SIST ISO 9000-1:1996
(Main)Quality management and quality assurance standards -- Part 1: Guidelines for selection and use
Quality management and quality assurance standards -- Part 1: Guidelines for selection and use
Normes pour le management de la qualité et l'assurance de la qualité -- Partie 1: Lignes directrices pour leur sélection et utilisation
Standardi za vodenje in zagotavljanje kakovosti - 1. del: Smernice za izbiro in uporabo
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INTERNATIONAL IS0
STANDARD 9000-I
First edition
1994-07-01
Quality management and quality assurance
standards -
Part 1:
Guidelines for selection and use
Normes pour le management de la qua/it6 et I’assurance de la qualit6 -
Partie 1: Lignes directrices pour leur s6lection et utilisation
Reference number
IS0 9000-I :I 994(E)
---------------------- Page: 1 ----------------------
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
2 Normative reference ,.,,.,*.,,,,.,.,,.,,,,,.
1
,.,.,,.,,.,.,,.,.,.,,.~
3 Definitions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4 Principal concepts
....................... 2
41 . Key objectives and responsibilities for quality
...................................... 3
42 . Stakeholders and their expectations
43 . Distinguishing between quality system requirements and product
.......................................................................... 3
requirements
3
....................................................
44 . Generic product categories
3
.....................................................................
45 . Facets of quality
4
46 . .
Concept of a process
5
...............................
47 . Network of processes in an organization
........ 6
48 . Quality system in relation to the network of processes
..................................................... 6
49 . Evaluating quality systems
6
.,.,.,.,.,,.
5 Roles of documentation
.,.,.,.,,.,,,. 6
5.1 Value of documentation
. . . . . . . . . . . . . . . . 7
5.2 Documentation and evaluation of quality systems
7
. . . . . . . . . .
5.3 Documentation as a support for quality improvement
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
5.4 Documentation and training
. . . . . . . . . . . . . .*. 7
6 Quality system situations
. . . . . . . . . . 8
7 Selection and use of International Standards on quality
8
,.,,,.,.,.,.~.,.,.,.,,.,.,.,.,.,.,.
7.1 General
8
7.2 Selection and use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
. . . . . . . . . . .~.~.~.~. 8
7.3 Application guidelines
9
7.4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 IS0 1994
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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0 IS0
IS0 9000=1:1994(E)
7.5 Dependability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.6 Quality assurance: design, development, production, installation and
servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
. . . . . . . 9
7.7 Quality assurance: production, installation and servicing
. . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.8 Quality assurance: final inspection and test
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.9 Quality management
10
7.10 Services . . . . . . . . . . . . . . . . . .*.
10
7.11 Processed materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.
7.12 Quality improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 10
7.13 Audits
10
7.14 Auditors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.15 Managing audits . 10
7.16 Quality assurance for measurement . 11
8 Selection and use of International Standards for external quality
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 11
assurance
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
8.1 General guidance
11
8.2 Selection of model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . 11
8.3 Demonstration of conformance to the selected model
8.4 Additional considerations in contractual situations . . . . . . . . . . . . . . 12
Annexes
Terms and definitions taken from IS0 8402:1994 . . . . . . . . . . . . . . . . 13
A
B Product and process factors . . . . .*. 15
B.1 Purpose ,,,,.,.,,,. 15
B.2 Factors .,.,. 15
C Proliferation of standards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
D Cross-reference list of clause numbers for corresponding topics 17
E Bibliography .,. 18
. . .
Ill
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0 IS0
IS0 9000=1:1994(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 9000-l was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
The first edititon of IS0 9000-l cancels and replaces IS0 9000:1987.
lSO/K 176 adopted in 1990 a strategy for revision of the IS0 9000 series
originally published in published in 1987. This is the first revision. This part
of IS0 9000, which has the role of road map for the series, has been ex-
panded substantially.
IS0 9000 consists of the following parts, under the general title Quality
management and quality assurance standards:
- Part 1: Guidelines for selection and use
- Part 2: Generic guidelines for the application of IS0 900 1, IS0 9002
and IS0 9003
- Part 3: Guidelines for the application of IS0 9001 to the develop-
ment, supply and maintenance of software
- Part 4: Guide to dependability programme management
Annex A forms an integral part of this part of IS0 9000. Annexes B, C, D
and E are for information only.
iv
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Q IS0
IS0 9000=1:1994(E)
Organizations - industrial, commercial or governmental - supply prod-
ucts intended to satisfy customers’ needs and/or requirements. Increased
global competition has led to increasingly more stringent customer ex-
pectations with regard to quality. To be competitive and to maintain good
economic performance, organizations/suppliers need to employ increas-
ingly effective and efficient systems. Such systems should result in con-
tinual improvements in quality and increased satisfaction of the
organization’s customers and other stakeholders (employees, owners,
subsuppliers, society).
Customer requirements often are incorporated in “specifications”. How-
ever, specifications may not in themselves guarantee that a customer’s
requirements will be met consistently, if there are any deficiencies in the
organizational system to supply and support the product. Consequently,
these concerns have led to the development of quality system standards
and guidelines that complement relevant product requirements given in
the technical specifications. The International Standards in the IS0 9000
family are intended to provide a generic core of quality system standards
applicable to a broad range of industry and economic sectors (clause 7).
The management system of an organization is influenced by the objectives
of the organization, by its products and by the practices specific to the
organization and, therefore, quality systems also vary from one organiz-
ation to another. A major purpose of quality management is to improve the
systems and processes so that continual improvement of quality can be
achieved.
This part of IS0 9000, which has the role of road map for the IS0 9000
family, has been expanded substantially. In particular, it contains guidance
concepts not included in the 1987 version. These additional concepts
- are needed for effective understanding and current application of the
IS0 9000 family, and
- are planned for complete integration into the architecture and content
of future revisions of the IS0 9000 family.
In revision of the IS0 9000 family, there are no major changes in the
architectures of IS0 9001, IS0 9002, IS0 9003 and IS0 9004. (However,
IS0 9003 does contain additional clauses compared to the 1987 version.)
Each of these International Standards has had small-scale changes. These
changes move toward future revisions to meet better the needs of users.
This part of IS0 9000 and all other International Standards in the IS0 9000
family are independent of any specific industry or economic sector. Col-
lectively they provide guidance for quality management and general re-
quirements for quality assurance.
The International Standards in the IS0 9000 family describe what el-
ements quality systems should encompass but not how a specific
V
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0 IS0
IS0 9000-l : 1994(E)
organization implements these elements. It is not the purpose of these
International Standards to enforce uniformity of quality systems. Needs
of organizations vary. The design and implementation of a quality system
must necessarily be influenced by the particular objectives, products and
processes, and specific practices of the organization.
This part of IS0 9000 clarifies the principal quality-related concepts con-
tained within the quality management and quality assurance International
Standards generated by lSO/lC 176 and provides guidance on their
selection and use.
Vi
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INTERNATIONAL STANDARD 0 IS0 IS0 90004 :1994(E)
Quality management and quality assurance
standards -
Part 1:
Guidelines for selection and use
The usage of all of these terms conforms with their
1 Scope
formal definitions in IS0 8402. The remaining differ-
ences in terminology in table 1 reflect, in part, a desire
This part of IS0 9000
to maintain historical continuity with usage in the
a) clarifies principal quality-related concepts and the 1987 edition of these International Standards.
distinctions and interrelationships among them;
NOTES
b) provides guidance for the selection and use of the
1 In all these International Standards, the grammatical
IS0 9000 family of International Standards on
format of the guidance or requirements text is addressed
quality management and quality assurance.
to the organization in its role as a supplier of products (the
third column of table 1).
2 Normative reference
2 In the IS0 9000 row of table 1, the use of
“subsupplier” emphasizes the supply chain relationship of
The following standard contains provisions which,
the three organizational units, using the self-defining term
through reference in this text, constitute provisions
in relation to “supplier”.
Where appropriate, especially in
of this part of IS0 9000. At the time of publication, the
discussing quality management situations, the term
edition indicated was valid. All standards are subject
“organization” is used rather than “supplier”.
to revision, and parties to agreements based on this
3 In the IS0 9001, IS0 9002 and IS0 9003 rows of
part of IS0 9000 are encouraged to investigate the
table 1, the use of “subcontractor” reflects the fact that, in
possibility of applying the most recent edition of the
an external quality assurance context, the relevant relation-
standard indicated below. Members of IEC and IS0
ship often is (explicity or implicitly) contractual.
maintain registers of currently valid International
Standards.
4 In the IS0 9004 row of table 1, the use of
“organization” reflects the fact that quality management
IS0 8402: 1994, Quality management and quality as-
guidance is applicable to any organizational unit, irrespective
surance - Vocabulary.
of the categories of products it may supply, or whether it is
a free-standing unit or part of a larger organization.
3 Definitions
For the purposes of this part of IS0 9000, the defi-
nitions given in IS0 8402, together with the following
This revision of IS0 9000, IS0 9001, IS0 9002,
definitions, apply.
IS0 9003 and IS0 9004 has improved the
harmonization of terminology for organizations in the
NOTE 5 For the convenience of users of this part of
supply chain. Table 1 shows the supply chain termin-
IS0 9000, some relevant definitions from IS0 8402 are
ology used in these International Standards. contained in annex A.
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IS0 9000-I : 1994(E)
Table 1 - Relationships of organizations in the supply chain
supplier or
-> customer
IS0 9000-l Subsupplier ->
organization
IS0 9001,
->
IS0 9002, Subcontractor -> supplier customer
IS0 9003
-> organization -> customer
IS0 9004-l Subcontractor
3.1 hardware: Tangible, discrete product with dis- the supplier organization and the environment in
tinctive form. which it operates.
NOTE 6 Hardware normally consists of manufactured,
3.6 IS0 9000 family: All those International Stan-
constructed or fabricated pieces, parts and/or assemblies.
dards produced by the technical committee
lSO/TC 176.
3.2 software: An intellectual creation consisting of
NOTE 14 At present, the family comprises
information expressed through supporting medium.
a) all the International Standards numbered IS0 9000
NOTES
through to IS0 9004, including all parts of IS0 9000 and
IS0 9004;
7 Software can be in the form of concepts, transactions
or procedures.
b) all the International Standards numbered IS0 10001
through to 10020, including all parts; and
A computer program is a specific example of software.
8
c) IS0 8402.
3.3 processed material: Tangible product gener-
ated by transforming raw material into a desired state.
4 Principal concepts
NOTES
9 The state of processed material can be liquid, gas,
particulate material, ingot, filament or sheet.
4.1 Key objectives and responsibilities for
quality
10 Processed material is typically delivered in drums,
bags, tanks, cylinders, cans, pipelines or rolls.
An organization should:
3.4 industry/economic sector: A grouping of sup-
achieve, maintain and seek to improve continu-
a)
pliers whose offerings meet similar customer needs
ously the quality of its products in relationship to
and/or whose customers are closely interrelated in the
the requirements for quality;
marketplace.
improve the quality of its own operations, so as
b)
NOTES
to meet continually all customers’ and other
stakeholders’ stated and implied needs;
11 Dual use of “industry sector” and “economic sector”
recognizes that each term is used for the intended meaning
provide confidence to its internal management
d
in specific countries or languages.
and other employees that the requirements for
12 Industry/economic sectors include administration, quality are being fulfilled and maintained, and that
aerospace, banking, chemicals, construction, education,
quality improvement is taking place;
food, health care, leisure, insurance, mining, retailing, tele-
communications, textiles, tourism, and so .forth.
provide confidence to the customers and other
d)
stakeholders that the requirements for quality are
Industry/economic sectors apply to the global economy
13
being, or will be, achieved in the delivered prod-
or a national economy.
uct;
3.5 stakeholder: An individual or group of individ- provide confidence that quality system require-
e)
uals with a common interest in the performance of ments are fulfilled.
2
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0 IS0 IS0 9000=1:1994(E)
International Standards in the IS0 9000 family, both
4.2 Stakeholders and their expectations
guidance and requirements, are written in terms of
the quality system objectives to be satisfied. These
Every organization as a supplier has five principal
International Standards do not prescribe how to
groups of stakeholders: its customers, its employees,
achieve the objectives but leave that choice to the
its owners, its subsuppliers and society.
management of the organization.
The supplier should address the expectations and
needs of all its stakeholders.
Supplier’s stake- Typical expectations or needs
4.4 Generic product categories
holders
Customers Product quality
It is useful to identify four generic product categories
Employees Career/work satisfaction
(see clause 3 and annex A), as follows:
Owners Investment p&formance
a) hardware;
Subsuppliers Continuing business opportunity
Society Responsible stewardship
b) software;
The International Standards in the IS0 9000 family
c) processed materials;
focus their guidance and requirements on satisfying
the customer.
d) services.
The requirements of society, as one of the five
These four generic product categories encompass all
stakeholders, are becoming more stringent world-
the kinds of product supplied by organizations. Inter-
wide. In addition, expectations and needs are be-
national Standards in the IS0 9000 family are appli-
coming more explicit for considerations such as:
cable to all four generic product categories. The
workplace health and safety; protection of the en-
quality system requirements are essentially the same
vironment (including conservation of energy and
for all generic product categories, but the terminology
natural resources); and security. Recognizing that the
and management system details and emphases may
IS0 9000 family of International Standards provides a
differ.
widely used approach for management systems that
can meet requirements for quality, these manage-
Two or more of the generic product categories usually
ment principles can be useful for other concerns of
are present in the marketplace offerings of any
society. Compatibility of the management system ap-
organization, whatever the industry/economic sector
proach in these several areas can enhance the effec-
(see clause 3) in which the organization operates. For
tiveness of an organization. In the same manner that
example, most organizations that supply hardware,
product and process technical specifications are sep-
software or processed materials have a service com-
arate from management systems requirements, the
ponent to their offering. Customers (and other stake-
technical specifications in these other areas should
holders) will look for value in each generic product
be separately developed.
category that is present in the offering.
Analytical instruments are examples where hardware
(i.e. the instrument), software (for computing tasks
4.3 Distinguishing between quality system
within the instrument), processed materials (such as
requirements and product requirements
titrating solutions or reference materials) and services
(such as training or maintenance servicing) might all
The IS0 9000 family of International Standards makes
be important features of the offering. A service
a distinction between quality system requirements
organization such as a restaurant will have hardware,
and product requirements. By means of this dis-
software and processed materials as well as service
tinction, the IS0 9000 family applies to organizations
components.
providing products of all generic product categories,
and to all product quality characteristics. The quality
system requirements are complementary to the
technical requirements of the product. The applicable
technical specifications of the product (e.g. as set out
4.5 Facets of quality
in product standards) and technical specifications of
the process are separate and distinct from the appli- Four facets that are key contributions to product
cable IS0 9000 family requirements or guidance. quality may be identified as follows.
3
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0 IS0
IS0 9000=1:1994(E)
Quality due to definition of needs for the satisfactory market share, the customer is likely to
a)
product place higher value on the supplier’s offering.
- The supplier’s financial status and strategy: if the
The first facet is quality due to defining and up-
supplier has an established and reputable financial
dating the product, to meet marketplace require-
status and/or a strategy that is improving financial
ments and opportunities.
performance, the customer is likely to place higher
Quality due to product design value on the supplier’s offering.
b)
- The supplier’s human resources status and strat-
The second facet is quality due to designing into
egy: if the supplier has an established and repu-
the product the characteristics that enable it to
table human resources status and/or a strategy
meet marketplace requirements and oppor-
that is developing improved skills, diversity and
tunities, and to provide value to customers and
commitment in its human resources, the customer
other stakeholders. More precisely, quality due to
is likely to place higher value on the supplier’s of-
product design is the product design features that
fering.
influence the intended performance within a given
grade, plus product design features that influence
These additional factors are of vital importance in
the robustness of product performance under
managing a supplier organization as a total enterprise.
variable conditions of production and use.
NOTE 15 Product value involves both quality and price
Quality due to conformance to product design
d
and, as such, price is not a facet of quality.
The third facet is quality due to maintaining day-
to-day consistency in conforming to product de-
sign and in providing the designed characteristics
4.6 Concept of a process
and values for customers and other stakeholders.
The International Standards in the IS0 9000 family are
Quality due to product support
d
founded upon the understanding that all work is ac-
complished by a process (see figure 1). Every process
The fourth facet is quality due to furnishing sup-
has inputs. The outputs are the results of the process.
port throughout the product life cycle, as needed,
The outputs are products, tangible or intangible. The
to provide the designed characteristics and values
process itself is (or should be) a transformation that
for customers and other stakeholders.
adds value. Every process involves people and/or
other resources in some way. An output may be, for
t-or some products, the important quality character-
example, an invoice, computing software, liquid fuel,
istics include dependability characteristics. Depend-
a clinical device, a banking service, or a final or inter-
ability (i.e. reliability, maintainability and availability)
mediate product of any generic category. There are
may be influenced by all four facets of product quality.
opportunities to make measurements on the inputs,
at various places in the process, as well as on the
A goal of the guidance and requirements of the Inter-
outputs. As shown in figure2, inputs and outputs are
national Standards in the IS0 9000 family is to meet
of several types.
the needs for all four facets of product quality. Some
facets of quality may be specifically important, for
example, in contractual situations, but, in general, all Examples
TYPe
facets contribute to the quality of the product. The
Product-related Raw materials
IS0 9000 family explicitly provides generic quality
(solid lines in Intermediate product
management guidance and external quality assurance
figure 2) Final product
requirements on facets a), b), c) and d).
Sampled product
Information-related Product requirements
When considering the complete product offering, the
(dashed lines in Product characteristics and status
customer will bear in mind additional factors. These
figure 2) information
include the following.
Support-function communications
Feedback on product perform-
- The supplier’s market status and strategy: if the
ance and needs
supplier has an established and reputable market-
Measurement data from sampled
place status and/or a strategy that is achieving a
product
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IS0 9000=1:1994(E)
Inputs outputs
PROCESS
0
h
Exampies:
A value-adding
Invoice
transformation
Computing software
involving people
Liquid fuel
andotherresources
Clinical device
Banking service
Intermediate product
0 = Opportunities to measure
- All work is accomplished by a process
Figure 1
Requirements Requirements
-----------------------
----------------------m
1 I 1
I I
:
I
I
I I
I I
I
I
1 , I B , 1
\ \ /
Product-related inputs
Product-related outputs
m
SUPPLIER’S - CUSTOMER’S
SUBSUPPLIER’S
--------------me ----------------
PROCESS PROCESS PROCESS
Product characteristics
Product characteristics
4 i 4
, l
1 and status
1 and status
I
1
I I t
I I I I
1 ----------------------- J 1 ----------------------- J
Feedback Feedback
Figure 2 - Supply chain relationship of processes, with product-related and information-related flow
of processes. The structure of the network is not
Figure2 shows the supplier in a supply chain re-
lationship to a subsupplier and a customer. In this usually a simple sequential structure, but typically is
supply chain structure, the various inputs and outputs quite complex.
need to flow in different directions, as illustrated in
In an organization there are many functions to be
figure 2. It is emphasized that in this context
“product” includes all four generic product categories. performed. They include production, product design,
technology management, marketing, training, human
Quality management is accomplished by managing
resources management, strategic planning, delivery,
the processes in the organization. It is necessary to
invoicing and maintenance. Given the complexity of
manage a process in two senses: .
most organizations, it is important to highlight the
main processes and to simplify and prioritize pro-
- the structure and operation of the process itself
cesses for quality management purposes.
within which the product or information flows; and
An organization needs to identify, organize and man-
- the quality of the product or information flowing
age its network of processes and interfaces. The
within the structure.
organization creates, improves and provides consist-
ent quality in its offerings through the network of
processes. This is a fundamental conceptual basis for
4.7 Network of processes in an organization
the IS0 9000 family. Processes and their interfaces
should be subject to analysis and continuous im-
Every organization exists to accomplish value-adding
provement.
work. The work is accomplished through a network
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0 IS0
IS0 9000=1:1994(E)
Problems tend to arise where people have to manage ments found in IS0 9001, IS0 9002 or IS0 9003. The
results of internal audits and external audits are an
several processes and their interrelationships, par-
important source of information. It is important that
ticularly for large processes that may span several
the outcome of the management review should lead
functions. To clarify interfaces, responsibilities and
to increased effectiveness and efficiency of the qual-
authorities, a process should have an owner as the
person responsible. The quality of executive manage- ity system.
ment’s own processes, such as strategic planning, is
especially important.
4.
...
SLOVENSKI STANDARD
SIST ISO 9000-1:1996
01-maj-1996
1DGRPHãþD
SIST ISO 9000:1996
Standardi za vodenje in zagotavljanje kakovosti - 1. del: Smernice za izbiro in
uporabo
Quality management and quality assurance standards -- Part 1: Guidelines for selection
and use
Normes pour le management de la qualité et l'assurance de la qualité -- Partie 1: Lignes
directrices pour leur sélection et utilisation
Ta slovenski standard je istoveten z: ISO 9000-1:1994
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST ISO 9000-1:1996 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO 9000-1:1996
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SIST ISO 9000-1:1996
INTERNATIONAL IS0
STANDARD 9000-I
First edition
1994-07-01
Quality management and quality assurance
standards -
Part 1:
Guidelines for selection and use
Normes pour le management de la qua/it6 et I’assurance de la qualit6 -
Partie 1: Lignes directrices pour leur s6lection et utilisation
Reference number
IS0 9000-I :I 994(E)
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SIST ISO 9000-1:1996
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
2 Normative reference ,.,,.,*.,,,,.,.,,.,,,,,.
1
,.,.,,.,,.,.,,.,.,.,,.~
3 Definitions
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4 Principal concepts
....................... 2
41 . Key objectives and responsibilities for quality
...................................... 3
42 . Stakeholders and their expectations
43 . Distinguishing between quality system requirements and product
.......................................................................... 3
requirements
3
....................................................
44 . Generic product categories
3
.....................................................................
45 . Facets of quality
4
46 . .
Concept of a process
5
...............................
47 . Network of processes in an organization
........ 6
48 . Quality system in relation to the network of processes
..................................................... 6
49 . Evaluating quality systems
6
.,.,.,.,.,,.
5 Roles of documentation
.,.,.,.,,.,,,. 6
5.1 Value of documentation
. . . . . . . . . . . . . . . . 7
5.2 Documentation and evaluation of quality systems
7
. . . . . . . . . .
5.3 Documentation as a support for quality improvement
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
5.4 Documentation and training
. . . . . . . . . . . . . .*. 7
6 Quality system situations
. . . . . . . . . . 8
7 Selection and use of International Standards on quality
8
,.,,,.,.,.,.~.,.,.,.,,.,.,.,.,.,.,.
7.1 General
8
7.2 Selection and use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘.
. . . . . . . . . . .~.~.~.~. 8
7.3 Application guidelines
9
7.4 Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 IS0 1994
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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SIST ISO 9000-1:1996
0 IS0
IS0 9000=1:1994(E)
7.5 Dependability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.6 Quality assurance: design, development, production, installation and
servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
. . . . . . . 9
7.7 Quality assurance: production, installation and servicing
. . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.8 Quality assurance: final inspection and test
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.9 Quality management
10
7.10 Services . . . . . . . . . . . . . . . . . .*.
10
7.11 Processed materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*.
7.12 Quality improvement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 10
7.13 Audits
10
7.14 Auditors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7.15 Managing audits . 10
7.16 Quality assurance for measurement . 11
8 Selection and use of International Standards for external quality
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 11
assurance
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
8.1 General guidance
11
8.2 Selection of model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . 11
8.3 Demonstration of conformance to the selected model
8.4 Additional considerations in contractual situations . . . . . . . . . . . . . . 12
Annexes
Terms and definitions taken from IS0 8402:1994 . . . . . . . . . . . . . . . . 13
A
B Product and process factors . . . . .*. 15
B.1 Purpose ,,,,.,.,,,. 15
B.2 Factors .,.,. 15
C Proliferation of standards
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
D Cross-reference list of clause numbers for corresponding topics 17
E Bibliography .,. 18
. . .
Ill
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SIST ISO 9000-1:1996
0 IS0
IS0 9000=1:1994(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 9000-l was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
The first edititon of IS0 9000-l cancels and replaces IS0 9000:1987.
lSO/K 176 adopted in 1990 a strategy for revision of the IS0 9000 series
originally published in published in 1987. This is the first revision. This part
of IS0 9000, which has the role of road map for the series, has been ex-
panded substantially.
IS0 9000 consists of the following parts, under the general title Quality
management and quality assurance standards:
- Part 1: Guidelines for selection and use
- Part 2: Generic guidelines for the application of IS0 900 1, IS0 9002
and IS0 9003
- Part 3: Guidelines for the application of IS0 9001 to the develop-
ment, supply and maintenance of software
- Part 4: Guide to dependability programme management
Annex A forms an integral part of this part of IS0 9000. Annexes B, C, D
and E are for information only.
iv
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SIST ISO 9000-1:1996
Q IS0
IS0 9000=1:1994(E)
Organizations - industrial, commercial or governmental - supply prod-
ucts intended to satisfy customers’ needs and/or requirements. Increased
global competition has led to increasingly more stringent customer ex-
pectations with regard to quality. To be competitive and to maintain good
economic performance, organizations/suppliers need to employ increas-
ingly effective and efficient systems. Such systems should result in con-
tinual improvements in quality and increased satisfaction of the
organization’s customers and other stakeholders (employees, owners,
subsuppliers, society).
Customer requirements often are incorporated in “specifications”. How-
ever, specifications may not in themselves guarantee that a customer’s
requirements will be met consistently, if there are any deficiencies in the
organizational system to supply and support the product. Consequently,
these concerns have led to the development of quality system standards
and guidelines that complement relevant product requirements given in
the technical specifications. The International Standards in the IS0 9000
family are intended to provide a generic core of quality system standards
applicable to a broad range of industry and economic sectors (clause 7).
The management system of an organization is influenced by the objectives
of the organization, by its products and by the practices specific to the
organization and, therefore, quality systems also vary from one organiz-
ation to another. A major purpose of quality management is to improve the
systems and processes so that continual improvement of quality can be
achieved.
This part of IS0 9000, which has the role of road map for the IS0 9000
family, has been expanded substantially. In particular, it contains guidance
concepts not included in the 1987 version. These additional concepts
- are needed for effective understanding and current application of the
IS0 9000 family, and
- are planned for complete integration into the architecture and content
of future revisions of the IS0 9000 family.
In revision of the IS0 9000 family, there are no major changes in the
architectures of IS0 9001, IS0 9002, IS0 9003 and IS0 9004. (However,
IS0 9003 does contain additional clauses compared to the 1987 version.)
Each of these International Standards has had small-scale changes. These
changes move toward future revisions to meet better the needs of users.
This part of IS0 9000 and all other International Standards in the IS0 9000
family are independent of any specific industry or economic sector. Col-
lectively they provide guidance for quality management and general re-
quirements for quality assurance.
The International Standards in the IS0 9000 family describe what el-
ements quality systems should encompass but not how a specific
V
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SIST ISO 9000-1:1996
0 IS0
IS0 9000-l : 1994(E)
organization implements these elements. It is not the purpose of these
International Standards to enforce uniformity of quality systems. Needs
of organizations vary. The design and implementation of a quality system
must necessarily be influenced by the particular objectives, products and
processes, and specific practices of the organization.
This part of IS0 9000 clarifies the principal quality-related concepts con-
tained within the quality management and quality assurance International
Standards generated by lSO/lC 176 and provides guidance on their
selection and use.
Vi
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SIST ISO 9000-1:1996
INTERNATIONAL STANDARD 0 IS0 IS0 90004 :1994(E)
Quality management and quality assurance
standards -
Part 1:
Guidelines for selection and use
The usage of all of these terms conforms with their
1 Scope
formal definitions in IS0 8402. The remaining differ-
ences in terminology in table 1 reflect, in part, a desire
This part of IS0 9000
to maintain historical continuity with usage in the
a) clarifies principal quality-related concepts and the 1987 edition of these International Standards.
distinctions and interrelationships among them;
NOTES
b) provides guidance for the selection and use of the
1 In all these International Standards, the grammatical
IS0 9000 family of International Standards on
format of the guidance or requirements text is addressed
quality management and quality assurance.
to the organization in its role as a supplier of products (the
third column of table 1).
2 Normative reference
2 In the IS0 9000 row of table 1, the use of
“subsupplier” emphasizes the supply chain relationship of
The following standard contains provisions which,
the three organizational units, using the self-defining term
through reference in this text, constitute provisions
in relation to “supplier”.
Where appropriate, especially in
of this part of IS0 9000. At the time of publication, the
discussing quality management situations, the term
edition indicated was valid. All standards are subject
“organization” is used rather than “supplier”.
to revision, and parties to agreements based on this
3 In the IS0 9001, IS0 9002 and IS0 9003 rows of
part of IS0 9000 are encouraged to investigate the
table 1, the use of “subcontractor” reflects the fact that, in
possibility of applying the most recent edition of the
an external quality assurance context, the relevant relation-
standard indicated below. Members of IEC and IS0
ship often is (explicity or implicitly) contractual.
maintain registers of currently valid International
Standards.
4 In the IS0 9004 row of table 1, the use of
“organization” reflects the fact that quality management
IS0 8402: 1994, Quality management and quality as-
guidance is applicable to any organizational unit, irrespective
surance - Vocabulary.
of the categories of products it may supply, or whether it is
a free-standing unit or part of a larger organization.
3 Definitions
For the purposes of this part of IS0 9000, the defi-
nitions given in IS0 8402, together with the following
This revision of IS0 9000, IS0 9001, IS0 9002,
definitions, apply.
IS0 9003 and IS0 9004 has improved the
harmonization of terminology for organizations in the
NOTE 5 For the convenience of users of this part of
supply chain. Table 1 shows the supply chain termin-
IS0 9000, some relevant definitions from IS0 8402 are
ology used in these International Standards. contained in annex A.
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SIST ISO 9000-1:1996
IS0 9000-I : 1994(E)
Table 1 - Relationships of organizations in the supply chain
supplier or
-> customer
IS0 9000-l Subsupplier ->
organization
IS0 9001,
->
IS0 9002, Subcontractor -> supplier customer
IS0 9003
-> organization -> customer
IS0 9004-l Subcontractor
3.1 hardware: Tangible, discrete product with dis- the supplier organization and the environment in
tinctive form. which it operates.
NOTE 6 Hardware normally consists of manufactured,
3.6 IS0 9000 family: All those International Stan-
constructed or fabricated pieces, parts and/or assemblies.
dards produced by the technical committee
lSO/TC 176.
3.2 software: An intellectual creation consisting of
NOTE 14 At present, the family comprises
information expressed through supporting medium.
a) all the International Standards numbered IS0 9000
NOTES
through to IS0 9004, including all parts of IS0 9000 and
IS0 9004;
7 Software can be in the form of concepts, transactions
or procedures.
b) all the International Standards numbered IS0 10001
through to 10020, including all parts; and
A computer program is a specific example of software.
8
c) IS0 8402.
3.3 processed material: Tangible product gener-
ated by transforming raw material into a desired state.
4 Principal concepts
NOTES
9 The state of processed material can be liquid, gas,
particulate material, ingot, filament or sheet.
4.1 Key objectives and responsibilities for
quality
10 Processed material is typically delivered in drums,
bags, tanks, cylinders, cans, pipelines or rolls.
An organization should:
3.4 industry/economic sector: A grouping of sup-
achieve, maintain and seek to improve continu-
a)
pliers whose offerings meet similar customer needs
ously the quality of its products in relationship to
and/or whose customers are closely interrelated in the
the requirements for quality;
marketplace.
improve the quality of its own operations, so as
b)
NOTES
to meet continually all customers’ and other
stakeholders’ stated and implied needs;
11 Dual use of “industry sector” and “economic sector”
recognizes that each term is used for the intended meaning
provide confidence to its internal management
d
in specific countries or languages.
and other employees that the requirements for
12 Industry/economic sectors include administration, quality are being fulfilled and maintained, and that
aerospace, banking, chemicals, construction, education,
quality improvement is taking place;
food, health care, leisure, insurance, mining, retailing, tele-
communications, textiles, tourism, and so .forth.
provide confidence to the customers and other
d)
stakeholders that the requirements for quality are
Industry/economic sectors apply to the global economy
13
being, or will be, achieved in the delivered prod-
or a national economy.
uct;
3.5 stakeholder: An individual or group of individ- provide confidence that quality system require-
e)
uals with a common interest in the performance of ments are fulfilled.
2
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SIST ISO 9000-1:1996
0 IS0 IS0 9000=1:1994(E)
International Standards in the IS0 9000 family, both
4.2 Stakeholders and their expectations
guidance and requirements, are written in terms of
the quality system objectives to be satisfied. These
Every organization as a supplier has five principal
International Standards do not prescribe how to
groups of stakeholders: its customers, its employees,
achieve the objectives but leave that choice to the
its owners, its subsuppliers and society.
management of the organization.
The supplier should address the expectations and
needs of all its stakeholders.
Supplier’s stake- Typical expectations or needs
4.4 Generic product categories
holders
Customers Product quality
It is useful to identify four generic product categories
Employees Career/work satisfaction
(see clause 3 and annex A), as follows:
Owners Investment p&formance
a) hardware;
Subsuppliers Continuing business opportunity
Society Responsible stewardship
b) software;
The International Standards in the IS0 9000 family
c) processed materials;
focus their guidance and requirements on satisfying
the customer.
d) services.
The requirements of society, as one of the five
These four generic product categories encompass all
stakeholders, are becoming more stringent world-
the kinds of product supplied by organizations. Inter-
wide. In addition, expectations and needs are be-
national Standards in the IS0 9000 family are appli-
coming more explicit for considerations such as:
cable to all four generic product categories. The
workplace health and safety; protection of the en-
quality system requirements are essentially the same
vironment (including conservation of energy and
for all generic product categories, but the terminology
natural resources); and security. Recognizing that the
and management system details and emphases may
IS0 9000 family of International Standards provides a
differ.
widely used approach for management systems that
can meet requirements for quality, these manage-
Two or more of the generic product categories usually
ment principles can be useful for other concerns of
are present in the marketplace offerings of any
society. Compatibility of the management system ap-
organization, whatever the industry/economic sector
proach in these several areas can enhance the effec-
(see clause 3) in which the organization operates. For
tiveness of an organization. In the same manner that
example, most organizations that supply hardware,
product and process technical specifications are sep-
software or processed materials have a service com-
arate from management systems requirements, the
ponent to their offering. Customers (and other stake-
technical specifications in these other areas should
holders) will look for value in each generic product
be separately developed.
category that is present in the offering.
Analytical instruments are examples where hardware
(i.e. the instrument), software (for computing tasks
4.3 Distinguishing between quality system
within the instrument), processed materials (such as
requirements and product requirements
titrating solutions or reference materials) and services
(such as training or maintenance servicing) might all
The IS0 9000 family of International Standards makes
be important features of the offering. A service
a distinction between quality system requirements
organization such as a restaurant will have hardware,
and product requirements. By means of this dis-
software and processed materials as well as service
tinction, the IS0 9000 family applies to organizations
components.
providing products of all generic product categories,
and to all product quality characteristics. The quality
system requirements are complementary to the
technical requirements of the product. The applicable
technical specifications of the product (e.g. as set out
4.5 Facets of quality
in product standards) and technical specifications of
the process are separate and distinct from the appli- Four facets that are key contributions to product
cable IS0 9000 family requirements or guidance. quality may be identified as follows.
3
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SIST ISO 9000-1:1996
0 IS0
IS0 9000=1:1994(E)
Quality due to definition of needs for the satisfactory market share, the customer is likely to
a)
product place higher value on the supplier’s offering.
- The supplier’s financial status and strategy: if the
The first facet is quality due to defining and up-
supplier has an established and reputable financial
dating the product, to meet marketplace require-
status and/or a strategy that is improving financial
ments and opportunities.
performance, the customer is likely to place higher
Quality due to product design value on the supplier’s offering.
b)
- The supplier’s human resources status and strat-
The second facet is quality due to designing into
egy: if the supplier has an established and repu-
the product the characteristics that enable it to
table human resources status and/or a strategy
meet marketplace requirements and oppor-
that is developing improved skills, diversity and
tunities, and to provide value to customers and
commitment in its human resources, the customer
other stakeholders. More precisely, quality due to
is likely to place higher value on the supplier’s of-
product design is the product design features that
fering.
influence the intended performance within a given
grade, plus product design features that influence
These additional factors are of vital importance in
the robustness of product performance under
managing a supplier organization as a total enterprise.
variable conditions of production and use.
NOTE 15 Product value involves both quality and price
Quality due to conformance to product design
d
and, as such, price is not a facet of quality.
The third facet is quality due to maintaining day-
to-day consistency in conforming to product de-
sign and in providing the designed characteristics
4.6 Concept of a process
and values for customers and other stakeholders.
The International Standards in the IS0 9000 family are
Quality due to product support
d
founded upon the understanding that all work is ac-
complished by a process (see figure 1). Every process
The fourth facet is quality due to furnishing sup-
has inputs. The outputs are the results of the process.
port throughout the product life cycle, as needed,
The outputs are products, tangible or intangible. The
to provide the designed characteristics and values
process itself is (or should be) a transformation that
for customers and other stakeholders.
adds value. Every process involves people and/or
other resources in some way. An output may be, for
t-or some products, the important quality character-
example, an invoice, computing software, liquid fuel,
istics include dependability characteristics. Depend-
a clinical device, a banking service, or a final or inter-
ability (i.e. reliability, maintainability and availability)
mediate product of any generic category. There are
may be influenced by all four facets of product quality.
opportunities to make measurements on the inputs,
at various places in the process, as well as on the
A goal of the guidance and requirements of the Inter-
outputs. As shown in figure2, inputs and outputs are
national Standards in the IS0 9000 family is to meet
of several types.
the needs for all four facets of product quality. Some
facets of quality may be specifically important, for
example, in contractual situations, but, in general, all Examples
TYPe
facets contribute to the quality of the product. The
Product-related Raw materials
IS0 9000 family explicitly provides generic quality
(solid lines in Intermediate product
management guidance and external quality assurance
figure 2) Final product
requirements on facets a), b), c) and d).
Sampled product
Information-related Product requirements
When considering the complete product offering, the
(dashed lines in Product characteristics and status
customer will bear in mind additional factors. These
figure 2) information
include the following.
Support-function communications
Feedback on product perform-
- The supplier’s market status and strategy: if the
ance and needs
supplier has an established and reputable market-
Measurement data from sampled
place status and/or a strategy that is achieving a
product
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SIST ISO 9000-1:1996
IS0 9000=1:1994(E)
Inputs outputs
PROCESS
0
h
Exampies:
A value-adding
Invoice
transformation
Computing software
involving people
Liquid fuel
andotherresources
Clinical device
Banking service
Intermediate product
0 = Opportunities to measure
- All work is accomplished by a process
Figure 1
Requirements Requirements
-----------------------
----------------------m
1 I 1
I I
:
I
I
I I
I I
I
I
1 , I B , 1
\ \ /
Product-related inputs
Product-related outputs
m
SUPPLIER’S - CUSTOMER’S
SUBSUPPLIER’S
--------------me ----------------
PROCESS PROCESS PROCESS
Product characteristics
Product characteristics
4 i 4
, l
1 and status
1 and status
I
1
I I t
I I I I
1 ----------------------- J 1 ----------------------- J
Feedback Feedback
Figure 2 - Supply chain relationship of processes, with product-related and information-related flow
of processes. The structure of the network is not
Figure2 shows the supplier in a supply chain re-
lationship to a subsupplier and a customer. In this usually a simple sequential structure, but typically is
supply chain structure, the various inputs and outputs quite complex.
need to flow in different directions, as illustrated in
In an organization there are many functions to be
figure 2. It is emphasized that in this context
“product” includes all four generic product categories. performed. They include production, product design,
technology management, marketing, training, human
Quality management is accomplished by managing
resources management, strategic planning, delivery,
the processes in the organization. It is necessary to
invoicing and maintenance. Given the complexity of
manage a process in two senses: .
most organizations, it is important to highlight the
main processes and to simplify and prioritize pro-
- the structure and operation of the process itself
cesses for quality management purposes.
within which the product or information flows; and
An organization needs to identify, organize and man-
- the quality of the product or information flowing
age its network of processes and interfaces. The
within the structure.
organization creates, improves and provides consist-
ent quality in its offerings through the network of
process
...
NORME Is0
INTERNATIONALE 9000-I
Premiere bdition
1994-07-01
Normes pour le management de la qualit
et I’assurance de la qualit -
Partie 1:
Lignes directrices pour leur Mection et
utilisation
Quality management and quality assurance standards -
Part 1: Guidelines for selection and use
Numbo de rbfbrence
I SO 9000-l : 1994(F)
---------------------- Page: 1 ----------------------
IS0 9000=1:1994(F)
Sommaire
Page
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1 Domaine d’application
1
2 Mfkrence normative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Dkfinitions
2
4 Concepts principaux . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . .C. 2
4.1 Objectifs cl& et responsabiliths pour la qualith
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.2 Les parties prenantes et leurs attentes
4.3 Distinction entre les exigences du systeme qualit et les exigences
3
relatives au produit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
. . . . . . . . . . . . . . . . .*. 3
4.4 Categories g&Wiques de produits
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.5 Facettes de la qualit
,.,,.,. 5
4.6 Concept d’un processus
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
4.7 Le rhseau de processus d’un organisme
. . . . . 6
4.8 Le syst&me qualit par rapport au r&eau des processus
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.9 haluation des systbmes qualit
.,.,.,.,.,.*. 7
5 R8les de la documentation
7
5.1 Valeur de la documentation .,.~.,,,.,.,,,.
. . . . . . . . . . . . . . 7
5.2 Documentation et 6valuation des syst&mes qualitk
5.3 Documentation en tant que soutien pour I’amblioration de la
7
qualit . . . . . . . . . . . . . . . . . . .~.~.~.~.~~~.~.~.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
5.4 Documentation et formation
7
6 Situations relatives aux systemes qualit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
7 Wection et utilisation des Normes internationales relatives a la
8
qualiti! . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
7.1 G&n&alit&
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
7.2 S6lection et utilisation
..,...,,,,......................,...........,. 9
7.3 Lignes directrices d’application
ca IS0 1994
Droits de reproduction reserves. Sauf prescription differente, aucune partie de cette publi-
cation ne peut Qtre reproduite ni utilisee sous quelque forme que ce soit et par aucun pro-
cede, electronique ou mecanique, y compris la photocopie et les microfilms, sans I’accord
ecrit de l’editeur.
Organisation internationale de normalisation
Case Postale 56 l CH-1211 Geneve 20 l Suisse
lmprime en Suisse
ii
---------------------- Page: 2 ----------------------
0 IS0
IS0 9000=1:1994(F)
7.4 Logiciels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 9
7.5 Sijrete de fonctionnement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.6 Assurance de la qualite: conception, developpement, production,
installation et prestations associees . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 10
7.7 Assurance de la qualite: production, installation et prestations
associees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.8 Assurance de la qualite: controles et essais finals . . . . . . . . . . . . . . 10
7.9 Management de la qualite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
7.10 Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
7.11 Produits issus de processus a caractere continu . . . . . . . . . . . . . . . 11
7.12 Amelioration de la qualite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.13 Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
7.14 Auditeurs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 11
7.15 Gestion des audits
7.16 Assurance de la qualite pour le mesurage ,.,.,.,.,. 11
Selection et utilisation des Normes internationales pour I’assurance
8
de la qualite externe .,.,.,.,.,.,., 12
8.1 Conseils generaux . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.2 Selection d’un modele . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
8.3 Demonstration de la conformite au modele selectionne . . . . . 12
8.4 Considerations supplementaires dans des situations
contractuelles . . . . . . . . . . . . .*. 13
Annexes
A Termes et definitions tires de I’ISO 8402:1994 . . . . . . . . . . . . . . . . . . . . 14
B Facteurs relatifs au produit et au processus . . . . . . . . . . . . . . . . . . . . . . . . . 16
B.l Objet ,.,.,,.*.,.,.
16
8.2 Facteurs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
C Proliferation des normes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
D Tableau de correspondance entre les numeros des articles, des
paragraphes et les sujets correspondants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
E Bibliographie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
. . .
III
---------------------- Page: 3 ----------------------
63 IS0
IS0 9000=1:1994(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une federation
mondiale d’organismes nationaux de normalisation (comites membres de
I’ISO). L’elaboration des Normes internationales est en general confide aux
comites techniques de I’ISO. Chaque comite membre inter-es& par une
etude a le droit de faire partie du comite technique tree a cet effet. Les
organisations internationales, gouvernementales et non gouvernemen-
tales, en liaison avec I’ISO participent egalement aux travaux. L’ISO colla-
bore etroitement avec la Commission electrotechnique internationale (CEI)
en ce qui concerne la normalisation electrotechnique.
Les projets de Normes internationales adopt& par les comites techniques
sont soumis aux comites membres pour vote. Leur publication comme
Normes internationales requiert I’approbation de 75 % au moins des co-
mites membres votants.
La Norme internationale IS0 9000-I a ete elaboree par le comite techni-
que ISOFC 176, Management et assurance de la qua/it& sous-comite
.
SC 2, Systhmes qua/it&
Cette premiere edition de I’ISO 9000-l annule et remplace
I’ISO 9000:1987. L’ISO/rC 176 a adopte en 1990 une strategie pour la
revision de la serie IS0 9000 initialement publiee en 1987. Ceci est la
premiere revision. La presente partie de I’ISO 9000, qui a un role de carte
rout&e pour la serie, a ete substantiellement developpee.
L’ISO 9000 comprend les parties suivantes, presentees sous le titre ge-
neral Normes pour le management de la qua/it6 et /‘assurance de la
qua/it&
- Partie 1: Lignes directrices pour leur sblection et utilisation
- Partie 2: Lignes directrices pour I’application de I’ISO 9001, /‘/SO
9002 et I’ISO 9003
- Partie 3: Lignes directrices pour I’application de I’ISO 900 1 au d&
veloppement, 9 la mise 9 disposition et 9 la maintenance du logiciel
- Partie 4: Guide de gestion du programme de s&et& de fonction-
nement
L’annexe A fait partie integrante de la presente partie de I’ISO 9000. Les
annexes B, C, D et E sont donnees uniquement a titre d’information.
IV
---------------------- Page: 4 ----------------------
0 IS0
IS0 9000=1:1994(F)
Introduction
Les organismes - industriels, commerciaux ou gouvernementaux -
fournissent des produits destines a satisfaire les besoins et/au exigences
des clients. Une concurrence globale accrue a entraM des attentes de
plus en plus contraignantes en ce qui concerne la qualite. Pour Qtre com-
petitifs et maintenir de bonnes performances economiques, les orga-
nismes/fournisseurs doivent utiliser des systemes de plus en plus effi-
cients et efficaces. II convient que ces systemes entraTnent des amelio-
rations continues de la qualite et une satisfaction accrue des clients de
I’organisme et des autres parties prenantes (employ&, proprietaires,
sous-contractants, sock%>.
Les exigences du client sont souvent integrees aux ((specifications)). Ce-
pendant, des specifications techniques peuvent ne pas assurer elles-
memes que les exigences du client seront pleinement satisfaites, si des
deficiences se produisent dans le systeme organisationnel de fourniture
et de soutien au produit. En consequence, ces preoccupations ont abouti
au developpement de normes et lignes directrices de systeme qualite qui
completent les exigences applicables relatives au produit donnees dans
les specifications techniques. Les Normes internationales de la famille
IS0 9000 sont destinees a procurer un tronc commun generique de nor-
mes applicables a une large gamme d’industries et de secteurs economi-
ques (voir article 7).
Le systeme de management d’un organisme est influence par ses objec-
tifs, par ses produits et par les pratiques specifiques a I’organisme, et, en
consequence, les systemes qualite varient egalement d’un organisme a
un autre. L’objectif majeur du management de la qualite est d’ameliorer
les systemes et processus afin qu’une amelioration continue de la qualite
soit realisee.
La presente partie de I’ISO 9000, qui joue le role de carte routiere pour la
famille IS0 9000, a ete substantiellement developpee. En particulier, la
presente pat-tie de I’ISO 9000 contient des concepts qui ne sont pas dans
. la version de 1987. Ces concepts supplementaires
- sont necessaires 8 une comprehension efficace et une application
courante de la famille IS0 9000, et
- sont planifies pour une integration complete dans I’architecture et le
contenu des revisions futures de la famille IS0 9000.
Dans la revision de la famille IS0 9000, il n’y a pas de changements ma-
jeurs dans les architectures de I’ISO 9001, I’ISO 9002, I’ISO 9003 et
I’ISO 9004. (Cependant, I’ISO 9003 contient des articles supplementaires
par rapport a la version de 1987.) Chacune de ces Normes internationales,
en particulier I’ISO 9004, comporte des changements mineurs. Ces chan-
gements constituent une avancee vers de futures revisions, afin de mieux
satisfaire les besoins des utilisateurs.
V
---------------------- Page: 5 ----------------------
IS0 9000-l : 1994(F) 0 IS0
La prbsente pat-tie de I’ISO 9000 et toutes les autres Normes internatio-
nales de la famille IS0 9000 sont indbpendantes de tout secteur industriel
ou 6conomique particulier. Elles fournissent de faGon collective des
conseils pour le management de la qualith et les exigences gkhrales en
mat&e d’assurance de la qualit&
Les Normes internationales de la famille IS0 9000 dkcrivent les 6lbments
qu’il convient que les systbmes qualith englobent, mais non pas comment
un organisme spkifique met ces &ments en cauvre. L’objectif de ces
Normes internationales n’est pas de renforcer I’uniformit& des systemes
qualit& Les besoins des organismes varient. La conception et la mise en
ceuvre d’un systeme qualit doivent nkessairement &re influencbes par
les objectifs, les produits et processus, ainsi que les pratiques spkifiques .
de I’organisme particulier.
La pr&ente partie de I’ISO 9000 clarifie les principaux concepts relatifs 8
la qualit contenus dans les Normes internationales de management de
la qualite et d’assurance de la qualit 6laborbes par I’lSOnC 176 et fournit
des conseils quant B leur sklection et leur utilisation.
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE 0 IS0 IS0 9000=1:1994(F)
Normes pour le management de la qualit et
I’assurance de la qualit -
Partie I:
Lignes directrices pour leur sblection et utilisation
bleau 1 montre la terminologie de la chaTne d’approvi-
1 Domaine #application
sionnement utilisee dans ces Normes internationales.
La presente partie de I’ISO 9000
L’utilisation de tous ces termes est conforme 8 leurs
a) clarifie les principaux concepts relatifs a la qualite definitions formelles donnees dans I’ISO 8402. Les
et les distinctions et les relations entre eux; differences de terminologie restant dans le tableau 1
refletent, en partie, une volonte de conserver une
b) fournit des conseils pour la selection et I’utilisation continuite historique par rapport 8 l’utilisation dans
des Normes internationales de la famille IS0 9000 I’edition 1987 de ces Normes internationales.
relatives au management de la qualite et a I’assu-
NOTES
rance de la qualite.
1 Dans toutes ces Normes internationales, le format
2 Rbfbrence normative grammatical du texte des conseils ou des exigences
concerne I’organisme dans son role de fournisseur de pro-
La norme suivante contient des dispositions qui, par duits (la troisieme colonne du tableau 1).
suite de la reference qui en est faite, constituent des
2 Dans la ligne IS0 9000 du tableau 1, en anglais, I’utili-
dispositions valables pour la presente partie de I’ISO
sation de ((sous-contractant)) souligne la relation de type
9000. Au moment de la publication, l’edition indiquee
chaine d’approvisionnement entre les trois unites
etait en vigueur. Toute norme est sujette 8 revision
organisationnelles, en utilisant ce terme qui implique le sta-
et les parties prenantes des accords fond& sur la
tus de ((fournisseuw Lorsque cela convient, particu-
presente pat-tie de I’ISO 9000 sont invitees 8 recher-
lierement en debattant des situations de management de la
cher la possibilite d’appliquer l’edition la plus recente
qualite, le terme ((organisme)) est utilise de preference a
((fournisseuw.
de la norme indiquee ci-apres. Les membres de la CEI
et de I’ISO possedent le registre des Normes inter-
3 Dans la ligne IS0 9001, IS0 9002 et IS0 9003 du ta-
nationales en vigueur 8 un moment donne.
bleau 1, I’utilisation de ((sous-contractant)) reflete le fait que,
dans un contexte d’assurance de la qualite externe, la rela-
IS0 8402:1994, Management de la qua/it6 et assu-
tion applicable est souvent (explicitement ou implicitement)
rance de la qua/it6 - Vocabulaire.
contractuelle.
4 Dans la ligne IS0 9004 du tableau 1, I’utilisation de ((or-
3 Dhfinitions
ganismeu reflete le fait que les conseils en matiere de ma-
nagement de la qualite s’appliquent a toute unite
1
.5 presente revision de I’ISO 9000, I’ISO 9001,
organisationnelle, independamment des categories de pro-
I’ISO 9002, I’ISO 9003 et I’ISO 9004 a ameliore I’har-
duits qu’elle peut fournir, ou que ce soit une unite inde-
monisation de la terminologie des organismes jouant
pendante ou une partie d’un organisme plus grand.
un role dans la chaTne d’approvisionnement. Le ta-
1
---------------------- Page: 7 ----------------------
IS0 9000-1:1994(F
Tableau 1 - Relations des organismes dans la chaine d’approvisionnement
->
ous-contractant
->
-> fournisseur
Sous-contractant
12 Les secteurs industrielskkonomiques comprennent
Dans le cadre de la presente partie de I’ISO 9000, les
I’administration, I’aeronautique, la finance, la chimie, la ’
definitions donnees dans I’ISO 8402 ainsi que les de-
construction, I’education, I’alimentation, la Sante, les loisirs,
finitions suivantes s’appliquent.
les assurances, les mines, la vente au detail, les telecom-
munications, le textile, le tourisme et ainsi de suite.
NOTE 5 Par commodite pour les utilisateurs de la pre-
sente partie de I’ISO 9000, certaines definitions de
13 Les secteurs industriels/economiques s’appliquent a
I’ISO 8402 sont contenues dans I’annexe A.
I’economie globale ou a une economic nationale.
3.1 materiel: Produit tangible se presentant sous
3.5 parties prenantes: Personne ou groupe de per-
forme d’article distinct.
sonnes ayant un inter& commun dans les resultats
de I’organisme fournisseur et dans I’environnement
NOTE 6 Les materiels sont en principe constitues de
dans lequel il agit.
pieces, elements et/au ensembles manufactures, construits
ou fabriques.
3.6 famille IS0 9000: Toutes les Normes interna-
3.2 logiciel: Creation intellectuelle consistant en in-
par le comite technique
tionales produites
formations, mises sur un support.
lSO/T-C 176.
NOTES
NOTE 14 La famille comprend actuellement
7 Un logiciel peut prendre la forme de concepts, transac-
a) toutes les Normes internationales numerotees
tions ou procedures.
IS0 9000 a IS0 9004, y compris toutes les parties de
I’ISO 9000 et de I’ISO 9004;
8 Un programme informatique est un exemple particulier
de logiciel.
b) toutes les Normes internationales numerotees
IS0 10001 a I’ISO 10020, y compris toutes les parties;
3.3 produits issus de processus & caracthre
et
continu: Materiaux obtenus par transformation de
matiere premiere. c) I’ISO 8402.
NOTES
9 L’etat des produits issus de processus a caractere
4 Concepts principaux
continu peut etre liquide, gazeux, sous forme de particules,
de lingots, de fils ou de feuilles.
10 Les produits issus de processus a caractere continu
4.1 Objectifs cl6s et responsabilit6s pour la
sont generalement livres par f&s, sacs, reservoirs, cylin-
qualit
dres, boites, conduites ou rouleaux.
II convient qu’un organisme
3.4 secteur konomique/industrieI: Groupement
de fournisseurs dont les offres satisfont aux besoins
a) realise, maintienne et recherche une amelioration
similaires et/au dont les clients sont etroitement lies
continue de la qualite de ses produits en regard
sur le marche.
des exigences en matiere de qualite;
NOTES
b) ameliore la qualite de ses propres operations, de
facon a satisfaire continuellement les besoins ex-
1 l II est admis que I’une des expressions ((secteur indus-
primes ou implicites des clients et des autres
triel)) et ((secteur economique)) sera utilisee selon le sens
parties prenantes;
voulu dans des pays ou des langues specifiques.
2
---------------------- Page: 8 ----------------------
0 IS0 IS0 9000-l :1994(F)
donne confiance a sa direction interne et aux au- 4.3 Distinction entre les exigences du
d
tres employ& en ce que les exigences en mat&e
systhme qualit et les exigences relatives au
de qualite sont satisfaites et maintenues, et en ce
produit
que I’amelioration de la qualite est mise en ceuvre;
Les Normes internationales de la famille IS0 9000
donne confiance aux clients et autres parties pre-
d)
font une distinction entre les exigences du systeme
nantes en ce que les exigences en mat&e de
qualite et les exigences relatives au produit. Grace 8
qualite sont ou seront satisfaites dans le produit
cette distinction, la famille IS0 9000 s’applique 8 des
livre;
organismes fournissant des produits de toute catego-
rie generique et a toutes les caracteristiques relatives
e) donne confiance en ce que les exigences du sys-
8 la qualite des produits. Les exigences du systeme
teme qualite sont satisfaites.
qualite sont complementaires aux exigences techni-
ques relatives au produit. Les specifications techni-
4.2 Les parties prenantes et leurs attentes
ques du produit applicables (par exemple celles
etablies dans des normes de produits) et les speci-
Chaque organisme, en tant que fournisseur, comporte
fications techniques du processus applicables sont
cinq groupes principaux de parties prenantes: ses
separees et distinctes des exigences ou des conseils
clients, ses employ&, ses proprietaires, ses sous-
applicables de la famille IS0 9000.
contractants et la societe.
Les Normes internationales de la famille IS0 9000,
II est recommande que le fournisseur satisfasse les
tant pour les conseils que pour les exigences, sont
attentes et besoins de toutes ses parties prenantes.
redigees en termes d’objectifs de systeme qualite 8
satisfaire. Ces Normes internationales ne prescrivent
Parties pre- Attentes ou besoins caracthis-
pas comment realiser les objectifs mais en laissent le
nantes du four- tiques
choix 8 la direction de I’organisme.
nisseur
Clients Qualit du produit
Satisfaction dans le travaiI/carri&e
Employ&
4.4 Categories ghnhriques de produits
Proprihtaires Msultat des investissements
Sous-contractants Opportunite permanente d’affaires
II est utile d’identifier quatre categories generiques de
SociM Intendance responsable
produits (voir article 3 et annexe A), comme suit:
Les Normes internationales de la famille IS0 9000
a) materiels;
centrent leurs conseils et leurs exigences sur la sa-
tisfaction du client.
b) logiciels;
Les exigences de la sock%, I’une des cinq parties
c) produits issus de processus 8 caractere continu;
prenantes, deviennent plus contraignantes dans le
monde entier. En outre, les attentes et les besoins
d) services.
deviennent plus explicites pour des considerations
telles que l’hygiene et la securite sur le lieu de travail,
Ces quatre categories generiques de produits englo-
la protection de I’environnement (y compris la
bent tous les types de produits fournis par des orga-
conservation de l’energie et des ressources natu-
nismes. Les Normes internationales de la famille
relles), et la sirrete. Reconnaissant. que les Normes
IS0 9000 s’applique 8 ces quatre categories generi-
internationales de la famille IS0 9000 fournissent une
ques de produit. Les exigences du systeme qualite
approche largement utilisee des systemes de mana-
sont essentiellement les memes pour toutes les ca-
gement qui peuvent satisfaire les exigences en ma-
tegories generiques de produit mais la terminologie,
tiere de qualite, ces principes de management
les details et les points importants des systemes de
peuvent etre utiles pour d’autres preoccupations de
management peuvent varier.
la societe. La compatibilite des approches des syste-
Deux ou plusieurs categories generiques de produits
mes de management dans ces differents domaines
sont generalement presentes dans les offres de tout
peut renforcer I’efficacite d’un organisme. De la
rneme facon que les specifications techniques du organisme sur le marche, quel que soit le secteur
produit et du processus sont separees des exigences industriel/economique (voir article 3) dans lequel I’or-
des systemes de management, il convient que les ganisme opere. Par exemple, la plupart des organis-
specifications techniques de ces autres domaines mes qui fournissent des materiels, logiciels ou
soient developpees separement. produits issus de processus a caractere continu ont
3
---------------------- Page: 9 ----------------------
IS0 9000=1:1994(F) @3 IS0
une composante service dans leur offre. Les clients d) Qualit dkoulant du soutien du produit
(et autres parties prenantes) rechercheront la part de
La quatrieme facette est la qualite decoulant de la
chacune des categories generiques de produit pre-
fourniture d’un soutien tout au long du cycle de
sente dans l’offre.
vie du produit, comme necessaire, pour fournir les
Les instruments analytiques sont des exemples dans
caracteristiques et valeurs de conception pour les
lesquels les materiels (c’est-a-dire I’instrument), les
clients et autres parties prenantes.
logiciels (pour informatiser les taches a I’interieur de
l’instrument), les produits issus de processus 8 ca- Pour certains produits, les caracteristiques impor-
tantes relatives a la qualite incluent les caracteris-
ractere continu (comme le titrage de solutions ou le
tiques de surete de fonctionnement. La surete de
raccordement a des etalons de reference), et les ser-
vices (comme la formation ou la maintenance) peu- fonctionnement (c’est-a-dire la fiabilite, la main-
vent tous etre des caracteristiques importantes de tenabilite et la disponibilite) peut etre influencee par
I’offre. Un organisme de service, tel qu’un restaurant, les quatre facettes de la qualite du produit.
comportera des materiels, logiciels et produits issus
La satisfaction des besoins concernant les quatre fa-
de processus a caractere continu, ainsi que des ele-
cettes de la qualite du produit est un des objectifs des
ments de service.
conseils et des exigences des Normes internationales
de la famille IS0 9000. Certaines facettes de la qualite
peuvent etre particulierement importantes, par exem-
ple dans des situations contractuelles, mais en gene-
4.5 Facettes de la qualit
ral, toutes les facettes contribuent 8 la qualite du
produit. La famille IS0 9000 fournit explicitement des
Quatre facettes contribuent de facon essentielle 8 la
conseils generiques relatifs au management de la
qualite du produit. Ce sont les suivantes.
qualite et des exigences relatives 8 I’assurance ex-
terne de la qualite sur les facettes a), b), c) et d).
a) Qualit dkoulant de la definition des besoins
relatifs au produit
Lors de la prise en compte de l’offre totale concernant
le produit, le client aura a I’esprit des facteurs sup-
La premiere facette est la qualite decoulant de la
plementaires. Ceux-ci incluent les aspects suivants.
definition et de la mise 8 jour du produit, pour re-
pondre aux exigences et aux opportunites du
- Le statut du fournisseur sur son march6 et sa
march&
strategie dans ce domaine: si le fournisseur a un
statut et/au une strategie etablie et reputee sur le
b) Qualit6 dkoulant de la conception du produit
marche, qui lui vaut une part de marche satisfai-
La seconde facette est la qualite decoulant de la Sante, le client est susceptible d’accorder une va-
conception, dans le produit, des caracteristiques leur plus grande a I’offre du fournisseur.
qui lui permettent de repondre aux exigences et
- Le statut financier du fournisseur et sa strategie
aux opportunites du marche, et de fournir un plus
aux clients et autres parties prenantes. Plus pre- dans ce domaine: si le fournisseur a un statut
et/au une strategie etablie et reputee en mat&e
cisement, la qualite decoulant de la conception du
de finance, qui lui vaut d’ameliorer ses perfor-
produit est constituee des proprietes relatives a la
mances financieres, le client est susceptible d’ac-
conception du produit qui influencent les resultats
attendus dans une certaine mesure, ainsi que des corder une valeur plus grande a l’offre du
proprietes relatives a la conception du produit qui fournisseur.
influencent la stabilite des resultats du produit
- Le statut du fournisseur en mat&e de ressources
dans des conditions variables de production et
humaines et sa strategie dans ce domaine: si le
d’utilisation.
fournisseur a un statut et/au une strategie etablie
c) Qualitii dhoulant de la conformit du produit et reputee en mat&e de ressources humaines,
qui lui permet d’ameliorer ses competences, la di-
de sa conception
versite et I’engagement dans ses ressources hu-
La troisieme facette est la qualite decoulant du
maines, le client est susceptible d’accorder une
maintien, de la coherence journal&e dans la
valeur plus grande a l’offre du fournisseur.
conformite du produit par rapport 9 sa conception
et de la fourniture des caracteristiques et valeurs Ces facteurs supplementaires ont une importance vi-
de conception des clients et autres parties pre- tale dans le management d’un organisme fournisseur
nantes. en tant qu’entreprise globale.
4
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0 IS0 IS0 9000-l :1994(F)
NOTE 15 La valeur du produit implique a la fois la qualite existe des possibilites de realiser des mesures sur les
et le prix et, en tant que tel, le prix nest pas une facette
entrants, en divers endroits du processus, ainsi que
de la qualite.
sur les sortants. Comme indique a la figure2, les en-
trants et les sortants sont de plusieurs types.
4.6 Concept d’un processus
Exemples
TY
...
Questions, Comments and Discussion
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