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With so much focus these days on collecting and analyzing data, and implementing Six Sigma and other

initiatives to ensure that design goals are met, its possible that critical details such as the datas level of
accuracy have gone unnoticed. We might not realize how this inaccuracy translates into false acceptance and
rejection risks associated with measurement-based decisions. These risks define the probabilities associated
with defective products being accepted while good products are scrapped.
Because measurements in research and development and manufacturing acquire traceability from calibration
and, in turn, often determine product quality or a products target value through testing, these
measurements own quality is extremely important. This is where ISO/IEC 17025 accreditation comes in.
Fundamentally, the standard is about measurement quality.
You might point out that your existing calibration and testing programs require your providers to produce
measurements traceable to some national or international reference, like those of the National Institute of
Standards and Technology. But what exactly does that guarantee? If, for example, I calibrate a gage block
with a NIST-traceable ruler, doesnt that make the gage block traceable to NIST? Although this example
exaggerates what happens in the real world, Ive actually seen a laboratory calibrate gage blocks with a
micrometer, rather than the other way around.
Are you beginning to worry about your measurement data yet?

Measurement uncertainty
Measurement data should concern us because no matter what we do, some quantity of unknown error in
measured values will exist because measurement provides only an estimation of the measurand (i.e., the
particular quantity subject to measurement). This unknown error creates doubt in a measurements result.
The probable quantity of unknown error can be defined only through a further estimate known as
measurement uncertainty. This is calculated in accordance with the ISO Guide to the Expression of
Uncertainty in Measurement (GUM).
GUM defines measurement uncertainty as parameter, associated with the result of a measurement, that
characterizes the dispersion of the values that could reasonably be attributed to the measurand.
GUM further states, The word uncertainty means doubt, and thus, in the broadest sense, uncertainty of
measurement means doubt about the validity of a measurement.

Example of an Uncertainty Statement The statement to the left tells us that the laboratory measured the 1
Measured value = 1.0000022 in.
Expanded uncertainty (U95) = 3.6
in. (0.0000036 in.)

in. gage block and found it to be 2.2 in. over nominal size, with an
uncertainty, expressed at the 95 percent level of confidence, of 3.6
in. In other words, the lab determined that a 95 percent probability
exists that the measured value is in error by not more than 83.6 in.

Recipients of measurement values and compliance statements based


on measurement values are entitled to an estimate of the amount of
uncertainty associated with the measured values. Without a realistic estimate of measurement uncertainty,
the client cant judge the measurement results quality. An unknown uncertainty means the measured value
must be considered unreliable and, hence, useless. As NISTs Ted Doiron aptly observes about this dilemma,
A calibration without a valid uncertainty estimate is simply exercise, the result of which is properly
expressed in calories.
If this information is new to you, it shouldnt be. The requirement for an estimate of measurement
uncertainty isnt new. In fact, ISO 9001:1994 requires it in Section 4.11: Inspection, measuring and test
equipment shall be used in a manner which ensures that the measurement uncertainty is known and is
consistent with the required measurement capability.

Although ISO/IEC 17025 doesnt--and indeed cant--mandate perfect measurements, it does provide some
assurance that laboratory measurement quality is evaluated, defined and controlled. Its then our
responsibility to use this assurance to determine if labs meet our needs.
Upon successful laboratory accreditation, the accreditation body issues a scope of accreditation that usually
defines either the tests a lab has been accredited to perform or the best-measurement capability a
calibration lab has demonstrated in accredited measurement disciplines.
The scope of accreditation might not include the measurement uncertainty that exists for measurements
performed on your devices and/or objects. However, to be compliant with ISO/IEC 17025, the lab must
calculate and maintain measurement uncertainty estimates for all data provided to clients or used in
determining in tolerance or out of tolerance status. The standards Section 5.4.6.1 states, A calibration
laboratory, or a testing laboratory performing its own calibrations, shall have and shall apply a procedure to
estimate the uncertainty of measurement for all calibrations and types of calibrations. Section 5.4.6.2 adds,
Testing laboratories shall have and shall apply procedures for estimating uncertainty of measurement.
(Certain exceptions are given for some testing activities.)
The process of uncertainty estimation is somewhat subjective and requires adequate, unbiased technical
review to ensure credibility. This review is achieved through expert third-party assessment from
accreditation bodies. Because all aspects of the measurement process feed into measurement uncertainty,
adequately assessing the measurement process is also required. Combine this need with that of consistency
as well as continuous improvement as realized through compliance to ISO 9001, and you arrive at ISO/IEC
17025 accreditation.

Traceability
How many organizations do you know that claim their measurements are traceable? What exactly does
that mean? ISOs Vocabulary of International Metrology defines traceability as property of the result of a
measurement or the value of a standard whereby it can be related to stated references, usually national or
international standards, through an unbroken chain of comparisons all having stated uncertainties.
This means that for a measurement to be traceable, uncertainty must be stated. How many certificates have
you seen that claim traceability yet provide no stated uncertainty? ISO/IEC 17025 accreditation resolves this
problem by requiring uncertainties to be stated.

Current state of accreditation in the United States


Ideally, all ISO/IEC 17025-accredited laboratories should be in full compliance to the standard.
Unfortunately, my experience has shown that some arent, but considering the magnitude of the task, labs
and accreditation bodies are doing fairly well and continuously improving. The requirements are involved,
and practical solutions for compliance are in constant development.
During the interim, you have a better chance of receiving quality measurements from an accredited
laboratory than from one that doesnt meet ISO/IEC 17025 requirements. Moreover, with a bit of knowledge,
you can then compare laboratory capabilities based on their measurement uncertainty.

Accredited services
ISO/IEC 17025 accreditations fundamental purpose is to ensure competency in testing and calibration
measurement processes. However, client involvement is critical to ensure that adequate services are
received.
ISO/IEC 17025 can empower a labs client. With this power comes responsibility, and without adequate
knowledge, clients might still not get the service they need--although under those circumstances, theyd

have no one to blame but themselves. Thus, its important to become familiar with the requirements in order
to use ISO/IEC 17025 to your advantage--for example, knowing which questions to ask a potential supplier.
The following concepts address several issues that you should consider when evaluating a testing or
calibration supplier, given the current state of accreditation:
Estimated measurement uncertainty. Inquire as to whether the lab provides measurement uncertainty with
the data. These values are needed when determining calibration or test adequacy and subsequent
conclusions.
Ask whether the provided uncertainty is really the measurement uncertainty as required by ISO/IEC
17025, or if its the reference equipments uncertainty or some other value used to fill in the blank because
the lab hasnt gotten around to fully meeting the standard.
For organizations that have done their homework and understand how to analyze measurement uncertainty,
ask for a copy of the analysis. If the lab claims its proprietary information, ask if you can view the analysis
at its location.
Calibration and/or test data. Prior to submitting a device or object for testing or calibration, ask for a list of
the measurements that will be taken and a sample data report--especially if youre requesting in-tolerance
or out-of-tolerance reporting. For calibration work, you will also want to ensure the measurements taken
during the performance test adequately cover the functions and ranges you use.
Ensuring quality of calibration and testing results. ISO/IEC 17025 lists many methods that labs can use to
ensure the quality of their calibration and testing results. One of these, proficiency testing, has since become
a requirement by many accreditation bodies. Others are recommended for use by labs to add reliability and
credibility to measurement results.
Proficiency testing is a professional service that puts a labs measurement uncertainty claims to the test.
This is done by providing an artifact that has a known value with an uncertainty smaller than the
participating labs. The lab reports its measurement and uncertainty to the provider. The results are
statistically analyzed and reported along with a satisfactory or unsatisfactory result.
If youre really concerned about the accuracy of a labs estimated measurement uncertainty, ask whether
the given measurement process has been proficiency tested.
Note: To limit initial accreditation costs, many accreditation bodies allow labs to spread their proficiency
testing program over a four-year period.
Witness some of your contracted tests and/or calibrations. ISO/IEC 17025 provides lab clients with the
right to witness contracted tests and calibrations, assuming the lab isnt violating other clients
confidentiality. Use this to your benefit by taking the time to witness the measurements for yourself. Ask the
technician questions and become familiar with your provider. Although you might not have the technical
expertise to assess the labs measurement quality, youll undoubtedly develop an impression that will either
enhance your confidence or cause you some concern regarding your providers capability.

Summary
Without ISO/IEC 17025 accreditation, traceability to a national standard is only a phrase printed on a
report. With accreditation, clients can assume some validity to the measurements provided by their
calibration and testing suppliers, defined via a valid estimate of the measurement uncertainty. ISO/IEC
17025 accreditation offers a major step in bringing a valid traceability chain to general industrys front
door.

Because measurements are usually the fundamental basis of most manufactured product-quality
evaluations, the concepts of measurement quality, traceability and uncertainty put forth by ISO/IEC 17025
are useful wherever measurement-based decisions are made. In the manufacturing arena, measurement
uncertainty, combined with process capability and other quality assurance data, can facilitate measurementbased decision risk analysis. Risk analysis defines the probabilities associated with defective product being
accepted and good product being scrapped. These sciences can give quality departments greater capability
in producing proactive, rather than reactionary, solutions.
Organizations selecting calibration and testing suppliers must understand the concepts of measurement
quality. Because accreditation is based on periodic assessments rather than continuous monitoring, clients of
these services must take active roles in monitoring their suppliers. Any apparent noncompliance observed by
recipients of accredited services should be reported to the labs accreditation body. Lets not forget that
quality is primarily customer-driven, but customers must be clear about the nature of the quality they seek.

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