traceability is
established through the use of certified reference materials, intrinsic standards or
consensus standards.
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Note: This should not be confused with an internal calibration. In this case (T4) is not
applicable; rather (T1) and (T5) of this document applies.
For all in-house calibrations having a significant effect on the accuracy or validity of the
result of the accredited test, calibration or sampling on the CAB’s A2LA Scope of
Accreditation:
1. The CAB shall maintain documented procedures for the in-house calibrations;
3. Calibration records shall be retained minimally for the length of time between full
A2LA assessments;
4. The CAB shall maintain training records for calibration personnel and these records
shall demonstrate the technical competence of the personnel performing the
calibrations: evidence of competence includes, for example, documented training and
the results of measurement audits;
5 See also P102a – Policy on Reference Material Traceability for Life Sciences Testing Laboratories.
6 An accredited reference material producer is one that is accredited to ISO Guide 34 by an AB that is
recognized by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) www.aplac.org for accrediting
reference material producers.
7 Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which includes the
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6. Where available, the CAB shall use reference materials from accredited 8 reference
material producers or an NMI7;
7. Measurement uncertainty:
a) The CAB shall have and apply a procedure for evaluating measurement
uncertainty;
b) The data from which the origin of the uncertainty was determined shall be
documented and the assumptions made for the determination of the uncertainty
shall be specified and documented.
d) At a minimum, all uncertainty analysis shall take into consideration the following
contributors and documentation of the consideration shall be made.
1. Repeatability;
2. Resolution 9;
3. Reference standard uncertainty;
4. Reference standard stability;
5. Environmental factors
The CAB shall have a policy or procedure for establishing and changing calibration
intervals which shall be based on the historical behavior of the reference standard 10
1. The external calibration of all reference standards and M&TE having a significant
effect on the accuracy or validity of the result of the accredited test, calibration or
8 An accredited reference material producer is one that is accredited to ISO Guide 34 by an AB that is
recognized by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) www.aplac.org for accrediting
reference material producers.
9 It should be noted that uncertainty components, such as resolution, may also contribute to other components
such as repeatability. Therefore simply combining all components on an equal basis could result in an
overstatement of the measurement uncertainty.
10 See, for example, NCSLI RP-1 "Establishment & Adjustment of Calibration Intervals" (3/96).
11 See Appendix A for an example accredited (endorsed) calibration certificate.
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2. When Test Uncertainty Ratios (TURs) are reported, they shall be calculated using the
expanded uncertainty of the measurement, not the “collective uncertainty of the
measurement standards”; these implicit uncertainty statements shall be accompanied
by words to the effect that the TUR was calculated using the expanded measurement
uncertainty. In addition, the coverage factor and confidence interval shall also be
stated (e.g. expressed at approximately the 95% confidence level using a coverage
factor of k=2).
This statement will affirm that the calibration reported was conducted using standards
whose values are traceable to an appropriate national, international, intrinsic, or mutual
consent standard. For example, if the traceability chain for a given CAB originates at
NIST, then the statement will affirm that “This calibration was conducted using
standards traceable to the SI through NIST”, or words to that effect.
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Accredited calibration certificates and reports which do not contain equivalent statements
of traceability, or which only refer to NIST report of test numbers as evidence of
traceability are insufficient to demonstrate measurement traceability and do not meet
this traceability policy.
Measurement uncertainty analysis is required for all calibrations and dimensional tests.
A2LA requires measurement uncertainty to be calculated in accordance with the JCGM
100:2008 Evaluation of measurement data – Guide to the expression of uncertainty in
measurement (GUM).
For applicability of measurement uncertainty analysis in testing see A2LA P103 - Policy
on Estimating Measurement Uncertainty for Testing Laboratories and the relevant
Annexes P103a - Annex: Policy on Estimating Measurement Uncertainty for Automotive
& Materials Testing Labs (pdf); P103b - Annex: Policy on Estimating Measurement
Uncertainty for Life Sciences Testing Lab; P103c - Annex: Policy on Estimating
Measurement Uncertainty for Electro-Mechanical Testing Labs; P103d - Annex: Policy on
Estimating Measurement Uncertainty for Construction Materials & Geotechnical Testing
Labs; P103e - Annex: Policy on Estimating Measurement Uncertainty for Forensic
Conformity Assessment Bodies
It is often the case that a calibration certificate will contain the statement “in tolerance”,
or words to that effect, along with a statement to the effect that the measurement
uncertainty does not exceed a certain fraction of the tolerance. Such fractions are often
called “test uncertainty ratios”, TURs for short. Uncertainty statements phrased in terms
of TURs are implicit statements of the uncertainty: knowing the tolerance ratio allows
one to determine the largest possible value of the measurement uncertainty. Implicit
statements of uncertainty are acceptable on accredited calibration certificates as long as
the measurement uncertainty and the measurement results are also provided.
14Accredited reference materials are those provided from a reference material producer that is
accredited to ISO Guide 34 by an AB that is recognized by the Asia Pacific Laboratory Accreditation
Cooperation (APLAC) www.aplac.org.
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Note: It is common practice for a reference material producer to package their reference
materials under a different organization’s name. In these instances, it is possible for the
reference materials to meet A2LA P102 if the accompanying certificate includes reference
to the specific, recognized accreditation body, and the accreditation certificate number.
Note: For those laboratories using saturated salt solutions for the purposes of
traceability, those solutions mixed on demand from reagent grade salts and distilled
water may be treated as comparable to an intrinsic standard. In these instances, the
laboratories are not required to meet item (1) as listed above, but must be able to provide
evidence of meeting (2) through (4).
15 Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which includes the
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The use of specified methods and/or consensus standards are deemed traceable when they
are clearly described and agreed by all parties concerned in the contract for service and
where participation in a suitable program of interlaboratory comparisons (where possible)
is successfully completed,
A2LA requires that the dimensional testing laboratory shall comply with A2LA R205 -
Specific Requirements: Calibration Laboratory Accreditation Program in cases
where the dimensional artifact serves as a link in the traceability chain.
Traceability for measuring and test equipment is typically established through the
procurement of accredited calibration service. In cases where a dimensional artifact
serves as a link in the traceability chain, such as when it will be used by the owner to
measure another item, traceability is also established. Therefore it is necessary for the
dimensional testing laboratory to be evaluated for compliance with A2LA R205.
For example, a mechanical testing CAB that performs dimensional testing and that
issues an accredited test report or certificate containing appropriate statements of
measurement results, measurement uncertainty, and traceability, in accordance with the
requirements of ISO/IEC 17025:2005 Section 5.10, A2LA R205 and this policy document
can be considered as having produced a traceable calibration regardless of the title of the
report issued. This can be particularly useful for complex dimensional artifacts that most
calibration laboratories will not include on their Scope of Accreditation.
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Before placing work with an accredited organization, it is important that the customer
request a copy of the organization’s Scope (not the Certificate of Accreditation) so that the
customer can ensure that the organization is accredited to perform the needed
measurements. In addition, customers shall ensure that the organization’s measurement
uncertainties are suitable for their needs.
Currently, the primary mutual recognition agreements (MRAs) among accrediting bodies
are the International Laboratory Accreditation Cooperation (ILAC 16), the Asia-Pacific
Laboratory Accreditation Cooperation (APLAC 17), and the Inter-American Accreditation
Cooperation (IAAC 18). As signatories to these MRAs, A2LA is committed to promoting
the recognition and acceptance of accreditations granted by its fellow signatories.
A2LA recognizes reference material certificates that are issued by reference material
producers that are accredited by the accreditation bodies recognized by the APLAC MRA.
Furthermore it is required that the results be reported in a certificate meeting ISO Guide
31 and endorsed by the AB’s symbol (or which other reference to accredited status by a
specific, recognized AB) and an indication of the accreditation certificate number assigned
by the AB.
16 http://www.ilac.org/
17 http://www.aplac.org
18 http://iaac.org.mx
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The NIST Calibration Program 19 often receives calls to verify the authenticity of a NIST
Report of Test numbers appearing on another organization's report. Although NIST can
verify the authenticity of its report numbers, having an authentic number does not
provide assurance or evidence that the measurement value provided by another
organization is traceable. Not only should there be an unbroken chain of comparisons,
each measurement should be accompanied by a statement of uncertainty associated with
the farthest link in the chain from NIST, that is, the last facility providing the
measurement value. NIST does not have that information; only the facilities that
provided the measurement values to the customer can provide the associated
uncertainties and describe the traceability chain.
To establish an audit trail for traceability, a proper calibration result should include: the
assigned value, a stated uncertainty, identification of the standards used in the
calibration, and the specification of any environmental conditions of the calibration where
correction factors should be applied, if the standard or equipment were to be used under
different environmental conditions.
It should also be noted that nationally and internationally recognized standards dealing
with test and measurement quality requirements such as ANSI/NCSL Z540-1, ISO 10012,
ISO/IEC 17025 and the ISO9000 series do not require the use or reporting of NIST test
report numbers to establish traceability.
Consequently, A2LA neither requires nor accepts the presence of NIST test report
numbers on test or calibration reports as sufficient evidence of the traceability of a
measurement result.
19 http://www.nist.gov/traceability/nist_traceability_policy_external.cfm.
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All measuring and test equipment (M&TE) and reference standards having a significant
effect on the accuracy or validity of the result of the accredited test, calibration or
sampling shall be calibrated before being put into service. The calibration shall be
conducted by:
3. A U.S. State Weights and Measures facility with a current certificate of measurement
traceability. Please see http://www.nist.gov. for a copy of current certificates.
1. For cases where the National Institute of Standards and Technology (NIST) service is
suitable for the intended need but is not covered by the CIPM MRA, A2LA will accept
services covered under the NIST SP 250 Series on NIST Measurement Services.
2. A CAB may use a calibration laboratory whose service is suitable for the intended
need, but is not covered by the ILAC MRA under the following conditions:
b) The CAB maintains evidence of a calibration certificate that contains all of the
following:
c) The CAB maintains evidence that the reference standard(s) noted on the
calibration certificate are traceable to the SI through NIST (or equivalent21) or an
accredited laboratory;
d) The CAB maintains evidence of the calibration interval for the measuring and test
equipment (M&TE) or reference standard.
21 Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which includes the
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Note: This should not be confused with an internal calibration. In this case (T4) is not
applicable; rather (T1) and (T5) of this document applies.
For all in-house calibrations having a significant effect on the accuracy or validity of the
result of the accredited test, calibration or sampling on the CAB’s A2LA Scope of
Accreditation:
1. The CAB shall maintain documented procedures for the in-house calibrations;
3. Calibration records shall be retained minimally for the length of time between full
A2LA assessments;
4. The CAB shall maintain training records for calibration personnel and these records
shall demonstrate the technical competence of the personnel performing the
calibrations: evidence of competence includes, for example, documented training and
the results of measurement audits;
6. Where available, the CAB shall use reference materials from accredited22 reference
material producers or an NMI25;
22 An accredited reference material producer is one that is accredited to ISO Guide 34 by an AB that is
recognized by the Asia Pacific Laboratory Accreditation Cooperation (APLAC) www.aplac.org for accrediting
reference material producers.
23 See also P102a – Policy on Reference Material Traceability for Life Sciences Testing Laboratories.
24 Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which includes the
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7. Measurement uncertainty:
a) The CAB shall have and apply a procedure for evaluating measurement
uncertainty;
b) The data from which the origin of the uncertainty was determined shall be
documented and the assumptions made for the determination of the uncertainty
shall be specified and documented ;
d) At a minimum, all uncertainty analysis shall take into consideration the following
contributors and documentation of the consideration shall be made:
1. Repeatability;
2. Resolution 25;
3. Reference standard uncertainty;
4. Reference standard stability;
5. Environmental factors;
Note: It is recommended to also consider reproducibility per A2LA R205 -
Specific Requirements: Calibration Laboratory Accreditation Program.
9. The CAB shall have a policy or procedure for establishing and changing calibration
intervals which shall be based on the historical behavior of the reference standard 26
1. The external calibration of all M&TE and reference standards having a significant
effect on the accuracy or validity of the result of the accredited test, calibration or
sampling shall be recorded in a calibration certificate or report and shall include:
25 It should be noted that uncertainty components, such as resolution, may also contribute to other
components such as repeatability. Therefore simply combining all components on an equal basis could result
in an overstatement of the measurement uncertainty.
26 See, for example, NCSLI RP-1 "Establishment & Adjustment of Calibration Intervals" (3/96).
27 See Appendix A for an example accredited (endorsed) calibration certificate.
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2. When Test Uncertainty Ratios (TURs) are reported they shall be calculated using the
expanded uncertainty of the measurement, not the “collective uncertainty of the
measurement standards”; these implicit uncertainty statements shall be accompanied
by words to the effect that the TUR was calculated using the expanded measurement
uncertainty. In addition, the coverage factor and confidence interval shall also be
stated (e.g. expressed at approximately the 95% confidence level using a coverage
factor of k=2).
2. Reference materials obtained from an NMI shall include an endorsement by the NMI.
28 See A2LA R205 6.4.1 for exceptions on including the measurement uncertainty.
29 Services covered by the CIPM MRA can be viewed in Appendix C of the BIPM KCDB which includes the
range and uncertainty of each listed service (http://kcdb.bipm.org/).
30 Accredited reference materials are those obtained from a reference material producer that is accredited to
ISO Guide 34 by an AB that is recognized by the Asia Pacific Laboratory Accreditation Cooperation (APLAC)
www.aplac.org.
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Note: It is common practice for a reference material producer to package their reference
materials under a different organization’s name. In these instances, it is possible for the
reference materials to meet A2LA P102 if the accompanying certificate includes reference
to the specific, recognized accreditation body, and the accreditation certificate number.
Note: For those laboratories using saturated salt solutions for the purposes of
traceability, those solutions mixed on demand from reagent grade salts and distilled
water may be treated as comparable to an intrinsic standard. In these instances, the
laboratories are not required to meet item (1) as listed above, but must be able to provide
evidence of meeting (2) through (4).
A2LA requires that the dimensional testing laboratory shall comply with A2LA R205 -
Specific Requirements: Calibration Laboratory Accreditation Program in cases
where the dimensional artifact serves as a link in the traceability chain.
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CALIBRATION CERTIFICATE
T5.1.a
Cert# 0000.01
Environmental 25 °C T5.1.d
Conditions:
This calibration was conducted using standards traceable to the SI through NIST.
Reported uncertainties represent expanded uncertainties expressed at approximately
the 95% confidence level using a coverage factor of k = 2. T5.2
TUR reported as 4:1 and the uncertainty ratio was calculated using the expanded
measurement uncertainty expressed at approximately the 95% confidence level using a
coverage factor of k=2.
Page 1 of 1
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Date Description
5/7/2014 • Editorial changes as a result of A2LA P101 change to R105
(clauses T1.a., T2.a.2., T2.d.2).
• T1.a, 2nd bullet, deleted ‘R205c’
• T1.b, 1st bullet, deleted ‘in combination with ISO/IEC 17025’
• Added Annex P103e to footnote 6
• References to P605 updated to P905/P705.
3/5/2015 • Title change to “A2LA Policy on Metrological Traceability”
• Scope and Field updated for metrological traceability concepts
• Addition of many new definition of terms (only calibration was
previously defined)
• T1:
updated to include standards and equipment having a
significant effect on the accuracy or validity of the result
T1.3 and reference to T9 removed
Changed website to NIST.gov
Added a note on traceability via A2LA scope of
accreditation
• T2: New Section pertaining to exceptions on external
calibration service
• T3 renamed for reference materials
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Date Description
• T4 renamed for in-house calibrations:
Redefined in-house calibration
Removed paragraph 2, 3 and the last paragraph
Changed “must” to “shall”
Changed record retention minimum to the time between
renewal assessments
Added minimum contributor requirements for
measurement uncertainty
Changed requirement for the calibration interval as
needing either a policy or procedure
Added a note on traceability via an A2LA scope of
accreditation
Moved T9 elements to T4
• T5 renamed for accredited (endorsed) calibration certificates
(or equivalent):
updated to include standards and equipment having a
significant effect on the accuracy or validity of the result
updated to include measurement result and uncertainty
that meets ILAC P14
Moved old T4, T5, T6 and T7 to T5
• Acceptable Accreditors of Calibration and Testing Providers:
Removed paragraph 1
Revised paragraph 3 & 4
• Revised to Use of NIST Test Report Numbers as Evidence of
Traceability header to NIST Test Report Numbers and
Traceability
• Revised the Summary of Specific Requirements for all the
noted changes
• Added Appendix A Example Calibration Certificate
• Changed old Appendix A to Appendix B
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