Measurement Traceability:

Complying with ISO 17025

Requirements
Introduction
Measurement traceability is an important factor for your laboratory to meet the
requirements of ISO/IEC 17025 accreditation. In fact, measurement traceability is
one of the top 10 cited deficiencies of all ISO/IEC 17025 audits.
If you are not currently meeting this requirement, I encourage you to read this
article to learn how to get your measurement results traceable to the SI.

What is Measurement Traceability?

According to the International Vocabulary of Metrology (VIM), Metrological
Traceability or Measurement Traceability is a “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 addition to the definition, the VIM provides some supplementary notes that
should be taken into consideration;
“NOTE 1 For this definition, a ‘reference’ can be a definition of a measurement unit through its
practical realization, or a measurement procedure including the measurement unit for a non-
ordinal quantity, or a measurement standard.
NOTE 2 Metrological traceability requires an established calibration hierarchy.
NOTE 3 Specification of the reference must include the time at which this reference was used in
establishing the calibration hierarchy, along with any other relevant metrological information
about the reference, such as when the first calibration in the calibration hierarchy was performed.
NOTE 4 For measurements with more than one input quantity in the measurement model, each
of the input quantity values should itself be metrologically traceable and the calibration hierarchy
involved may form a branched structure or a network. The effort involved in establishing
metrological traceability for each input quantity value should be commensurate with its relative
contribution to the measurement result.”
Below is an image of the measurement traceability pyramid. It is the most
commonly used graphical representation to demonstrate measurement
traceability and the calibration hierarchy from the realization of the SI Unit down
to the measurements performed in the industrial environment.

Why is Measurement Traceability Important?

Measurement traceability is important because it gives you confidence and
assurance that your measurement results agree with national or international
standards within the statement of uncertainty in measurement.
Without traceability, a laboratory can claim anything they want in a test or
calibration report. With traceability and the independent verification of an
accreditation or inspection body, you can minimize the risk of falling victim to
fraudulent information and activities.
The important thing to remember is the results you report to your customers may
be used to provide calibrations, perform tests, manufacture products, or make
decisions which could affect health, safety, and even court proceedings. It is a big
deal!

Think about it for a minute…

If you provide results to a manufacture that makes or services aircraft, you could
be putting other people’s lives at risk. Would you put your family on that plane?
Another customer of yours could be using equipment to make medical decisions
that affect someone’s health. What is the patient was your spouse or child?
Maybe your results will be used in court as evidence which can affect the outcome
of a case. Would you be confident if you were on trial for murder?
While some of these examples are extreme, they are real-world scenarios that
happen every day. The work that you perform in the laboratory can significantly
impact society. This is why measurement traceability is important.
How Does Traceability Affect Measurement Uncertainty
Measurement traceability can have a direct impact on the uncertainty of your
measurement results.
Have you ever considered how your measurement uncertainty is affected by where
you send your equipment for calibration?
Well, the estimates of measurement uncertainty that you publish in your scope of
accreditation and in your test and calibration reports are directly affected by
metrological traceability.
When you send your equipment out for calibration, you normally receive a
calibration report when the instruments are returned to you. In these reports are
estimates of measurement uncertainty that are associated with the reported
measurement results.
The uncertainty estimates in these reports are your traceable uncertainty and are
commonly referred to as calibration uncertainty or reference standard uncertainty.
This uncertainty will be used in your uncertainty budgets to estimate your
Calibration and Measurement Capability (CMC) uncertainty published in your scope
of accreditation.

Typically, the shorter the chain between your laboratory and a national metrology
institute, the smaller the uncertainty in measurement you can expect to see.
For example, if you send your PRT Thermometer to NIST for calibration, you should
expect to see less uncertainty in a measurement than if you sent it to an accredited
calibration laboratory.
So, if your goal is to perform measurements with less uncertainty, be sure to review
your calibration laboratory’s scope of accreditation before sending in your
equipment for calibration.
Traceability Requirements of ISO/IEC 17025
If your laboratory is seeking ISO/IEC 17025 accreditation, you will need to ensure
that your quality system meets the requirements of the international standard.
In this section, I will cover the requirements of the ISO/IEC 17025 standard and the
ILAC P10 policy on traceability. If you are unfamiliar with either one of these
documents, I recommend that you read them both.
General Traceability Requirements
In section 5.6 of the ISO/IEC 17025, the standard states the following:
“5.6.1 General
All equipment used for tests and/or calibrations, including equipment for subsidiary
measurements (e.g. for environmental conditions) having a significant effect on the accuracy
or validity of the result of the test, calibration or sampling shall be calibrated before being put
into service. The laboratory shall have an established programme and procedure for the
calibration of its equipment.
NOTE Such a programme should include a system for selecting, using, calibrating, checking,
controlling and maintaining measurement standards, reference materials used as
measurement standards, and measuring and test equipment used to perform tests and
calibrations.”
In summary;
• If the equipment you use has a significant effect on your measurement results, it
should be calibrated.
• You need a program and a procedure for calibrating your equipment.
Traceability Requirements for Calibration Laboratories
If you are a calibration laboratory, the ISO/IEC 17025 standard states:
“5.6.2.1.1 For calibration laboratories, the programme for calibration of equipment shall be
designed and operated so as to ensure that calibrations and measurements made by the
laboratory are traceable to the International System of Units (SI) (Système international
d’unités).
A calibration laboratory establishes traceability of its own measurement standards and
measuring instruments to the SI by means of an unbroken chain of calibrations or comparisons
linking them to relevant primary standards of the SI units of measurement. The link to SI units
may be achieved by reference to national measurement standards. National measurement
standards may be primary standards, which are primary realizations of the SI units or agreed
representations of SI units based on fundamental physical constants, or they may be
secondary standards which are standards calibrated by another national metrology institute.
When using external calibration services, traceability of measurement shall be assured by the
use of calibration services from laboratories that can demonstrate competence, measurement
capability and traceability. The calibration certificates issued by these laboratories shall
contain the measurement results, including the measurement uncertainty and/or a statement
of compliance with an identified metrological specification (see also 5.10.4.2).”

Furthermore, the standard has requirements for your reference standards:

“5.6.3.1 The laboratory shall have a programme and procedure for the calibration of its
reference standards. Reference standards shall be calibrated by a body that can provide
traceability as described in 5.6.2.1. Such reference standards of measurement held by the
laboratory shall be used for calibration only and for no other purpose, unless it can be shown
that their performance as reference standards would not be invalidated. Reference standards
shall be calibrated before and after any adjustment.”

In summary;
• You need to establish traceability via an unbroken chain of calibrations linking
your measurement standards to primary standards of the SI units of measure.
• You need to use calibration services that are competent, capable, and traceable.
Traceability for Testing Laboratories
If you are a testing laboratory, the ISO/IEC 17025 standard states:
“5.6.2.2.1 For testing laboratories, the requirements given in 5.6.2.1 apply for measuring and
test equipment with measuring functions used, unless it has been established that the
associated contribution from the calibration contributes little to the total uncertainty of the
test result. When this situation arises, the laboratory shall ensure that the equipment used
can provide the uncertainty of measurement needed.
NOTE The extent to which the requirements in 5.6.2.1 should be followed depends on the
relative contribution of the calibration uncertainty to the total uncertainty. If calibration is the
dominant factor, the requirements should be strictly followed.”

In addition to the ISO/IEC 17025 standard, the ILAC P10 policy states:
“5) If the calibration of instruments used in testing contributes significantly to the overall
uncertainty, the same policy for traceability applies (as detailed under 1) to 4) above).
6) If a calibration is not a dominant factor in the testing result, the laboratory shall have
quantitative evidence to demonstrate that the associated contribution of a calibration
contributes little (insignificantly) to the measurement result and the measurement
uncertainty of the test and therefore traceability does not need to be demonstrated.”

In summary;
• If your lab equipment affects the uncertainty of your test result, it should be
calibrated.
• If your lab equipment does not affect the uncertainty of the test result and you
believe that you do not need measurement traceability, you better have objective
evidence to support your decision.
Common Problems with Measurement Traceability
According to ILAC, there are two common problems associated with measurement
traceability;
• Misconception of Measurement Traceability
• Harmonizing Measurement Traceability
In the section below, I will show you more about some of the common problems
associated with traceability.
Misconception of Measurement Traceability
The ILAC P10 policy provides a great explanation of what measurement traceability
is not:
“The persistent misconception that metrological traceability may be linked to a particular
organization (e.g., “traceable to a specific National Metrology Institute”) fosters continued
confusion with regard to its nature. Metrological traceability pertains to reference quantity
values of measurement standards and results, not the organization providing the results.”
Think about that next time you read a traceability statement that declares “traceable to
NIST.”

Harmonizing Measurement Traceability

Additionally, ILAC identifies several factors that prevent worldwide harmonization
of a measurement traceability policy:
“Factors that influence the establishment of a harmonized ILAC policy on metrological
traceability of measurement results include the following:
(a) The concept of metrological traceability of measurement results in fields such as the
chemical, medical, and biological sciences is still under development;
(b) Not all economies have the complete range of national measurement standards or
calibration and measurement capabilities needed to support the calibration and testing needs
of all applicants for accreditation in their economy;
(c) The role of reliable and traceable certified reference materials in providing metrological
traceability of measurement results has not yet been fully established internationally.”

International Agreements on Measurement Traceability

There are two major international recognition agreements on measurement
traceability. They are the CIPM MRA and the ILAC MRA.
CIPM Mutual Recognition Agreement
The CIPM is an international committee of 18 members that promotes worldwide
uniformity in units of measurement. To accomplish international equivalence in
measurements, they have created the CIPM MRA.
The CIPM Mutual Recognition Agreement (MRA) is an open and transparent system
where National Metrology Institutes provide information on the comparability of
their services and measurement standards. Participating institutes have their
calibration and measurement capabilities (CMC) peer-reviewed and approved
before they are published in the CIPM MRA database, also known as the BIPM Key
Comparison Database (KCDB).
If you are obtaining metrological traceability via a National Metrology Institute,
verify that they are a signatory to the CIPM MRA and that their measurement
services are published in the BIPM Key Comparison Database (KCDB).
ILAC Mutual Recognition Agreement
ILAC is an international organization for accreditation bodies operating in
accordance with ISO/IEC 17011 that accredit laboratories seeking ISO/IEC 17025,
ISO 15189, and ISO/IEC 17020 accreditation.
The goal of the ILAC Mutual Recognition Arrangement (MRA) is to develop an
international network of accredited laboratories and promote the mutual
acceptance of their test and calibration data for international trade and commerce.
To ensure that you are obtaining metrological traceability from a laboratory that is
accredited via a signatory to the ILAC MRA, check out the ILAC MRA Signatory
Search Database.