TRACEABILITY of MEASURING EQUIPMENT

in
TESTING LABORATORIES

Bart van Oostrom

Accreditation & Metrology Consultant
[email protected]
Phone: 011 975 2494 Cell 072 120 2098

15 September 2009 1
 Seeing it once is better than being told a hundred times.
Old Chinese proverb: Zhou Chongguo (Han Dynasty)

If a laboratory assessed obtain traceability from an outside

laboratory (service provider) than the laboratory being
assessed must show that the traceability is compliant with
requirements.

It is not the calibration facilities (service provider)

responsibility, the responsibility is with the laboratory
being assessed.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 2

A Non-Conformance (NC) will be raised when:-

Calibration certificate that does not make reference to

accreditation, (by use of the SANAS Accreditation Symbol or
equivalent),

Traceability is obtained from an accredited laboratory, however

the calibrations where performed outside the scope and/or range
of the accredited facilities schedule of accreditation,

Calibration was performed by a non-accredited calibration
laboratory.

Calibration was performed by personnel with no proven

competency.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 3

Contract Review

Equipment is send to accredited calibration laboratories with no

instructions or requirements specified by the user and/or no
contract review ISO/IEC 17025:2005 section 4.4 is done by the
calibration laboratory.

Certificates issued by accredited calibration laboratories, which do
not bear the accreditation logo nor is a reference to the accreditation
system made.

The reasons for this are numerous; sometimes it is due to

misinterpretation of ISO/IEC 17025:2005 and the SANAS
requirements as documented in the “R” and “TR” series of
documentation.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 4

In addition, some test laboratories perform calibrations of its own
equipment, which support their accreditation schedule however, they
cannot provide evidence of a detailed procedure or competency this is
due to not only lack of knowledge of the accreditation requirements
but also misunderstanding of the terms

“Traceability”

“Calibration”

“Verification

“Validation”.
AND
Sometimes it is due to other motives.

The reasons for these are not part of this presentation.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 5

 Let us first see what the definitions for Traceability and Calibration in
accordance to International vocabulary of metrology.

Metrological Traceability
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

Note The ILAC considers the elements for confirming metrological traceability to
be an unbroken metrological traceability chain to an international
measurement standard or a national measurement standard, a documented
measurement uncertainty, a documented measurement procedure, accredited
technical competence, metrological traceability to the SI, and calibration
intervals (see ILAC P-10:2002).

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 6

 Traceability Chain

Sequence of measurement standards and calibrations that is used to

relate a measurement result to a reference.

Note 1 A metrological traceability chain is defined through a calibration hierarchy.

Note 2 A metrological traceability chain is used to establish metrological traceability
of a measurement result.
Note 3 A comparison between two measurement standards may be viewed as a
calibration if the comparison is used to check and, if necessary, correct the
quantity value and measurement uncertainty attributed to one of the
measurement standards.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 7

 Calibration
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.
Note 1 A calibration may be expressed by a statement, calibration function,
calibration diagram, calibration curve, or calibration table. In some cases, it
may consist of an additive or multiplicative correction of the indication
with associated measurement uncertainty.
Note 2 Calibration should not be confused with adjustment of a measuring system,
often mistakenly called “self-calibration”, nor with verification of
calibration.
Note 3 Often, the first step alone in the above definition is perceived as being
calibration.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 8

ISO/IEC 17025:2005(e)

Section 5.6.2.1.1 states:-

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.

Note Calibration laboratories fulfilling the requirements of this International

Standard are considered to be competent.

A calibration certificate bearing an accreditation body logo from a

calibration laboratory accredited to this International Standard, for the
calibration concerned, is sufficient evidence of traceability of the calibration
data reported.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 9

ISO/IEC 17025:2005(e)

Section 5.6.2.2.1 states:-

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.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 10

SANAS Document R79

“Requirements for the Issue of SANAS Calibration Certificates”

Section 6.1 states:-
Laboratories are encouraged to issue calibration certificates or reports
bearing the accreditation symbol (logo) for calibrations covered by their
schedule of accreditation.

Any certificate or report issued without the SANAS accreditation

symbol (logo) shall be viewed as having been issued outside of
the accredited scope of the laboratory.

>>> This is a clear statement<<<

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 11
 Therefore there is NO REASON

 Why an accredited calibration laboratories issues certificates

that are not supported by the accreditation system, unless
the calibration is done outside the requirements of
ISO/IEC 17025:2005 and/or the accreditation system under
which accreditation was granted.

OR

 Why a customer should accept a calibration certificate that

is not supported by the accreditation system.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 12

In support of the ISO/IEC 17025:2005
SANAS has issued Technical requirements documents TR 25.
Applicable to all SANAS accredited facilities.

This document is to assist user laboratories (Cal and Test), to specify

criteria for performing calibration and intermediate checks on
equipment used in accredited facilities .

AND NOT

for an accredited laboratory as a motivation to perform

calibrations and reporting results in whatever format
which do not comply with the requirements and/or
prove competency to it’s customs.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 13

SANAS Document TR 25
“Criteria for the Performing Calibration and Intermediate Checks on
Equipment used in Accredited Facilities” Section 3.1 states:-

Equipment used, which could affect the validity of results in the

laboratory, must, where possible be calibrated by an accredited
calibration laboratory.

Traceability of measurement and competence in performance of

the calibration will be accepted by viewing the calibration
certificate.

This is the easiest route for an accredited facility to obtain

traceability of measurement.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 14

SANAS Document TR 25
Section 3.2 states:-
Should equipment be calibrated by a non-accredited calibration
laboratory, the accredited organization using the equipment is
responsible for providing sufficient evidence to confirm competent
performance of the calibration and suitable traceability of
measurement.
At least the following records shall be available:
 Calibration procedures;
 Proof of competence of the metrologist performing the
calibration i.e. Training records;
 Proof of traceability of calibration;
 Proof that the metrologist competently transferred traceability to
the instrument.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 15

SANAS Document TR 25
What does section 3.2 imply

The laboratory being asset must provide evidence of compliance with

ISO/IEC 17025 sections
Calibration Procedures

Compliance with:-
Section 5.4 “Test and Calibration Methods and Method Validation”

Including:-

Estimation of Uncertainty of Measurements.

Inter-Laboratory Comparison (PT/ILC) in compliance with SANAS
R 48 covering the range and accuracy requirement.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 16

 SANAS Document TR 25
What does section 3.2 imply

Proof of Competence of the Metrologist Performing the Calibration

Compliance with:-
Section 5.2 “Personnel”

Including:-

Training Records

Calibrations Performed

Declaration of Competency

Who declared the Metrologist Competent

Criteria for Competency

Participation and results in PT/ILC

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 17

SANAS Document TR 25
What does section 3.2 imply

Proof of Traceability of the Calibration

Compliance with:-

Section 5.6 “Measurement Traceability”

Including:-

Certificates issued in Compliance with SANAS R 79

Compliance with SANAS TR 25

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 18

 SANAS Document TR 25
What does section 3.2 imply

Proof that the Metrologist Competently Transferred the Traceability

Compliance with:-

Section 5.9 “Assuring the Quality of test and Calibration results”

Including:-

Vertical Assessments

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 19

SANAS Document TR 25

Section 3.3 states:-

Proving this competent transfer of traceability may require an

assessment by a metrologist appointed by SANAS.

The accredited facility will bear the costs for this additional visit.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 20

Verification & Validation
A few mainly test laboratories perform verification checks and call it
incorrectly calibration.

Example:- Laboratories have a set of mass pieces, calibrated by an

accredited laboratory. The laboratory perform what they
say is a calibration of their balances at the points the
laboratory is using in the test method only, with no
compliance with the Standard, SANAS TR documentation.

This is neither a calibration nor verification as it is not in line with the

requirements of ISO/IEC 17025:2005 and/or TR 25.

The definitions for verification and validation as described in the

International Vocabulary of Metrology (VIM) are:-

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 21

 Verification

Provision of objective evidence that a given item fulfils specified

requirements

Example 1 Confirmation that a given reference material as claimed is homogeneous for the
quantity value and measurement procedure concerned, down to a measurement
portion having a mass of 10 mg.

Example 2 Confirmation that performance properties or legal requirements of a measuring

system are achieved.

Example 3 Confirmation that a target measurement uncertainty can be met.

Note! Verification should not be confused with calibration. Not every verification
is a validation.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 22

 Validation
ISO/IEC 17025 states:-
Validation is the confirmation by examination and provision of
objective evidence that the particular requirements for a specific
intended use are fulfilled.

International Vocabulary of Metrology (VIM) states:-

Verification, where the specified requirements are adequate for an
intended use
Example 1 A measurement procedure, ordinarily used for the measurement of X, may be
validated also for measurement in Y.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 23

Conclusion - 1
When equipment is calibrated by an outside calibration laboratory
(service provider)
Always.
 Select an accredited calibration service provider who can and will
comply with YOUR requirement.
 Ask if the service provider is accredited for the parameters, range
and uncertainty that you require.
 Insist on a Certificate of Calibration bearing the accreditation
Symbol or equivalent.
 When an accredited laboratory does not issue a certificate of
calibration bearing the accreditation symbol or equivalent, ask WHY,
(for the record only) and look for another service provider.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 24

Conclusion - 2
Provide your calibration service provider in writing with YOUR
requirements
 Model/Type of Equipment,
 Accuracy and/or Uncertainty required,
 Calibration interval, (An accredited calibration laboratory is not
allowed to specify the next cal date except for legal purposes)
 Calibrate in accordance with Manufacturer procedure and/or
specific calibration points,
 Any other requirements you may have. (turn around time, etc.)
Note! See also presentation M104 Test and Measurement Conference 2005.
Laboratories who perform there own calibrations of equipment supporting
there accreditation must comply with TR 25. The technical and competency
requirements for a test laboratory are the same as for an accredited
calibration laboratory when performing in-house calibrations.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 25

Conclusion - 3
When equipment is calibrated in-house

The Laboratory Must.

 Comply with the requirements of TR 25 and any other SANAS
applicable requirement as documents in the SANAS “R” & “TR”
series of documentation.

15 September 2009 Traceability of Measuring Equipment in Testing Laboratories 26

 THANK YOU

QUESTIONS

When know say so, if you don’t know say so.

That is real knowledge.
Old Chinese proverb:- Kong Qui (Confucius) 551-479 v.C