General Accreditation Criteria: Metrological Traceability Policy

General Accreditation Criteria
Metrological Traceability Policy
October 2018
© Copyright National Association of Testing Authorities, Australia 2014
This publication is protected by copyright under the Commonwealth of Australia Copyright

Act 1968.
NATA’s accredited facilities or facilities seeking accreditation may use or copy this
publication or print or email this publication internally for accreditation purposes.
Individuals may store a copy of this publication for private non-commercial use or copy a
reasonable portion of this publication in accordance with the fair dealing provisions in Part III
Division 3 of the Copyright Act 1968.
You must include this copyright notice in its complete form if you make a copy of this
publication.
Apart from these permitted uses, you must not modify, copy, reproduce, republish, frame,
upload to a third party, store in a retrieval system, post, transmit or distribute this content in
any way or any form or by any means without express written authority from NATA.
General Accreditation Criteria: Metrological Traceability Policy
Table of Contents
Purpose ....................................................................................................................... 4
Terms and definitions .................................................................................................. 4
Policy for traceability when performing calibrations ..................................................... 6
Policy for traceability when performing tests and measurements ................................ 8
Policy for traceability obtained through a reference material (RM) and certified
reference material (CRM) ............................................................................................ 8
Further information ...................................................................................................... 9
Amendment Table ....................................................................................................... 9
Appendix A: Practical examples of metrological traceability of test and

measurement processes ........................................................................................... 10
October 2018 Page 3 of 24

Purpose
This document covers NATA’s requirements on metrological traceability concerning
testing and/or calibration activities.
This policy applies to:
 all NATA applicant and accredited facilities;
 all measurements, whether physical, chemical or biological determinations;
Note: It is acknowledged that the concept of metrological traceability of
measurement results in activity types such as the chemical, medical, and
biological sciences is still under development.
 calibrations performed by a facility for its own activities and which are not part of
its Scope of Accreditation (so called “in-house calibrations” - refer to NATA’s
General Accreditation Guidance: Equipment Assurance, in-house calibration and
equipment verification).
To assist facilities to apply these requirements, several practical examples of test
and measurement processes have been included in this document as Appendix A.
Terms and definitions

The following definitions apply throughout this document:
Metrological traceability (VIM 3 clause 2.41):
Property of a measurement result whereby the result can be related to a reference
through a documented unbroken chain of calibrations, each contributing to the
measurement uncertainty.
In ISO/IEC 17025:2017 and ISO 15189:2012 the term “traceability” is equivalent to
the VIM’s “Metrological traceability” and the term “traceability” is used throughout this
document.
Note: ISO/IEC 17025 clause 6.4.6 requires measuring equipment to be calibrated when:
 the measurement accuracy or measurement uncertainty affects the validity of the
reported results, and/or
 calibration of the equipment is required to establish the metrological traceability
of the reported results.
Reference Material: material, sufficiently homogeneous and stable with respect to
one or more specified properties, which has been established to be fit for its intended
use in a measurement process. (Clause 2.1.1 of ISO Guide 30:2015).
Certified Reference Material: reference material characterized by a metrologically
valid procedure for one or more specified properties, accompanied by a RM
certificate that provides the value of the specified property, its associated
uncertainty, and a statement of metrological traceability. (Clause 2.1.2 of ISO Guide
30:2015).
For example: Glyphosate in water with assigned property value in terms of g/L used
as a calibrant or measurement trueness control material. This CRM will have been
produced in a way where metrological traceability to volume and mass has been
evaluated along with associated parameters such as temperature to support the
entire traceability chain.

Note: ISO 17034:2016 clause 7.14 outlines the minimum content of a CRM certificate to
ensure reporting of the property value, uncertainty of measurement for the reported
property value and to include a statement on how metrological traceability has been
supported. A product information sheet supplied with a Reference Material will not
necessarily include this additional information, in which case the laboratory
intending to use such material as a calibrant will have assessed the material as a
critical consumable.
BIPM (International Bureau of Weights and Measures):
The BIPM is an intergovernmental organisation established by the Metre
Convention, through which Member States act together on matters related to
measurement science and measurement standards.
The key task of the Bureau is to ensure worldwide uniformity of measurements and
their traceability to the International System of Units (SI).
CIPM MRA (International Committee for Weights and Measures Mutual
Recognition Arrangement):
Signatories to the MRA include BIPM Member States, Associates of the BIPM
General Conference on Weights and Measures, and other international
organisations. The MRA provides a means of comparability of national metrology
services including national measurement standards and calibration / measurement
certificates issued by NMIs.
ILAC MRA (International Laboratory Accreditation Cooperation Mutual
Recognition Arrangement):
NATA is a member of the ILAC MRA for Testing and Calibration to ISO/IEC 17025
and Inspection to ISO/IEC 17020.
Note: For details of NATA’s current MRA partners, refer to NATA’s website:
www.nata.com.au.
JCTLM (Joint Committee for Traceability in Laboratory Medicine):
The joint committee includes the CIPM, IFCC (International Federation of Clinical
Chemistry) and ILAC.
KCDB (BIPM Key Comparison Database):
The KCDB is a public website containing all information relating to the CIPM MRA,
an arrangement establishing the equivalence of measurements made by, and
certificates issued by, all the participating signatories.
The KCDB comprises two main sections, one containing information about the
internationally recognised Calibration and Measurement Capabilities (CMCs) of the
participating signatories and the other containing information about the comparisons
supporting these CMCs.
NMI (National Metrology Institute):
NMIs and Designated Institutes (DI) maintain standards in countries (or regions) all
over the world. Throughout this document, the term “NMI” is used to cover both
National Metrology Institutes as well as Designated Institutes. Australia’s national
metrology institute is called the National Measurement Institute and is often referred
by the same NMI acronym.
Note: Appendix A includes a set of terms used within the appendix only.

Policy for traceability when performing calibrations

For equipment and reference standards that must be calibrated, the policy is that this
shall be achieved by one of the following:
Services which are subject to peer review
a) An NMI whose service is suitable for the intended need and is covered by the
CIPM MRA. Services covered by the CIPM MRA can be viewed in Appendix C
of the BIPM KCDB which includes the range and uncertainty for each listed
service.
Notes: Some NMIs may also indicate that their service is covered by the CIPM MRA
by including the CIPM MRA logo on their calibration certificates, however, the
fixing of the logo is not mandatory and the BIPM KCDB remains the
authoritative source of verification.
NMIs from Member States participating in the Metre Convention may take
traceability directly from measurements made at the BIPM. The KCDB
provides an automatic link to the relevant BIPM calibration services (including
the range and uncertainty). Individual calibration certificates issued by the
BIPM are also listed.
b) An accredited calibration laboratory whose service is suitable for the intended
need (i.e. the Scope of Accreditation specifically identifies the appropriate
calibration) and the accrediting body is covered by the ILAC MRA for
calibration.
Note: Some calibration laboratories indicate that their service is covered by the
ILAC Arrangement by including the ILAC Laboratory Combined MRA mark on
the calibration certificate. Alternatively, the accreditation symbol of the
accreditation body that is a signatory to the ILAC Arrangement and/or a
recognised regional MRA e.g. Asia Pacific Laboratory Accreditation
Cooperation (APLAC), may be included on the calibration certificate. Both of
these options may be taken as evidence of traceability.
Services which are not subject to peer review
The following two options should only be applicable when options a) and b) above
are not possible for a particular calibration.
c) An NMI whose service is suitable for the intended need but not covered by the
CIPM MRA.
d) A non-accredited calibration laboratory whose service is suitable for the
intended need.
It is unlikely that a decision to choose option c) and d) will be made purely on
economic grounds and is more likely to be a last resort. It should be noted that
choosing one of these options will require significant effort by the facility i.e. it shall
be required to demonstrate that there is evidence of claimed traceability and
measurement uncertainty of the calibration services selected. This evidence will be
reviewed by NATA at assessments of the facility (which will add to the duration of
assessments with associated additional fees reflective of the effort required).
The evidence the facility must maintain of the competence and claimed metrological
traceability is likely to include but not be limited to the following (the numbers in
brackets refer to the clause numbers of ISO/IEC 17025:2017):
 Audits of the calibration service provider (6.6 and 8.8);

 Documentation for competence of staff (6.2);

 Documentation for accommodation and environmental conditions (6.3);
 Records of calibration method validation (7.2.2);
 Procedures for evaluation of uncertainty (7.6);
 Documentation for traceability of measurements (6.5);
 Documentation for assuring the validity of calibration results (7.7).
In practical terms, the facility would need to have evidence of an assessment of the
calibration service provider similar to that which would be conducted by an
accreditation body which is signatory to the ILAC MRA.
Note: In-house calibrations that support accredited testing and form part of the
assessment of a testing facility are assessed using these criteria and the criteria as
stated in NATA’s General Accreditation Guidance: Equipment assurance, in-house
calibration and equipment verification.
Note: In instances where the National Measurement Institute Australia is not accredited
for a specific calibration but is accredited for similar measurements, or where the
calibration laboratory is an applicant facility with NATA, NATA may accept their
unendorsed calibration certificates on request from the user of these reports.
When metrological traceability to SI units is not technically possible
ISO/IEC 17025, clause 6.5.3 states:
When metrological traceability to the SI units is not technically possible, the
laboratory shall demonstrate metrological traceability to an appropriate
reference, e.g.:
a) certified values of certified reference materials provided by a competent
producer;
b) results of reference measurement procedures, specified methods or
consensus standards that are clearly described and accepted as providing
measurement results fit for their intended use and ensured by suitable
comparison.
Clause 6.5.3 can only apply when the facility has demonstrated that options a) to d)
above cannot reasonably be met. It is the responsibility of the facility to choose a
way to satisfy the clause and to provide the appropriate evidence which shall be
reviewed by NATA at assessments of the facility.

Policy for traceability when performing tests and

measurements
For tests and measurements:
e) If the results of calibration of equipment used contributes significantly to the
overall uncertainty and validity of the result, the same policy for traceability
applies (as detailed above).
f) If the result of a calibration is not a dominant factor in the test or measurement
result, the facility shall have evidence to support this claim. This requires
demonstrating that the calibration contributes insignificantly to the accuracy or
validity of the test or measurement result and associated measurement
uncertainty and therefore traceability does not need to be demonstrated.
When traceability to SI units is not possible
ISO/IEC 17025:2017, clause 6.5.3 as noted above applies.
ISO 15189:2012, clause 5.3.1.4 states:
Metrological traceability shall be to a reference material or reference procedure
of the higher metrological order available.
Note: Documentation of calibration traceability to a higher order reference material
or reference procedure may be provided by an examination system
manufacturer. Such documentation is acceptable as long as the
manufacturer’s examination system and calibration procedures are used
without modification.
Where this is not possible or relevant, other means for providing confidence in
the results shall be applied including but not limited to the following:
 use of certified reference materials;
 examination or calibration by another procedure;
 mutual consent standards or methods which are clearly established,
specified, characterised and mutually agreed upon by all parties
concerned.
Accordingly, where traceability to SI units cannot be achieved, it is the responsibility
of the facility to choose a way to satisfy the clause and to provide the appropriate
evidence which shall be reviewed by NATA at assessments of the facility.
Policy for traceability obtained through a reference

material (RM) and certified reference material (CRM)
ISO/IEC 17025:2017, clause 6.5.3 as noted above applies.
For ISO 15189:2012, clause 5.3.1.4 as noted above applies.
Values associated with RMs may not be metrologically traceable. Values associated
with CRMs are, by definition, metrologically traceable.
Traceability is considered to have been established where:
g) The values assigned to CRMs are produced by NMIs and included in the BIPM
KCDB or, produced by a Reference Material Producer (RMP) who has been

accredited for the production of reference materials listed under its accredited
Scope of Accreditation to ISO 17034:2016.
Note: RMPs accredited by a signatory to ILAC or an ILAC recognised regional body,
are considered to have established valid traceability.
h) The values assigned to CRMs are covered by entries in the JCTLM database.
i) The majority of RMs and CRMs are produced by other RMPs. These can be
considered as critical consumables and the facility shall demonstrate that each
RM or CRM is suitable for its intended use.
Further information
If you have any queries in relation to this policy please contact your nominated NATA
Client Coordinator. General questions on measurement traceability may be sent to
the Sector Manager Calibration, Paul McMullen, paul.mcmullen@nata.com.au.
Amendment Table
The table below provides a summary of changes made to the document with this
issue.
Section or Amendment
Clause
Whole Clauses have been aligned with ISO/IEC 17025:2017.

document The document includes editorial changes with no new
interpretative criteria.

Appendix A
(Informative)
Practical examples of metrological traceability of test and

measurement processes
General
The purpose of this appendix is to assist applicant and accredited facilities in
applying NATA’s policy on metrological traceability. This information is intended for
guidance only.
It includes a number of practical examples of test or measurement processes
commonly performed in a range of facilities. The examples appear in the following
order:
Autoanalyser platform testing enzyme “y”
Autoanalyser testing analyte “x” (excluding enzyme activity)
Enzyme linked Immunosorbent Assay (ELISA) measuring analyte “x”
Erythrocyte sedimentation rate (ESR)
Isolation and identification of bacteria
Moisture content by oven drying
Part A – Solvent extraction of solid sample for organic analyte “Y”
Part B – LCMS measuring analyte “x”
Concrete compressive strength testing
Durometer hardness (Shore Type A)
Rockwell hardness tests
Movement of retention pin
The examples are not intended to be exhaustive.
Terms used
Component: anything used in a measurement process, including, but not limited to,
equipment (load cells, verniers, balances, ovens etc.), procedure or technique
selected (in-house, standard, consensus etc.), reference materials and standards
(calibrators, CRMs, RMs, physical artefacts etc.), consumables and reagents.
Measurement process: the method that includes everything, from selection of the
procedure or technique through to the report. The method can be in-house,
consensus or standard. Note that ‘black box’ equipment such as autoanalyser
platforms are considered a ‘standard method’.
Reference measurement procedure, Accepted consensus method, Standard
method, Specified method: terms describing published or widely accepted
measurement procedures that are clearly described, and accepted by appropriate
authoritative bodies.

Units directly or indirectly reported in the final result: if the units of the final
result include, for example, volume, then components measuring volume would be
captured by this question. Indirect reporting covers results that are calculated or
proportions where the inputs to the calculation would be included.
Critical: a component on which the validity of the measurement process relies. If
uncontrolled, the repeatability, reproducibility or bias of the test will be compromised.
VQ, CQ, UQ, RQ, PQ refer to the questions in the schema (see below).
How to use the schema

The schema in this Appendix is general in nature and should be used in combination
with each written example.
Each facility is encouraged to apply the schema as appropriate to their unique
situation and range of tests and measurements performed in an effort to assist in
determining if metrological traceability is required.

Consider all of the components of the measurement process (the “method”),

and the application1 of the result
For each component of the measurement process, consider:
Measurement
Consumables
Materials &
/ Reagents
Equipment
Reference
Procedure
Standards
Was the component controlled
through calibration during
Is the procedure a reference
validation or verification?
(VQ) measurement procedure or an
accepted consensus standard,
standard method or specified
method?
(PQ)
Does the component contribute

(directly or indirectly) to the units
of the reported result?
(UQ)
Is this component a Reference
Material or Measurement
Standard used in calibration or
measurement control?
(RQ)
Does this component have
values specified in the
measurement process that are
critical to the result?
(CQ)
If the answer to all questions is

If the answer to any question is ‘NO’, then traceability is not essential
‘YES’, then the Facility must for the component:
establish evidence of traceability Controls applied during validation or
for the component to a stated verification must continue to be
reference2, appropriate to the applied for the results to remain valid.
component and measurement Implement additional controls if these
task. improve measurement performance.
1 Applications of the results could include: 2 A stated reference can be but is not limited to:
 Regulatory or specified limits  SI Units

 Approximate/presumptive/screening test  Certified reference material (CRM)
versus definitive/precise/confirmatory  Reference measurement procedures
testing  Accepted specified method
 The clinical utility of a test  Accepted consensus standards
 Use for evidentiary purposes
Autoanalyser platform testing enzyme “y”

For this example, the measurand under consideration is enzyme activity (or, more
specifically, catalytic activity concentration of the enzyme as measured by the
conversion rate of NADH in the IFCC Reference procedure), calculated by the
instrument using Beer’s Law. While reference materials for some enzymes are
available from the IFCC, these are mostly used by equipment manufacturers to
validate their methods and equipment, and they are not available for all enzymes
(IFCC enzyme activity reference materials are traceable to SI units mole per second
per cubic metre (mol s-1 m-3, or kat m-3)). In this case there is no calibrator included
in the laboratory measurement process. The autoanalyser is a black box ‘standard
method’. The result is reported in units per volume.
Components of the measurement process include:
 Autoanalyser (the ‘standard method’); and
 Reagents.
Consider each component in turn:
Autoanalyser:
 Question PQ applies. In this case, for results to be traceable to the standard
method (i.e. comparable from laboratory to laboratory where each laboratory is
using the same standard method), the ‘standard method’ must be followed – that
is, the autoanalyser must demonstrably function correctly.
The manufacturer has validated the method against published IFCC methods,
and where possible, using Certified Reference Material.
 Evidence that the method is performing to specification could include, but is not
limited to:
 For new equipment, Installation and Operational Qualification records
(however named);
 Routine maintenance according to the manufacturer’s specifications;
 Satisfactory QAP results; and
 QA and QC showing that the method is in good statistical control.
Reagents:
 No question applies. Reagents in use are important to the measurement
process, but are not the source of traceability for the reported results.
 It is noted that lot-to-lot variation of reagents may affect the final result, and so
quality of the reagents must be monitored. Routine QC may be an indicator of
performance.
The reported result of this measurement process is traceable to SI units for
enzyme activity through the IFCC standard method, or IFCC CRM (depending
on the measurand), via the manufacturer.

Autoanalyser platform testing analyte “x” (excluding enzyme

activity)
The autoanalyser is a black box ‘standard method’. The result is reported in units
per volume.
 Autoanalyser (the ‘standard method’);
 Reagents; and
 Calibrator.
Autoanalyser:
 Question PQ applies. In this case, for results to be traceable to the standard
method (i.e. comparable from laboratory to laboratory where each laboratory is
using the same standard method), the ‘standard method’ must be followed – that
is, the autoanalyser must demonstrably function correctly.
 Evidence that the method is performing adequately could include, but is not
limited to:
 For new equipment, Installation and Operational Qualification records
(however named);
 Satisfactory QAP results; and
 QA and QC showing that the method is in good statistical control.
Calibrator:
 Questions UQ and RQ apply. Calibrators contribute to the units in the final report
and they are generally a reference material of some kind.
 Traceability is therefore required for calibrators. Note that this also captures
POVA, balances, Class A glassware etc. that may be used to make up the
calibrator.
 Traceable calibrators may be CRMs. Where non-certified RMs are used, the
laboratory must be able to demonstrate that they are fit-for-purpose.
Reagents:
 No question applies. Reagents in use are important to the measurement
process, but are not the source of traceability for the reported results.
 It is noted that lot-to-lot variation of reagents may affect the final result, and so
quality of the reagents must be monitored. Routine QC may be an indicator of
performance.
The reported result of this measurement process is traceable both to the value
assigned to the calibrator, and to the standard method.

Enzyme Linked Immunosorbent Assay (ELISA) measuring analyte

“x”
The result is reported in units per volume. Components of the measurement process include:
 Plate reader;
 Calibrator;
 Method;
 Incubator; and
 Reagent kit.
Plate reader:
 No question applies. Plate readers report the difference between two readings, not an absolute
measurement. Plate readers are generally verified with manufacturer supplied plates in use.
 Traceability need not be established for the plate reader. There must be evidence of adequate
performance usually achieved through the use of the standard plate, and ensuring that routine
maintenance and servicing is performed according to manufacturer’s specifications.
Calibrator:
 Questions UQ and RQ apply. Calibrators include the units in the final report and they are a
reference material.
 Traceability is therefore required for calibrators. Note that this also captures POVA, balances,
Class A glassware etc. that may be used to prepare the calibrator.
 Traceable calibrators may be CRMs. Where a non-CRM Reference Material (RM) is used, the
laboratory must be able to demonstrate that it is fit-for-purpose.
Method:
 If the method in use is a Standard or consensus method for this analyte, then PQ applies, and the
laboratory must be able to demonstrate that it is following the standard method in order for the
result to be comparable to other laboratories using this method.
 In-house methods must be validated, but are not considered ‘traceable’, and no question applies.
Incubator:
 Question CQ applies. Methods usually specify the optimal temperature required, but the decision
as to whether it is ‘critical’ will be made by the laboratory in consideration of their knowledge and
experience with both the method and the target analyte.
 Where the temperature is critical, the incubator temperature monitoring device must be calibrated.
 Where temperature is important, but not critical, Question VQ asks how the temperature
measuring device was controlled during method validation/verification.
 It was calibrated: the temperature measuring device must continue to be calibrated at
suitable intervals.
 It was checked, not calibrated: the temperature measuring device must continue to be
checked against a suitably calibrated reference thermometer at scheduled intervals.
Reagent kit:
 No question applies. Reagent kits are important, but are not the source of traceability for the
reported results.
 Note that POVA, balances, Class A glassware etc. that may be used to aliquot or prepare kit
reagents may be critical, and if so, each critical item must have evidence of metrological
traceability.
 It is noted that lot-to-lot variation of reagents may affect the final result, and so quality of the
reagents must be monitored. Routine QC may be an indicator of performance.
The reported result of this measurement process is traceable to the units of the calibrator.
The result may also be traceable to a standard method.

Erythrocyte sedimentation rate (ESR)

The rate of sedimentation of red cells in a column of standard size is measured over
a set time. The result is reported in millimetres per hour.
 Method;
 Standard column; and
 Timer.
Method:
 Question PQ applies. This is a longstanding, well-characterised method, and is
considered a standard method. For results to be traceable to the standard
method (i.e. comparable from laboratory to laboratory), performance of the
method must be assured.
 Evidence that the method is performing adequately could include satisfactory
QAP results.
Standard column:
 Question UQ applies. Columns are marked in millimetre gradations to facilitate
reading the result.
 When considering how traceability is demonstrated for this test it is important to
consider the application of this test – the clinical utility. For the ESR clinical utility
is limited, and the result is generally indicatory.
 Purchasing columns that are specifically made for the ESR is likely to be
sufficient traceability for the measurement component of the units.
Timer:
 Question UQ applies. The result is read at 60 minutes.
 When considering how traceability is demonstrated for this test it is important to
consider the application of this test – the clinical utility. For the ESR clinical utility
is limited, and the result is generally indicatory.
 Comparing the laboratory timer to a GPS timer will provide satisfactory
traceability for the time component of the units.
The reported result of this measurement process is traceable the SI Units time
and length, and to the standard method.

Isolation and identification of bacteria

A sample is applied to an agar plate, which is then incubated. Colonies are identified by
morphology. The result is reported as presence/absence of bacteria.
 Agar Plates;
 Incubator;
 Control organism; and
 Method.
Agar plates:
 These are consumables that must be quality controlled, but no questions are answered
‘Yes’ – metrological traceability is not essential. Controls must still be applied to the use
and manufacture of the plates.
Control organism:
 Question RQ applies as this is a reference material.
 Traceability is therefore required for control organisms. Note that this may also capture
storage conditions for sensitive organisms.
 Where traceability is claimed to wild strains, the laboratory must be able to demonstrate
that the control organism is fit-for-purpose. For example: demonstrate that the wild strain
gives the same morphological and biochemical reactions as strains from reference
collections.
Incubator:
 Question CQ applies. Methods usually specify the optimal temperature range for growth,
but the decision as to whether this is a ‘critical’ temperature will be made by the
laboratory in consideration of their knowledge and experience with both the method and
the target organism.
 If the temperature is determined to be critical, the incubator temperature monitoring
device must be calibrated.
 Where temperature is important, but not critical, Question VQ asks how the temperature
measuring device was controlled during method validation/verification.
 It was calibrated: the temperature measuring device must continue to be calibrated at
suitable intervals.
 It was checked, not calibrated: the temperature measuring device must continue be
checked against a suitably calibrated reference thermometer at scheduled intervals.
Method:
 If the method in use is a Standard or consensus method for growth and identification of
this organism, then Question PQ applies, and the laboratory must be able to
demonstrate that it is following that method in order for the result to be comparable to
other laboratories using this method.
 In-house methods must be validated, but are not considered ‘traceable’, and no question
applies.
The reported result of this measurement process is traceable to the reference
organism, and may also be traceable to a standard method.

Moisture content by oven drying

The method dries material in sequential steps until repeated weighing shows no
change. The result is reported as % moisture, which is calculated by a mass
comparison.
 Drying oven and temperature indicating device;
 Balance; and
 Method – AS 1289.2.1.1
Drying oven and temperature indicating device:
 In relation to question CQ, the method specifies that the oven is to operate within
the range 105-110 degrees, with adequate temperature recovery characteristics
when loaded with samples. Experience and knowledge of this method show that
modest deviations from the specified temperature range are unlikely to
compromise the test outcome for commonly tested materials. The oven
performance (stability, recovery, spatial uniformity) will be initially established and
controlled during testing, however, the accuracy, in absolute terms, of the
temperature indicating device is not necessarily critical to the result.
 To demonstrate suitability for the test, characterisation of an oven’s performance
will reflect the circumstances in which it is used. If the oven continually operates
at a fixed setting and the temperature stability has been verified at this fixed
setting then the temperature indicator is not relevant to the test (except as
potentially indicative of an equipment fault). If the temperature indicator is relied
upon as evidence of oven performance during testing then the indicator itself will
have been subject to a validation process appropriate to the nature of the testing,
in addition to other aspects of oven performance.
 It is noted that oven performance may change over time, and so affect the final
result. A program for monitoring the performance of equipment is necessary and
may include protocols for effective use of the oven, such as avoidance of
prolonged temperature suppression due to sample overloading.
Balance:
 Question UQ applies. Mass is an indirectly reported unit.
 Traceability is therefore expected for the balance.
Method AS 1289.2.1.1:
 Question PQ applies. The laboratory will need to demonstrate that it is following
the method in order for the result to be comparable to other laboratories using the
same method.
Reported results depend upon traceable measurement of mass and the correct
implementation of the method AS 1289.2.1.1.

Part A – Solvent extraction of solid sample for organic analyte “Y”

Preparation of sample for analysis with multiple measuring and extraction steps. The
prepared extract is analysed in a subsequent procedure (see example: Part B), from which a
reported result is in the units of mass of analyte per mass of sample.
 Method – validated internally, not standard;
 POVA;
 Balance;
 Reagents; and
 Volumetric Glassware.
Method:
 No question applies. The facility must still have evidence that the method has been
validated, and that recovery rates were established appropriately.
 Continued performance assurance may be demonstrated through QA, QC and PT.
Reagents:
 No questions apply. Solvents used for extraction were selected during method
development and demonstrated as fit-for-purpose during validation.
 Solvents and diluents in use are important to the measurement process, but are not the
source of traceability for the reported results.
 It is noted that lot-to-lot variation of reagents may affect the final result, and so quality of
the reagents must be monitored. Routine QC may be an indicator of performance.
POVA:
 No question applies. The POVA used to introduce a surrogate to monitor recovery is not
critical as repeatability is more important than the precise quantity, in the laboratory’s
estimation.
 The means of controlling POVA during validation or verification of the method must
continue to be applied for results to remain valid. For example, periodic gravimetric
checks to assure confidence in the volume dispensed.
 Additional controls should be implemented if necessary to improve measurement
performance.
Balance:
 Question UQ applies. The final reported result includes a stated amount of analyte per
mass of original sample.
Volumetric Glassware:
 Question CQ applies. The volumetric glassware used to dilute the concentrated extract
to a known volume is a critical step in the method. Traceability of the volume is required.
The concentration of the extract going forward for analysis is traceable to units for mass and
volume.
Consideration of the analysis of the extracted sample continues in example: Part B

Part B – LCMS measuring analyte “x”

(extracted as described in previous example above – Part A)
The LCMS is measuring the analyte extracted from a sample as described in
example: Part A; reference materials are run in parallel with the sample to be tested.
The reported result is in the units of mass of analyte per mass of sample.
 LCMS;
 Standard – CRM; and
 Sample preparation – Refer Example 8: Part A – Solvent Extraction of solid
sample for organic analyte Y.
LCMS:
 No question applies. The facility must still have evidence that the equipment is
performing adequately including:
 Installation and Operational Qualification records (however named);
 Satisfactory PT results (reflecting the whole method);
 QA and QC showing that the method is in statistical control;
 CRM in compliance with acceptance criteria.
Standard - CRM:
 Questions UQ and RQ apply. CRMs include the units in the final report and they
are reference materials;
 Traceability is therefore required for reference materials and standards. Note
that this also captures POVA, balances, Class A glassware etc. that may be used
to make up the reference materials and standards;
 Where non-certified RMs are used, the laboratory must be able to demonstrate
that they are fit-for-purpose.
Sample Preparation:
Refer example: Part A – Solvent Extraction of solid sample for organic analyte “Y”
 Question UQ applies. The final reported result includes a stated amount of
analyte per mass of original sample. The balance used to measure the amount of
sample used must be traceable.
 Question CQ also applies to volumetric glassware used for critical dilutions
sample preparation method. Traceability of the volume is required.
The reported result of this measurement process is traceable to the units of
the reference material and SI units for mass and volume.

Concrete compressive strength testing

This measurement process determines compressive strength of concrete. The result
is reported in force per area.
 Dimensional measuring device (may be a vernier and/or measuring jig);
 Compression machine; and
 Method – AS 1012.9.
Dimensional measuring device:
 Question UQ applies. The measuring device(s) returns a length measurement
used to calculate area, which is part of the reported result.
 Traceability is therefore expected for the measuring device.
Compression machine
 Question UQ applies. The compression machine returns a force measurement
which is part of the reported result.
 Traceability is therefore expected for the compression machine.
Method:
that method in order for the result to be comparable to other laboratories using
this method.
Reported results depend upon traceable measurement of length, force as well
as the correct implementation of the method AS 1012.9.

Durometer hardness (Shore Type A)

Hardness of elastomeric material is determined by the penetration of specified
indenters into the material under prescribed conditions. Durometer Rubber Degrees,
Type A, is used for measuring softer materials (in the range of 30-90 IRHD). The
result is reported as Hardness, expressed as Type A degrees.
 Type A Durometer;
 Standard rubbers;
 Conditioning; and
 Method – AS1683.15.2
Durometer:
 Questions CQ, UQ and VQ apply: AS1683.15.2 describes how conformance with the
stipulated calibration equation is established for the spring. This involves balancing the
forces applied to the spring and indicating mechanism against known masses at various
scale readings. Since the durometer hardness reading is directly related to the force
applied, traceability is expected to extend to all of the known masses used. To ensure
the indenting force is applied in a controlled manner during testing, a number of
equipment dimensions have also been defined in AS 1683.15.2, including the critical
distance by which the indenter protrudes beyond the pressor plate in the relaxed state.
 The readings depend upon parameters normally controlled through calibration of the
durometer.
Conditioning:
 Question CQ applies: A range is specified for temperature (and for humidity for
elastomers whose hardness is affected by relative humidity) and this is considered
critical to the reported outcome.
 Traceability is expected for the equipment used to monitor environmental conditions.
Standard rubbers:
 Questions PQ and VQ apply: AS 1683.15.2 describes a ‘verification’ process by which a
set of standard rubbers (at least 6) is used to establish the ongoing performance of a
Type A durometer. However, since these rubbers are subject to physical change over
time, the standard also details a periodic ‘calibration’ process for the standard rubbers
themselves, which involves use of a ‘certified’ dead-load IRHD hardness testing device.
Given this particular process described within AS1683.15.2, the standard rubber
hardness can be inferred to have been controlled by traceable means during the
validation of the standard method.
 On this basis, traceability would be expected for the hardness of standard rubbers (or the
dead-load IRHD hardness device used for ‘calibrating’ the rubbers, as described in the
standard) where these are used for verifying durometer performance.
Method:
 Question PQ applies. The laboratory will need to demonstrate that it is following that
method in order for the result to be comparable to other laboratories using this method.
Reported results depend upon the calibration of the durometer, compliance
with the standard method AS1683.15.2 and traceable measurement of
temperature (and humidity where applicable) and the hardness of standard
rubbers (where used to validate durometer performance).

Rockwell hardness tests

An indenter of specified size, shape and material is forced into the flat surface of a
test piece in two steps under specified conditions. The permanent depth h of
indentation is measured under preliminary test force after removal of additional test
force. From the values h and that of the two constants N (number specific to the
scale) and S (Scale unit specific to the scale), the Rockwell hardness is calculated
according to the formula:
Rockwell hardness = N – h/S and expressed as HR(S) where “S” is the scale (A, B,
C, D, E, F, G, H, K, N, T)
 Testing machine;
 Method – AS 1815.1; and
 Test block.
Testing machine:
 Question UQ applies. Following the application of a test force using an indenter
whose characteristics have been established, the depth measuring system
returns a value (h) which is used in the calculation of the reported hardness test
result. Due to the risk of wear during use, the condition of indenters is also
expected to be checked at defined intervals using appropriate optical devices
(microscope, magnifying glass, etc.).
 Traceability is expected for the measurement of the applied force, depth
measurement and initial characterisation of the indenter.
Method:
that method in order for the result to be comparable to other laboratories using
this method.
Test Block:
 No question applies: While ongoing checks against the blocks are used to
monitor machine drift over time as described in AS1815.2 Clause 5.1 (i.e., not as
a reference material contributing to the result), the blocks can be adequately
characterised for this purpose by measuring their hardness at the same time as
the machine calibration. The hardness will not alter over time and so periodic
visual inspection for deterioration can be adequate for ongoing verification
 Traceability is therefore not essential for test blocks.
Reported results depend upon compliance with the standard method AS
1815.1 and traceable control over the testing machine parameters, i.e. depth
measurement, applied force and indenter characterisation.

Movement of retention pin

This measurement process determines the axial movement of a retaining pin in a
freight container. Inspection considers the fitness for use of the container, including
labelling, seals, rigging, container history, as well as container structural integrity and
coating integrity. The specification indicates “excessive” movement in a retaining pin
is cause for holding the item for repair. To facilitate consistency between inspectors
the inspection body has determined to measure and report axial movement, and has
provided a magnetically mounted dial gauge to measure this movement.
 Dimensional measuring device (dial gauge)
 Method developed in-house.
Considering each component in turn:
Dimensional measuring device:
 Question UQ does not apply. While the measuring device(s) returns a length
measurement which is reported, the report addresses fitness for purpose of the
container rather than a measurement.
 Question CQ does not apply – no acceptance criteria are identified and the
measurement provides a framework for discussion rather than a pass/fail criteria.
 Traceability is therefore not expected for the measuring device.
Method:
 Question PQ does not apply. The procedure is a nominal method, and while it
may reflect a good practice it carries no weight as a reference, accepted of
specified method outside this facility.
 Question VQ does not apply. The method has not been subjected to validation or
verification as to how much movement is considered “excessive”.
 Question RQ does not apply. The determination is not used as a calibrator or
standard.
 Traceability is therefore not expected through the measuring method.
Reported measurement results are indicative and may be used to inform
discussions with the client / asset owner. Traceability is not required to
support this component of the inspection. However, additional controls such
as a spot check of equipment performance using a gauge block of relevant
thickness, and checks to establish co-axial alignment between pin and dial
gauge could be added to improve measurement performance.

General Accreditation Criteria: Metrological Traceability Policy

Uploaded by

Copyright:

Available Formats

General Accreditation Criteria: Metrological Traceability Policy

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

General Accreditation Criteria: Metrological Traceability Policy

Uploaded by

Copyright:

Available Formats

General Accreditation Criteria

Metrological Traceability Policy

This publication is protected by copyright under the Commonwealth of Australia Copyright

Terms and definitions .................................................................................................. 4

Policy for traceability when performing calibrations ..................................................... 6

Policy for traceability when performing tests and measurements ................................ 8

Further information ...................................................................................................... 9

Amendment Table ....................................................................................................... 9

Appendix A: Practical examples of metrological traceability of test and

October 2018 Page 3 of 24

Terms and definitions

October 2018 Page 4 of 24

October 2018 Page 5 of 24

Policy for traceability when performing calibrations

October 2018 Page 6 of 24

 Documentation for competence of staff (6.2);

October 2018 Page 7 of 24

Policy for traceability when performing tests and

Policy for traceability obtained through a reference

October 2018 Page 8 of 24

Whole Clauses have been aligned with ISO/IEC 17025:2017.

October 2018 Page 9 of 24

Practical examples of metrological traceability of test and

October 2018 Page 10 of 24

How to use the schema

October 2018 Page 11 of 24

Consider all of the components of the measurement process (the “method”),

Does the component contribute

If the answer to all questions is

 Regulatory or specified limits  SI Units

Autoanalyser platform testing enzyme “y”

October 2018 Page 13 of 24

Autoanalyser platform testing analyte “x” (excluding enzyme

October 2018 Page 14 of 24

Enzyme Linked Immunosorbent Assay (ELISA) measuring analyte

October 2018 Page 15 of 24

Erythrocyte sedimentation rate (ESR)

October 2018 Page 16 of 24

Isolation and identification of bacteria

October 2018 Page 17 of 24

Moisture content by oven drying

October 2018 Page 18 of 24

Part A – Solvent extraction of solid sample for organic analyte “Y”

October 2018 Page 19 of 24

Part B – LCMS measuring analyte “x”

October 2018 Page 20 of 24

Concrete compressive strength testing

October 2018 Page 21 of 24

Durometer hardness (Shore Type A)

October 2018 Page 22 of 24

Rockwell hardness tests

October 2018 Page 23 of 24

Movement of retention pin

October 2018 Page 24 of 24

You might also like