1 General

Annex F of MID describes conformity assessment procedures, where a notified body

chosen by the manufacturer carries out the appropriate examinations and tests, or
have them carried out, to check the conformity of the instruments with the type as
described in the EC-type examination certificate and the appropriate requirements of
this Directive. Annex F1 of MID describes conformity assessment procedures, where
a notified body carries out the appropriate examinations and tests, or have them
carried out, to check the conformity of the instruments with the appropriate
requirements of this Directive. Verification can be done by examination and testing of
every instrument in accordance with MID Annex F, section 4 or Annex F1, section 6
or by statistical verification in accordance with MID Annex F, point 5 or Annex F1,
point 7.
Typical applications for statistical verification are material measures (Annex MI-008)
or electronic electricity meters (Annex MI-003). Statistical verification is based on
sampling plans agreed between notified bodies and manufacturers taking into
account the provisions given in MID, Annex F or F1.
This Guide is intended to support notified bodies when creating suitable sampling
plans for conformity assessment acc. to Annex F and F1., statistical methods can
also be used for Annexes A11 or for Annexes D, D1, E, E1, H and H12.
The guide provides a practicable tool for the application of already existing
documents and standards (in particular ISO 2859) with regard to MID conditions.
This Guide is intended to improve understanding and applicability of standards for
non-professionals and does make no claim to be complete.
1 This annex requires product checks by the notified body. If appropriate the notified body may decide to
create
its sampling plans according to statistical methods.
2 These annexes do not include specific requirements for final product inspection by the manufacturer. The
decision whether to perform testing of every instrument, statistical control of the process or the product
remains
with the manufacturer. In the latter case the notified body has to evaluate the sampling plans.
5
2. Terms
Sampling plan
combination of sample size(s) to be used and associated lot acceptability criteria
NOTE 1 A single sampling plan is a combination of sample size and acceptance and
rejection numbers. A double sampling plan is a combination of two sample sizes and
acceptance and rejection numbers for the first sample and for the combined sample.
NOTE 2 A sampling plan does not contain the rules on how to draw the sample.
NOTE 3 For the purposes of this part of ISO 2859, a distinction should be made
between the terms sampling plan (3.1.17), sampling scheme (3.1.18) and sampling
system (3.1.19).
[ISO 2859-1:1999 , 3.1.17]
Sampling scheme
combination of sampling plans with rules for changing from one plan to another
[ISO 2859-1:1999 , 3.1.18]
Sampling system
collection of sampling plans, or of sampling schemes, each with its own rules for
changing plans, together with sampling procedures including criteria by which
appropriate plans or schemes may be chosen
NOTE This part of ISO 2859 is a sampling system indexed by lot-size ranges,
inspection levels and AQLs. A sampling system for LQ plans is given in ISO 2859-2.
[ISO 2859-1:1999 , 3.1.19]
Operating characteristic curve (OC curve)
A curve showing, for a given sampling plan, the probability of accepting a lot, as a
function of the quality level of the process from which the lots come; also as used for
some types of plans, a curve showing the percentage of lots, or product items, that
may be expected to be accepted as a function of the process quality level
NOTE: This type of operating curve is known as Type B. There are also operating
characteristic curves of Type A and C.
Producers risk
For a given sampling plan, the probability of non-acceptance of a lot when the lot or
process quality level (e.g. the fraction nonconforming) has a value stated by the plan
as acceptable (e.g. an acceptable quality level, AQL)
Consumers risk
For a given sampling plan, the probability of acceptance of a lot or process when the
quality level (e.g. fraction nonconforming) has a value stated by the plan as
unsatisfactory (e.g. a limiting quality level, LQL)
6
Acceptance quality limit AQL 3
quality level that is the worst tolerable process average when a continuing series of
lots is submitted for acceptance sampling
NOTE 1 This concept only applies when a sampling scheme with rules for switching
and for discontinuation, such as in ISO 2859-1 or ISO 3951, is used.
NOTE 2 Although individual lots with quality as bad as the acceptance quality limit
may be accepted with fairly high probability, the designation of an acceptance quality
limit does not suggest that this is a desirable quality level. Sampling schemes found
in International Standards such as this part of ISO 2859, with their rules for switching
and for discontinuation of sampling inspection, are designed to encourage suppliers
to have process averages consistently better than the AQL.
Otherwise, there is a high risk that the inspection severity will be switched to
tightened inspection under which the criteria for lot acceptance become more
demanding. Once on tightened inspection, unless action is taken to improve the
process, it is very likely that the rule requiring discontinuation of sampling inspection
pending such improvement will be invoked.
[ISO 2859-1:1999 , 3.1.26]
Limiting quality LQ 4
when a lot is considered in isolation, a quality level which for the purposes of
sampling inspection is limited to a low probability of acceptance
[ISO 2859-1:1999 , 3.1.28]
p is the proportion of nonconforming items; 5
Pa probability of acceptance (in percent)
3 In MID analogous to level of quality
4 In MID analogous to limit quality
5 In MID analogous to non-conformity

7
3. MID-conditions for statistical verification
Requirements for statistical verification are given in Annex F, point 5 or Annex F1,
point 7 respectively.
More specific requirements are laid down in Annex F, 5.3 or Annex F1, 7.3.
The statistical control will be based on attributes. The sampling system shall ensure:
a level of quality corresponding to a probability of acceptance of 95 %,
with a non-conformity of less than 1 %;
a limit quality corresponding to a probability of acceptance of 5 %,
with a non-conformity of less than 7 %.
Explanations:
The sampling schemes agreed between notified body and manufacturer may only
consist of sampling plans, that fulfil both conditions.
Both conditions refer to two specified points of the Operating characteristic (OC)
curves of the sampling plan:
_ Pa (1 %) = 95%; (AQL)
_ Pa (7 %) = 5%; (LQ)
The first condition
Pa (AQL) = 95%, p<1%
requires that AQL (related to a probability of acceptance Pa of 95 %) has to be
smaller than 1 %, i.e. that a lot may only be accepted with a probability of 95 %, if it
has less than 1 % non-conforming products.
As a consequence the manufacturer has to accept a producers risk (risk that a lot
with a smaller number of nonconforming products is not accepted) of 5 %.
The second condition
Pa (LQ) = 5%, p<7%
requires, that LQ (related to a probability of acceptance Pa of 5 %) has to be smaller
than 7 %, i.e. that a lot has to be refused with a probability of 95 %, if it has 7 % or
more non-conforming products.
As a consequence the consumers risk (risk that lots with too many non-conformities
are accepted) equal to 5 %.
8
4. Creation of sampling plans fulfilling MID
The standard ISO 2859-1 can be used to create and evaluate sampling plans in
accordance with MID. Up to the time of publication of this guide there is no standard
covering the MID conditions to the full extent.
The following procedure is recommended:
a) Clarify conditions for statistical verification, e.g
_ homogeneity of the lot
_ Suitable procedure for taking samples
b) Define attributes
c) Agree on sampling procedure, e.g.
_ Single Sampling plan using ISO 2859-1
_ Double Sampling plan using ISO 2859-1
_ Sequential sampling plans using ISO 8422
d) Suggest suitable sampling plans, e.g.
_ ISO 2859-1, table 1 and 2 A for Single Sampling plan for inspection
based on attributes
e) Check sampling plan for fulfilling conditions of MID by means of OC curves,
e.g.
_ ISO 2859-1, table 10-H and 10-H-1 for Single Sampling plan for
inspection based on attributes, or
_ with the help of computer applications (some freely available)
Note: The OC curves have to be on the left hand side of the points mentioned
in 3, Pa(1%) = 95% and Pa(7%) = 5%
f) Repeat d) and e) until sampling plan is completed.
9
5. Examples
Example 1:
Inspection based on attributes:
Single sampling plan for normal inspection (General inspection level II)
based on ISO 2859-1
Lot size
N
Single Sampling plan
nc
Sample
size code
letter
AQL p in %
1. requirement
Pa = 95 %;
p<1%
p in %
2. requirement
Pa = 5 %;
p<7
51 -
500
50 0 H 0,25 0,103 5,82
501 -
1200
80 1 J 0,65 0,446 5,79
1201 -
3200
125 2 K 0,65 0,657 4,95
3201 -
10 000
200 3 L 0,65 0,686 3,83
10 001 -
35 000
315 5 M 0,65 0,833 3,31
35 001 -
150 000
500 7 N 0,65 0,799 2,61
150 001 -
500 000
800 10 P 0,65 0,773 2,11
500 001
and more
1250 14 Q 0,65 0,741 1,75
Abbreviations:
n = sample size AQL = Acceptance quality limit
c = acceptance number p = proportion of nonconforming items;
Pa = probability of acceptance (in %)
Note:
50 0 is the smallest sampling plan of ISO 2859-1, that still fulfils MID. The smallest
sampling plan calculated for inspection based on attributes with single sampling
plans, that fulfils MID is 42 0.
10
Example 2:
Inspection by attributes:
Double sampling plan for normal inspection (General inspection level II)
based on ISO 2859-1
Lot size
N
Double Sampling plan
n c1/d1 c1+2/d2
Sample
size code
letter
AQL p in %
1. requirement
Pa = 95 %;
p<1%
p in %
2. requirement
Pa = 5 %;
p<7%
501 -
1200
50 0/2 1/2 J 0,65 0,446 5,79
1201 -
3200
80 0/3 3/4 K 0,65 0,657 4,95
3201 -
10 000
125 1/3 4/5 L 0,65 0,686 3,83
10 001 -
35 000
200 2/5 6/7 M 0,65 0,833 3,31
35 001 -
150 000
315 3/6 9/10 N 0,65 0,799 2,61
150 001 -
500 000
500 5/9 12/13 P 0,65 0,773 2,11
500 001
and more
800 7/11 18/19 Q 0,65 0,741 1,75
Abbreviations:
n = sample size AQL = Acceptance quality limit
c1 = acceptance number 1. sample p = proportion of nonconforming items;
c1+2 = acceptance number 1. and 2. sample Pa = probability of acceptance (in %)
d1 = rejection number 1. sample d2 = rejection number 1. and 2. sample
Example 3:
Freely agreed sampling plan
Lot size
N
Single sampling plan
nc
p in %
1. requirement
Pa = 95 %; p < 1 %
p in %
2. requirement
Pa = 5 %; p < 7 %
50
and more
50 0
0,103
5,82
Abbreviations:
n = sample size p = proportion of nonconforming items;
c = acceptance number Pa = probability of acceptance (in %)
Note: This sampling plan (50 0) is applicable for every lot size and fulfils MID.
However it involves a high producers risk (approx 40%), in particular when avoiding
big lot sizes. This sampling plan can be of use, in case where the manufacturer runs
an effective production control or final product inspection delivering an only small
amount of non-conformities.11
6. Standards concerning Acceptance Sampling
1) ISO 2859-1:1999, Sampling procedures for inspection by attributes -- Part 1:
Sampling
schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
2) ISO 2859-1:1999/Cor 1:2001
3) ISO 2859-2:1985, Sampling procedures for inspection by attributes -- Part 2:
Sampling
plans indexed by limiting quality (LQ) for isolated lot inspection
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 continuing series but the consumer considers the lot received in isolation.
4) ISO/CD 2859-2, Sampling procedures for inspection by attributes -- Part 2: Sampling
plans indexed by limited quality (LQ) for isolated lot inspection
Revizion of ISO 2859-2:1985
5) ISO 2859-3:2005, Sampling procedures for inspection by attributes -- Part 3: Skip-lot
sampling procedures
ISO 2859-3:2005 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. This procedure extends the principle of the random
selection of sample items already applied in ISO 2859-1 to the random selection of lots. The skip-lot sampling
procedures specified in ISO 2859-3:2005 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.
6) ISO 2859-4:2002, Sampling procedures for inspection by attributes -- Part 4:
Procedures
for assessment of declared quality levels
ISO 2859-4:2002 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 to
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 ISO 2859-4:2002 are not applicable to acceptance assessment of lots. Generally, the
balancing of the risks of reaching incorrect conclusions in assessment procedures will differ from the balancing in
the procedures for acceptance sampling. ISO 2859-4:2002 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. The sampling plans provided in ISO 2859-4:2002
are applicable, but not limited, to inspection of a variety of products such as end items, components and raw
materials, operations, materials in process, supplies in storage, maintenance operations, data or records, and
administrative procedures. The procedures are primarily intended to be used when the quantity of interest is the
number or fraction of nonconforming items, for which the inspected items are classified as conforming or
nonconforming. With minor changes, the procedures may also be used when the quantity of interest is the number
of nonconformities or number of nonconformities per item. The necessary changes are the replacement of the
"number of nonconforming items" by the "number of nonconformities" and the replacement of the "percent
nonconforming items" by the "nonconformities per 100 items".
12
7) ISO 2859-5:2005, Sampling procedures for inspection by attributes -- Part 5: System
of
sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot
inspection
ISO 2859-5:2005 contains sequential sampling schemes that supplement the ISO 2859-1 acceptance sampling
system for inspection by attributes, whereby a supplier, through the economic and psychological pressure of lot
non-acceptance, can maintain a process average at least as good as the specified acceptance quality limit, while at
the same time provide an upper limit for the risk to the consumer of accepting the occasional poor lot. The
sampling schemes defined in ISO 2859-5:2005 are applicable, but not limited, to the inspection of: end items,
components and raw materials, operations, materials in process, supplies in storage, maintenance operations, data
or records, and administrative procedures. These schemes are designed to be applied to a continuing series of lots,
that is, a series long enough to permit the described switching rules to be applied. These switching rules provide: a)
enhanced protection to the consumer (by means of tightened sampling inspection criteria or discontinuation of
sampling inspection) should deterioration in quality occur; and b) an incentive, at the discretion of the responsible
authority, to reduce inspection costs (by means of reduced sampling inspection criteria) should consistently good
quality be demonstrated over time. The individual sampling plans are not designed to be applicable outside of the
schemes in which they are presented. If lots are produced in isolation or in a series too short for ISO 2859-5:2005
to apply, the user is advised to consult ISO 2859-2 for appropriate sampling plans.
8) ISO 2859-10:2006, Sampling procedures for inspection by attributes -- Part 10:
Introduction to the ISO 2859 series of standards for sampling for inspection by attributes
ISO 2859-10:2006 provides a general introduction to acceptance sampling by attributes and provides a brief
summary of the attribute sampling schemes and plans used in ISO 2859-1, ISO 2859-2, ISO 2859-3, ISO 2859-4
and ISO 2859-5, which describe specific types of attribute sampling systems. ISO 2859-10:2006 also provides
guidance on the selection of the appropriate inspection system for use in a particular situation.
9) ISO 3951-1:2005, Sampling procedures for inspection by variables -- Part 1:
Specification for single sampling plans indexed by acceptance quality limit (AQL) for
lotby-
lot inspection for a single quality characteristic and a single AQL
ISO 3951-1:2005 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. ISO 3951-1:2005 is primarily designed for
application under the following conditions: where 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; where only a single quality
characteristic x of these products is taken into consideration, which must be measurable on a continuous scale;
where the measurement error is negligible, i.e. with a standard deviation no more than 10% of the process standard
deviation; where 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; where a contract or standard
defines an upper specification limit U, a lower specification limit L, or both; an item is qualified as conforming if
and only if its measured quality characteristic x satisfies the appropriate one of the following inequalities: x greater
than or equal to L (i.e. the lower specification limit is not violated); x greater than or equal to U (i.e. the upper
specification limit is not violated); x greater than or equal to L and x less than or equal to U (i.e. neither the lower
nor the upper specification limit is violated). The first two inequalities are called cases with a single specification
limit, and the third a case with double specification limits. If double specification limits apply, it is assumed in ISO
3951-1:2005 that conformance to both specification limits is equally important to the integrity of the product; in
such cases it is appropriate to apply a single AQL to the combined percentage of product outside the two
specification limits. This is referred to as combined control.
10) ISO 3951-2:2006, Sampling procedures for inspection by variables -- Part 2: General
specification for single sampling plans indexed by acceptance quality limit (AQL) for
lotby-
lot inspection of independent quality characteristics
ISO 3951-2:2006 specifies an acceptance sampling system of single sampling plans for inspection by variables,
indexed in terms of the Acceptance Quality Limit (AQL). ISO 3951-2:2006 is primarily designed for use under the
following conditions: where 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; where the quality characteristics of the items
of product are measurable on a continuous scale; where the measurement error is negligible (i.e. with a standard
deviation no more than 10 % of the corresponding process standard deviation); where production is stable (under
statistical control) and the quality characteristics are distributed, at least to a close approximation, according to
normal distributions; where, in the case of multiple quality characteristics, the characteristics are independent of
one another, at least approximately; where a contract or standard defines an upper specification limit, a lower
specification limit, or both on each of the quality characteristics.
13
11) ISO 3951-3:2007, Sampling procedures for inspection by variables -- Part 3: Double
sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 3951-3:2007 specifies an acceptance sampling system of double sampling schemes for inspection by variables
for percent nonconforming. It is indexed in terms of the acceptance quality limit (AQL). The objectives of the
methods laid down in ISO 3951-3:2007 are to ensure that lots of acceptable quality have a high probability of
acceptance and that the probability of non-accepting inferior lots is as high as practicable. This is achieved by
means of the switching rules, which provide automatic protection to the consumer (by means of a switch to
tightened inspection or discontinuation of sampling inspection) should a deterioration in quality be detected, and
an incentive (at the discretion of the responsible authority) to reduce inspection costs (by means of a switch to a
smaller sample size) should consistently good quality be achieved. In ISO 3951-3:2007, the acceptability of a lot is
implicitly or explicitly determined from an estimate of the percentage of nonconforming items in the process,
based on either one or two random samples of items from the lot. ISO 3951-3:2007 is primarily designed for use
under the following conditions: where 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; where the items of product have a
single quality characteristic; where the quality characteristic is measurable on a continuous scale; where the
measurement error is negligible (i.e. with a standard deviation no more than 10 % of the corresponding process
standard deviation); where production is stable (under statistical control) and the quality characteristic is
distributed, at least to a close approximation, according to a normal distribution; where the possibility of having to
select and inspect a second sample is administratively acceptable; and where a contract or standard defines an
upper specification limit, a lower specification limit, or both on the quality characteristic. The procedures in ISO
3951-3:2007 are not suitable for application to lots that have been screened previously for nonconforming items.
12) ISO/WD 3951-4, Sampling procedures for inspection by variables -- Part 4:
Procedures
for assessment of declared quality levels
Under development
13) ISO 3951-5:2006, Sampling procedures for inspection by variables -- Part 5:
Sequential
sampling plans indexed by acceptance quality limit (AQL) for inspection by variables
(known standard deviation)
ISO 3951-5:2006 specifies a system of sequential sampling plans (schemes) for lot-by-lot inspection by variables.
The schemes are indexed in terms of a preferred series of acceptance quality limit (AQL) values, ranging from
0,01 to 10, which are defined in terms of percent nonconforming items. The schemes are designed to be applied to
a continuing series of lots. ISO 3951-5:2006 is designed for use under the following conditions: where 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; where only a single quality characteristic of these products is taken into
consideration, which must be measurable on a continuous scale; where the uncertainty of the measurement system
is negligible with respect to the production process standard deviation; where production is stable (under statistical
control) and the quality characteristic is distributed according to a normal distribution (or a close approximation to
the normal distribution) or a distribution which may be mathematically transformed to a normal distribution; where
the standard deviation of the quality characteristic is known; and where a contract or standard defines an upper
specification limit, a lower specification limit or both.
14) ISO 8422:2006, Sequential sampling plans for inspection by attributes
ISO 8422:2006 contains sequential sampling plans and procedures for inspection by attributes of discrete items.
The plans are indexed in terms of the producer's risk point and the consumer's risk point. Therefore, they can be
used not only for the purposes of acceptance sampling, but for a more general purpose of the verification of simple
statistical hypotheses for proportions. ISO 8422:2006 provides procedures for sequential assessment of inspection
results that may be used to induce the supplier, through the economic and psychological pressure of nonacceptance
of lots of inferior quality, to supply lots of a quality having a high probability of acceptance. At the
same time, the consumer is protected by a prescribed upper limit to the probability of accepting lots of poor
quality. ISO 8422:2006 provides sampling plans that are applicable, but not limited, to inspection of different
fields, such as: end items, components and raw materials, operations, materials in process, supplies in storage,
maintenance operations, data or records, and administrative procedures. The sampling plans from ISO 8422:2006
should primarily be used for the analysis of samples taken from processes. For example, they may be used for the
acceptance sampling of lots taken from a process that is under statistical control. However, they may also be used
for the acceptance sampling of an isolated lot when its size is large, and the expected fraction nonconforming is
small (significantly smaller than 10%). In the case of the acceptance sampling of continuing series of lots, the
system of sequential sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection published
in ISO 2859-5 should be applied.
14
15) ISO/DIS 8423, Sequential sampling plans for inspection by variables for percent
nonconforming (known standard deviation)
16) ISO 8423:1991, Sequential sampling plans for inspection by variables for percent
nonconforming (known standard deviation)
Applies if all of the following conditions are satisfied: a) inspected are 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.
17) ISO 8423:1991/Cor 1:1993
Amends values in table 1 and subclause C.2.3 and equations in subclauses 3.2.2.1 and 3.2.3.1.
18) ISO/TR 8550:1994, Guide for the selection of an acceptance sampling system,
scheme or
plan for inspection of discrete items in lots
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. 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.
19) ISO/TR 8550-1:2007, Guidance on the selection and usage of acceptance sampling
systems for inspection of discrete items in lots -- Part 1: Acceptance sampling
ISO TR 8550-1:2007 gives general guidance on the selection of an acceptance sampling system, scheme or plan. It
does this principally in the context of standards that either already exist or are presently under development. The
guidance is confined to acceptance sampling of products that are supplied in lots and that can be classified as
consisting of discrete items (i.e. discrete articles of product). It is assumed that each item in a lot can be identified
and segregated from the other items in the lot and has an equal chance of being included in the sample. Each item
of product is countable and has specific characteristics that are measurable or classifiable as being conforming or
nonconforming (to a given product specification). Standards on acceptance sampling are typically generic, as a
result of which they can be applied to a wide variety of inspection situations. These include, but are not limited to,
the following: end items, such as complete products or sub-assemblies; components and raw materials; services;
materials in process; supplies in storage; maintenance operations; data or records; and administrative procedures.
Although ISO TR 8550-1:2007 is written principally in terms of manufacture and production, this should be
interpreted liberally, as it is applicable to the selection of sampling systems, schemes and plans for all types of
products and processes as defined in ISO 9000.
20) ISO/TR 8550-2, Guidance on the selection and usage of acceptance sampling
systems for
inspection of discrete items in lots -- Part 2: Sampling by attributes
ISO/TR 8550-2:2007 provides guidance for acceptance sampling of products that are supplied in lots and that can
be classified as consisting of discrete items (i.e. discrete articles of product). Each item in a lot can be identified
and segregated from the other items in the lot and has an equal chance of being included in the sample. Each item
of product is countable and has specific characteristics that are measurable or classifiable as being conforming or
nonconforming (to a given specification). Standards on acceptance sampling by attributes are applicable to a wide
variety of inspection situations. These include, but are not limited to, the following: end items, such as complete
products or sub-assemblies; components and raw materials; services; materials in process; supplies in storage;
maintenance operations; data or records; administrative procedures. Although ISO/TR 8550-2:2007 is written
principally in terms of manufacture and production, it is applicable to the selection of sampling systems, schemes
and plans for all types of product and processes as defined in ISO 9000.
15
21) ISO/TR 8550-3:2007, Guidance on the selection and usage of acceptance sampling
systems for inspection of discrete items in lots -- Part 3: Sampling by variables
ISO/TR 8550-3:2007 provides guidance for acceptance sampling of products that are supplied in lots and that can
be classified as consisting of discrete items (i.e. discrete articles of product). Each item in a lot can be identified
and segregated from the other items in the lot and has an equal chance of being included in the sample. Each item
of product is countable and has specific characteristics that are measurable on a continuous scale. Each
characteristic has, at least to a good approximation, a normal distribution or a distribution that can be transformed
so that it closely resembles a normal distribution. Standards on acceptance sampling by variables are applicable to
a wide variety of inspection situations. These include, but are not limited to, the following: end items, such as
complete products or sub-assemblies; components and raw materials; services; materials in process; supplies in
storage; maintenance operations; data or records; administrative procedures. Although ISO/TR 8550-3:2007 is
written principally in terms of manufacture and production, it should be interpreted liberally as it is applicable to
the selection of sampling systems, schemes and plans for all types of product and processes as defined in ISO
9000.
22) ISO 13448-1:2005, Acceptance sampling procedures based on the allocation of
priorities
principle (APP) -- Part 1: Guidelines for the APP approach
ISO 13448-1:2005 provides guidelines specifying the organizational principles of acceptance sampling in
situations where the contract or the legislation provides for successive inspection to be carried out by different
parties: the supplier, the customer and/or a third party. These guidelines are designed for inspection of populations
of any product supplied or delivered in discrete items in lots. They are applicable to supplier inspection (final
inspection, product certification upon supplier's request), customer inspection (incoming inspection, audit
inspection, acceptance sampling), and third-party inspection (certification of product, inspection and supervision
for observance of International Standard requirements, quality inspection carried out at the supplier, and/or
customer, request), where the quality levels and the lot acceptability criteria are specified unilaterally by the
supplier or contractually by the supplier and the customer. These guidelines are also applicable to situations when
only one sampling inspection is actually needed. The guidelines provided can be applied in developing standards
on acceptance sampling for standard inspection models, specific items or quality levels, as well as in developing
contracts, specifications and instructions. In contractual use of the APP, the parties concerned should acknowledge
in the contract that they approve of its principles (also by referring to the present guidelines). The parties may also
provide for the use of the APP in disputes and arbitration.
23) ISO 13448-2:2004, Acceptance sampling procedures based on the allocation of
priorities
principle (APP) -- Part 2: Coordinated single sampling plans for acceptance sampling by
attributes
ISO 13448-2:2004 provides attributes sampling procedures and single sampling plans for successive independent
inspections of the same lot conducted by the supplier, consumer and/or a third party. ISO 13448-2:2004 addresses
supplier inspection (final inspection, product certification upon supplier's request), consumer inspection (incoming
inspection, surveillance, acceptance sampling), and third party inspection. ISO 13448-2:2004 may also be
applicable when only one inspection is needed. A catalogue of single sampling plans is given, indexed by the
normative quality limits (NQLs). ISO 13448-2:2004 provides sampling procedures for finished product,
components and discrete items, operations; discrete items and the processes that produce them, and data and
records. Attributes sampling procedures are provided for inspection of an isolated lot or a continuing series of lots
of a discrete product. These procedures are applicable when a normative quality limit (NQL) is given expressed in
terms of percent nonconforming or nonconformities per 100 items. ISO 13448-2:2004 provides a co-ordinated
system of supplier, consumer and third party acceptance sampling procedures. It is also applicable to the case
where a supplier individually, or on agreement with a consumer, in a contract, specifies a lot quality criterion
expressed in terms of an NQL. In either case, it provides a coherent methodology for designating lots as
satisfactory or unsatisfactory for shipment and proposed use.
24) ISO 14560:2004, Acceptance sampling procedures by attributes -- Specified quality
levels in nonconforming items per million
ISO 14560:2004 specifies, for quality levels expressed as nonconforming items per million items, procedures for
estimating the quality level of a single entity (e.g. a lot) and, when the production process is in statistical control,
for estimating the process quality level based on evidence from several samples. Procedures are also specified for
using this information when selecting a suitable sampling plan so as to verify that the quality level of a given lot
does not exceed a stated limiting quality level (LQL). For the case where no prior sample data is available,
guidance is given for presuming a process quality level in selecting a plan.
16
25) ISO 18414:2006, Acceptance sampling procedures by attributes -- Accept-zero
sampling
system based on credit principle for controlling outgoing quality
ISO 18414:2006 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. ISO 18414:2006 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. ISO 18414:2006 can be suitable for
regulatory purposes, as control of the expected quality of items reaching the market-place is achieved with the
smallest possible sample sizes, and long-term control of the realized, or actual quality level in the market-place is
achieved with certainty, regardless of how long or short individual suppliers' series may be. ISO 18414:2006 can
be used by suppliers/producers, buyers/consumers and regulatory agencies to provide control of the expected
quality of the totality of accepted product of each type from each source.
26) ISO 21247:2005, Combined accept-zero sampling systems and process control
procedures for product acceptance
ISO 21247:2005 provides a set of accept-zero sampling systems and procedures for planning and conducting
inspections to assess quality and conformance to specified requirements. In addition, ISO 21247:2005 provides
requirements for alternative acceptance methods proposed by the supplier. Such alternative methods would be
based upon establishing and implementing an internal prevention-based quality management system as a means of
ensuring that all products conform to requirements specified by the contract and associated specifications and
standards. ISO 21247:2005, when cited in contract, is applicable to the supplier and extends to subcontractors or
vendors. The quality plans are to be applied as specified in the contract documents, and deliverables may be
submitted for acceptance if the requirements of ISO 21247:2005 have been met. Sampling systems and procedures
in ISO 21247:2005 are applicable, when appropriate, to assess conformance to requirements of end items;
components or basic materials; operations or services; materials in process; supplies in storage; maintenance
operations; data or records; administrative procedures. The sampling systems and procedures of ISO 21247:2005
are not intended for use with destructive tests or where product screening is not feasible or desirable. In such cases,
the sampling systems to be used will be specified in the contract or product specifications.
27) ISO/DIS 24153, Random sampling and randomization procedures
28) ISO/CD 28801, Sampling by attributes -- Double sampling plans with minimal
sample
sizes indexed by producer's risk quality (PRQ) and consumer's risk quality (CRQ)
29) ISO 3534-2:1993: Statistics Vocabulary and symbols Part 2