ISO/TC 69 Secretariat

Your contact: Laurent PARROT

Direct line: +33 1 41 62 81 19
ISO/TC69 N 778
Laurent.parrot@afnor.org
APPLICATIONS OF STATISTICAL METHODS
APPLICATION DES METHODES STATISTIQUES
Assistant: Laurence VARIN
Direct line: +33 1 41 62 86 77
laurence.varin@afnor.org

2007-06-05 (Rev 4)

Object Application of ISO Statistical International Standards to the

Technical Requirements of ISO/IEC 17025:2005

From

Action

Dead line
 Page 2

Ad Hoc Group 1
Application ISO/IEC 17025

Application of ISO Statistical International Standards to

the Technical Requirements of ISO/IEC 17025:2005

Introduction
To meet the technical requirements of the ISO/IEC 17025:2005 under Clause 5, testing
and calibration laboratories need to understand and adopt several statistical methods.
The ISO TC 69 (Applications of Statistical Methods) has over the years developed a
wealth of statistical standards which are relevant and applicable to this situation.

This document gives guidance on the selection and an overview of the referenced
International Standards, Guides, Technical Reports and DIS developed by ISO/TC 69,
other ISO Technical Committees and international organizations on statistical methods.
It is presented from the user perspective in the form of a table, comparing the relevant
ISO/IEC 17025 sub-clauses against these standard documents. DIS are drafts which
can be amended but all documents are available to the public.

The list of ISO statistical International Standards and other relevant documents cited in
this document is neither complete nor exhaustive, and does not preclude the use of any
other ISO standards which are deemed to be of help. Furthermore, this document does
not attempt to prescribe which statistical technique(s) are to be implemented.

A roadmap prepared by the TC69 on the ISO statistical standards is given in Annex A
(Informative). This will provide a quick glance at the statiscal standards available.

A short abstract of each ISO document produced by ISO TC 69 and the other Technical
Committees is appended in Annex B (Informative).
 Page 3

Table 1 - Comparison of the ISO/IEC 17025:2005 Subclauses vs ISO

applicable documents

ISO17025 Summary of Applicable ISO docs Annex Com-

Subclause Contents B ments
ISO 3534-1/3 : Statistics -- Vocabulary and 28-30
symbols (parts 1 to 3)
- Part 1: General statistical terms and terms 28
used in probability
5.4.1 General Lab shall use appropriate - Part 2: Applied statistics 29
Test and methods, including
calibration sampling, estimating - Part 3: Design of experiments 30
methods and measurement
method uncertainty, and ISO /R 10017 : Guidance on statistical 55
validation statistical techniques techniques for ISO 9001:2000
ISO/TR 13425 : Guidelines for the selection 57
of statistical methods in standardization and
specification
ISO 16269-6/8 : Statistical interpretation of 7-9 16269-3,
16269-4 in
data preparation

–Part 6: Statistical interpretation of data - 7

Part 6: Determination of statistical tolerance
intervals
5.4.2 – 5.4.5 Validating lab-developed –Part 7: Statistical interpretation of data - 8
Methods and non-standard Part 7: Median -- Estimation and confidence
methods: intervals

- Part 8: Statistical interpretation of data - 9

Part 8: Determination of prediction intervals

5.4.2 : - quality assurance of ISO 10012: Measurement management 37

Selection of equipment performance systems -- Requirements for measurement
methods processes and measuring equipment

- accuracy : repeatability ISO 5725-1/6 : Accuracy (trueness and

and reproducibility precision) of measurement methods and
(precision), bias results 31- 36
(trueness) - Part 1: General principles and definitions
31

5.4.3 : - Part 2: Basic method for the determination 32

of repeatability and reproducibility of a
Laboratory- standard measurement method
developed - Part 3: Intermediate measures of the 33
methods precision of a standard measurement method

- detection limit
5.4.4 :
Non-standard (capability of detection)
methods
- calibration and linearity
using reference
standards or reference
materials
- robustness against
external influences
5.4.5 : and/or cross-sensitivity
Validation of against interference from
methods sample matrix
Page 4
- Part 4: Basic methods for the determination 34
of the trueness of a standard measurement
method
- Part 5: Alternative methods for the 35
determination of the precision of a standard
measurement method
- Part 6: Use in practice of accuracy values 36
ISO 11843-1/4 : Capability of detection 43-46
- Part 1: Terms and definitions 43
- Part 2: Methodology in the linear calibration 44
case
- Part 3: Methodology for determination of 45
the critical value for the response variable
when no calibration data are used
- Part 4: Methodology for comparing the 46
minimum detectable value with a given value
ISO Guide 30 Terms and definitions used in 39
connection with reference materials
ISO Guide 32: : Calibration in analytical 40
chemistry and use of certified reference
materials
ISO Guide 33: : Uses of certified reference 41
materials
ISO Guide 35: : Reference materials -- 42
General and statistical principles for
certification
ISO 11095 : Linear calibration using 38
reference materials
ISO 5725-1/6 : Accuracy (trueness and 31- 36
precision) of measurement methods and
results
- Part 1: General principles and definitions 31
- Part 2: Basic method for the determination 32
of repeatability and reproducibility of a
standard measurement method
- Part 3: Intermediate measures of the 33
precision of a standard measurement method
 Page 5

- Part 4: Basic methods for the determination 34

of the trueness of a standard measurement
method
- Part 5: Alternative methods for the 35
determination of the precision of a standard
measurement method
- Part 6: Use in practice of accuracy values 36

ISO 13528 : Statistical methods for use in 50

proficiency testing by interlaboratory
comparisons
ISO/TR 22971 : Accuracy (trueness and 51
precision) of measurement methods and
results -- Practical guidance for the use of
ISO 5725-2:1994 in designing, implementing
and statistically analysing interlaboratory
repeatability and reproducibility results
ISO Guide 43-1/2: Proficiency testing by 52-53
- interlaboratory interlaboratory comparisons
comparison and
proficiency testing - Part 1: Development and operation of 52
proficiency testing schemes

- Part 2: Selection and use of proficiency 53

testing schemes by laboratory accreditation
bodies
ISO 13528 : Statistical methods for use in
proficiency testing by interlaboratory 50
comparisons
ISO/TR 22971 : Accuracy (trueness and 51
precision) of measurement methods and
results -- Practical guidance for the use of
ISO 5725-2:1994 in designing, implementing
and statistically analysing interlaboratory
repeatability and reproducibility results
ISO 2602 : Statistical interpretation of test 1
results -- Estimation of the mean --
Confidence interval
ISO 2854 : Statistical interpretation of data – 2
Part 4: Techniques of estimation and tests
relating to means and variances
ISO 3494 : Statistical interpretation of data -- 3
Power of tests relating to means and
variances
ISO 3301 : Statistical interpretation of data -- 4
Comparison of two means in the case of
paired observations
 Page 6

ISO 5479 : Statistical interpretation of data – 5

Part 7: Tests for departure from the normal
distribution
ISO 16269 Part 4: Statistical interpretation of 10
- criteria for data data -- Part 4: Detection and treatment of
approval/ rejection; outliers (in preparation)
systematic assessment
of the factors influencing
the result

ISO 11453 : Statistical interpretation of data - 6 (see

- Tests and confidence intervals relating to 5.4.6
proportions clause
below)
ISO 16269-3/8 : Statistical interpretation of 7-10
data 16269-3
- assessment of
and 16269-
uncertainty of measured - part 6: Determination of statistical tolerance 7 4 in
values intervals preparation
- part 7: Estimation and confidence intervals 8

- part 8: Determination of prediction intervals 9

Measurement ISO/IEC Guide 98 : Guide to the expression

uncertainty of uncertainty in measurement (GUM) 49 Other ISO
references:
ISO/TS 21748 : Guidance for the use of 47 2602
repeatability, reproducibility and trueness 3301
estimates in measurement uncertainty 3494
estimation 5479
ISO 5725-1/6 : Accuracy (trueness and 31-36 16269-7
precision) of measurement methods and (replacing
results 8595)
5.4.6 - Part 1: General principles and definitions 31 11453
Estimation of
measurement - Part 2: Basic method for the determination 32
uncertainty of repeatability and reproducibility of a
standard measurement method
- Part 3: Intermediate measures of the 33
precision of a standard measurement method
- Part 4: Basic methods for the determination 34
of the trueness of a standard measurement
method
- Part 5: Alternative methods for the 35
determination of the precision of a standard
measurement method
- Part 6: Use in practice of accuracy values 36
 Page 7

ISO/TS 21749 : Measurement uncertainty for 48

metrological applications -- Repeated
measurements and nested experiments
ISO Guide 32: Calibration in analytical 40
chemistry and use of certified reference
5.5 materials
Equipment ISO Guide 33: Uses of certified reference 41
materials
5.6 Calibration of equipment
Measurement and apparatus, and ISO Guide 35: Reference materials -- 42
traceability maintaining confidence General and statistical principles for
in calibration status via certification
5.6.2.1.2 statistical means; use of
Use of CRM CRM ISO 10012 : Measurement management 37
systems - Requirements for measurement
5.6.3.1 processes and measuring equipment
Reference ISO 11095 : Linear calibration using 38
standards reference materials

ISO/TR 8550 series : Guidance on the 22 11648-

5.7 Sampling selection and usage of acceptance sampling 3/4 (in
systems for inspection of discrete items in preparati
lots on)
ISO 2859: Sampling procedures for 11 – 15
inspection by attributes

- Part 0: Introduction to the ISO 2859 11

attribute sampling system.

- Part 1: Sampling schemes indexed by 12

acceptance quality limit (AQL) for lot-by-lot
To have a sampling plan inspection
or procedures for - Part 2: Sampling plans indexed by limiting 13
sampling quality (LQ) for isolated lot inspection
- Part 3: Skip-lot sampling procedures 14

- Part 4: Procedures for assessment of 15

declared quality levels
ISO 3951 : Sampling procedures for 16
inspection by variables
ISO 8422 : Sequential sampling plans for 17
inspection by attributes
ISO 8423 : Sequential sampling plans for 18
inspection by variables for percent
nonconforming (known standard deviation)
ISO 11648-1/4 : Statistical aspects of 19-21
sampling from bulk materials
- Part 1: General principles 19
- Part 2: Sampling of particulate materials 20
 Page 8

ISO 18414: Acceptance sampling procedures 57

by attributes : Accept-zero sampling system
on credit principles for controlling outgoing
quality

- use of certified ISO 11095 : Linear calibration using (see also

reference materials reference materials 38 relevant
(CRM) clauses
above)
ISO Guide 43-1/2: Proficiency testing by 52-53
- participation in interlaboratory comparisons
interlaboratory
comparison checks - Part 1: Development and operation of 52
proficiency testing schemes

- Part 2: Selection and use of proficiency 53

testing schemes by laboratory accreditation
bodies
ISO 13528 : Statistical methods for use in 50
proficiency testing by interlaboratory
comparisons
ISO TR 22971 : Accuracy (trueness and 51
5.9 precision) of measurement methods and
Assuring results -- Practical guidance for the use of
quality of test ISO 5725-2:1994 in designing, implementing
and statistically analysing interlaboratory
repeatability and reproducibility results
ISO 2602: Guide to statistical interpretation of 1 Other ref
- replicate analyses data — Estimation of the mean - confidence 2854/4
and calibrations interval. 3494/5
26269/6-7

ISO/TR7871 : Cumulative sum charts -- 24

- use of control charts Guidance on quality control and data analysis
using CUSUM techniques
ISO 7870 : Control charts -- General guide 23
and introduction
ISO 7873 : Control charts for arithmetic 25
average with warning limits
ISO 7966 : Acceptance control charts 26

ISO 8258 : Shewhart control charts 27

 Page 9

5.10.3 - Statement of ISO 10576 Part 1 : Statistical Methods – 54

Test Reoirts compliance with a Guidelines for the evaluation of conformity
specification with specified requirements – General
5.10.3.1 (c) Principles
Compliance

5.10.4.2
Compliance
with a
specification
 Page 10

Annex A
(Informative)

Roadmap for the ISO Statistical Standards

The cause-and-effect diagram shown below indicates the use of various ISO statistical
standards to arrive at a certain purpose. Although the roadmap does not claim itself to
be complete or exhaustive, it does serve a good purpose for those who wish to have a
quick reference to their needs. It does not preclude the use of any other ISO standards
which are deemed to be of help.
 Page 11

ISO Statistical
. standards ATTRIBUTES

ISO 2859-1
VARIABLES
ISO 3951-1
ISO 3951-2
(Click on one standard to find the corresponding abstract) ISO 2859-2 ISO 3951-5

PREDICTION MEAN
. ISO 2859-3
ISO 2859-4
ISO 2859-5
ISO 8423

Bulk material
MEDIAN DIFFERENCE
INTERVAL OF 2 MEANS ISO FDIS 2859-10 ISO 10725
ISO 2854 VARIANCES MEANS ISO FDIS 8422 ISO 11648-1
ISO 16269-7 ISO 2602
ISO 16269-8 ISO 2854 ISO 14560 ISO 11648-2
ISO 2854 ISO 2854
ISO 3301 APP Approach
ISO 13448-1
GUIDE ISO 13448-2
ISO TR 8550-1
ISO TR 8550-2
TOLERANCE NORMAL DESIGN OF
INTERVAL DISTRIBUTION PROPORTIONS POWER OF EXPERIMENTS ISO TR 8550-3 Accept-zero
VARIANCE PROPORTION TESTS ISO 21247
ISO 16269-6 ISO 5479 ISO 11453 ISO 18414
ISO 11453 ISO 3301 ISO 3534-3
Sampling
ISO 2854
ISO 3494 PROCESS
PERFORMANCE
ISO 21747
ISO DTR 12783

TERMINOLOGY
Describe Explain Accept
Statistics Design of experiments Compare
ISO FDIS 3534-1 ISO 3534-3
ISO FDIS 3534-2
Applied statistics
Metrology
VIM
ISO DIS 3534-2 MAKE
ISO 5725-1
ISO 11843-1
A
Follow in ACCURACY
Measurement
DECISION
Metrology
MAINTAINABILITY ADJUSTMENT the time ISO 5725-1 control
VIM
CEI 60706-6-9 CEI 60605-6 ISO 5725-2 GUM
CEI 61649
ISO 5725-3
Reliability
ISO 5725-4 CAPABILITY OF DETECTION
ESTIMATION SAMPLING PLANS
ISO 5725-5 ISO 11843-1
CEI 61073 CEI 60410 CEI 61123 ISO 11843-2 REFERENCE
CEI 60605-4 CEI 61070 LABORATORIES ISO 11843-3 MATERIALS
CAPABILITIES ISO 11843-4
ISO 11095
ISO/CEI Guide 43 ISO Guide 33
ISO 13528 ISO Guide 35
CONTROL CHARTS PROCESS
SPC
ISO DIS 7870-1 CAPABILITY
ISO 21747 UNCERTAINTY OF SPECIFICATION
ISO 11462-1 ISO 7870 ISO 8258
DTR 12783 MEASUREMENT LIMITS
ISO 7966 ISO7873
ISO TR 7871
ISO 13005 (GUM) ISO 10576-1
..\..\abstracts\ISO
ISO TS 21748
7873.doc
Evolution ISO TS 21749
 Page 1

Annex B
(Informative)

Bibliography with abstracts of the ISO publications listed in

Table 1

a) Statistical interpretation of data

(1) ISO 2602:1980, Guide to statistical interpretation of data — Estimation of

the mean - confidence interval.

This International Standard concerns the estimation of the mean of a normal

population on the basis of a series of tests applied to a random sample of
individuals drawn from this population, when the variance of the population mean is
unknown and calculation of the confidence interval for the population mean is based
the sample standard deviation. Test method may be subject to systematic errors.

(2) ISO 2854:1976, Guide to statistical interpretation of data — Part 4:

Techniques of estimation and tests relating to means and variances.

Comparison of a variance with a given value, estimation of a variance, comparison

of two variances, estimation of the ratio of two variances, and the same procedures
for a mean with known or unknown variance are dealt with by this standard.
Techniques are valid for sample elements drawn at random and being independent,
when the distribution of the observed variable is normal, for a sample size not too
small (5 to 10 at least) approximately also when the distribution does not deviate
very much from the normal. Techniques of verification of the hypothesis of normality
are briefly dealt with in the examples.

(3) ISO 3494:1976, Guide to statistical interpretation of data — Part 5: Power of

tests relating to means and variances.

This International Standard follows on from ISO 2854 and puts forward notions of
the type II risk, the probability of not rejecting the null hypothesis when it is false.
Deals with comparison of a mean with a given value (variance known or unknown),
of two means (variance known or unknown), of a variance with a given value, and of
two variances, and gives sets of curves for these type II risk for a given alternative
and given size of sample and to determine the size of sample to be selected for a
given alternative and a given values of type II risk.

(4) ISO 3301:1975, Guide to statistical interpretation of data — Part 6:

Comparison of two means in the case of paired observations.

A method is specified for comparing the mean of a population of differences with

zero or any other pre-assigned value. It may be applied to establish a difference
between two treatments, where ‘treatment’ should be understood in a wide sense,
e.g. as a test method, measuring instrument or laboratory involved, and is
applicable under the conditions that the series of differences can be considered as
a series of independent random items and the distribution of the differences is
normal or approximately normal. If the distribution deviates from the normal, it
remains valid provided the sample size is sufficiently large (100 and more).
 Page 2

(5) ISO 5479:1997, Guide to statistical interpretation of data — Part 7: Tests for
departure from normality.

This International Standard gives guidance on methods and tests for use in deciding
whether or not the hypothesis of a normal distribution should be rejected, assuming
that the observations are independent. Tests for departure from the normal
distribution are very ineffective for samples of size less than eight.

(6) ISO 11453:1996, Statistical interpretation of data — Tests and confidence

intervals relating to proportions.

This International Standard describes specific statistical methods for the

interpretation of data and for determining the two-sided confidence limits for a
described confidence level.

(7) ISO 16269-6:2005, Statistical interpretation of data – Part 6: Determination

of statistical tolerance intervals

This International Standard describes procedures for establishing tolerance

intervals that include at least a specified proportion of the population with a
specified confidence level. Both one-sided and two-sided statistical tolerance
intervals are provided, a one-side interval having either an upper or a lower limit
while a two-sided interval has both upper and lower limits. Two methods are
provided, a parametric method for the case where the characteristic being studied
has a normal distribution and a distribution-free method for the case where nothing
is known about the distribution except that it I continuous.

(8) ISO 16269-7:2001, Statistical interpretation of data — Part 7: Median:

Estimation and confidence intervals.

This International Standard specifies the procedures for establishing a point

estimate and confidence intervals for the median of any continuous probability
of a population, based on a random sample size from the population. These
procedures are distribution-free, i.e. they do not require knowledge of the family
of distributions to which the population distribution belongs. Similar procedures
can be applied to estimate quartiles and percentiles.

(9) ISO 16269-8:2004, Statistical interpretation of data – Part 8: Determination

of a prediction interval

This International Standard specifies methods of determining prediction intervals

from a single continuously distributed variable. These are ranges of values of the
variable, derived from a random sample of size n, for which a prediction relating to a
further randomly selected sample of size m from the same population may be made
with a specified confidence.

Three different types of population are considered, namely normally distributed with
unknown standard deviation, normally distributed with known standard deviation,
and continuous but of unknown form. For each of these three types of population,
two methods are presented, one for one-sided prediction intervals and one for
symmetric two-sided prediction intervals. In all cases, there is a choice from among
six confidence levels.
 Page 3

(10) ISO 16269, Statistical interpretation of data (The following parts are in
preparation):
Part 3: Tests for departure from normality {and below}
Part 4: Detection and treatment of outliers.
Part 5: Estimation and tests for means and variances for the normal distribution,
with power functions for tests.

b) Statistical sampling procedures

(11) ISO 2859-0:1995, Sampling procedures for inspection by attributes — Part

0: Introduction to the ISO 2859 attribute sampling system.

This International Standard explains the terms used in acceptance sampling,

describes the various schemes and plans, gives practical advice on sampling
inspection and discusses some of the theoretical aspects.

(12) ISO 2859-1: 1999 Sampling procedures for inspection by attributes — Part
1: Specification for sampling plans indexed by acceptable quality level (AQL)
for lot-by-lot inspection.

This International Standard specifies an acceptance sampling system for inspection

by attributes. It is indexed in terms of the acceptance quality limit (AQL). Its
purpose is to induce a suppler through the economic and psychological pressure of
lot non acceptance to maintain a process average at least as good as the specified
acceptance quality limit, whilst at the same time providing an upper limit for the risk
to the consumer of accepting the occasional poor lot.

(13) ISO 2859-2:1985, Sampling procedures for inspection by attributes — Part

2: Specification for sampling plans indexed by limiting quality (LQ) for isolated
lot inspection.

This standard can be used when the switching rules in ISO 2859-1 are not applied.
Indexing is by a preferred series of limiting qualities with a consumer’s risk usually
below 10 % and always below 13 %. Procedures are provided to cater for two
situations: Procedure A to be used when the supplier and the consumer both wish
to regard the lot in isolation (shall be used unless there is a specific instruction to
use Procedure B), Procedure B to be used when the supplier regards the lot as one
of a continuing series but the consumer considers the lot received in isolation.

(14) ISO 2859-3:1993, Sampling procedures for inspection by attributes — Part

3: Specification for skip-lot procedures.

This standard specifies generic skip-lot sampling procedures for acceptance

inspection by attributes. The purpose of these procedures is to provide a way of
reducing the inspection effort on products of high quality submitted by a supplier
who has a satisfactory quality assurance system and effective quality controls. The
reduction in inspection effort is achieved by determining at random, with a specified
probability, whether a lot presented for inspection will be accepted without
inspection. The procedure extends the principle of the random selection of sample
items already applied in ISO 2859-1 to the random selection of lots.
 Page 4

The skip-lot sampling procedures specified in this standard are applicable to, but
not limited to, inspection of end items, such as complete products or sub-
assemblies, components and raw materials, and materials in process.

(15) ISO 2859-4:2000, Sampling procedures for inspection by attributes — Part

4: Procedures for assessment of stated quality levels.

This standard establishes the sampling plans and the procedures that can be used
to assess whether the quality level of an entity (lot, process, etc) conforms to a
declared value. The sampling plans have been devised so as o obtain a risk of less
than 5% of contradicting a correct declared quality level. The risk is 10 % of failing
to contradict an incorrect declared quality level that is related to the limiting quality
ratio. Sampling plans are provided corresponding to three levels of discriminatory
ability.
In contrast to the procedures in the other parts of ISO 2859, the procedures in this
standard are not applicable to acceptance assessment of lots. Generally, the
balancing of risks of reaching incorrect conclusions in assessment procedures will
differ from the balancing in the procedures for acceptance sampling.
This standard may be used for various forms of quality inspection in situations
where objective evidence of conformity to some declared quality level is to be
provided by means of inspection of a sample. The procedures are applicable to
entities such as lots, process output, etc that allow random samples of individual
items to be taken from the entity.

(16) ISO 3951:1989, Sampling procedures and charts for inspection by

variables for percent nonconforming

This standard specifies an acceptance sampling system of single sampling plans for
inspection by variables, in which the acceptability of a lot is implicitly determined
from an estimate of the percentage of nonconforming items in the process, based
on a random sample of items from the lot. It is primarily designed for application
under the following conditions:

- the inspection procedure is to be applied to a continuing series of lots of

discrete products all supplied by one producer using one production process;

- only a single quality characteristic x of these products is taken into

consideration which must be measurable on a continuous scale;

- the measurement error is negligible, i.e. with a standard deviation no more

than 10 % of the process standard deviation;

- production is stable (under statistical control) and the quality characteristic x

is distributed according to a normal distribution or a close approximation to
the normal distribution;

- a contract or standard defines an upper specification limit U, a lower

specification limit L, or both.
 Page 5

(17) ISO 8422:1991, Sequential sampling plans for inspection by attributes.

The specified plans apply to end items, components and raw materials, operations,
materials in process, supplies in storage, maintenance operations, data or records,
administrative procedures. Annexes A, B and C form an integral part of this
standard.

(18) ISO 8423:1991, Sequential sampling plans for percent nonconforming

(known standard deviation).

This International Standard applies if all the following conditions are satisfied:

a) inspection on continuing series of lots of discrete items supplied by one

producer from one production process;

b) only a single quality characteristic x is taken into consideration;

c) production is stable and x has a known standard deviation

d) an upper or lower limit (or both) is defined.

(19) ISO 11648-1:2003, Statistical aspects of sampling from bulk materials —

Part 1: General introduction.

This standard establishes the general principles for the application and statistical
treatment of the sampling of bulk materials. It also provides general guidance and
examples for estimating necessary variances and checking precision and bias when
the average value of a quality characteristic is investigated. Furthermore, it also
gives information relating to the statistical analyses of serial data, by the use of
variograms and correlograms.

(20) ISO 11648-2:2001, Statistical aspects of sampling from bulk materials —

Part 2: Sampling of particulate materials.

This standard establishes the basic methods for sampling particulate materials
in bulk (e.g. ores, mineral concentrates, coal, industrial chemicals in powder or
granular form, and agricultural products such as grains) from moving stream and
stationary situations, including stopped-belt sampling, to provide samples for
measuring one or more variables in an unbiased manner and with a known degree
of precision.

It is concerned with the methods of sampling particulate materials in bulk with the
objective of obtaining unbiased measurements of one or more variables of the
material with a known degree of precision. It does not, however, provide methods
for deciding whether to accept or reject a bulk material lot with specified degree of
risk of accepting a sub-standard lot, or of rejecting what is in fact an acceptable lot.

(21) ISO 11648, Statistical aspects of sampling from bulk materials (The
following parts are in preparation):
Part 3: Sampling of liquids.
Part 4: Sampling of gases.
 Page 6

(22) ISO/TR 8550-1/3:1994, Guide for the selection of an acceptance sampling

system, scheme or plan for inspection of discrete items in lots

This ISO series describes the selection process, general considerations influencing
a selection, making a comparison of the methods for sampling inspection, other
methods sometimes adopted in practice, market and production conditions - effect
on the selection process, the final selection. It is applicable to a wide variety of
inspection situations including end items (e.g. complete products or sub-
assemblies), components and raw materials, services, materials in process,
supplies in storage, maintenance operations, data or records.

c) Control Charts

(23) ISO 7870:1993, Control charts — General guide and introduction.

This International Standard presents key elements and philosophy of the control
chart approach, and identifies a wide variety of control charts, including those
related to the Shewhart control chart, the acceptance control chart and the adaptive
control chart. It presents an overview of the basic principles and concepts and
illustrates the relationships among various control chart approaches to aid in the
selection of the most appropriate standard for given circumstance, It does not
specify statistical control methods using control charts.

(24) ISO/TR 7871:1997, Cumulative Sum charts – Guidance on quality control

and data analysis using CUSUM techniques.

This International Standard gives the principles of CUSUM charting and includes
guidance on the preparation and interpretation of CUSUM charts using basic
decision rules.

(25) ISO 7873:1993, Control charts for arithmetic average with warning limits.

This standard specifies procedures for the statistical control of processes by using
control charts based on calculating the arithmetic average of a sample and using
warning limits and action limits. It is assumed that for large lots and for the mass
output of piece and batch production, such a measure of quality is a random
variable following a normal distribution. However, when averages of four or more
items are plotted, this assumption of a normal distribution is not necessary for
control purposes.

(26) ISO 7966:1993, Acceptance control charts.

This International Standard gives guidance on the uses of acceptance control charts
and establishes general procedures for determining sample sizes, action limits and
decision criteria. Examples are included to illustrate a variety of circumstances in
which this technique has advantages and to provide details of the determination of
the sample size, the action limits and the decision criteria.

(27) ISO 8258:1991, Shewhart control charts.

This International Standard establishes a guide to the use and understanding of the
control chart approach to the methods for statistical control of a process.
 Page 7

d) Statistical vocabulary and symbols

(28) ISO 3534-1:1993, Statistics,- Vocabulary and symbols — Part 1-:Probabilty

and general statistical terms. (Under revision)

This International Standard defines 204 probability and general statistical terms in
English and French which may be used in the drafting of other international
standards. The terms are classified under the following main headings:

- Terms used in the theory of probability,

- General statistical terms,
- General terms relating to observations and test results,
- General terms relating to methods of sampling.
Annex A gives a list of symbols and abbreviations used.

(29) ISO 3534-2:2006, Statistics,- Vocabulary and symbols — Part 2 – Applied

statistics

This standard defines applied statistics terms, and expresses them in a conceptual
framework in accordance with ISO normative terminology practice. Term entries are
arranged thematically. An alphabetical index is provided. Standardized symbols and
abbreviations are defined.
Its two principal purposes are, specifically, to establish a common vocabulary for
use throughout ISO/TC 69 standards, together with the broader intent to enhance
the preciseness, clarity and cohesiveness in the usage/application of applied
statistics generally. The mathematical level has deliberately been kept to a low level
in order for the content to be made readily comprehensible to the widest possible
readership.

(30) ISO 3534-3:1999, Statistics - Vocabulary and symbols — Part 3 - Design of

experiments.

This standard defines the terms used in the field of design of experiments and may
be used in the drafting of other International Standards.

e) Accuracy

(31) ISO 5725-1:1994, Accuracy (trueness and precision) of measurement

methods and results — Part 1: General principles and definitions.

The purpose is to outline the general principles to be understood when assessing

accuracy (trueness and precision) of measurement methods and results, and in
applications, and to establish practical estimations of the various measures by
experiment. It is concerned exclusively with measurement methods which yield
values on a continuous scale and give a single value as the test result. It may be
applied to a very wide range of materials, including liquids, powders and solid
objects, manufactured or naturally occurring, provided that due consideration is
given to any heterogeneity of the material.
 Page 8

(32) ISO 5725-2:1994, Accuracy (trueness and precision) of measurement

methods and results — Part 2: Basic methods for the determination of
repeatability and reproducibility of a standard measurement method.

This International Standard amplifies the general principles to be observed in

designing experiments for the numerical estimation of the precision of measurement
methods by means of a collaborative interlaboratory experiment, provides a detailed
practical description of the basic method for routine use in estimating the precision
of measurement methods, provides guidance to all personnel concerned with
designing, performing or analysing the results of the tests for estimating precision.

Annex B provides practical examples of estimating the precision of measurement

methods by experiments.

(33) ISO 5725-3:1994, Accuracy (trueness and precision) of measurement

methods and results — Part 3: Intermediate measures of the precision of a
standard measurement method.

This International Standard specifies four intermediate measures due to changes in

observation conditions (time, calibration, operator and equipment) within a
laboratory. These intermediate measures can be established by an experiment
within a specific laboratory or by an interlaboratory experiment. Furthermore, it
discusses the implications of the definitions of intermediate precision measures,
presents guidance on the interpretation and application of the estimates of
intermediate precision measures in practical situations, discusses the connection
between trueness and measurement conditions.

(34) ISO 5725-4:1994, Accuracy (trueness and precision) of measurement

methods and results — Part 4: Basic methods for the determination of the
trueness of a standard measurement method.

This standard provides basic methods for estimating the bias of a measurement
method and the laboratory bias when a measurement method is applied. In order
that the measurements are made in the same way, it is important that the
measurement method has been standardized. It can be applied only if the accepted
reference value can be established a s a conventional true value, e.g. by
measurement standards or suitable reference materials or by referring to a
reference measurement method or by preparation of a known sample.

(35) ISO 5725-5:1998, Accuracy (trueness and precision) of measurement

methods and results — Part 5: Alternative methods for the determination of the
precision of a standard measurement method.

Part 5 of ISO 5725 describes two experiments that may be used in circumstances
where the experiment described in Part 2 would give biased estimates of
repeatability and reproducibility standard deviations. One is appropriate when there is
a risk that operators may allow the result of a measurement on one sample to
influence the result of a subsequent measurement on another sample of the same
material. The other is appropriate when the materials to be used in the experiment
are such that one cannot be confident that identical samples can be prepared. Part 5
also describes "robust" methods of analysing the data obtained from the experiments
described in Part 2 and 5..
 Page 9

(36) ISO 5725-6:1994, Accuracy (trueness and precision) of measurement

methods and results — Part 6: Use in practice of accuracy values.

The purpose is to give some indications of the way in which accuracy data can be
used in various practical situations by:

- giving a standard method of calculating the repeatability limit, the reproducibility

limit and other limits,

- providing a way of checking the acceptability of test results obtained under

repeatability or reproducibility conditions,

- describing how to assess the stability of results within a laboratory over a

period of time,

- describing how to asses whether a given laboratory is able to use a given

standard measurement method in a satisfactory way,

- describing how to compare alternative measurement methods.

f) Quality assurance requirements

(37) ISO 10012:2003, Measurement management systems – Requirements for

measurement processes and measuring equipment

This International Standard specifies generic requirements and provides guidance

for the management of measurement processes and metrological confirmation of
measuring equipment used to support and demonstrate compliance with
metrological requirements. It specifies quality management requirements of a
measurement management system that can be used by an organisation performing
measurements as part of the overall management system, and to ensure
metrological requirements are met.

This International Standard is not intended to be used as a requisite for

demonstrating conformance with ISO 9001, ISO 14001 or any other standard.
Interested parties can agree to use this standard as an input for satisfying
measurement management system requirements in certification activities. Other
standards and guides exist for particular elements affecting measurement results,
for example, details of measurement methods, competence of personnel,
interlaboratory comparisons. This International Standard is also not intended as a
substitute for, or as an addition to, the requirements of ISO/IEC 17025.

g) Calibration & reference materials

(38) ISO 11095:1996, Linear calibration using reference materials

This International Standard outlines the general principles needed to calibrate a

measurement system and to maintain that system in a state of statistical control. It
provides a basic method for estimating a linear calibration function, a control
method for extending use of a calibration function and two alternative methods to
the basic method.
 Page 10

(39) ISO Guide 30:1992, Terms and definitions used in connection with
reference materials
This Guide recommends the terms and their meaning used in connection
with reference materials, taking into account those terms which are used
in reference material certificates and appropriate test reports.

(40) ISO Guide 32:1997, Calibration in analytical chemistry and use of certified
reference materials

(41) ISO Guide 33:2000, Use of certified reference materials

(42) ISO Guide 35:1989, Certification of reference materials – General and

statistical principles

h) Capability of detection

(43) ISO 11843-1:1997, Decision limit, detection limit, capability of detection –

Part I: Terms and definitions.

This standard specifies terms and definitions relating to the detection of a

Difference between an actual state of a system and its basic state. Critical values
can be derived from an actual measurement series so as to assess the unknown
state of system included in the series, whereas the minimum detectable value of
the net state variable as a characteristic of the measurement method serves for the
selection of appropriate measure processes.

(44) ISO 11843-2:2000, Capability of detection – Part 2: Methodology in the

linear calibration case

Part 2 of this International Standard sets out the design of experiments that may be
used to estimate the terms defined in Part 1, and describes how to calculate
estimates of their values from the experimental data. In the section on the reporting
and use of results in contains the important requirement that results that fall below
the critical value of the net state variable should not be reported as “zero” or
“smaller than minimum detectable value” – in such cases the actual value should
always be reported.

(45) ISO 11843-3:2003, Capability of detection – Part 3: Methodology for

determination of the critical value for the response variable where no
calibration data are used.

This standard gives a method of estimating the critical value of the response
variable from the mean and standard deviation of repeated measurements of the
reference state in certain situations in which the value of the net state variable is
zero, for all reasonable and foreseeable purposes. Hence, it can be decided
whether values of the response variable in an actual state (or test sample) are
above the range of values attributable to the reference state.
The procedure given in this part of ISO 11843 is recommended for situations in
which it is difficult to obtain a large amount of the actual states although a large
amount of the basic state can be prepared.
 Page 11

(46) ISO 11843-4:2003, Capability of detection – Part 4: Methodology for

comparing the minimum detectable value with a given value.

This standard deals with the assessment of the capability of detection of a

measurement method without the assumptions in ISO 11843-2 of a linear
calibration curve and certain relationships between the residual standard deviation
and the value of the net state variable
Instead of estimating the minimum detectable value, ISO 11843-4:2003 provides a
criterion for judging whether the minimum detectable value is less than a given
level of the net state variable, and the basic experimental design for testing the
conformity of this criterion.

i) Measurement uncertainty

(47) ISO/TS 21748:2004, Guide to the use of repeatability, reproducibility and

trueness estimates in measurement uncertainty estimation.

This Technical Specification gives guidance for the evaluation of measurement

uncertainties using data obtained from studies conducted in accordance with ISO
5725-2, and for the comparison of collaborative study results with measurement
uncertainty obtained using formal principles of uncertainty propagation. This TS is
applicable in all measurement and test fields where an uncertainty associated with a
result has to be determined, but does not describe the application of repeatability
data in the absence of reproducibility data. The recommendations in this document
are primarily for guidance.

(48) ISO/TS 21749:2005, Measurement and uncertainty for metrological

applications – Repeated measurements and nested experiments

This Technical Specification follows the approach taken in the GUM and establishes
the basic structure for stating and combining components of uncertainty. To this
basic structure, it adds a statistical framework using the analysis of variance
(ANOVA) for estimating individual components, particularly those obtained by Type
A evaluation of uncertainty, i.e. based on the use of statistical methods. A short
description of Type B evaluation of uncertainty (non-statistical) is included for
completeness.

This Technical Specification covers experimental situations where the components

of uncertainty can be estimated from statistical analysis of repeated measurements,
instruments, test items or check standards. It provides methods for obtaining
uncertainty from single-, two- and three-level nested designs only. More
complicated experimental situations where, for example, there is interaction
between operator effects and instrument effects or a cross effect, are not covered.
It is applicable to a wide variety of measurements, e.g. lengths, angles, voltages,
resistances, masses and densities.

(49) ISO/IEC Guide 98:1995, Guide to the expression of uncertainty in

measurement (GUM)

The Guide establishes general rules for evaluating and expressing uncertainty in
measurement that can be followed at various levels of accuracy and in many fields
– from the shop floor to fundamental research. Therefore, the principles of the
Guide are intended to be applicable to a broad spectrum of measurements,
 Page 12

including those required for: maintaining quality control and quality assurance in
production; complying with and enforcing laws and regulations; conducting basic
research, and applied research and development in science and engineering;
calibrating standards and instruments and performing tests throughout a national
measurement system in order to achieve traceability to national standards;
developing, maintaining, and comparing international and national physical
reference standards, including reference materials. The Guide is primarily
concerned with the expression of uncertainty in the measurement of a well-defined
physical quantity – the measurand – that can be characterized by an essentially
unique value. It is also applicable to evaluating and expressing uncertainty
associated with the conceptual design and theoretical analysis of experiments,
methods of measurement and complex components and systems. The Guide
provides general rules for evaluating and expressing uncertainty in measurement
rather than detailed, technology-specified instructions. Both short and more detailed
examples are included.

j) Inter-laboratory comparison and proficiency testing

(50) ISO 13528:2005, Statiscal methods fro use in proficiency testing by

interlaboratory comparisons
This International Standard complements ISO Guide 43 (all parts) by providing
detailed descriptions of sound statistical methods for organizers to use to analyse
the data obtained from proficiency testing schemes, and by giving recommendations
on their use in practice by participants in such schemes and by accreditation bodies.
It can be applied to demonstrate that the measurement results obtained by
laboratories do not exhibit evidence of an unacceptable level of bias. It is applicable
to quantitative data but not qualitative data.

(51) ISO/TR 22971:2005, Accuracy (trueness and precision) of measurement

methods and results – Practical guidance for the use of ISO 5725-2:1994 in
designing, implementing and statistically analysing interlaboratory
repeatability and reproducibility results

This Technical Report provides users with practical guidance to the use of ISO
5725-2:1994 and presents simplified step-by-step approaches for the design,
implementation, and statistical analysis of inter-laboratory studies for assessing the
variability of a standard measurement method and in the determination of
repeatability and reproducibility of data obtained in inter-laboratory testing.

(52) ISO Guide 43-1, Proficiency testing by interlaboratory comparisons – Part

1: Development and operation of proficiency testing schemes

(53) ISO Guide 43-2, Proficiency testing by interlaboratory comparisons – Part

2: Selection and use of proficiency testing schemes by laboratory accreditation
bodies.

k) Conformity of specifications

(54) ISO 10576-1, Statistical Methods – Guidelines for the evaluation of

conformity with specified requirements : General Principles
 Page 13

ISO 10576-1:2002 sets out guidelines for drafting requirements that may be
formulated as limiting values for a quantifiable characteristic and for checking
conformity to such requirements when the test or measurement result is subject to
uncertainty.

It is applicable whenever the uncertainty may be quantified according to the

principles laid down in the Guide to the expression of uncertainty in measurement.
The term uncertainty is thus a descriptor for all elements of variation in the
measurement result, including uncertainty due to sampling.

It is outside the scope of ISO 10576-1:2002 to give rules for how to act when an
inconclusive result of a conformity test has been obtained.

l) Other ISO relevant documents

(55) ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2000.

This Technical Report provides guidance on the selection of appropriate statistical

techniques that may be useful to an organisation in developing, implementing,
maintaining and improving a quality management system in compliance with ISO
9001. This is done by examining those requirements of ISO 9001 that involve the
use of quantitative data, and then identifying and describing the statistical
techniques that can be useful when applied to such data. The list of statistical
techniques cited in this TR is neither complete nor exhaustive, and does not
preclude the use of any other techniques (statistical or otherwise) that are deemed
to be beneficial to the organisation. Furthermore, this technical report does not
attempt to prescribe which statistical technique(s) are to be implemented.

(56) ISO 11462-1:2001 Guidance for implementation of statistical process

control (SPC) - Part 1 Elements of SPC

Statistical process control (SPC) concerns the use of statistical techniques and/or
statistical or stochastic control algorithms to achieve one or more of the following
objectives:
a) to increase knowledge about a process;
b) to steer a process to behave in the desired way;
c) to reduce variation of final-product parameters, or in other ways improve
performance of a process.

These guidelines give the elements for implementing an SPC system to achieve
these objectives.

(57) ISO/TR 13425:2006 Guide for the selection of statistical methods in

standardization and specification.

This Technical Report gives guidance on the selection and an overview of all the
referenced International Standards, Guides, Technical Reports and DIS developed
by ISO/TC 69 from a user perspective. DIS are drafts which can be amended. All
these documents are available to the public. This TR also gives two descriptions of
the content of the International Standards by two sets of abstracts: non-technical
abstracts and technical abstracts of all these documents. Each abstract presents a
brief survey of the content of the actual standard or DIS. It also gives indications of
the use of the document in different areas.
 Page 14

(58) ISO 18414:2006, Acceptance sampling procedures by attributes : Accept-

zero sampling system on credit principles for controlling outgoing quality

This International Standard specifies a system of single sampling schemes for lot-
by-lot inspection by attributes. All the sampling plans of the system are of accept-
zero form, i.e. no lot is accepted if the sample from it contains one or more
nonconforming items. The schemes depend on a suitably-defined average outgoing
quality limit (AOQL), the value of which is chosen by the user; no restrictions are
placed on the choice of the value of the AOQL or on the sizes of successive lots in
the series. The methodology ensures that the overall average quality reaching the
customer or market-place will not exceed the AOQL in the long run.
It is designed for use under the following conditions: 1) where the inspection
procedure is to be applied to a series of lots of discrete items that are intended to
be identical, and which are all supplied by one producer using one production
process; 2) where one or more quality characteristics of these products are taken
into consideration, which must all be classifiable as either conforming or
nonconforming; 3) where the inspection error involved in classifying the state of a
product's quality characteristic(s) is negligible; and 4) where inspection is non-
destructive.

(59) ISO 21747:2006, Statistical Methods - Process performance and capability

statistics for measured quality characteristics

This International Standard describes a procedure for the determination of

statistics in order to estimate the quality capability of product and process
characteristics. The process results of these quality characteristics are tabularized
into eight possible distribution types. Calculation formulae for the statistical values
are placed with every distribution. These statistics relate to continuous quality
characteristics exclusively. It is applicable to processes in any industrial or
economical sector.

(60) ISO Guide 65 :1996, General requirements for bodies operating

product certification systems

This Guide provides general requirements for bodies operating a

system for third-party product certification (which may include a process
or service) as a means of assurance that the system complies with
specified Standards and other normative documents. It replaces ISO/IEC
Guide 40:1983.