AS/NZS ISO 8402:1 994

Australian/New Zealand Standard

Quality management and quality

assurance—Vocabulary
AS/NZS ISO 8402:1994
This Joint Australian/New Zealand S tandard was prepared by Joint Technical
Committee QR/7, Quality Terminology. It was approved on behalf of the Council of
Standards Australia on 1 August 1 994 and on behalf of the Council of Standards
New Zealand on 1 August 1 994. It was published on 19 S eptember 1994.

The following interests are represented on Committee QR/7:

Australian B ankers Association

Australian Electrical & Electronic Manufacturers Association
Australian Information Industry Association
Australian Organization for Quality
Australian Quality Council
Bureau of S teel Manufacturers of Australia
CS IRO, Division of Mathematics and Statistics (Australia)
Department of Defence (Australia)
Department of Primary Industries & Energy (Australia)
Department of Transport & Communications (Australia)
Electricity Supply Association of Australia
Institution of Engineers Australia
Institution of Radio and Electronic Engineers Australia
Printing and Allied Trades Employers Federation of Australia
Quality S ociety of Australasia
Standards New Zealand
Telecom Australia

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Zealand Standards are subj ect to periodic review and are kept up to date by the issue
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This Standard was issued in draft form for comment as DR 92059.

 AS/NZS ISO 8402:1 994

Australian/New Zealand Standard

Quality management and quality

assurance—Vocabulary

First publi shed in Australia as AS 1 057—1971 .

Second editi on 1982.
Third editi on 1985.
First publi shed in New Zealand as NZS 5604:1 987.
Jointl y revised and redesignated in part as Joint Standard
AS/NZS ISO 8402:1 994.

PUBLI SHED JOINTLY BY:

STANDARDS AUSTRALI A
1 The Crescen t,
Homebush NSW 21 40 Au stral ia
STANDARDS NEW ZEALAND
Le vel 1 0, Stan dards Hou se,
1 5 5 Th e Terrace,
Wel li n gton 600 1 New Zeal an d
ISBN 0 7262 921 4 1
AS/N ZS I SO 8402:1 994 ii

PREFACE
This S tandard was prepared by the Joint S tandards Australia/ S tandards New Zealand Committee
QR/7 on Quality Terminology to supersede NZS 5604: 1 987 and AS 1057-1 985, which have been
withdrawn.
This S tandard is identical with and has been reproduced from ISO 8402, Quality management and
quality assurance—Vocabulary; however, non-English text has been deleted. Committee QR/7
provided input to the International Committee, ISO/TC 1 76, in the preparation of the International
Standard. It is issued as a Joint S tandard under the terms of the Active Cooperation Agreement
between S tandards Australia and S tandards New Zealand.
At the time of publication, Committee QR/7 is preparing an Australian supplement to incorporate
relevant terms which were defined in the superseded AS 1 057 and are referenced in current
Australian S tandards, but are not included in AS/NZS IS O 8402.
For the purpose of this S tandard, the IS O text should be modified as follows:
(a) Terminology The words ‘ this Australian S tandard’ , ‘this New Zealand S tandard’ or ‘this Joint
Australian/New Zealand S tandard’ should replace the words ‘ this International S tandard’ ,
wherever they appear.
(b) References The references to IS O/IEC Guide 2 should be replaced by reference to S tandards
Australia/S tandards New Zealand Handbook S AA/SNZ HB 1 8.2, Guidelines for third-party
certification and accreditation, Guide 2— General terms and their definitions concerning
standardization and related activities .
(c) Bibliographical references Annex A provides references to other documents for information
and guidance only.

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 ii i AS/N ZS I SO 8402:1 994

CON TEN TS

Pag e
Sco pe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Te rms and d efin i ti ons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Secti on 1 : Gen eral terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Secti on 2 : Terms rel ated to qu al i ty . . . . . . . . . . . . . . . . . . . . . . . . . 3
Secti on 3 : Terms rel ated to th e qu ali ty system . . . . . . . . . . . . . . . . . 6
Secti on 4: Terms rel ated to to ol s and tech ni q ue s . . . . . . . . . . . . . . . 9
An n ex A Bibl io g raph y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Al pha betic al i n de x . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
AS/N ZS I SO 8402:1 994 iv

Foreword

ISO (the International Organization for Standardization) is a worldwi de

federation of national standards bodies (ISO m ember bodies). The work
of preparing International Standards is norm ally carried out through ISO
technical comm ittees. E ach member body interested in a subject for
which a technical comm ittee has been established has the right to be
represented on that comm ittee. International organizations, governmental
and nongovernmental, in liaison wi th ISO , also take part in the work. ISO
collaborates closely wi th the International E lectrotechnical Comm ission
(IEC ) on all m atters of electrotechnical standardization.
Draft International Standards adopted by the technical commi ttees are
circulated to the m ember bodies for voting. Pu blication as an
International Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard ISO 8402 was prepared by Technical Commi ttee
ISO/TC 1 76, Quality management and quality assurance, Subcomm ittee
SC 1 , Concepts and termi nology .
This second edition cancels and replaces the first edition
(ISO 8402:1 986), which has been revised and substantially extended.
Annex A of this International Standard is for information only.
 v AS/N ZS I SO 8402:1 994

Introdu ction
Many ordinary words, in everyday use, are used in the quality field in a
specific or restricted m anner compared with the full range of dictionary
definitions, due to such reasons as:
— the adoption of quality term inology by different sectors of business
and industry to suit their specific perceived needs,
— the introduction of a multiplicity of terms by quality professionals in
different industrial and economi c sectors.
The intent of this International Standard is to clarify and standardize the
quality terms as they apply to the field of quality management. These
term s and definitions are discussed and grouped together in the text
according to logical topics. They are also regrouped in an alphabetical
index at the end for convenience.
The word quality (2.1 ) in popular usage often means different things to
different people. In this International Standard quali ty is defined as the
totali ty of characteri sti cs of an entity that bear on its abili ty to
satisfy stated and i mpl ied needs.

There are many different usages of the word quality. These different
usages create considerable confusion and m isunderstanding. Two such
usages are ”conformance to requirements” and ”degree of excellence”.
”Conform ance to requirements” leads people to argue that ”quality costs
less”, which in some cases it does. Conversely, ”degree of excellence”
im plies that ”quality costs more”, which in some cases it does. In order to
resolve some of the confusion in the usage of the word quality, another
term grade (2.2) can be used to describe the degree of excellence. The
term grade is used, when needed, to describe the sense of technical
excellence. Grade reflects a planned or recognized difference in the
requirements for quality. Although the different categories of grade do not
necessarily stand in rank order relationship to each other, grade
indicators can readily be used in a rank order sense to describe the
sense of technical excellence. An example of this usage is that it costs
more to provide and run a five-star hotel than a boarding house.
The term product (1 .4) is used throughout this International Standard. It
is the result of acti vities or processes and can be tangible or
intangible, or a combination thereof. In current ISO quality management
standardization, products are classified in four generic product
categories:
— hardware (e.g. parts, components, assemblies),
— software (e.g. computer programs, procedures, information, data,
records),
— processed m aterials (e.g. raw m aterials, liquids, solids, gases,
sheets, wires),
— services (e.g. insurance, banking, transport).
It is recognized that products generally involve combinations of these
generic product categories. The terms and concepts presented in this
International Standard are intended to be applicable to any product.
AS/NZS I SO 8402:1 994 vi

In this International Standard, the term entity (1 .1 ) includes the term

product, but extends further to cover, for example, activity, process
(1 .2), organization (1 .7) or person.
Confusion has arisen in understanding the terms quality control (3.4),
quality assurance (3.5), quality management (3.2) and total quality
management (3.7). This International Standard is intended to clarify
these concepts.
In sim plified terms, quality control concerns the operational means to
fulfil the quality requirements, while quality assurance aim s at
providing confidence in this fulfilment, both within the organization and
externally to customers (1 .9) and authorities. Within International
Standards, the E nglish term s ”ensure” and ”assure” are used in the
following sense: ”ensure” means to make sure or certain, ”assure” m eans
to give confidence to oneself or to others.
Quality management includes both quality control and quality
assurance , as well as the additional concepts of quality policy (3.1 ),
quality planning (3.3) and quality improvement (3.8). Quality
management operates throughout the quality system (3.6). These
concepts can be extended to all parts of an organization.
Total quality management brings to these concepts a long-term global
management strategy and the participation of all m embers of the
organization for the benefit of the organization itself, its members, its
customers and society as a whole.
Al l concepts addressed in this International Standard have both
economic and tim e im plications. This should be recognized in the
interpretation of all definitions in this International Standard even though
it has not been explicitly stated in each definition.
The distinction m ade in this International Standard between the terms
defect (2.1 1 ) and nonconformity (2.1 0) is crucial as it has legal
connotations, particularly those associated wi th product liability (2.1 2)
issues. Consequently, the term defect should be used with extreme care.
The term s defined in this International Standard have direct application to
the International Standards on quality given in annex A.
Other pertinent standards are listed in annex A. Special attention should
be paid to vocabulary standards in the statistics field: parts 1 to 3 of
ISO 3534.
 1 AS/NZS ISO 8402:1 994

AUSTRALI AN/NEW ZEALAND STANDARD

Quality management and quality assurance—
Vocabulary

Scope Section 1 : 1 .3
General terms procedure
This International Standard specified way to perform an
defines the fundamental terms activity
relating to quality concepts, as
they apply to all areas, for the 1 .1 NOTES
pr epa rat i o n an d u s e of
quality-related standards and entity 1 In many cases, procedures are
for m utual understanding in item documented [e.g . quali ty system
international comm unications. (3.6) procedures ] .
that which can be individually
described and considered 2 Wh e n a p r o ce d u re i s
documented, the term ”wri tten
Terms and definitions NOTE — An entity may be, for pro ced u re ” o r ” d o cu m e n t e d
example: procedure ” i s frequently used.
In the following definitions, the
te rm s ap pe ar i n g i n th e — an activity or a process (1 .2), 3 A wri tt en or d ocum ente d
alphabetical index are in procedure usual ly contai ns the
semi -bold type. Within each — a product (1 .4), purposes and scope of an acti vity;
definition, reference is made to what shall be done and by whom;
the number where they are when, where and how i t shall be
— an organization (1 .7), a done; what m aterials, equipment
defined. system or a person, or and documents shall be used; and
The num bered term s and how it shall be controlled and
— any combination thereof. record ed.
definitions are classified under
the following m ain headings:
— general terms;
1 .2 1 .4
— term s related to quality; process product
result of activities or processes
— term s related to the quality set of inter-related resources (1 .2)
system; and activities which transform
— term s related to tools and inputs into outputs NOTES
techniques. NOTE—Resources m ay i ncl ude 1 A product may in clude service
pe rs on ne l , f i n an ce , f aci l i t i e s, ( 1 . 5 ) , h ar d w a r e , p r o ce s s e d
e q u i p m e n t , t e ch n i q u e s an d m a t e r i a l s , s o f t wa r e o r a
meth ods. combin ation thereof.

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AS/N ZS I SO 8402:1 994 2

2 A product can be tangi ble (e. g. 1 .8 1 .1 2

assembli es or processed m aterials) organi zational structure contractor
or in tangible (e.g . knowledge or
con cept s) , or a co m bi n ati o n responsibilities, authorities and supplier (1 .1 0) in a contractual
th ereof. relationships, arranged in a situation
pattern, through which an
3 A product can be ei th er organi zation (1 .7) perform s its NOTES
i n te nd ed [ e. g . o ff e ri ng t o functions
custom ers ( 1 . 9) ] or uni ntended 1 The contractor is sometimes
(e.g . pollu tant or unwanted effects). 1 .9 referred to as the ” business first
custom er party”.
recipient of a product (1 .4)
1 .5 provided by the supplier (1 .1 0) 2 In French, the ”titulaire du
con trat ” i s som eti m es cal l ed
service ”contractant”.
result generated by activities at NOTES
the interface between the sup- 1 .1 3
pli er (1 .1 0) and the custom er 1 In a contractual situati on, th e
(1 .9) and by supplier internal custom er (1 .9) i s call ed the subcontractor
activities to meet the custom er ” pu rchaser ” (1 . 1 1 ). organization (1 .7) that provides
needs a product (1 .4) to the supplier
2 The custom er m ay be, for (1 .1 0)
NOTES example, th e ulti mate consumer,
user, benefi ci ary or purchaser . NOTES
1 The suppli er or th e custom er
may be represented at the in terface 3 The custo mer can be ei th er 1 In English, the subcontractor may
by personnel or equi pment. ext er n al o r i nt e rn al t o th e also be called ”subsupplier”.
organi zati on.
2 Cu st om er acti vi ti es at th e 2 In French, the ” sous-contractant”
in terface wi th th e suppl ier m ay be may also be called, as appropriate,
essential to the servi ce deli very 1 .1 0 ”s ou s - t ra i t a n t” o r ” s o u s -
(1 .6). commandier”.
supplier
organization (1 .7) that provides
3 Delivery or use of tangible a product (1 .4) to the customer
products ( 1 . 4) may form part of th e
service d el ivery .
(1 .9)

4 A servi ce may be li nked with the NOTES

manufacture and supply of tangi bl e
product . 1 In a contractual situation, the
supplier may be called the ”con-
tractor” (1 .1 2).

1 .6 2 The supplier may be, for ex-

service del ivery ample, the producer, distributor,
those suppli er (1 .1 0) activities im porter, assembl er or servi ce
necessary to provi de the organization.
service (1 .5)
3 The supplier can be either
1 .7 e xt e r nal o r i n te r n al to t he
organization .
organi zation
company, corporation, firm , 1 .1 1
enterprise or institution, or part
thereof, whether incorporated or purchaser
not, public or private, that has customer (1 .9) in a contractual
i ts o wn f un c ti on s an d situation
admi nistration
NOTE—The purchaser is some-
NOTE—The above defi ni ti on is times referred to as the ”business
vali d for th e purposes of quali ty second party”.
standards. The term ”organi zati on”
is defin ed differently in I SO/I EC
Guide 2.

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 3 AS/N ZS I SO 8402:1 994

Section 2: b) ” qu al it y level” in a quanti tati ve 2.3

sense (as used i n acceptance requirem ents for quali ty
Terms related to sampli ng) and ” q uali ty measure”
where precise technical evaluations expression of the needs or their
q uality translation into a set of
are carried out.
quantitatively or qualitatively
stated requirements for the
5 The achi evement of sati sfactory characteristics of an entity
qual it y i nvolves all stages of the
qual it y l oop (4. 1 ) as a whole. The
(1 .1 ) to enable its realization
contri buti ons to qu al it y of these and examination
2.1 vari ous stages are someti mes
quality identi fi ed separately for emphasi s; NOTES
totality of characteristics of an for exampl e, q u al it y due to
defi ni ti on of needs, qual it y due to 1 It is cru cia l that the
entity (1 .1 ) that bear on its product (1 .4) desig n, qu al it y due
ability to satisfy stated and requ irem ents fo r qual it y fu ll y
to conformance, qu al it y due to refl ect th e stated and i mpli ed needs
im plied needs product support throughout i ts of th e custo mer (1 . 9) .
li feti me.
NOTES 2 The term ”requi rements” covers
6 In some references, qual it y i s market-based and contractu al as
1 In a contractual environment, or referred to as ”fitness for use” or well as an organi zati on’s (1 . 7)
in a regulated environment, such as ”fitness for purpose” or ” custom er in tern al requi rements. They m ay be
(1 .9) sati sfacti on” or ”conformance developed, detail ed and updated at
th e nuclear safety (2.8) field, needs di fferent planni ng stages.
are specified, whereas in oth er to t he requ i rem ents ”. Thes e
envi ronments, i mpli ed needs should represent only cert ai n facets of
qual it y, as defin ed above. 3 Qu ant itativ ely s tated
be i dentified and defin ed.
requirements for the characteri stics
in clu de, for i nstance, nomi nal
2 In many in stances, needs can valu es, rated val ues, l im i ti ng
change wi th tim e; thi s im plies a 2. 2 devi ations and tolerances.
peri odic revi ew of requi rements grade
fo r q uali ty (2. 3) .
4 The requ irem ents fo r q uali ty
category or rank gi ven to enti ti es should be expressed i n fu ncti onal
3 Needs are usually translated (1 .1 ) havin g the same functional term s and documented.
in to characteri stics wi th specified use but different requ irem ents fo r
criteria [see requi rement s f or qual it y (2. 3)
qu al it y (2.3)] . N eeds may i nclu de,
fo r e x am p l e, a sp ec t s o f
p e rf or m an c e , u s a bi l i t y , NOTES 2.4
dependabil it y (2. 5) (avail abil ity, requirem ents of society
reli abil ity, m ai ntai nabi li ty), safety, 1 Grade refl ects a planned or obligations resulting from laws,
envi ronment [see requi rements of re co g ni z e d d i f fe re n ce i n reg ul ati on s, ru les, co des,
soci ety (2.4)] , economi cs and requ irem ents fo r qu al it y. The
aestheti cs. s tat ute s a nd o th er
emphasis i s on th e fu ncti onal use considerations
and cost relationshi p.
4 The term ” q uali ty” should not NOTES
be used as a sin gl e term to express 2 A hi gh-g rade ent it y (e. g. a
a degree of excell ence in a l u xu ri ou s ho te l ) can b e of
comparative sense, nor shoul d i t be unsati sfactory qu al it y (2.1 ) and 1 ”Oth er considerations” in clude
used in a quantitative sense for vi ce versa. n o t a b l y p r o t e ct i o n o f t h e
techni cal evaluations. To express envi ronment, heal th , safety (2.8),
these m eani ngs, a qual ifyi ng securi ty, conservati on of energ y
adjective should be used. For 3 Wh ere g ra d e i s den ote d and natu ral resources.
example, use can be made of th e numeri call y, the hig hest g rade i s
foll owin g terms: usuall y designated as 1 , wi th th e 2 Al l requi rements of soci ety
lower g rades extendin g to 2, 3, 4, should be taken in to account when
etc. Where grade i s denoted by a defi ni ng the requ irem ents fo r
a) ”rel ative q uali ty” where ent it ies point score, such as a number of qual it y (2. 3) .
are ranked on a rel ative basi s in stars, the l owest grade usual ly has
th e degree of excell ence or th e l east poi nts or stars.
comparative sense [not to be 3 Re q u i rem en t s of s oc i et y
confused with grade (2.2)] ; in clude j urisdi ctional and regulatory
requirements. These m ay vary from
one ju ri sdicti on to another.

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AS/N ZS I SO 8402:1 994 4

2.5 2.8 2.1 2

dependabili ty safety product l iabili ty
collective term used to describe state in which the risk of harm
the availability perform ance and (to persons) or damage is lim - generic term used to describe
its influencing factors: reliability ited to an acceptable level the onus on a producer or
perform ance, m ai ntainabi lity others to make restitution for
performance and maintenance- loss related to personal injury,
support perform ance NOTES
property damage or other harm
caused by a product (1 .4)
NOTES 1 Safety i s one of the aspects of
qual it y (2. 1 ) .
NOTE—The l egal and fin ancial
1 Dependabil it y is used only for im pl ications of produ ct l iabi li ty
g en eral d e s cr i pt i on s i n 2 The above defi ni ti on i s vali d for may vary from one juri sdicti on to
non-quanti tati ve term s. th e purposes of quality standards. another.
The term ”safety” i s defin ed
2 Dependabil it y is one of th e di fferentl y in ISO/IEC Guide 2.
ti me-rel ated aspects of qu al it y
(2.1 ). 2.1 3
qualificati on process
3 The defin ition of d ependabi li ty 2.9
and note 1 gi ven above are taken
pro cess of d e m on strati ng
conform i ty whether an entity (1 .1 ) is
from I EC 50(1 91 ) , whi ch also fu l fi l m e n t o f s pe cif i ed
i n cl u d e s r e l at ed t e r m s an d capable of fulfilling specified
defi ni ti ons.
requirements requirements

NOTE—The above defi ni ti on is NOTE—The term ”q uali fi cati on” is

vali d for th e purposes of quali ty someti mes used to desi gnate th is
standards. The term ”conformi ty” i s process (1 . 2) .
2.6 d e fi ne d d i ff er e ntl y i n
com patibili ty ISO/IE C Gui de 2.
ability of entities
(1 .1 ) to be
used together under specific 2.1 4
conditions to fulfil relevant qualified
requirements 2.1 0
status given to an entity (1 .1 )
nonconform i ty when the capability of fulfilling
NOTE—The above defi ni ti on is nonfulfilm ent of a specified specified requirem ents has
vali d for th e purposes of quali ty requirement been demonstrated
standards. The term ”compati bi li ty”
i s d e fi ne d d if f ere n tly i n
ISO/IEC G ui de 2. NOTE—The defi ni ti on covers the
depart ure or absence of one or 2.1 5
more qu al it y ( 2. 1 ) characteri stics
[i ncl u di ng d epen d abi l i t y (2 . 5) inspection
2.7 characteri stics], or qu al it y system activity such as m easuring,
interchangeabi lity (3. 6) el ements from specifi ed examining, testing or gauging
requirements. one or more characteristics of
ability of an enti ty (1 .1 ) to be
used in place of another, an enti ty (1 .1 ) and comparing
wi thout m odification, to fulfil the the results with specified
same requirements 2.1 1
requi rem en ts in order to
establish whether conform ity
defect (2.9) is achieved for each
NOTES
nonfulfilm ent of an intended characteristic
1 A qualifier such as ”functional
u s ag e re qu i re m e nt or
interchangeability” or ”dimensional re a s o n ab l e ex pe c ta ti on , NOTES
interchangeability” should be used including one concerned wi th
depending on specific circumstances safety (2.8)
1 In French, th e term ”i nspection”
may designate an activity of qu al it y
2 The above defi ni ti on i s vali d for NOTE—The expectation must be survei ll ance (4.7) carried out
th e purposes of qual ity standards. reasonable under the exi stin g wi th in the framework of a defi ned
The term ”interchangeabi li ty” is ci rcumstances. assignment.
defin ed di fferentl y i n I SO/IEC
Guide 2.

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 5 AS/N ZS I SO 8402:1 994

2 The above defi ni ti on i s vali d for 2 Va l i d a ti on i s n o rm a l l y

th e purposes of qual it y standard s. perf ormed on the fi nal produ ct
The term ”i nspection” i s defi ned under defin ed operati ng condi ti ons.
di fferentl y in ISO/IE C Guide 2. It m ay be necessary in earli er
stages.

3 The term ” vali dated ” i s used to

desi gnate th e correspondi ng status.
2.1 6
sel f-i nspection 4 Mu ltiple val id atio ns m ay be
inspection (2.1 5) of the work carried out if there are di fferent
by the perform er of that work, in tended uses.
according to specified rules

N O TE —T he r es ul ts o f se l f-
in specti on may be used for 2.1 9
process ( 1 . 2) control .
objective evidence
inform ation which can be
proved true, based on facts
obtained through observation,
2.1 7 measurement, test or other
verifi cation means
confirmation by examination
and provision of objecti ve
evi dence (2.1 9) that specified
requirements have been fulfilled

NOTES

1 In desig n and devel opment,

veri fi cati on concerns the process
(1 .2) of examin in g th e resul t of a
g i ve n ac t i vi t y t o de t e r m i n e
conformi ty (2.9) wit h th e stated
requirements for th at activity.

2 The term ” verif ied ” is used to

desi gnate th e correspondi ng status.

2.1 8
val idation
confirmation by examination
and provision of objecti ve
evi de nce (2. 1 9) that th e
particular requirements for a
specific intended use are
fulfilled

NOTES

1 In desig n and devel opment,

vali dati on concerns the process
(1 .2) of exami ni ng a produ ct (1 .4)
to determ in e conformi ty ( 2. 9) wi th
user needs.

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AS/NZS I SO 8402:1 994 6

Section 3: 3.3 NOTES

Terms related to quality planning
activities that establish the 1 There are both i nternal and
the quality system objectives and requirements external purposes for quali ty
for quality (2.3) and for the assurance :
application of quality system
(3.6) elements. a) in ternal qual ity assurance :
wit hi n an organization ( 1 . 7) ,
q u al i t y assu ran ce p r o vi d es
NOTE—Quali ty planning covers: confidence to the management;
3.1
quality policy a) pr o d u c t ( 1 . 4 ) p l an n i n g : b) extern al quali ty assurance : i n
i d e n t i f y i n g , cl a s s i f y i n g a n d contractual or other sit uati ons,
overall intentions and direction weig htin g the characteristi cs for q u al i t y assu ran ce p r o vi d es
of an organization (1 .7) wi th quality (2.1 ) as wel l as establ ishi ng confidence to th e customers (1 .9)
regard to quality (2.1 ), as th e objectives, requirements for or others.
form ally expressed by top quality and constrai nts;
management 2 Some quality control (3 .4) and
b) m anageri al and operati onal quality assurance acti ons are
NOTE—The quali ty poli cy form s pl anni ng: preparin g the appli cati on in terr el ated.
one el em ent of the corporate poli cy of th e quality system i nclu di ng
an d i s au t h o ri z ed by top organi zi ng and schedul in g;
3 U nl e s s req u i rem en t s f o r
management. quality ( 2. 3) ful ly reflect th e needs
c) th e preparati on of quali ty plans of the user, quality assurance may
(3.1 3) and the maki ng of provisions not provi de adequate confidence.
for quali ty i mprovement (3.8).
3.2
quality management
all activities of the overall 3.4
m anag em e nt functio n th at 3.6
determ ine the quality policy quality control quality system
( 3 . 1 ) , o b j e c ti ve s a n d operational techniques and
responsibilities; and implement activities that are used to fulfil organizational structure (1 .8),
them by means such as quality requirements for quality (2.3) procedures (1 .3), processes
(1 .2) and resources needed to
planning (3.3), quality control imple men t q ua li t y
(3.4), quality assurance (3.5) NOTES management (3.2)
and quality improvement (3.8)
wi thin the quality system (3.6). 1 Q u al i t y co n t ro l i n vo l ve s
o p e r at i o n al t e c h n i q u e s a n d
acti vi ti es ai med both at moni tori ng NOTES
NOTES a process ( 1 . 2) and at el im in atin g
c a u s e s of u n s a t i sf ac to r y 1 The quality system should be
perf ormance at al l stages of the as comprehensive as needed to
1 Quality management is th e quality l oop ( 4. 1 ) i n order to meet th e quali ty (2.1 ) objectives.
responsi bi li ty of all l evel s of achi eve economi c effectiveness.
management but m ust be l ed by top
management. It s im pl em entati on 2 The quali ty system of an
in vol ves al l mem bers of the 2 Some quali ty control and organizati on is desi gned pri mari ly
organizati on ( 1 . 7) . quality assurance ( 3. 5) acti ons are to sati sfy th e i nternal manageri al
in terr el ated. needs of the organizati on (1 .7). I t
is broader th an th e requi rements of
2 I n q u al i t y m an ag em en t , a part icul ar customer (1 .9), who
consideration is gi ven to economi c eval uates only th e relevant part of
aspects. 3.5 th e quality system .
quality assurance
all the planned and systematic 3 For contractu al or m andatory
activities im plemented within q u a l i t y a s se s s m e n t ( 4 . 6 )
the quality system (3.6), and purposes, demonstration of the
demonstrated as needed, to im pl em entati on of identi fi ed quali ty
provide adequate confidence system elements may be requi red.
that an entity (1 .1 ) wi ll fulfil
requirements for quality (2.3)

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 7 AS/NZS ISO 8402:1 994
3.7 3.9 NOTE—A design review can be
total quality management management review conducted at any stage of the
desi gn process (1 .2), but should i n
management approach of an fo rm al e val uation by top any case be conducted at the
organization (1 .7), centred on management of the status and completi on of th is process .
quality (2.1 ), based on the ad eq uacy of the qu al i ty
participation of all its members system (3.6) in relation to
an d ai m in g at l ong - term qu ali ty poli cy (3. 1 ) and
success through customer objectives 3.1 2
(1 .9) satisfaction, and benefits quality manual
to al l m e m be rs of th e document stating the quality
organization and to society NOTES policy (3.1 ) and describing the
quality system (3.6) of an
NOTES organization (1 .7)
1 Management revi ew m ay
in clude revi ew of th e quality
1 Th e e x p r e s s i o n ” al l i t s poli cy. NOTES
members” desi gnates personnel i n
al l depart ments and at all levels of 1 A quality manual may relate to
th e organizati onal structure (1 . 8) . 2 Quality audit (4.9) results are
one of th e possi ble in puts to th e totali ty of an organizati on’s
management review. acti viti es or onl y to a part of i t. The
2 The strong and persistent ti tl e and scope of the m anual
leadership of top management and refl ects th e field of appli cati on.
th e education and train in g of all 3 The term ”top m anagement”
members of the organizati on are refers to the m anagement of th e
organizati on ( 1 . 7) whose quality 2 A quality manual wil l norm al ly
essential for th e success of thi s contai n or refer to, as a mi ni mum:
approach. system i s bei ng reviewed.
a) quality poli cy;
3 In total quality management ,
th e concept of quali ty relates to th e 3.1 0
achi evement of al l m anagerial contract review b) th e responsibil ities, authori ti es
objectives. and i nter-relationshi ps of personnel
systematic activities carried out who manage, perform , verify or
by the supplier before signing revi ew work affecti ng quality (2. 1 ) ;
4 The concept ”be nefi ts t o the contract to ensure that
soci et y” i m pl i e s, as nee ded,
fu lfil ment of the requirements of requirements for quality (2.3) c) the q ual i ty syst em (3. 6 )
society (2.4). are adequately defined, free procedures (1 .3) and i nstructi ons;
from ambiguity, documented
and can be realized by the d) a statement for revi ewin g,
5 Total quali ty management supplier (1 .1 0)
(TQM) or parts of it are sometim es upd ati n g and con trol l i ng t he
call ed ” total quali ty”, ” CWQC ” manual .
(company-wide quali ty control) , NOTES
” TQC ” (total quality control) and 3 A quali ty manual can vary in
so on. 1 The contract review i s th e depth and format to sui t th e needs
responsibi li ty of th e supplier but of an organi zati on . I t m ay
can be carried out j oi ntly with th e compri se more than one document.
customer (1 . 9) . Dependin g on the scope of the
manual , a quali fi er may be used,
3.8 2 A contract review may be
for example, ” quality assurance
quality improvement manual ”, ” quali ty management
repeated at different phases of the manual ”.
actions taken throughout the contract as needed.
organization (1 .7) to increase
the effectiveness and efficiency
of activities and processes 3.1 3
(1 .2) in order to provide added 3.1 1 quality plan
benefits to both th e design review
docum ent setting out the
or g a ni za ti on a n d i ts docum ented, com prehensive specific quality (2.1 ) practices,
customers (1 .9) and systematic examination of resources and sequence of
a design to evaluate its activities relevant to a particular
ca pab i l i ty t o f u l f i l t h e product (1 . 4), project or
requirements for quality (2.3), contract
identify problems, if any, and
propose the development of
solutions

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AS/N ZS I SO 8402:1 994 8

NOTES 3.1 6
traceability
1 A q uali ty pl an usuall y makes ability to trace the history,
reference to th e part s of the q uali ty application or location of an
manu al ( 3. 1 2) appl icable to th e
entity (1 .1 ) by means of
specific case.
recorded identifications
2 Dependin g on the scope of the
pl an, a qualifier may be used, for
exampl e, ” qual it y assurance plan ” NOTES
” qu al it y management pl an ”.
1 The term ” t raceabil it y” may
have one of th ree m ai n meanings:
3.1 4
specificati on a) in a product (1 .4) sense, it m ay
relate to
document stating requirements
— th e orig in of m aterials and
NOTES part s,

1 A quali fi er should be used to — th e product processing history,

in di cate the type of speci fi cati on ,
su ch a s ”p ro du c t ( 1 .4) — th e di stri buti on and l ocation of
sp eci f i c at i on ”, ”te st spe ci fi -
th e product after delivery;
cati on ”.
b) in a calibrati on sense, it rel ates
2 A speci fi cati on should refer to measurin g equi pment to nati onal or
or in clude drawin gs, patterns or in tern ational standards, prim ary
other relevant documents and standards, basi c physical constants
in di cate the m eans and the cri teri a o r p r o p er t i e s , o r r e f e re n ce
whereby conformi ty (2. 9) can be materi als;
checked.
c) in a data-collection sense, it
relates cal cul ati ons and data
generated th roughout th e q uali ty
3.1 5 lo op (4.1 ) someti mes back to the
requ irem ents fo r qu al it y (2.3) for
record
an enti ty.
docum ent w hi ch
furni shes
obj ective evidence (2.1 9) of 2 Al l aspects of traceabi li ty
activities performed or results requirements, i f any, should be
achieved clearl y speci fi ed, for exampl e, in
term s of peri ods of ti me, poi nt of
orig in or identi fi cati on.
NOTES

1 A qu al it y (2. 1 ) record provides

objective evid ence (2. 1 9) of th e
extent of th e fulfi lm ent of th e
requ irem ents for qu al it y (2. 3)
[e.g . product ( 1 . 4) q uali ty record ]
or th e eff ecti vene ss o f the
operation of a qu al it y system (3.6)
el ement (e. g. q uali t y system
record ) .

2 Some of the purposes of

qu al it y records are demonstration,
traceabi li ty (3. 1 6) and preventive
(4.1 3) and correcti ve acti ons
(4.1 4) .

3 A record can be written or

stored on any data m ediu m.

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 9 AS/NZS ISO 8402:1 994

Section 4: 4.4 3 An overall supplier (1 .1 0)

quali ty eval uation al so m ay
Terms related to model for quality assurance in clude an appraisal of fin ancial
tools and techniques standardized or selected set of
quality system (3.6) require-
and techni cal resources.
ments combined to satisfy the 4 In Engli sh, quali ty evaluation
quality assurance (3.5) needs i s som eti m es cal l ed ” qual i ty
of a given situation assessment ”, ” quali ty appraisal ”
4.1 or ” quality survey ” in specific
quality loop ci rcumstances.
conceptual model of interacting 4.5
activities that influence quality
(2.1 ) at the various stages degree of demonstration
ranging from the identification extent to which evidence is 4.7
of needs to the assessment of produced to provide confidence quality surveillance
whether these needs have been that specified requirements are con ti n u al m on i to r i n g an d
satisfied fulfilled verification (2.1 7) of the status
of an entity (1 .1 ) and analysis
NOTE—The quality spiral is a of records (3.1 5) to ensure that
si mi lar concept. NOTES specified requirem ents are
being fulfilled
1 . The degree of demonstrati on
may range from an affi rm ation of NOTES
4.2 existence to furni shin g detail ed
quality-related costs documents and objecti ve evidence 1 Quality surveil lance m ay be
(2.1 9) of fulfi lm ent. carried out by, or on behal f of, the
those costs incurred in ensuring customer (1 . 9) .
and assu ri n g sati sfacto ry
quality (2.1 ), as well as the 2. The extent depends on cri teri a
such as economi cs, compl exity, 2 Qu al i ty survei l l ance m ay
l os s es i n cu rre d wh e n i nn ovat i on, safety ( 2. 8) and
satisfactory quality is not in clude observi ng and m onitorin g
envi ronmental consi derati ons. controls whi ch can prevent the
achieved deteri oration or degradati on of an
enti ty [e. g. a process (1 .2)] with
ti me.
NOTES 4.6
quality evaluation 3 ”Conti nual” may m ean ei th er
1 Qual i ty-rel ated co sts ar e systematic examination of the constant or frequent.
classi fi ed wi th in an organizati on extent to which an entity (1 .1 )
(1 .7) accordi ng to its own cri teri a. is capable of fulfilling specified 4 In F re n ch , a q u a l i t y
requirements surveill ance acti vi ty carried out
2 Some l osses m ig ht be diffi cult wi th in the framework of a defi ned
to quanti fy but can be very as s i g n m e n t m ay b e cal l e d
si gnificant, such as l oss of goodwi ll . NOTES
”i nspection”.
1 A quality evaluati on m ay be
used to determi ne supplier (1 . 1 0)
quality (2.1 ) capabi li ty. In th is 4.8
4.3 cas e, de pend i ng on spe ci fi c hold point
quality losses ci rcumstances, the result of quality
losses caused by not realizing evaluati on m ay be used for point, defined in an appropriate
the potential of resources in qual i fi cati on (2. 1 3) , approval , document, beyond which an
r e g i s t r at i o n , ce r t i f i cat i o n o r activity m ust not proceed
processes (1 .2) and activities accreditation purposes. wi thout the approval of a
designated organization (1 .7)
2 An addi ti onal qualifier may be or authority
NOTE—Some examples of quality used wi th th e term ” quali ty
losses are the loss of customer evaluati on ” dependi ng on the
( 1 . 9 ) s a t i s f ac t i o n , l o s s o f NOTE—The approval to proceed
s cop e [ e . g . process ( 1 . 2 ) , beyond a hold point i s gi ven
opport unity to add m ore val ue to personnel, system], and ti mi ng (e. g.
th e customer, th e organizati on usuall y i n wri tten form, but i t may
pr econ tr act) o f t he ” q ual i ty be given by any other agreed
(1 .7) or society, as well as waste of evaluati on ” such as ”precontract
resources and m aterials. system of authori zati on.
process quality evaluation ”.

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AS/NZS I SO 8402:1 994 10

4.9 N O T E —A q u a l i t y a u d i t o r — ” correcti ve acti on ” relates to

quality audit desi gnated to m anage a quali ty th e eli mi nati on of the causes of a
audit is call ed a ” l ead quali ty ” nonconformity ”.
systematic and independent auditor ”.
e xam i nati on to d eterm in e
whether quality (2.1 ) activities
and related results comply with
planned arrangem ents and 4.1 2 4.1 5
whether these arrangements auditee disposition of nonconformity
are im plemented effectively and org ani zati on ( 1 . 7) bei n g
are su i t abl e t o ach i eve audited action to be taken to deal with
objectives an existi ng non conform i ng
entity (1 .1 ) in order to resolve
NOTES
the nonconformity (2.1 0)

1 The quali ty audit typi call y 4.1 3 NOTE—The acti on may take the
applies to, but is not li mi ted to, a preventive action form of, for example, correction
quality system (3. 6) or elements action taken to elimi nate the such as repair (4. 1 8) or rework
th ereof, to processes (1 .2), to (4.1 9) , regrade, scrap, concession
cau se s o f a p ote nti al (4. 1 7) and amendment of a
products (1 .4) or to services (1 .5). nonconformity (2.1 0), defect
Such audits are often called document or a requi rement.
” quality system audit ”, ” process
(2.1 1 ) or other undesirable
quality audit ”, ” product quality situation in order to prevent
audit ” or ”service quali ty audit ”. occurrence
4.1 6
2 Quality audits are carried out NOTE—The preventi ve actions production permit
b y s taf f n o t havi n g d i r e ct may involve changes, such as i n deviation permit
responsi bi li ty in the areas bein g procedures (1 .3) and systems, to
audi ted but, preferably, worki ng i n achi eve quali ty i mprovement (3.8) written authorization to depart
cooperati on with the rel evant at any stage of th e quality l oop from the originally specified
personnel. (4.1 ). requirements for a product
(1 .4) prior to its production
3 One purpose of a quali ty audit
is to evaluate the need for 4.1 4 NOTE—A producti on permi t i s for
im provement or corrective acti on a l im ited quanti ty or peri od and for
(4.1 4) . An audit should not be corrective action a specifi ed use.
confused with quali ty surveil lance action taken to elimi nate the
(4.7) or i nspection (2. 1 5) activities cau s e s o f a n e xi s ti n g
performed for the purposes of nonconformity (2.1 0), defect
process co nt rol or prod uct (2.1 1 ) or other undesirable 4.1 7
acceptance. situation in order to prevent waiver
recurrence concession
4 Q u a l i t y a u d i t s ca n b e
conducted for i nternal or external written authorization to use or
purposes. NOTES release a product (1 .4) which
does not conform to the
1 The correcti ve actions m ay specified requirements
in volve changes, such as i n
4.1 0 procedures (1 .3) and systems, to
quality audit observation achi eve quali ty i mprovement (3.8) NOTE—A waiver is li mi ted to the
at any stage of th e quality l oop shipment of a product th at has
statement of fact made during a (4.1 ). sp ec ific no n co nf orm i ng
q u al i t y a u d i t ( 4. 9) and ch aracte ri sti cs wi th i n spe ci f i c
substantiated by objective devi ations, for a li mi ted ti me or
evidence (2.1 9) 2 There is a disti ncti on between quanti ty.
” correcti on ” an d ” correcti ve
acti on ”:

4.1 1 — ” correcti on ” refers to repair

quality auditor (4.1 8) , rework (4. 1 9) or adjustm ent
and rel ates to th e dispositi on of
person qualified (2.1 4) to an exi sting nonconformity (4.1 5) ;
perform quality audits (4.9)

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 11 AS/N ZS I SO 8402:1 994

4.1 8
repair
actio n taken on a
nonconform ing product (1 .4)
so that it wi ll fulfil the intended
usage requirements although it
m ay not conform to the
originally specified requirements

NOTES

1 Re pai r i s on e ty pe of
di sposition of a nonconformi ng
product .

2 Repair i nclu des remedi al acti on

taken to restore, for usage, a once
conformi ng but now nonconform in g
product, for exam pl e, as part of
main tenance.

4.1 9
rework
action taken on a nonconfor-
mi ng product (1 .4) so that it
w i l l f u l f i l th e s p e ci fi e d
requirements

NOTE—Rework is one type of

di sposition of a nonconformi ng
product .

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AS/N ZS I SO 8402:1 994 12

Annex A ISO 9000-4:1 993, Quality mana- ISO 1 001 1 -3:1 991 , Guidelines for
gement and quality assurance au d iti ng q uali ty system s—
(informative) standards—Part 4: Guide to Part 3: Management of audit
d e p en d ab i l i ty p ro g ra m m e programmes.
management.
Bibl i ography ISO 1 001 2-1 :1 992, Quality assur-
ance requirements for measuring
ISO 9001 :1 994, Quality systems equipment—P art 1 : M etrological
ISO 3534-1 :1 993, Statistics—Vo- —Model for quality assurance in c o n f i r m a ti o n s y s t e m f o r
cabulary and symbols—Part 1 : design, development, production, measuring equipment.
Probability and general statistical installation and servicing .
terms .
ISO 9002:1 994, Quality systems
ISO 3534-2:1 993, Statistics—Vo- —Model for quality assurance in
cabulary and general symbols— production, installation and
Part 2: Statistical quality control. servicing .

ISO 9003:1 994, Quality systems

ISO 3534-3:1 985, Statistics—Vo- —Model for quality assurance in
cabulary and general symbols— final inspection and test.
Part 3: Design of experiments.
ISO 9004:1 987, Quality manage-
ISO/IEC Guide 2:1 991 , General ment and quality system ele-
terms and definitions concerning ments—Guidelines.
standardization and related
activities . ISO 9004-1 :1994, Quality manage-
ment and quali ty system ele-
IEC 50(1 91 ):1 990, International ments—Part 1 : Guidelin es.
El ectrotechnical Vocabulary—
Chapter 1 91 : Dependability and ISO 9004-2:1991, Quali ty mana-
quality of service . gement and quali ty system ele-
ments—Part 2: Guideli nes for
services .
ISO 9000:1 987, Quality manage-
ment and quality assurance ISO 9004-3:1993, Quality manage-
sta n d ar d s—G u i d e l i n e s for ment and quali ty system ele-
selection and use. ments—Part 3: Guideli nes for
processed materials .
I SO 90 0 0 -1 : 1 99 4, Q u ali ty
m a n ag em e n t an d q u a l i t y ISO 9004-4:1993, Quality manage-
assurance standards—Part 1 : ment and quali ty system ele-
Guidelines for selection and use. ments—Part 4: Guideli nes for
quali ty improvement.
I SO 90 0 0 -2: 1 99 3 , Q u ali ty
m a n ag em e n t an d q u a l i t y ISO 1 001 1 -1 :1 990, Guidelines for
assurance standards—Part 2: auditing quality systems—Part 1 :
Generic guidelines for the Auditing.
appl ication of I SO 9001 ,
ISO 9002 and ISO 9003. ISO 1 001 1 -2:1 991 , Guidelines for
auditing quality systems—Part 2:
I SO 90 0 0 -3 : 1 99 1 , Q u ali ty Qualification criteria for quality
m a n ag em e n t an d q u a l i t y systems auditors .
assurance standards—Part 3:
Guidelines for the application of
ISO 9001 to the development,
supply and maintenance of
software .

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 13 AS/N ZS I SO 8402:1 994

Alphabetical index

A E O
action, corrective 4.1 4 entity 1 .1 objective evidence 2.1 9
action, preventive 4.1 3 evaluation, quality 4.6 observation, quality audit 4.1 0
appraisal, quality 4.6 evidence, objective 2.1 9 organization 1 .7
assessment, quality 4.6 organizational structure 1 .8
assurance, model for quality 4.4
assurance, quality 3.5
audit, process quality 4.9 G
audit, product quality 4.9 P
audit, quality 4.9 grade 2.2
audit, quality system 4.9 party, business first 1 .1 2
audit, service quality 4.9 party, business second 1 .1 1
auditee 4.1 2 permit, deviation 4.1 6
auditor, lead quality 4.1 1 H
permit, production 4.1 6
auditor, quality 4.1 1 plan, quality 3.1 3
hold point 4.8
plan, quality assurance 3.1 3
B planning, quality 3.3
I point, hold 4.8
business first party 1 .1 2 policy, quality 3.1
business second party 1 .1 1 improvement, quality 3.8 preventive action 4.1 3
procedure 1 .3
inspection 2.1 5
process 1 .2
C inspection, self- 2.1 6 process, qualification 2.1 3
interchangeability 2.7 process quality audit 4.9
company-wide quality control 3.7 item 1 .1 process quality evaluation 4.6
compatibility 2.6
concession 4.1 7 product 1 .4
conformity 2.9 product liability 2.1 2
L product quality audit 4.9
contract review 3.1 0
contractor 1 .1 2 production permit 4.1 6
c o n tr o l , c o m p a n y - wi d e lead quality auditor 4.1 1 purchaser 1 .1 1
quality 3.7 liability, product 2.1 2
control, quality 3.4 loop, quality 4.1
control, total quality 3.7 losses, quality 4.3 Q
correction 4.1 4
corrective action 4.1 4 qualification 2.1 3
costs, quality-related 4.2 M
customer 1 .9 qualification process 2.1 3
CWQC 3.7 qualified 2.1 4
management, quality 3.2 quality 2.1
management, total quality 3.7 quality appraisal 4.6
D management review 3.9 quality assessment 4.6
manual, quality 3.1 2 quality assurance 3.5
defect 2.1 1 model for quality assurance 4.4 quality assurance manual 3.1 2
degree of demonstration 4.5 quality assurance, model for 4.4
delivery, service 1 .6 quality assurance plan 3.1 3
demonstration, degree of 4.5
dependability 2.5 N quality audit 4.9
design review 3.1 1 quality audit, process 4.9
deviation permit 4.1 6 nonconformity 2.1 0 quality audit, product 4.9
disposition of nonconformity 4.1 5 nonconformity, disposition of 4.1 5 quality audit, service 4.9

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AS/N ZS I SO 8402:1 994 14

quality audit observation 4.1 0 R survey, quality 4.6

quality auditor 4.1 1 system, quality 3.6
quality auditor, lead 4.1 1 record 3.1 5
quality control 3.4 repair 4.1 8
q u al i ty con tro l , co m pan y- requirements for quality 2.3
wide 3.7 T
quality control, total 3.7 requirements of society 2.4
quality evaluation 4.6 review, contract 3.1 0 total quality 3.7
quality improvement 3.8 review, design 3.1 1 total quality control 3.7
quality loop 4.1 review, management 3.9 total quality management 3.7
quality losses 4.3 rework 4.1 9 TQC 3.7
quality management 3.2
TQM 3.7
quality management manual 3.1 2
quality management plan 3.1 3 traceability 3.1 6
S
quality management, total 3.7
quality manual 3.1 2 self-inspection 2.1 6
quality plan 3.1 3 V
service 1 .5
quality planning 3.3
quality policy 3.1 service delivery 1 .6
service quality audit 4.9 validated 2.1 8
quality record 3.1 5
society, requirements of 2.4 validation 2.1 8
quality-related costs 4.2
quality, requirements for 2.3 specification 3.1 4 verification 2.1 7
quality surveillance 4.7 spiral, quality 4.1 verified 2.1 7
quality survey 4.6 structure, organizational 1 .8
quality spiral 4.1 subcontractor 1 .1 3
quality system 3.6 subsupplier 1 .1 3 W
quality system record 3.1 5 supplier 1 .1 0
quality, total 3.7 waiver 4.1 7
surveillance quality 4.7

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