1

(Laboratory Management)

1.01 Accreditation
(ISO/IEC Guide 58: 1993)
Procedure by which an authoritative
body gives formal recognition that a
body or person is competent to carry
out specific tasks.
Note: Accreditation does not of itself
qualify the laboratory to approve
any particular product. However,
accreditation may be relevant to
approval and certification authorities
when they decide whether or not to
accept data produced by a given
laboratory in connection with their own
activities.
1.02 Accreditation body
(ISO/IEC Guide 2: 1996)
Body that conducts and administers
an accreditation system and grants
accreditation.
1.03 Auditee (ISO 10011-1: 1990)
An organization to be audited.

1.04 Auditor (ISO 10011-1: 1990)

A person who has the qualification to
perform quality audits.
Notes:
1. To perform a quality audit, the
auditor must be authorized for that
particular audit.

2. An auditor designated to manage a

quality audit is called a lead
auditor

1.05 Certification body

(ISO/IEC Guide 2 : 1996)
Body that conducts certification.
Note: A certification body may
operate its own testing and inspection
activities or oversee these activities
carried out on its behalf by other
bodies.
1.06 Corrective action (ISO 9000: 2000)
Action to eliminate the cause of a
detected nonconformity or other
undesirable situation.

1.

technical
auditor
2.

lead auditor /

1.07 Management review (ISO 8402:1994)

Formal evaluation by top management
of the status and adequacy of the
quality system in relation to quality
policy and objectives.
Notes:
1. Management review may include
review of the quality policy.
2. Quality audit results are one of the
possible inputs to management
review.
3. The term top management refers
to the management of the
organization whose quality system
is being reviewed.

1.

2.

3.

1.08 Management system (ISO 9000:2000)

To establish policy and objectives and
to achieve those objectives.

1.09 Nonconformity (ISO 10011-1: 1990)

The nonfulfilment of specified
requirements.

1.10 Observation (ISO 10011-1: 1990)
A statement of fact made during an
audit and substantiated by objective
evidence.

1.11 Preventive action (ISO 9000: 2000)

Action to eliminate the cause of a
potential nonconformity or other
undesirable potential situation.

1.12 Quality Audit (ISO 10011-1: 1990)

A systematic and independent
examination to determine whether
quality activities and related results
comply with planned arrangements and
whether these arrangements are
implemented effectively and are
suitable to achieve objectives.
Notes:
1. The quality audit typically applies to,
but is not limited to, a quality system
or elements thereof, to processes,
to products or to services . Such
audits are often called quality
system audit, process quality
audit, product quality audit or
service quality audit.
2. Quality audits are carried out by staff
not having direct responsibility in the
areas being audited but, preferably,
working in coorperation with the
relevant personnel.

1.

2.

3. One purposes of a quality audit is

to evaluate the need for improvement or corrective action. An audit
should not be confused with
surveillance or inspection
activities performed for the sole
purpose of process control or
product acceptance.
4. Quality audits can be conducted for
internal or external purposes.

1.13 Quality assurance (ISO 8402: 1994)

All the planned and systematic
activities implemented within the
quality system, and demonstrated
as needed, to provide adequate
confidence that an entity will fulfil
requirements for quality.

1.14 Quality control (ISO 8402: 1994)

Operational techniques and activities
that are used to fulfil requirements for
quality.
Note: Quality control involves
operational techniques and activities
aimed both at monitoring a process
and at eliminating causes of
unsatisfactory performance at all
stages of the quality loop in order to
achieve economic effectiveness.

3.

4.

1.15 Quality improvement(ISO 8402:1994)

Actions taken throughout the
organization to increase the
effectiveness and efficiency of
activities and processes in order to
provide added benefits to both the
organization and its customers.
1.16 Quality manual (ISO 9000: 2000)
Document specifying the quality
management system of an
organization.
Note: Quality manuals can vary in
detail and format to suit the size
and complexity of an individual
organization.
1.17 Quality policy (ISO 9000: 2000)
Overall intentions and direction of
an organization related to quality
as formally expressed by top
management.
Note : The quality policy forms one
element of the corporate policy and is
authorized by top management.
1.18 Quality system (ISO 8402: 1994)
Organizational structure, procedures,
processes and resources needed to
implement quality management.

Notes:
1. The quality system should be as
comprehensive as needed to meet
the quality objectives.
2. The quality system of an
organization is designed primarily to
satisfy the internal managerial
needs of the organization. It is
broader than the requirements of a
particular customer, who evaluates
only the relevant part of the quality
system.
3. For contractual or mandatory
quality assessment purposes,
demonstration of the implementation
of identified quality system elements
may be required.

1.

2.

3.

(Measuring Instrument and Characteristics of Measuring Instrument)

2.01 Calibration (VIM : 1984)

The set of operations which establish,
under specified conditions, the
relationship between values indicated
by measuring instrument or measuring
system, and the corresponding
standard or known values derived
from the standard

2.03 Discrimination Threshold

(VIM :1984)
The smallest change in a stimulus
which produces a perceptible change
in the response of a measuring
instrument.
Note: The discrimination threshold
may depend on, for example, noise
(internal or external), friction, damping,
inertia, quantization.

2.02 Discrimination (VIM :1984)

The ability of a measuring instrument
to respond to small changes in the
value of the stimulus.

( ),
, , ,

2.04 Response time (VIM :1984)

The time interval between the instant
when a stimulus is subjected to
specified abrupt change and the
instant when the response reaches
and remains within specified limits of
its final steady value.

2.05 Sensitivity (VIM :1984 and IUPAC

Orange Book)
The change in the response of a
measuring instrument divided by the
corresponding change in the stimulus.
Note : Stimulus may for example be
the amount of the measurand present.
Sensitivity may depend on the value
of the stimulus. Although this definition
is clearly applied to a measuring
instrument, it can also applied to the
analytical method as a whole, taking
into account other factors such as the
effect of concentration steps.


10

(Test Method)

3.01 Accuracy (ISO 3534-1 : 1993)

The closeness of agreement between
a test result and the accepted
reference value.
Note : The term accuracy, when applied
to a set of test results, involves a
combination of random components
and a common systematic error or bias
component.
3.02 Bias (ISO 3534-1 : 1993)
The difference between the expectation
of the test results and an accepted
reference value.
Note : Bias is the total systematic error
as contrasted to random error. There
may be one or more systematic error
components contributing to the bias.
A larger systematic difference from the
accepted reference value is reflected
by a larger bias value.
3.03 Calibration Curve
(AOAC-PVMC:1993)
Graphical representation of measuring
signal as a function of quantity of
analyte.

 11

3.04 Cross reactivity (NCCLS : 1998)

In Immunology, the reaction of an
antibody with an antigen other than
that which elicited its formation, as
a result of shared, similar, or identical
antigenic determinants.
3.05 Error ( of Measurement ) (VIM :1993)
The result of a measurement minus the
true value of the measurand.
Note : Since a true value cannot be
determined, in practice a conventional
true value is used.
3.06 Random error (VIM :1993)
Result of a measurement minus the
mean that would result from an infinite
number of measurements of the
same measurand carried out under
repeatability conditions.
Note : Random error is equal to error
minus systematic error. Because only
a finite number of measurements can
be made, it is possible to determine
only an estimate of random error.


12

3.07 Systematic Error (VIM :1993)

Mean that would result from an
infinite number of measurements of
the same measurand carried out
under repeatability conditions minus
a true value of the measurand
3.08 False Negatives/ Positives

(AOAC Research Institute Performance

Tested Methods Programme)

For qualitative methods the false

positives/negatives rate may be
determined. Data from a confirmatory
method comparison should be provided
if such method (s) is applicable to the
same matrix(es) and concentration
range(s). In the absence of a method
comparison, populations of negative
and positive fortified samples must be
analysed.
False positives / negatives may be
determined as follow :
False positive rate (%)
= false positives X 100
total known negatives
False negative rate(%)
= false negativesX 100
total known positives

(%)
= x100

(%)
= x 100

 13

3.09 Fitness for Purpose

(IUPAC Orange Book)
Degree to which data produced by a
measurement process enables a
user to make technically and
administratively correct decisions for
a stated purpose.

3.10 Limit of detection

(NATA Tech Note # 17: 1997)
The lowest concentration of analyte
in a sample that can be detected, but
not necessarily quantitated under the
stated conditions of test.
3.11 Limit of Quantitation
(NATA Tech Note # 17: 1997)
The lowest concentration of an
analyte that can be determined with
acceptable precision (repeatability)
and accuracy under the stated
conditions of the test.
3.12 Linearity (AOAC PVMC : 1993)
Defines the ability of the method to
obtain test results proportional to the
concentration of analyte.


14

3.13 Measurand (VIM : 1993)

Particular quantity subject to
measurement.
Note : Specification of a measurand
may require statements about
quantities such as time, temperature
and pressure

3.15 Measurement Procedure (VIM :1993)

Set of operations, described
specifically, used in the performance
of measurements according to a
given method.
Note : A measurement procedure is
normally recorded in a document that
is sometimes itself a measurement
procedure or measurement method and
is usually in sufficient detail to enable
the operator to carry out a
measurement without additional
information.

3.14 Measurement (VIM : 1993)

Set of operations having the object of

determining a value of a quantity.

 15

3.16 Method of Measurement (VIM : 1993)

A logical sequence of operations,
described generically, used in the
performance of measurements.
3.17 Precision (ISO 3534-1 : 1993)
The closeness of agreement between
independent test results obtained
under stipulated conditions.
Note : Precision depends only on the
distribution of random errors and does
not relate to the true value or the
specified value. The measure of
precision is usually expressed in terms
of imprecision and computed as a
standard deviation of the test results.
Less precision is reflected by a larger
standard deviations. Independent test
results means results obtained in a
manner not influenced by any previous
result on the same or similar test object.
Quantitative measures of precision
depend critically on the stipulated
conditions. Repeatability and
reproducibility conditions are particular
sets of extreme stipulated conditions.

(imprecision)


16

3.18 Range (NATA Tech Note 17: 1997)

The range of applicability of the test
method is the interval between the
upper and lower levels of concentration
of the analyte that have been
demonstrated to be capable of
determination with the required
precision, accuracy and linearity under
the stated conditions of test.
3.19 Recovery (AOAC - PVMC)
The fraction of analyte added to a test
sample (fortified or spiked sample) prior
to analysis, the unfortified and fortified
samples, percentage recovery (%R) is
calculated as follows:
%R = [(CF-CU)/CA] x 100

Where
- CF is the concentration of analyte
measured in the fortified sample;
- CU is the concentration of analyte
measured in the unfortified sample;
- CA is the concentration of analyte
added (measured value, not
determined by method) in fortified
sample.

(
fortified sample spiked
sample)

%R = [(CF-CU)/CA] x 100

- CF

- CU

- CA
(CA
)

 17

3.20 Repeatability (ISO 3534-1 : 1993)

Precision under repeatability
conditions, i.e. conditions where
independent test results are obtained
with the same method on identical test
items in the same laboratory by the
same operator using the same
equipment within short intervals of
time.

3.21 Reproducibility (ISO 3534-1 : 1993)

Precision under reproducibility
conditions, i.e. conditions where test
results are obtained with the same
method on identical test items in
different laboratories with different
operators using different equipment.
3.22 Result of a Measurement (VIM :1993)
Value attributed to a measurand,
obtained by measurement.
Note : When the term result of a
measurement is used, it should be
made clear whether it refers to: the
indication; the uncorrected result; the
corrected result, and whether several
values are averaged. A complete
statement of the result of a
measurement includes information
about the uncertainty of measurement.


18

3.23 Robustness
(ICH Q2A, CPMP/ICH/381/95)
The robustness of an analytical
procedure is a measure of its capacity
to remain unaffected by small, but
deliberate variations in method
parameters and provides an indication
of its reliability during normal usage.
3.24 Ruggedness
(AOAC International: Intralaboratory
Analysis Method Short Course)
The ability of a method to resist
changes in the final result arising from
minor changes in local or environment
variables.

3.25 Selectivity or Specificity

(NATA Technical Note 17 : 1997)
The ability of a method to determine
accurately and specifically the analyte
of interest in the presence of other
components in a sample matrix under
the stated conditions of the test.

 19

3.26 Sensitivity in clinical (NCCL : 1998)

The proportion of patients with a welldefined clinical disorder whose test
values are positive or exceed a defined
decision limit (i.e., a positive result and
identification of the patients who have
a disease).
Note : The clinical disorder must be
defined by criteria independent of the
test under consideration.
3.27 Trueness (ISO 3534-1 : 1993)
The closeness of agreement between
the average value obtained from a large
set of test results and an accepted
reference value.
Note : The measure of trueness is
normally expressed in terms of bias.
The reference to trueness as accuracy
of the mean is not generally
recommended.


20

3.28 Uncertainty (of Measurement)

(VIM:1993)
Parameter associated with the result
of a measurement,that characterises
the dispersion of the values that could
reasonably be attributed to the
measurand.
Note : The parameter may be, for
example, a standard deviation (or a
given multiple of it), or the half width of
a confidence interval. Uncertainty of
measurement comprises, in general,
many components. Some of these
components may be evaluated from
the statistical distribution of the results
of a 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. It is understood that
the result of the measurement is 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.

(
)

 21

3.29 Standard Uncertainty

(ISO/TAG4: 1993)
U (xi) uncertainty of the result of a
measurement expressed as a
standard deviation.

(component)

1

3.30 Type A evaluation (of uncertainty) Type A

(ISO/TAG4 : 1993)
method of evaluation of uncertainty by
the statistical analysis of series of
observations.

3.31 Type B evaluation (of uncertainty) Type B

(ISO/TAG4 : 1993)
method of evaluation of uncertainty by
means other than the statistical
analysis of series of observations.
3.32 Combined Standard Uncertainty
(ISO/TAG4 : 1993)
Uc(y) standard uncertainty of the
result of a measurement when the
result is obtained from the values of a
number of other quantities , equal to
the positive square root of a sum of
terms, the terms being the variances
or co-variances of these other
quantities weighted according to how
the measurement result varies with
changes in these quantities.

(result)

(law of propagation of
uncertainty) root - sum - of squares


22

3.33 Expanded Uncertainty

(ISO/TAG4 : 1993)
U quantity defining an interval about
the result of a measurement that may
be expected to encompass a large
fraction of the distribution of values that
could reasonably be attributed to the
measurand.
Notes:
1.The fraction may be viewed as the
coverage probability or level of
confidence of the interval.

1.

2.To associate a specific level of 2.

confidence with the interval defined

by the expanded uncertainty requires

explicit or implicit assumptions

regarding the probability distribution

characterised by the measurement

result and its combined standard

uncertainty. The level of confidence

that may be attributed to this interval

can be known only to the extent to

which such assumptions may be

justified.
3.An expanded uncertainty U is 3. U
calculated from a combined standard

uncertainty Uc and a coverage factor

U c
k using :
k
U = k x Uc

 23

3.34 Coverage factor (ISO/TAG4 : 1993)

k numerical factor used as a multiplier
of the combined standard uncertainty
in order to obtain an expanded
uncertainty.
Note: A coverage factor is typically
in the range 2 to 3.

2 3

3.36 Accepted Reference Value

(ISO 3534-1 : 1993)
A value that serves as an agreed-upon
reference for comparison and which
is derived as :
a) a theoretical or established value,
based on scientific principles;

3.35 Validation (ISO 8402: 1994)

Confirmation by examination and
provision of objective evidence that
the particular requirements for a
specific intended use are fulfilled.

)

b) an assigned or certified value, )
based on experimental work of

some national or international

organization;

c) a consensus or certified )
value, based on collaborative

experimental work under the

auspices of a scientific or
engineering group ;


24

d) when a), b) and c) are not available,

the experimentation of the
(measurable) quantity, i.e. the
mean of a specified population of
measurements.

3.37 True value ( of a quantity )

(ISO 3534-1 : 1993)
The value which characterizes a
quantity perfectly defined in the
conditions which exist when that
quantity is considered.
Note : The true value of a quantity is a
theoretical concept and in general,
cannot be known exactly.
3.38 Conventional true value(of a quantity)
(ISO 3534-1 : 1993)
A value of a quantity which, for a given
purpose, may be substituted for the
true value.
Note : A conventional true value is, in
general, regarded as sufficiently close
to the true value for the difference to
be insignificant for the given purpose.

) ) ) )

 25

3.39 Verification (ISO 8402: 1994)

Confirmation by examination and
provision of objective evidence that
specified requirements have been
fulfilled.


26

(Reference Material)

4.01 Certified reference material (CRM)

(ISO Guide 30: 1992)
Reference material, accompanied by
a certificate, one or more of whose
property values are certified by a
procedure which establishes its
traceability to an accurate realization
of the unit in which the property values
are expressed, and for which each
certified value is accompanied by
an uncertainty at a stated level of
confidence.
4.02 Consensus value (of a given quantity)
(ISO Guide 30: 1992)
For a reference material, the value of
the quantity obtained by interlaboratory
testing, or by agreement between
appropriate bodies or experts.
Note: A consensus value could,
through appropriate action by a
certifying body, become a certified
value.

 27

4.03 Homogeneity (ISO Guide 30: 1992)

Condition of being of uniform structure
or composition with respect to one or
more specified properties. A reference
material is said to be homogenous with
respect to a specified property if the
property value, as determined by tests
on samples of specified size, is found
to lie within the specified uncertainty
limits, the samples being taken either
from different supply units (bottles,
packages, etc.) or from a single supply
unit.
4.04 Interlaboratory test
(ISO Guide 30:1992)
Series of measurements of one
or more quantities performed
independently by a number of
laboratories on samples of a given
material.
Notes:
1.Other terms, including round robin
test, collaborative reference
programme, and collaborative
analytical study, are also used.
2.Interlaboratory tests are carried out
for many purposes other than the
characterization of reference
materials.

(/)

/


( )

1. round robin test,

collaborative reference programme,
collaborative analytical study

2.


28

4.05 Primary standard (VIM : 1993)

Standard that is designated or widely
acknowledged as having the highest
metrological qualities and whose value
is accepted without reference to other
standards of the same quantity.
4.06 Reference material (RM)
(ISO Guide 30: 1992)
Material or substance one or more of
whose property values are sufficiently
homogenous and well established to
be used for the calibration of an
apparatus, the assessment of a
measurement method, or for assigning
values to materials.
Note: A reference material may be in
the form of a pure or mixed gas, liquid
or solid.

4.07 Reference material certificate

(ISO Guide 30: 1992)
Document accompany by a certified
reference material stating one or more
property values and their uncertainties,
and confirming that the necessary
procedures have been carried out to
ensure their validity and traceability.

 29

4.08 Reference Standard (VIM : 1993)

Standard, generally having the highest
metrological quality available at a given
location or in a given organization, from
which measurements made there are
derived.

4.10 Stability (ISO Guide 30: 1992)

Ability of a reference material, when
stored under specified conditions, to
maintain a stated property value within
specified limits for a specified period
of time.

4.09 Secondary standard (VIM : 1993)

Standard whose value is assigned by
comparison with a primary standard of
the same quantity.

4.11 Traceability (ISO Guide 30: 1992)

Property of the result of a
measurement or the value of a
standard whereby it can be related,
with a stated uncertainty, to stated
references, usually national or
international standards, through an
unbroken chain of comparisons.


30

(Proficiency Testing)

5.01 Assigned value (VIM : 1993)

Value attributed to a particular
quantity and accepted, sometimes
by convention, as having an
uncertainty appropriate for a given
purpose.

5.02 Interlaboratory comparisons

(ISO/IEC Guide 43-1:1996)
Organization, performance and
evaluation of tests on the same or
similar test items by two or more
laboratories in accordance with
predetermined conditions.
Note: In some circumstances, one of
the laboratories involved in the
intercomparison may be the laboratory
which provided the assigned value for
the test item.

 31

5.03 Laboratory proficiency testing

(ISO/IEC Guide 43-1:1996)
Determination of laboratory testing
performance by means of
interlaboratory comparisons.

Note : For the purposes of this Guide,

the term laboratory proficiency testing
is taken in its widest sense and
includes, for example:
a)Qualitative schemes for example
where laboratories are required to
identify a component of a test item.
b)Data transformation exercises for
example where laboratories are
furnished with sets of data and are
required to manipulate the data to
provide further information.
c)Single item testing where one item
is sent to a number of laboratories
sequentially and returned to the
organizer at intervals.
d)One-off exerciseswhere laboratories
are provided with a test item on a
single occasion.
e)Continuous schemes - where
laboratories are provided with test
items at regular intervals on a
continuing basis.

)


)


32

f) Sampling for example where

individuals or organization are
required to take samples for
subsequent analysis.

5.05 Extreme results

(ISO/IEC Guide 43-1:1996)
Outliers and other values which are
grossly inconsistent with other
members of the data set .
Note : These results can have a
profound influence on summary
statistics such as the mean and
standard deviation.

5.04 Outlier (ISO 5725-1 : 1994)

A member of a set of values which is
inconsistent with the other members
of that set.

5.06 Robust statistical Techniques

(ISO/IEC Guide 43-1:1996)
Techniques to minimize the influence
that extreme results can have on
estimates of the mean and standard
deviation.
Note : These techniques assign less
weight to extreme results, rather than
eliminate them from a data set.

 33

5.07 Test (ISO/IEC Guide 2 : 1996)

Technical operation that consists of
the determination of one or more
characteristics of a given product,
process or service according to a
specified procedure .

5.08 Test item (ISO/IEC Guide 43-1:1996)

Material or artefact presented to the
participating laboratory for the purpose
of proficiency testing.

5.10 Testing laboratory

(ISO/IEC Guide 2 : 1996)
Laboratory that performs tests.
Note : The term testing laboratory can
be used in the sense of a legal entity,
a technical entity or both.

5.09 Test method

(ISO/IEC Guide 2 : 1996)
Specified technical procedure for

performing a test.


34

 35

1. ISO 3534-1:1993. Statistics Vocabulary and symbols Part 1: Probability and

general statistical terms.
2. ISO 5725-1 : 1994. Accuracy ( trueness and precision ) of measurement methods
and results - Part 1: General principles and definitions.
3. ISO 8402 : 1994. Quality management and quality assurance - Vocabulary.
4. ISO 9000:2000. Quality management systems - Fundamentals and vocabulary.
5. ISO 10011-1 : 1990. Guidelines for auditing quality systems - Part 1 : Auditing.
6. ISO Guide 30 : 1992. Terms and definitions used in connection with reference
materials.
7. ISO/IEC Guide 2 : 1996. Standardization and related activities General
vocabulary.
8. ISO/IEC Guide 43-1 : 1996. Proficiency testing by interlaboratory comparisons
Part 1 : Development and operation of proficiency testing schemes.
9. ISO/IEC Guide 58: 1993. Guidelines for third party certification and accreditation
Guide 58-Calibration and testing laboratory accreditation systems - General
requirements for operation and recognition.
10. ISO/TAG4: 1993. Guide to the Expression of Uncertainty.
11. VIM : 1984. International vocabulary of basic and general terms in metrology.
12. VIM : 1993. International vocabulary of basic and general terms in metrology.
13. NCCL : 1998. Terminology and Definitions For Use in NCCLS Documents; Approved
Standard.
14. NATA Technical Note # 17: 1997. Requirements for the Format and Content of Test
Methods and Recommended Procedures for the Validation of Test Method.
15. ICH Topic Q2A. Definitions and Terminology (CPMP / ICH / 381 / 95).
16.
. 2545.
17.
: .. . 2542.
18. :
. 9000 2534 108 99
4 2534.


36

19. 1
. 10011 1 2540 115 5
15 2541.
20.
. 1300
111 40 19 2537.
21. . 235 14-2531
105 155 22 2531.
22.
: - - 6 30
2530.
23. 3 2532.

 37

ACIL
A2LA
ANSI
APLAC
APLMF
ASQ-MQD
AOAC
ASTM
BIPM
BLQS
BSI
CEN
CITAC
CNACL

EA
EAL
EOTC
EPA
EU
EURACHEM
EUROLAB
FAPAS
FDA
GUM
GALP
GAMP
GAP

American Council of Independent Laboratories

American Association for Labortoray Accreditation
American National Standards Institute
Asia Pacific Laboratory Accreditation Cooperation
Asia-Pacific Legal Metrology Forum
American Society for Quality-Measurement Quality Division
Association of Official Analytical Chemists
American Society for Testing Materials
Bureau International des Poids et Measures
Bureau of Laboratory Quality Standards
British Standards Institute
European Committee For Standardization
Co-operation of International Traceability in Analytical
Chemistry
Chinas-China National Accreditation Committee of
Laboratories
European co-operation for Accreditation
European Cooperation for Accreditation of Laboratories
European Organization for Conformity Assessment
US Environmental Protection Agency
European Union
European network of analytical chemistry laboratories
European network of testing laboratories
A proficiency testing scheme for food analysis
Food and Drug Administration
Guide to the Uncertainty of Measurement
Good Automated Laboratory Practice
Good Automated Manufacturing Practice
Good Analytical Practice


38

GCP
GLP
GMP
HOKLAS
IAAC
IAF
IEC
IFCC
ILAC
IMEKO
INMS
InstMC
ISA
ISO
IUPAC
JAS-ANZ
JNLA
LGC
NACLA
NAMAS
NATA
NCCLS
NCSL
NELAC

NIST
NORAMET
Nordtest
OECD
OIML
PAC
PTB

Good Clinical Practice

Good Laboratory Practice
Good Manufacturing Practice
HongKongs-Laboratory Accreditation Scheme
Inter American Accreditation Co-operation
International Accreditation Forum
International Electrotechnical Comission
Interantional Federation for Clinical Chemistry
International Laboratory Accreditation Cooperation
International Measurement Confederation
Institute for National Measurement Standards (Canada)
British Institute of Measurement and Control
International Society for Measurement and Control
International Organization for Standardization
International Union of Pure and Applied Chemistry
Joint Accreditation System, Australia & New Zealand
Japan National Laboratory Accreditation
Laboratory of the Government Chemist , Teddington , UK
National Cooperation for Laboratory Accreditation
National Measurement and Accreditation System
National Association of Testing Authorities
National Committee for Clinical Laboratory Standards
National Conference of Standards Laboratories
National Environmental Laboratory Accreditation
Conference
National Institute of Standards and Technology
North American Cooperation in Metrology
Organisation for Testing in the Nordic Countries
Organization for Economic Co-operation and Development
International Organization of Legal Metrology
Pacific Accreditation Cooperation
Physikalisch Technische Bundesanstatt (Germany)

 39

REMCO
RSC
UKAS
USP
VIM

WELMEC
WMO

- Council Committee of Reference Materials of the

International Organization
- The Royal Society of Chemistry
- United Kingdom Accreditation Service
- U.S. Pharmacopeia
- International vocabulary of basic and general terms in
metrology
- European Cooperation in Legal Metrology
- World Meteorological Organization


40

 41

Accepted Reference Value

Accreditation
Accreditation body
Accuracy
Assigned Value
Auditee
Auditor
Bias
Calibration
Calibration Curve
Certification body
Certified reference material
Combined Standard Uncertainty
Consensus value (of a given quantity)
Conventional true value (of a quantity)
Corrective action
Coverage factor
Cross-reactivity

B
C

3.36
1.01
1.02
3.01
5.01
1.03
1.04
3.02
2.01
3.03
1.05
4.01
3.32
4.02
3.38
1.06
3.34
3.04


42

Discrimination
Discrimination threshold
Error (of Measurement)
Expanded Uncertainty
Extreme results
False Negatives / Positives
Fitness for Purpose
Homogeneity
Interlaboratory comparisons
Interlaboratory test
Laboratory proficiency testing
Limit of detection
Limit of Quantitation
Linearity

D
E

F
H
I
L

2.02
2.03
3.05
3.33
5.05
3.08
3.09
4.03
5.02
4.04
5.03
3.10
3.11
3.12

 43

Management review
Management system
Measurand
Measurement
Measurement Procedure
Method of measurement
Nonconformity
Observation
Outlier
Precision
Preventive action
Primary standard
Quality assurance
Quality Audit
Quality control
Quality improvement
Quality manual
Quality policy
Quality system

N
O
P

1.07
1.08
3.13
3.14
3.15
3.16
1.09
1.10
5.04
3.17
1.11
4.05
1.13
1.12
1.14
1.15
1.16
1.17
1.18


44

Random error
Range
Recovery
Reference material
Reference material certificate
Reference standard
Repeatability
Reproducibility
Response time
Result of a measurement
Robustness
Robust statistical techniques
Ruggedness
Secondary standard
Selectivity
Sensitivity
Sensitivity in clinical
Specificity
Stability
Standard Uncertainty
Systematic error

3.06
3.18
3.19
4.06
4.07
4.08
3.20
3.21
2.04
3.22
3.23
5.06
3.24
4.09
3.25
2.05
3.26
3.25
4.10
3.29
3.07

 45

Test
Test item
Test method
Testing laboratory
Traceability
Trueness
True value (of a quantity)
Type A evaluation (of uncertainty)
Type B evaluation (of uncertainty)
Uncertainty (of Measurement)
Validation
Verification

U
V

5.07
5.08
5.09
5.10
4.11
3.27
3.37
3.30
3.31
3.28
3.35
3.39


46