EN ISO 9000-1:1994
(Main)Quality management and quality assurance standards - Part 1: Guidelines for selection and use (ISO 9000-1:1994)
Quality management and quality assurance standards - Part 1: Guidelines for selection and use (ISO 9000-1:1994)
Normen zum Qualitätsmanagement und zur Qualitätssicherung/QM-Darlegung - Teil 1: Leitfaden zur Auswahl und Anwendung (
Normes pour le management de la qualité et l'assurance de la qualité - Partie 1: Lignes directrices pour leur sélection
Standardi za vodenje in zagotavljanje kakovosti - 1. del: Smernice za izbiro in uporabo (ISO 9000-1:1994)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9000-1:1997
01-december-1997
1DGRPHãþD
SIST ISO 9000-1:1996
Standardi za vodenje in zagotavljanje kakovosti - 1. del: Smernice za izbiro in
uporabo (ISO 9000-1:1994)
Quality management and quality assurance standards - Part 1: Guidelines for selection
and use (ISO 9000-1:1994)
Normen zum Qualitätsmanagement und zur Qualitätssicherung/QM-Darlegung - Teil 1:
Leitfaden zur Auswahl und Anwendung (
Normes pour le management de la qualité et l'assurance de la qualité - Partie 1: Lignes
directrices pour leur sélection
Ta slovenski standard je istoveten z: EN ISO 9000-1:1994
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST EN ISO 9000-1:1997 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9000-1:1997
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SIST EN ISO 9000-1:1997
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SIST EN ISO 9000-1:1997
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SIST EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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.
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SIST EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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.
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SIST EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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 EN ISO 9000-1:1997
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 managem
...
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