GUIDELINES FOR IMPLEMENTATION OF THE INSPECTION, MEASURING AND

TEST EQUIPMENT REQUIREMENTS IN REFERENCE TO THE ISO 9000:2000 SERIES

STANDARDS

1. INTRODUCTION

This document aims to give auditors and organisations a practical understanding of how to
establish and maintain an effective system for managing inspection, measuring, and test
equipment.

AS/NZS ISO 9001:2000 requires organisations to ‘carry out measurements in a manner that
provides evidence of the conformity of product and that, where necessary, measuring
equipment shall be calibrated periodically against standards traceable to national standards and
that the results of calibration be maintained.’

When assessing an organisation to ISO 9001, auditors expect to find that measuring equipment
is within its calibration interval and that the performance (e.g. accuracy) of the equipment is
suitable for its application. Auditors also expect to see records of calibration, and a process to
assess previous measurement results when equipment is found not to conform to requirements.

2. EQUIPMENT CATEGORIES

2.1 General

One of the major considerations associated with the implementation of a system to control
Inspection Measuring and Test Equipment (IMTE) under an ISO 9001 system is the extent
to which formal calibration needs to be applied. For those organisations undertaking work
that requires highly accurate measurements on which product quality is dependent, formal
and fully traceable calibration arrangements need to be applied.

There are however many applications where verification of product conformance, or

process control requirements, do not require such high accuracy, or directly traceable,
measurements. Lastly, some equipment simply requires a visual or self test.

2.2 Categories of Equipment

To assist in the implementation of the ISO 9001 IMTE requirements, three broad
categories of equipment have been identified and are described in Annex A. These
categories are based on equipment usage, not on the type of equipment (e.g. a
micrometer may appear in Category A or Category B depending on the criticality and
accuracy of the measurement being made).

It is stressed that these categories are for guidance only and a risk assessment and/or
common sense must still be applied when determining which equipment category is
applicable.

In evaluating the category into which equipment fits, the following approach is suggested:

a) Identify which measurements are critical to ensuring product conformance and

performance. These measurements include physical measurements of the product

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 (e.g. size, weight, volts, etc), values of specified performance parameters (e.g.
capacity, strength, gain, etc), and overall process control parameters that are
critical to ensuring final product quality.

b) Identify the tolerance & accuracy required for these measurements.

c) Then determine the extent/frequency of calibration required.

Annex A comprised two sections designed to be used as follows:

Part 1: Provides guidelines for selecting relevant equipment categories.

Part 2: Provides guidance regarding the "calibration and checking" requirements for each
equipment category.

3. TRACEABILITY

3.1 General

a) The concept of traceability has two components.

a) Traceability of the measurement equipment chain, and

b) Traceability of competence (accredited skill of calibration personnel)

(a) means that a working instrument must be calibrated against a reference

instrument that has in turn been calibrated against a more accurate reference
instrument and so on until the calibration chain reaches the primary national and
international standards. In Australia the primary standards are held by the CSIRO
National Measurement Institute (http://www.measurement.gov.au).

(b) means that the facilities and personnel working in the organisation performing
the test or calibration have been assessed by NATA as competent to undertake the
work (or is an approved verifying authority), and can issue a NATA Endorsed (or
full) calibration report under the designated signatory.

Note. The Australian Measurement Hierarchy is shown on Annex B.

b) An integral part of traceability is confidence in the total accuracy of the calibration.

Calibrations conducted internally (e.g. Cat B instruments calibrated against an

externally calibrated Cat A instrument) naturally have a diminished accuracy, often
declared at 5-10 times less than the Cat A reference, but still perfectly acceptable.
Confidence in externally sourced calibrations can be gained, and demonstrated to
customers and auditors by having the calibration performed by one of the following:

i) Calibration performed by CSIRO National Measurement Institute (NMI).

ii) Calibration performed by a NATA accredited calibration facility and reported

on a NATA endorsed calibration report.

iii) Calibrations performed by a national measurement laboratory that holds

Statements of Equivalent with the CSIRO NMI (e.g. NIST (USA), NPL (UK),
NRC (Canada), JRL (NC) or is recognised by CSIRO NMI as demonstrating
competence.

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 iv) Calibration performed by a calibration facility that is accredited by another
laboratory accreditation organisation recognised under a Mutual Recognition
Agreement with NATA (e.g. TELARC, HOKLAS, NAMAS, NVLAP, A2LA,
STERLAB and SWEDAC).

v) Calibration performed by a laboratory or facility recognised by the CSIRO NMI

as a verifying authority (i.e. trade measurement) for the particular calibration.

3.2 Traceability Requirements for Category "A" Equipment

a) Calibrations are conducted by one of the calibration sources listed in Paragraph

3.1 (i)-(v) (above).

b) Acceptable documentary evidence of traceable calibrations from external sources

is:

i) A calibration report issued by the CSIRO NMI or a recognised overseas

facility.

ii) A NATA endorsed calibration report issued by a calibration facility accredited

by NATA for the particular calibration.

iii) A calibration report issued by a calibration facility accredited by a laboratory

accreditation body recognised under a Mutual Recognition Agreement with
NATA. (NATA can provide information on request).

iv) A Regulation 13 Certificate issued under the National Measurement

Regulations 1999 by a calibration laboratory appointed by the CSIRO NMI as
a Verifying Authority.

3.3 Traceability Requirements for Category "B" Equipment

a) Traceability for this category of equipment must still be maintained. However, the
requirements are not as stringent as for Category "A" equipment.

b) "In-house" equipment checks must meet the following criteria:

i) Checks are performed using an "in-house" approved (or proven) method.

ii) Checks must be performed by appropriately trained staff.

iii) Reference standards used are traceable to CSIRO NMI through one of the
sources detailed in Paragraph 3.1 (above).

iv) Full records of calibration results and environment (where appropriate) are
maintained.

c) Equipment checks forming the calibration “chain” may be performed by internal or

external sources provided that the above requirements are met as a minimum.

d) Acceptable documentary evidence of traceability for reference sources are given in

Paragraph 3.2 (b).

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3.4 Traceability Requirements for Category "C" Equipment

a) There are no specific traceability requirements for equipment in this category.

4. PURCHASING IMPLICATIONS

4.1 General

When calibration services are "purchased" from an external source, the full requirements
of the purchasing clause of the relevant ISO 9001 standard is applicable. The logic is
very simple - if you do not specify what you want, you have no guarantee of getting it.

4.2 Assessment of Suppliers

Before placing an order for calibration services, the capability of the supplier must be
ascertained. This can be done by asking the supplier to provide a copy of their NATA
scope of accreditation, or an equivalent document that establishes the scope of the
supplier's competence and authority under the relevant trade measurement legislation.

If you have determined that a particular instrument (i.e. Cat A) requires a NATA endorsed
calibration/test certificate, only a NATA endorsed supplier can issue it. However if your
risk is lower (e.g. Cat B equipment), then a non NATA endorsed certificate is valid.

Calibration providers who have been evaluated as above should be incorporated on the
list of approved suppliers.

4.3 Purchasing Information

Purchase orders for calibration services are best issued or confirmed in writing. The PO should
state the make, model & serial No. of the instrument. Then describe the type of calibration
required (e.g. NATA endorsed calibration report, or certificate of conformance, and any special
requirements such as specific ranges that will (or will not) require calibration, or perhaps a
requirement to “calibrate to manufacture’s specifications”.

5. CALIBRATION REPORTS

Two forms of reporting are usually offered by calibration providers: a NATA Endorsed (or full
calibration) report, or Non-NATA Endorsed (or certificate of conformance).

A calibration report provides (as a minimum) a set of results that show the performance of the
instrument being calibrated in comparison to a reference instrument or standard.
Measurements are recorded for each function, range and points tested, and the uncertainty of
the measurement is stated, usually in the range 95-99%. The report enables users to be aware
of the errors of their instrument, and if necessary, apply corrections based on the results given
in the report. Depending on the magnitude of errors the calibrator or equipment owner may
decide to have the instrument adjusted.

When a non-endorsed calibration certificate is requested, it usually states the compliance of an

instrument against the manufacturer's specification (unless some other specific report is
requested). Measurements made by the instrument being calibrated are compared to the
manufacturer's specification. If the instrument is within specification, a statement that the
instrument meets the manufacturer's specification at the points tested is made in the
conformance certificate. Any points that are outside specification, or not able to be determined,

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are reported as exceptions. Assessment of meeting the manufacturer's specification takes into
account the measurement uncertainty. A statement of conformance to the manufacturer's
specification may also be given in calibration reports.

It is essential that calibration reports are examined to determine if any corrections or repairs
were carried out that may trigger the need to re-check stock, or at worse, a product recall.

6. CALIBRATION INTERVALS

A question that is often asked is 'How often do I need my instrument calibrated?' The answer is
not straightforward and depends on factors such as: the impact of the instrument on quality, the
environment and the way in which the instrument is used, periodic checking against other
instruments, and recorded history of the instrument. Ultimately it comes down to the risk period
that, should the equipment become faulty, the company is prepared to continue delivering
product. This in turn is a factor of cost and business impact in the event of a recall.

The supplementary requirements for accreditation by NATA to ISO 17025 are a useful guide in
determining calibration intervals. The NATA document sets out the requirements for the
frequency of recalibration of test equipment used by testing and calibration laboratories. For
digital instruments the required recalibration interval is a maximum of 12 months and this
interval is frequently used for instrument calibration generally. However if the instrument is
subject to wear or physical impact, 6 months might be more prudent. If the equipment is used to
verify critical parameters that are costly to correct after delivery, 3 months is common.

Manufacturers often recommend calibration intervals for their instruments. These

recommendations are based on their knowledge of the design of the instrument and the
performance history of a significant number of the same instruments over a period of time.
Generally manufacturers recommend an extended calibration interval once they have gained
confidence in the instrument's performance.
Calibration intervals can always be supplemented by more frequent equipment checks.

7. DEFINITIONS

The following definitions are taken from the International Vocabulary of Basic and General
Terms in Metrology published by ISO/IEC (2nd Ed., 1993).

7.1 True value (of a quantity) - value consistent with the definition of a given particular
quantity.

Notes: 1. This is a value that would be obtained by a perfect measurement.

2. True values are by nature indeterminate.

7.2 Measurement - set of operations having the object of determining a value of a quantity.

Note: The operation may be performed automatically.

7.3 Measurand - particular quantity subject to measurement.

Example: Vapour pressure of a given sample of water at 20oC.

Note: The specification of a measurand may require statements about quantities
such as time, temperature and pressure.

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7.4 Measuring instrument - device intended to be used to make measurements, alone or in
conjunction with supplementary devices.

7.5 Accuracy of measurement - closeness of the agreement between the result of a

measurement and a true value of a measurand.

Notes: 1. Accuracy is a qualitative concept.

2. The term "precision" should not be used for "accuracy".

7.6 Calibration - set of operations that establish, under specified conditions, the relationship
between values of quantities indicated by a measuring instrument or measuring system,
or values represented by a material measure or a reference material, and the
corresponding values realised by standards.

Notes: 1. The result of a calibration permits the assignment of values of measurands to

the indications or the determination of corrections with respect to indications.
2. A calibration may also determine other meteorological properties such as the
effect of influence quantities.
3. The result of a calibration may be recorded in a document, sometimes called a
calibration certificate or calibration report.

7.7 Material measure - device intended to reproduce or supply, in a permanent manner

during its use, one or more known values of given quantity.

Examples: a) a weight;
b) a measure of volume (of one or several values, with or without a scale);
c) a standard electrical resistor;
d) a gauge block;
e) a standard signal generator;
f) a reference material.

7.8 Repeatability (of a measuring instrument) - ability of a measuring instrument to provide

closely similar indications for repeated applications of the same measurand under the
same conditions of measurement.

Notes: 1. these conditions include:

- reduction to a minimum of variations due to the observer;
- the same measurement procedure;
- the same observer;
- the same measuring equipment, used under the same conditions;
- the same location;
- repetition over a short period of time.
2. Repeatability may be expressed quantitatively in terms of the dispersion
characteristic of the indications.

7.9 Repeatability (of results of measurements) - closeness of agreement between the

results of successive measurements of the same measurand carried out under the same
conditions of measurement.

Notes: 1. These conditions are called repeatability conditions.

2. Repeatability conditions include;
- the same measurement procedure;
- the same observer;
- the same measuring equipment, used under the same conditions;

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 - the same location;
- repetition over a short period of time.
3. Repeatability may be expressed quantitatively in terms of the dispersion
characteristics of the results.

7.10 Uncertainty of measurement - parameter associated with the result of a measurement

that characterises the dispersion of the values that could reasonably be attributed to the
measurand.

Notes: 1. The parameter may be, for example, a standard deviation (or a given multiple
of it), or the half-width of an interval having a stated level of confidence.
2. Uncertainty of measurement comprise, in general, many components. Some
of these components may be evaluated from the statistical distribution of the
results of series of measurements and can be characterised by experimental
standard deviations. The other components, which can also be characterised
by standard deviations, are evaluated from assumed probability distributions
based on experience or other information.
3. It is understood that the result of the measurement if the best estimate of the
value of the measurand, and that all components of uncertainty, including
those arising from systematic effects, such as components associated with
corrections and reference standards, contribute to the dispersion.

7.11 Measurement standard - material measure, measuring instrument, reference material or

measuring system intended to define, realise, conserve or reproduce a unit or one or
more values of a quantity to serve as a reference.

Examples: a) 1 kg mass standard;

b) 100 standard resistor;
c) standard ammeter;
d) caesium frequency standard;
e) standard hydrogen electrode;
f) reference solution of cortisol in human serum having a certified reference
concentration.

7.12 Traceability - 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.

Notes: 1. The concept is often expressed by the adjective "traceable".

2. The unbroken chain of comparisons is called a traceability chain.

7.13 Tolerance - The permissible range of variation of some characteristic from its nominal
value

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ANNEX A PART 1 – GUIDELINES FOR SELECTING RELEVANT EQUIPMENT CATEGORIES

This table is intended to help you to determine the appropriate measure confirmation requirements for measuring equipment based on the
purpose for which the measuring equipment is being used.

CATEGORY A CATEGORY B CATEGORY C

FORMAL CALIBRATION PERFORMANCE CHECK VISUAL INSPECTION
Formal calibration is required when the Performance checks are appropriate when Visual inspection may be adequate when
measuring equipment is being used to: measuring equipment is used to: measuring equipment is used to:

* verify conformance of product to specified * measure parameters that are less critical to * transfer or comparison measurements (e.g.
tolerances that are critical to product product performance and conformance to using callipers to transfer a dimension from
performance and conformance to manufacturers' or customers' specified one workpiece to another)
manufacturers' or customers' specified requirements
requirements * for indication but not measurement purposes
*monitor processes where control of process (e.g. to indicate an on/off situation)
* monitor processes where process limits parameters and variation is not critical for
critical to final product performance and ensuring product performance and * for broad tolerance measurements where
conformance have been specified conformance to specified requirements, but continued useability of the equipment can be
where manufacturing efficiencies may be confirmed by visual check for damage or
* meet regulatory requirements that specify affected deterioration (e.g. steel tape measurements
calibration as a mandatory requirement *monitor product or service parameters where for some application)
there is a subsequent verification in the
production process that fulfils final Note. Some Cat C equipment is self checking
requirements for conformance testing.

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ANNEX A GUIDANCE FOR CALIBRATION AND CHECKING REQUIREMENTS FOR EACH EQUIPMENT CATEGORY

MEASUREMENT CONFIRMATION CATEGORY "A" CATEGORY "B" CATEGORY "C"

FORMAL PERFORMANCE VISUAL
Which of the following actions would be required in each of the categories of
CALIBRATION CHECK INSPECTION
measurement verification?
1 Traceability of reference equipment to national standards- Direct YES
Indirect YES
2 A documented method with the following characteristics
- technical validation based on a recognised documented standard
where available YES
- an in-house work instruction YES YES
- a visual check instruction YES YES YES
3 Control/monitoring of calibration/checking environment. YES MAYBE
Knowledge of the influence of environment on use of the instrument. YES YES
4 Competent staff
- trained in the technique YES YES YES
- evaluated externally YES
- provided with internal references or sources YES

5 Data & Records

- required accuracy & tolerances YES YES
- applied, measured, and corrected values stated YES
- details of reference equipment or sources used YES YES
- NATA endorsed test report (or equivalent) YES

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ANNEX A CHOICES FOR CONFIRMING THE PERFORMANCE OF MEASURING EQUIPMENT

MEASUREMENT CONFIRMATION CATEGORY "A" CATEGORY "B" CATEGORY "C"

FORMAL PERFORMANCE VISUAL
CALIBRATION CHECK INSPECTION
Specified frequency of calibration/check YES YES YES
Safeguard against adjustment YES MAYBE
Identification of equipment YES YES YES

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ANNEX B THE AUSTRALIAN NATIONAL MEASUREMENT HIERACHY

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