ISO 9002:1994
(Main)Quality systems — Model for quality assurance in production, installation and servicing
Quality systems — Model for quality assurance in production, installation and servicing
Systèmes qualité — Modèle pour l'assurance de la qualité en production, installation et prestations associées
La présente Norme internationale spécifie des exigences en matière de système qualité à utiliser lorsque l'aptitude d'un fournisseur à fournir un produit conforme à une conception établie doit être démontrée. Les exigences spécifiées visent en premier lieu la satisfaction du client, par la prévention des non-conformités à tous les stades, depuis la production jusqu'aux prestations associées. La présente Norme internationale est applicable lorsque a) les exigences spécifiées pour le produit sont formulées en termes de conception ou de spécification établie, et b) la confiance dans la conformité du produit peut être obtenue par une démonstration adéquate des aptitudes d'un fournisseur en matière de production, installation et prestations associées. NOTE 1 Pour les références informatives, voir annexe A.
Sistemi kakovosti - Model zagotavljanja kakovosti v proizvodnji, vgradnji in servisiranju
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INTERNATIONAL
IS0
STANDARD
9002
Second edition
1994~07-03
Quality systems
- Model for quality
assurance in production, installation and
servicing
Systgmes qua/it6
- ModGle pour I’assurance de la qualit6 en production,
ins talla tion
et pres ta tions associbes
Reference number
IS0 9002: 1994(E)
---------------------- Page: 1 ----------------------
~.
%
.
. .
‘. ,
I ’
Contents
Page
1
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1
2 Normative reference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
3 Definitions . . . . . . . .~.~.~~.~.~.~~.~.~.~.~.~.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
4 Quality system requirements
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Management responsibility
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Quality system
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 Contract review
3
4.4 Design control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.5 Document ‘and data control
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.6 Purchasing
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.7 Control of customer-supplied product
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.8 Product identification and traceability
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .**.
4.9 Process control
5
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.10 Inspection and testing
. . . . . . . . . 6
Control of inspection, measuring and test equipment
4.11
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Inspection and test status
4.12
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.13 Control of nonconforming product
7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.14 Corrective and preventive action
8
. . . . .
4.15 Handling, storage, packaging, preservation and delivery
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.16 Control of quality records
8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
4.17 Internal quality audits
9
4.18 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
9
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.19 Servicing
9
.,.,.,.,.*.
4.20 Statistical techniques
43 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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Annex
10
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
A Bibliography
. . .
III
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IS0 9002:1994(E) (Q IS0
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 9002 was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
This second edition cancels and replaces the first edition
(IS0 9002:1987), which has been technically revised.
Annex A of this International Standard is for information only.
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Introduction
This International Standard is one of three International Standards dealing
with quality system requirements that can be used for external quality
assurance purposes. The quality assurance models, set out in the three
International Standards listed below, represent three distinct forms of
quality system requirements suitable for the purpose of a supplier dem-
onstrating its capability, and for the assessment of the capability of a
supplier by external parties.
a) IS0 9001, Quality systems - Model for quality assurance in design,
development, production, ins talla tion and sewicing
- for use when conformance to specified requirements is to be as-
sured by the supplier during design, development, production, in-
stallation and servicing.
b) IS0 9002, Quality systems - Model for quality assurance in pro-
duction, installation and sewicing
- for use when conformance to specified requirements is to be as-
sured by the supplier during production, installation and servicing.
c) IS0 9003, Quality systems - Model for quality assurance in final in-
spection and test
- for use when conformance to specified requirements is to be as-
sured by the supplier solely at final inspection and test.
It is emphasized that the quality system requirements specified in this
International Standard, IS0 9001 and IS0 9003 are complementary (not
alternative) to the technical (product) specified requirements. They specify
requirements which determine what elements quality systems have to
encompass, but it is not the purpose of these International Standards to
enforce uniformity of quality systems. They are generic and independent
of any specific industry or economic sector. The design and implemen-
. tation of a quality system will be influenced by the varying needs of an
organization, its particular objectives, the products and services supplied,
and the processes and specific practices employed.
It is intended that these International Standards will be adopted in their
present form, but on occasions they may need to be tailored by adding
or deleting certain quality system requirements for specific contractual
situations. IS0 9000-l provides guidance on’such tailoring as well as on
selection of the appropriate quality assurance model, viz. IS0 9001,
IS0 9002 or IS0 9003.
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INTERNATIONAL STANDARD 0 IS0 IS0 9002:1994(E)
- Model for quality assurance in
Quality systems
production, installation and servicing
3 Definitions
1 Scope
This International Standard specifies quality system For the purposes of this International Standard, the
definitions given in IS0 8402 and the following defi-
requirements for use where a supplier’s capability to
nitions apply.
supply conforming product to an established design
needs to be demonstrated.
3.1 product: Result of activities or processes.
The requirements specified are aimed primarily at
achieving customer satisfaction by preventing non- NOTES
conformity at all stages from production through to
2 A product may include service, hardware, processed
servicing.
materials, sofi!kare or a combination thereof.
This International Standard is applicable in situations
3 A product can be tangible (e.g. assemblies or processed
when
materials) or intangible (e.g. knowledge or concepts), or a
combination thereof.
a) the specified requirements for product are stated
in terms of an established design or specification,
4 For the purposes of this International Standard, the term
and
“product” applies to the intended product offering only and
not to unintended “by-products” affecting the environment.
b) confidence in product conformance can be at- This differs from the definition given in IS0 8402.
tained by adequate demonstration of a supplier’s
capabilities in production, installation and servic- 3.2 tender: Offer made by a supplier in response to
ing. an invitation to satisfy a contract award to provide
product.
NOTE 1 For informative references, see annex A.
3.3 contract: Agreed requirements between a sup-
plier and customer transmitted by any means.
2 Normative reference
The following standard contains provisions which, 4 Quality system requirements
through reference in this text, constitute provisions
of this International Standard. At the time of publi-
4.1 Management responsibility
cation, the edition indicated was valid. All standards
are subject to revision, and parties to agreements
based on this International Standard are encouraged 4.1.1 Quality policy
to investigate the possibility of applying the most re-
The supplier’s management with executive responsi-
cent edition of the standard indicated below. Mem-
bility shall define and document its policy for quality,
bers of IEC and IS0 maintain registers of currently
including objectives for quality and its commitment to
valid International Standards.
quality. The quality policy shall be relevant to the
IS0 8402: 1994, Qbality management and quality as- supplier’s organizational goals and the expectations
surance - Vocabulary. and needs of its customers. The supplier shall ensure
1
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IS0 9002: 1994(E) 0 IS0
that this policy is understood, implemented and 4.1.3 Management review
maintained at all levels of the organization.
The supplier’s management with executive responsi-
bility shall review the quality system at defined inter-
vals sufficient to ensure its continuing suitability and
4.1.2 Organization
effectiveness in satisfying the requirements of this
International Standard and the supplier’s stated quality
4.1.2.1 Responsibility and authority
policy and objectives (see 4.1 .l). Records of such re-
views shall be maintained (see 4.16).
The responsibility, authority and the interrelation of
personnel who manage, perform and verify work af-
4.2 Quality system
fecting quality shall be defined and documented, par-
ticularly for personnel who need the organizational
freedom and authority to: 4.2.1 General
The supplier shall establish, document and maintain
a quality system as a means of ensuring that product
conforms to specified requirements. The supplier
shall prepare a quality manual covering the require-
b) identify and record any problems relating to the
ments of this International Standard. The quality
product, process and quality system;
manual shall include or make reference to the quality
system procedures and outline the structure of the
initiate, recommend or provide solutions through
d
documentation used in the quality system.
designated channels;
NOTE 6 Guidance on quality manuals is given in
verify the implementation of solutions; IS0 10013.
d)
e) control further processing, delivery or installation
4.2.2 Quality system procedures
of nonconforming product until the deficiency or
unsatisfactory condition has been corrected.
The supplier shall
a) prepare documented procedures consistent with
4.1.2.2 Resources
the requirements of this International Standard
and the supplier’s stated quality policy, and
The supplier shall identify resource requirements and
provide adequate resources, including the assignment
b) effectively implement the quality system and its
of trained personnel (see 4.18), for management,
documented procedures.
performance of work and verification activities includ-
ing internal quality audits.
j-or the purposes of this International Standard, the
range and detail of the procedures that form part of
the quality system shall be dependent upon the com-
4.1.2.3 Management representative
plexity of the work, the methods used, and the skills
and training needed by personnel involved in carrying
The supplier’s management with executive responsi-
out the activity.
bility shall appoint a member of the supplier’s own
management who, irrespective of other responsi-
NOTE 7 Documented procedures may make reference to
bilities, shall have defined authority for
nstructions that define how an activity is performed.
work i
a) ensuring that a quality system is established, im-
4.2.3 Quality planning
plemented and maintained in accordance with this
International Standard, and
The supplier shall define and document how the re-
quirements for quality will be met. Quality planning
b) reporting on the performance of the quality sys-
shall be consistent with all other requirements of a
tem to the supplier’s management for review and
supplier’s quality system and shall be documented in
as a basis for improvement of the quality system.
a format to suit the supplier’s method of operation.
The supplier shall give consideration to the following
NOTE 5 The responsibility of a management represen-
activities, as appropriate, in meeting the specified re-
tative may also include liaison with external parties on mat-
ters relating to the supplier’s quality system. quirements for products, projects or contracts:
---------------------- Page: 8 ----------------------
0 IS0 IS0 9002: 1994(E)
b) any differences between the contract or order re-
a) the preparation of quality plans;
quirements and those in the tender are resolved;
the identification and acquisition of any controls,
b)
c) the supplier has the capability to meet the con-
processes, equipment (including inspection and
tract or order requirements.
test equipment), fixtures, resources and skills that
may be needed to achieve the required quality;
4.3.3 Amendment to a contract
ensuring the compatibility of the production pro-
cl
cess, installation, servicing, inspection and test
The supplier shall identify how an amendment to a
procedures and the applicable documentation;
contract is made and correctly transferred to the
functions concerned within the supplier’s organiz-
the updating, as necessary, of quality control, in-
d)
ation.
spection and testing techniques, including the
development of new instrumentation;
4.3.4 Records
e) the identification of any measurement require-
Records of contract reviews shall be maintained (see
ment involving capability that exceeds the known
4.16).
state of the art, in sufficient time for the needed
capability to be developed;
NOTE 9 Channels for communication and interfaces with
the customer’s organization in these contract matters
the identification of suitable verification at appro-
f)
should be established.
priate stages in the realization of product;
4.4 Design control
the clarification of standards of acceptability for
9)
all features and requirements, including those
The scope of this International Standard does not in-
which contain a subjective element;
clude quality-system requirements for design control.
This subclause is included to align the clause num-
the identification and preparation of quality rec-
h)
bering with IS0 9001.
ords (see 4.16).
NOTE 8 The quality plans referred to [see 4.2.3a)] may
4.5 Document and data control
be in the form of a reference to the appropriate documented
procedures that form an integral part of the supplier’s qual-
4.5.1 General
ity system.
The supplier shall establish and maintain documented
procedures to control all documents and data that re-
4.3 Contract review
late to the requirements of this International Standard
including, to the extent applicable, documents of ex-
4.3.1 General ternal origin such as standards and customer
drawings.
The supplier shall establish and maintain documented
NOTE 10 Documents and data can be in the form of any
procedures for contract review and for the coordi-
type of media, such as hard copy or electronic media.
nation of these activities.
4.5.2 Document and data approval and issue
4.3.2 Review
The documents and data shall be reviewed and ap-
Before submission of a tender, or the acceptance of
proved for adequacy by authorized personnel prior to
a contract or order (statement of requirement), the
issue. A master list or equivalent document control
tender, contract or order shall be reviewed by the
procedure identifying the current revision status of
supplier to ensure that:
documents shall be established and be readily avail-
able to preclude the use of invalid and/or obsolete
a) the requirements are adequately defined and
documents.
documented; where no written statement of re-
quirement is available for an order received by This control shall ensure that:
verbal means, -the supplier shall ensure that the
a) the pertinent issues of appropriate documents are
order requirements are agreed before their ac-
available at all locations where operations essen-
ceptance;
3
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IS0 9002: 1994(E) (Q IS0
tial to the effective functioning of the quality sys- 4.6.3 Purchasing data
tem are performed;
Purchasing documents shall contain data clearly de-
b) invalid and/or obsolete documents are promptly
scribing the product ordered, including where appli-
removed from all points of issue or use, or other-
cable:
wise assured against unintended use;
a) the type, class, grade or other precise identifi-
c) any obsolete documents retained for legal and/or
cation;
knowledge-preservation purposes are suitably
b) the title or other positive identification, and appli-
identified.
cable issues of specifications, drawings, process
requirements,. inspection instructions and other
relevant technical data, including requirements for
4.5.3 Document and data changes
approval or qualification of product, procedures,
process equipment and personnel;
Changes to documents and data shall be reviewed
and approved by the same functions/organizations
c) the title, number and issue of the quality system
that performed the original review and approval, un-
standard to be applied.
less specifically designated otherwise. The desig-
nated functions/organizations shall have access to
The supplier shall review and approve purchasing
pertinent background information upon which to base
documents for adequacy of the specified require-
their review and approval.
ments prior to release.
Where practicable, the nature of the change shall be
4.6.4 Verification of purchased product
identified in the document or the appropriate attach-
ments.
4.6.4.1 Supplier verification at subcontractor’s
premises
4.6 Purchasing Where the supplier proposes to verify purchased
product at the subcontractor’s premises, the supplier
shall specify verification arrangements and the
method of product release in the purchasing docu-
4.6.1 General
ments.
The supplier shall establish and maintain documented
procedures to ensure that purchased product (see 4.6.4.2 Customer verification of subcontracted
3.1) conforms to specified requirements. product
Where specified in the contract, the supplier’s cus-
tomer or the customer’s representative shall be af-
Evaluation of subcontractors
4.6.2
forded the right to verify at the subcontractor’s
premises and the supplier’s premises that subcon-
The supplier shall:
tracted product conforms to specified
...
NORME
IS0
INTERNATIONALE 9002
Dew&me bdition
1994-07-01
Systhmes qualit - ModQle pour
I’assurance de la qualit en production,
installation et prestations associbes
Quality systems - Model for quality assurance in production, installation
and servicing
Numbro de rbfbrence
IS0 9002: 1994(F)
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IS0 9002: 1994(F)
Sommaire
Page
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
1 Domaine d’application
1
2 Reference normative . . . . . . . . . . . .*.
1
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . .I.*.* 2
4 Exigences en mat&e de systeme qualite
.,.,.,.,.,.,.,.,., 2
4.1 Responsabilite de la direction
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Systeme qualite
3
4.3 Revue de contrat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
,.,,.,,.,,.,,,,.,.,,,,,.,.,.,.
4.4 MaTtrise de la conception
..,........................... 4
4.5 Maltrise des documents et des donnees
4
4.6 Achats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.7 Mai’trise du produit fourni par le client
5
Identification et tracabilite du produit . . . . . . . . . . . . . . . . .*.
4.8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
4.9 MaRrise des processus
6
4.10 Controles et essais . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
MaTtrise des equipements de controle, de mesure et d’essai
4.11
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.12 &at des controles et des essais
7
4.13 Ma%rise du produit non conforme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
..,.,.,.,,...,.,...,.,....,............ 8
4.14 Actions correctives et preventives
4.15 Manutention, stockage, conditionnement, preservation et
8
livraison . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
. . . . . . . . . . . . . . . . 9
4.16 Maltrise des enregistrements relatifs 8 la qualite
9
Audits qualite internes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.17
9
4.18 Formation .=*.,.,.
9
4.19 Prestations associees . . . . . . . .I.
Techniques statistiques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4.20
0 IS0 1994
Droits de reproduction r&erv6s. 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
Imprime en Suisse
ii
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IS0 goo2:1994( F)
@a IS0
Annexe
11
.,.,.,.,.,,.,.=.
A Bibliographie
. . .
III
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0 IS0
IS0 9002: 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 interesse 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 requiet-t I’approbation de 75 % au moins des co-
mites membres votants.
La Norme internationale IS0 9002 a ete elaboree par le comite technique
lSO/TC 176, Management et assurance de la qualit& sous-comite SC 2,
Systhmes qualitk
Cette deuxieme edition annule et remplace la premiere edition
e constitue une revision technique.
(IS0 9002:1987), d on t e II
L’annexe A de la presente Norme internationale est donnee uniquement
a titre d’information.
---------------------- Page: 4 ----------------------
0 IS0
IS0 9002: 1994(F)
Introduction
La presente Norme internationale fait partie d’une serie de trois Normes
internationales sur les exigences en matiere de systeme qualite qui peu-
vent etre utilisees dans le cadre de l’assurance externe de la qualite. Les
modeles pour I’assurance de la qualite, definis dans les trois Normes
internationales mentionnees ci-dessous, decrivent trois formes distinctes
d’exigences en matiere de systeme qualite qui conviennent pour la de-
monstration des aptitudes d’un fournisseur et leur evaluation par des par-
ties externes.
a) IS0 9001, Systhmes qualit - ModHe pour I’assurance de la qualit
en conception, dheloppemen t, production, ins talla tion et pres ta tions
associ6es
- 8 utiliser lorsque la conformite a des exigences specifiees est 8
assurer par le fournisseur pendant la conception, le develop-
pement, la production, I’installation et les prestations associees.
b) IS0 9002, Systemes qualit - Mod&le pour I’assurance de la qualit
en production, ins talla tion et pres ta tions associ&es
- a utiliser lorsque la conformite 8 des exigences specifiees est 8
assurer par le fournisseur pendant la production, I’installation et les
prestations associees.
c) IS0 9003, SystGmes qualit - Mod&le pour I’assurance de la qualit
en con tr6le et essais finals
- a utiliser lorsque la conformite a des exigences specifiees est a
assurer par le fournisseur uniquement lors des controles et essais
finals.
II faut souligner que les exigences en mat&e de systeme qualite, speci-
frees dans la presente Norme internationale, dans I’ISO 9001 et
I’ISO 9003, sont complementaires (et ne se substituent pas) aux exi-
gences techniques specifiees (pour le produit). Elles specifient des exi-
gences qui determinent les elements que doivent comprendre les
systemes qualite, mais leur but n’est pas d’imposer I’uniformite des sys-
temes qualite. Ces Normes internationales sont generiques, indepen-
dantes de tout secteur industriel ou economique particulier. La conception
et la mise en ceuvre d’un systeme qualite tiendront compte des differents
besoins d’un organisme, de ses objectifs particuliers, des produits et ser-
vices fournis et des processus et pratiques specifiques en usage.
II est prevu que ces Normes internationales soient utilisees telles quelles,
mais, dans certains cas, il peut etre necessaire de les ajuster en ajoutant
ou en supprimant certaines exigences de systeme qualite en fonction de
situations contractuelles particulieres. L’ISO 9000-l fournit des indications
sur cet ajustement et sur le choix du modele approprie pour I’assurance
de la qualite, a savoir IS0 9001, IS0 9002 ou IS0 9003.
---------------------- Page: 5 ----------------------
This page intentionally left blank
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE 0 IS0
IS0 9002: 1994(F)
Systhmes qualit - Modde pour I’assurance de la
qualit en production, installation et prestations
associbes
recente de la norme indiquee ci-apres. Les membres
1 Domaine d’application
de la CEI et de I’ISO possedent le registre des Nor-
mes internationales en vigueur a un moment donne.
La presente Norme internationale specific des exi-
gences en matiere de systeme qualite a utiliser lors-
IS0 8402:1994, Management de la qualit et assu-
que I’aptitude d’un fournisseur a fournir un produit
rance de la qualit - Vocabulaire.
conforme aI une conception etablie doit etre demon-
tree.
Les exigences specifiees visent en premier lieu la sa-
tisfaction du client, par la prevention des non-
3 Dbfinitions
conformites 8 tous les stades, depuis la production
jusqu’aux prestations associees.
Pour les besoins de la presente Norme internationale,
les definitions donnees dans I’ISO 8402 et les defini-
La presente Norme internationale est applicable lors-
tions suivantes s’appliquent.
we
3.1 produit: Resultat d’activites ou de processus.
a) les exigences specifiees pour le produit sont for-
mulees en termes de conception ou de specifica-
NOTES
tion etablie, et
2 Le terme produit peut inclure les services, les mat&iels,
b) la confiance dans la conformite du produit peut
les produits issus de processus $I caracthre continu, les lo-
etre obtenue par une demonstration adequate des
giciels, ou une combinaison des deux.
aptitudes d’un fournisseur en mat&e de produc-
3 Un produit peut &re materiel (par exemple, assem-
tion, installation et prestations associees.
blages ou produits issus de processus h caract&e continu)
ou immathiel (par exemple, connaissances ou concepts),
NOTE 1 Pour les &f&ences informatives, voir
ou une combinaison des deux.
annexe A.
4 Dans le cadre de la prhente Norme internationale, le
terme ((produit)) s’applique au produit intentionnel et ne
s’applique pas aux sous-produits non-intentionnels affectant
I’environnement. Ceci diffhre de la dhfinition donn6e dans
2 Rkfbrence normative
I’ISO 8402.
La norme suivante contient des dispositions qui, par
3.2 offre: Une offre est faite par un fournisseur en
suite de la reference qui en est faite, constituent des
reponse a un appel d’offre en vue de I’attribution d’un
dispositions valables pour la presente Norme interna-
contrat de fourniture d’un produit.
tionale. Au moment de la publication, l’edition indi-
quee etait en vigueur. Toute norme est sujette a
contrat: Exigences ayant fait I’objet d’un accord
revision et les parties prenantes des accords fond& 3.3
sur la presente Norme internationale sont invitees a entre un fournisseur et un client et transmises par un
rechercher la possibilite d’appliquer l’edition la plus moyen quelconque.
---------------------- Page: 7 ----------------------
0 IS0
IS0 9002: 1994(F)
d’autres responsabilites, doit avoir lane autorite definie
4 Exigences en matikre de systeme
pour
qualit
a) assurer qu’un systeme qualite est defini, mis en
4.1 Responsabilith de la direction
ceuvre et entretenu conformement a la presente
Norme internationale, et
4.1 .l Politique qualit
b) rendre compte du fonctionnement du systeme
La direction du fournisseur, qui a pouvoir de decision
qualite a la direction du fournisseur pour en faire
doit definir et consigner par ecrit sa politique en ma-
la revue et servir de base 8 I’amelioration du sys-
tiere de qualite, y compris ses objectifs et son enga-
teme qualite.
gement en la matiere. La politique qualite doit etre
NOTE 5
pertinente par rapport aux objectifs generaux du four- La responsabilitb du reprksentant de la direction
peut kgalement comprendre les relations avec des parties
nisseur et aux attentes et besoins de ses clients. Le
exthieurs en ce qui concerne les sujets relatifs au systkme
fournisseur doit assurer que cette politique est com-
qualit du fournisseur.
prise, mise en ceuvre et entrenue a tous les niveaux
de I’organisme.
4.1.3 Revue de direction
4.1.2 Organisation
La direction du fournisseur, qui a pouvoir de decision,
4.1.2.1 Responsabilith et autorite doit faire une revue du systeme qualite a une fre-
quence definie et suffisante pour assurer qu’il de-
La responsabilite, I’autorite et les relations entre les
meure constamment approprie et efficace afin de
personnes qui dirigent, executent et verifient des ta- satisfaire aux exigences de la presente Norme inter-
ches qui ont une incidence sur la qualite doivent etre
nationale ainsi qu’a la politique et aux objectifs qualite
definies par ecrit; cela concerne, en particulier les
fixes par le fournisseur (voir 4.1 .l). Des enregis-
personnes qui ont besoin de la liberte et de I’autorite
trements de ces revues doivent etre conserves (voir
sur le plan de I’organisation pour
4.16).
declencher des actions permettant de prevenir
a)
I’apparition de toute non-conformite relative au
4.2 Systhme qualit
produit, au processus et au systeme qualite;
4.2.1 G6nhalit6s
identifier et enregistrer tout probleme relatif au
b)
produit, au processus et au systeme qualite;
Le fournisseur doit etablir, consigner par ecrit et
entretenir un systeme qualite en tant que moyen pour
declencher, recommander ou fournir des solutions
d
assurer que le produit est conforme aux exigences
en suivant des circuits definis;
specifiees. Le fournisseur doit etablir un manuel qua-
lite couvrant les exigences de la presente Norme
verifier la mise en ceuvre des solutions;
d)
internationale. Le manuel qualite doit comprendre les
maltriser la poursuite des operations relatives au procedures du systeme qualite ou y faire reference,
e)
produit non conforme, sa livraison ou son instal- et exposer la structure de la documentation utilisee
lation jusqu’a ce que la deficience ou la situation dans le cadre du systeme qualite.
non satisfaisante ait ete corrigee.
NOTE 6 L’ISO 10013 fournit des conseils relatifs a Ma-
boration des manuels qualit&
4.1.2.2 Moyens
Le fournisseur doit identifier les exigences relatives
4.2.2 Prochdures du systeme qualit
aux moyens et fournir les moyens adequats, y com-
pris la designation de personnes formees (voir 4.18),
Le fournisseur doit
pour le management, I’execution et la verification des
taches, ainsi que les audits qualite internes.
a) etablir des procedures &rites coherentes avec les
exigences de la presente Norme internationale et
4.1.2.3 Representant de la direction
avec la politique qualite qu’il a formulee, et
irection du fournisseur, qui a pouvoir
La d de decision, b) mettre reellement en ceuvre le systeme qualite
nommer un de ses membres qui,
doit nonobstant et ses procedures &rites.
2
---------------------- Page: 8 ----------------------
@J IS0
IS0 9002: 1994(F)
NOTE 8 Les plans qualite mentionnes [voir 4.2.3a)]
Dans le cadre de la presente Norme internationale,
peuvent faire reference aux procedures &rites appropriees
l’etendue et le niveau de detail des procedures qui
qui font partie integrante du systeme qualite du fournisseur.
font partie du systeme qualite doivent dependre de la
complexite des tkhes, des methodes utilisees, des
competences et de la formation necessaires au per-
4.3 Revue de contrat
sonnel implique dans I’execution de ces taches.
NOTE 7 Les procedures &rites peuvent faire reference
4.3.1 Gh6ralit6s
a des instructions de travail qui definissent comment une
t&he est realisee.
Le fournisseur doit etablir et tenir a jour des procedu-
res &rites de revue de contrat et de coordination de
ces activites.
4.2.3 Planification de la qualit
Le fournisseur doit definir et consigner par ecrit com-
4.3.2 Revue
ment satisfaire les exigences pour la qualite. La pla-
nification de la qualite doit etre coherente avec
Avant soumission d’une offre ou acceptation d’un
I’ensemble des exigences du systeme qualite du
contrat ou d’une commande (formulation des exi-
fournisseur et doit etre consignee sous une forme
gence& l’offre, le contrat ou la commande doit etre
adaptee aux methodes de travail du fournisseur. Ce
revu(e) par le fournisseur afin d’assurer que
dernier doit porter toute son attention sur les activites
suivantes, s’il y a lieu, pour satisfaire aux exigences
a) les exigences sont definies et documentees de
specifiees pour les produits, les projets ou les con-
facon adequate; lorsqu’il n’existe pas d’exigences
trats:
&rites pour une commande verbale, le fournis-
seur doit assurer que les exigences de cette
l’etablissement de plans qualite;
a)
commande ont bien fait I’objet d’un accord avant
d’etre acceptees;
b) I’identification et I’acquisition de tous moyens de
maTtrise des activites, processus, equipements (y
b) toute difference entre les exigences d’un contrat
compris les equipements de controle et d’essai),
ou d’une commande et celles de l’offre a fait
dispositifs, ensemble des moyens et compe-
I’objet d’une solution;
tences qui peuvent etre necessaires pour obtenir
la qualite requise;
c) le fournisseur presente I’aptitude 8 satisfaire aux
exigences du contrat ou de la commande.
c) I’assurance de la compatibilite du processus de
production,: de I’instaI;la.ti.on, des prestations asso-
4.3.3 Avenant au contrat
c&es, des procedures de controle et d’essai et de
la documentation applicable;
Le fournisseur doit definir comment un avenant a un
contrat est traite et comment il le transmet correc-
d) la mise a jour, autant que necessaire, des techni-
tement aux fonctions concernees de son organisation.
ques de maltrise de la qualite, de controle et
d’essai, y compris le developpement d’une nou-
velle instrumentation;
4.3.4 Enregistrements
I’identification, en temps voulu, de toute exigence
e)
Des enregistrements de ces revues de contrat doi-
en mat&e de mesurage mettant en jeu une apti-
vent etre conserves (voir 4.16).
tude qui depasse les possibilites actuelles de
l’etat de I’art, afin de developper I’aptitude neces-
NOTE 9 II convient de constituer des circuits de com-
saire; munication et des interfaces avec le client en mat&e de
contrat.
des verifications adequates aux
I’identification
phases appropriees de la realisation du produit;
4.4 Maitrise de la conception
g) la clarification des normes d’acceptation pour
Le domaine d’application de la presente Norme inter-
toutes les caracteristiques et exigences, y com-
nationale ne comprend pas d’exigences de systeme
pris celles qui contiennent un element subjectif;
qualite pour la maTtrise de la conception. Ce paragra-
phe est inclus afin d’aligner la numerotation des arti-
h) I’identification et la preparation d’enregistrements
cles avec I’ISO 9001.
relatifs % la qualit (voir 4.16).
---------------------- Page: 9 ----------------------
0 IS0
IS0 9002: 1994(F)
4.6.4 Verification du produit achetk
4.9 Ma’itrise des processus
4.6.4.1 Vbrification par le fournisseur chez le
sous-contractant
Le fournisseur doit identifier et planifier les processus
Lorsque le fournisseur a I’intention de verifier le pro-
de production, d’installation et les processus relatifs
duit achete chez le sous-contractant, il doit specifier
aux prestations associees qui ont une incidence di-
dans les documents d’achat les dispositions 8 prendre
recte sur la qualite, et il doit aussi assurer que ces
pour la verification et les modalites de mise 8 dispo-
processus sont mis en oeuvre dans des conditions
sition du produit. ma7trisees. Ces dernieres doivent comprendre
a) des prochdures &rites dbfinissant les pratiques
4.6.4.2 Vkification par le client du produit
de production, d’installation et les pratiques rela-
sous-contract6
tives aux prestations associhes lorsque l’absence
de ces proc6dures pourrait avoir une incidence
Lorsque cela est specific dans le contrat, le client du
nefaste sur la qualite;
fournisseur ou son representant doit avoir le droit de
verifier dans les Iocaux du sous-contractant et du
b) I’utilisation d’kquipements ad6quats pour la pro-
fournisseur que le produit sous-contracte est
duction, l’installation et les prestations associees,
conforme aux exigences specifiees. Cette verification
ainsi qu’un environnement de travail approprie;
ne doit pas etre utilisee par le fournisseur comme
preuve de la maTtrise effective de la qualite par le
c) la conformite aux normes et codes de reference,
sous-contractant.
aux plans qualite et/au aux procedures &rites;
La verification par le client ne doit pas decharger le
d) le pilotage et la ma2rise des parametres des pro-
fournisseur de sa responsabilite de fournir un produit
cessus et des caracteristiques du produit appro-
acceptable, ni empecher un rejet ulterieur du produit
pries;
par le client.
e) I’approbation des processus et de I’equipement,
s’il y a lieu;
4.7 Maitrise du produit fourni par le client
f) les criteres d’execution qui doivent etre prescrits
Le fournisseur doit etablir et tenir 8 jour des procedu-
le plus clairement possible (par exemple au
res &rites pour la verification, le stockage et la pre-
moyen de normes &rites, d’echantillons repre-
servation du produit fourni par le client pour etre
sentatifs ou d’illustrations);
i
...
SLOVENSKI SIST ISO 9002
druga izdaja
STANDARD
junij 1995
Sistemi kakovosti - Model zagotavljanja kakovosti v proizvodnji,
vgradnji in servisiranju (identi~en z ISO 9002:1994)
Quality sistems - Model for quality assurance in production, installation
and servicing
Systèmes qualité - Modèle pour l’assurance de la qualité en production,
installation et prestations associées
Qualitaetssicherungssysteme - Modell zur Darlegung des
Qualitaetsmanagementsystems in Produktion, Montage und Wartung
Deskriptorji: zagotavljanje kakovosti, program zagotavljanja kakovosti, sistemi
zagotavljanja kakovosti, proizvodnja, vgradnja, poprodajne storitve,
referen~ni modeli
Referen~na {tevilka
ICS 03.120.10 SIST ISO 9002:1995 (sl, en)
Nadaljevanje na straneh od 2 do 30
© Standard je zalo`il in izdal Urad Republike Slovenije za standardizacijo in meroslovje pri Ministrstvu za znanost in tehnologijo.
Razmno`evanje ali kopiranje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST ISO 9002 : 1995
UVOD
Standard SIST ISO 9002, Sistemi kakovosti - Model zagotavljanja kakovosti v proizvodnji,
vgradnji in servisiranju, druga izdaja, 1995, ima status slovenskega standarda in je identi~en
mednarodnemu standardu ISO 9002, Quality sistems - Model for quality assurance in
production, installation and servicing, second edition, 1994-07-01.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 9002:1994 je pripravil tehni~ni odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje kakovosti in zagotavljanje kakovosti. Slovenski standard
SIST ISO 9002:1995 je prevod angle{kega besedila mednarodnega standarda ISO 9002:1994.
V primeru spora glede besedila slovenskega prevoda v tem standardu je odlo~ilen izvirni
mednarodni standard v angle{kem jeziku. Slovensko-angle{ko izdajo standarda je pripravil
tehni~ni odbor USM/TC QAS Zagotavljanje kakovosti.
Ta slovenski standard je dne 1995-06-23 odobril direktor USM.
ZVEZE S STANDARDI
S prevzemom tega mednarodnega standarda veljajo naslednje zveze:
SIST ISO 8402:-* idt ISO 8402:1994
*
SIST ISO 9000-1:- idt ISO 9000-1:1994
SIST ISO 9001:1995 idt ISO 9001:1994
SIST ISO 9003:1995 idt ISO 9003:1994
SIST ISO 9004-1:-* idt ISO 9004-1:1994
Oznake in naslovi navedenih slovenskih standardov so:
SIST ISO 8402:-* Vodenje kakovosti in zagotavljanje kakovosti - Slovar (identi~en z ISO
8402:1994)
SIST ISO 9000-1:-* Standardi za vodenje in zagotavljanje kakovosti - 1. del: Smernice za
izbiro in uporabo (identi~en z ISO 9000-1:1994)
SIST ISO 9001:1995 Sistemi kakovosti - Model zagotavljanja kakovosti v razvoju,
proizvodnji, vgradnji in servisiranju (identi~en z ISO 9001:1994)
SIST ISO 9003:1995 Sistemi kakovosti - Model zagotavljanja kakovosti v kon~ni kontroli in
presku{anju (identi~en z ISO 9003:1994)
SIST ISO 9004-1:-* Vodenje kakovosti in elementi sistema kakovosti - Smernice (identi~en
z ISO 9004-1:1994)
PREDHODNE IZDAJE
- SLS ISO 9002:1992
*
V pripravi.
2
---------------------- Page: 2 ----------------------
SIST ISO 9002 : 1995
OSNOVA ZA IZDAJO STANDARDA
- Prevzem standarda ISO 9002:1994, druga izdaja
OPOMBE:
- Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, pomeni to
v SIST ISO 9002:1995 “slovenski standard”.
- Uvod in nacionalni predgovor nista sestavni del standarda.
- Povsod, kjer se v angle{kem besedilu uporabljata besedi “design” in “development”, je
to v slovenskem besedilu standarda prevedeno kot “razvoj”.
- Slovenski standard SIST ISO 9002:1995 je identi~en tudi EN ISO 9002:1994.
3
---------------------- Page: 3 ----------------------
SIST ISO 9002 : 1995
VSEBINA stran CONTENTS page
1 Predmet.8 1 Scope.8
2 Zveza z drugimi standardi.8 2 Normative reference.8
3 Definicije.9 3 Definitions.9
4 Zahteve za sistem kakovosti.9 4 Quality system requirements.9
4.1 Odgovornost vodstva.9 4.1 Management responsibility.9
4.2 Sistem kakovosti.11 4.2 Quality system.11
4.3 Pregled pogodbe.13 4.3 Contract review.13
4.4 Obvladovanje razvoja.14 4.4 Design control.14
4.5 Obvladovanje dokumentov in 4.5 Document and data control.14
podatkov.14
4.6 Nabava.15 4.6 Purchasing.15
4.7 Obvladovanje proizvodov, ki 4.7 Control of customer-supplied
jih dobavi odjemalec.17 product.17
4.8 Identifikacija in sledljivost 4.8 Product identification and
proizvodov.17 traceability.17
4.9 Obvladovanje procesa.17 4.9 Process control.17
4.10 Kontrola in presku{anje.18 4.10 Inspection and testing.18
4.11 Obvladovanje kontrolne, merilne 4.11 Control of inspection, measuring
in preskusne opreme.20 and data test equipment.20
4.12. Status kontroliranja in 4.12 Inspection and test status.23
presku{anja.23
4.13 Obvladovanje neskladnih 4.13 Control of nonconforming
proizvodov.23 product.23
4.14 Korektivni in preventivni ukrepi.24 4.14 Corrective and preventive action.24
4.15 Ravnanje, skladi{~enje, 4.15 Handling, storage, packaging,
pakiranje, za{~ita in dostava.25 preservation and delivery.25
4.16 Obvladovanje zapisov o 4.16 Control of quality records.26
kakovosti.26
4.17 Notranje presoje kakovosti.27 4.17 Internal quality audits.27
4.18 Usposabljanje.27 4.18 Training.27
4.19 Servisiranje.28 4.19 Servicing.28
4.20 Statisti~ne metode.28 4.20 Statistical techniques.28
Dodatek Annex
A Bibliografija.29 A Bibliography.29
4
---------------------- Page: 4 ----------------------
SIST ISO 9002 : 1995
PREDGOVOR FOREWORD
ISO (Mednarodna organizacija za ISO (the International Organization for
standardizacijo) je svetovna zveza Standardization) is a worldwide federation of
nacionalnih organov za standarde (~lanov national standards bodies (ISO member
ISO). Mednarodne standarde obi~ajno bodies). The work of preparing International
pripravljajo tehni~ni odbori ISO. Vsak ~lan, Standards is normally carried out through
ki `eli delovati na dolo~enem podro~ju, za ISO technical committees. Each member
katero je ustanovljen tehni~ni odbor, ima body interested in a subject for which a
pravico biti zastopan v tem odboru. Pri delu technical committee has been established
has the right to be represented on that
sodelujejo tudi vladne in nevladne
mednarodne organizacije, povezane z ISO. committee. International organizations,
V vseh zadevah, ki so povezane s governmental and non-governmental, in
standardizacijo na podro~ju elektrotehnike, liasion with ISO, also take part in the work.
ISO tesno sodeluje z Mednarodno ISO collaborates closely with the
International Electrotechnical Commission
elektrotehni{ko komisijo (IEC).
(IEC) on all matters of electrotechnical
standardization.
Osnutki mednarodnih standardov, ki jih Draft International Standards adopted by the
sprejmejo tehni~ni odbori, se po{ljejo vsem technical committees are circulated to the
~lanicam v glasovanje. Za objavo member bodies for voting. Publication as an
mednarodnega standarda je treba pridobiti International Standard requires approval by
soglasje najmanj 75 odstotkov ~lanic, ki se at least 75 % of the member bodies
udele`ijo glasovanja. casting a vote.
Mednarodni standard ISO 9002 je pripravil International Standard ISO 9002 was
tehni~ni odbor ISO/TC 176 Vodenje prepared by Technical Committee ISO/TC
kakovosti in zagotavljanje kakovosti, 176, Quality management and quality
pododbor SC 2 Sistemi kakovosti. assurance, Subcommittee SC 2, Quality
systems.
Ta, druga izdaja preklicuje in zamenjuje This second edition cancels and replaces
prvo (ISO 9002:1987), ki je bila tehni~no the first edition (ISO 9002:1987), which has
predelana. been technically revised.
Dodatek A tega mednarodnega standarda je Annex A of this International Standard is for
podan samo kot informacija. information only.
5
---------------------- Page: 5 ----------------------
SIST ISO 9002 : 1995
UVOD INTRODUCTION
Ta mednarodni standard je eden od treh This International Standard is one of three
mednarodnih standardov, ki obravnavajo International Standards dealing with quality
zahteve za sistem kakovosti in se lahko system requirements that can be used for
uporabljajo za zagotavljanje kakovosti external quality assurance purposes. The
navzven. Modeli zagotavljanja kakovosti, quality assurance models, set out in the
opisani v treh spodaj navedenih three International Standards listed below,
mednarodnih standardih, predstavljajo tri represent three distinct forms of quality
razli~ne oblike zahtev za sistem kakovosti, system requirements suitable for the
ki so primerne tako, kadar dobavitelj `eli purpose of a supplier demonstrating its
dokazati svojo sposobnost, kot tudi, kadar capability, and for the assessment of the
`eli sposobnosti dobavitelja oceniti zunanja capability of a supplier by external parties.
stranka.
a) ISO 9001, Sistemi kakovosti - Model a) ISO 9001, Quality systems - Model for
zagotavljanja kakovosti v razvoju, quality assurance in design,
proizvodnji, vgradnji in servisiranju development, production, installation
and servicing
Uporablja se, kadar mora dobavitelj
zagotoviti skladnost s specificiranimi - for use when conformance to
zahtevami v razvoju, proizvodnji, specified requirements is to be
vgradnji in servisiranju. assured by the supplier during design,
development, production, installation
and servicing.
b) ISO 9002, Sistemi kakovosti - Model b) ISO 9002, Quality systems - Model for
zagotavljanja kakovosti v proizvodnji, quality assurance in production,
vgradnji in servisiranju installation and servicing
Uporablja se, kadar mora dobavitelj - for use when conformance to
zagotoviti skladnost s specificiranimi specified requirements is to be
zahtevami v proizvodnji, vgradnji in assured by the supplier during
servisiranju. production, installation and servicing.
c) ISO 9003, Sistemi kakovosti - Model c) ISO 9003, Quality systems - Model for
zagotavljanja kakovosti v kon~ni quality assurance in final inspection
kontroli in presku{anju and test
Uporablja se, kadar mora dobavitelj - for use when conformance to
zagotoviti skladnost s specificiranimi specified requirements is to be
zahtevami samo v kon~ni kontroli in assured by the supplier solely at final
presku{anju. inspection and test.
Poudariti je treba, da so zahteve za sistem It is emphasized that the quality system
kakovosti, specificirane v tem mednarodnem requirements specified in this International
standardu in v standardih ISO 9001 in ISO Standard, ISO 9001 and ISO 9003 are
9003, samo dopolnilo (ne zamenjava) complementary (not alternative) to the
tehni~nim zahtevam (za proizvod). Podrobno technical (product) specified requirements.
specificirajo zahteve, ki dolo~ajo, katere They specify requirements which determine
elemente morajo vsebovati sistemi kakovosti, what elements quality systems have to
pri ~emer ti mednarodni standardi nimajo encompass, but it is not the purpose of
namena vsiljevati enoli~nosti sistemov these International Standards to enforce
kakovosti. Ti standardi so splo{ni in uniformity of quality systems. They are
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SIST ISO 9002 : 1995
neodvisni od katerekoli specifi~ne industrije generic and independent of any specific
ali gospodarskega sektorja. Na razvoj in industry or economic sector. The design
izvedbo sistema kakovosti bodo vplivale and implementation of a quality system will
razli~ne potrebe organizacije, njeni posebni be influenced by the varying needs of an
cilji, vrste proizvodov in storitev ter organization, its particular objectives, the
uporabljeni procesi in specifi~ni postopki products and services supplied, and the
izvajanja. processes and specific practices employed.
Namen je, da se ti mednarodni standardi It is intended that these International
uporabljajo v izvirni obliki, vendar se v Standards will be adopted in their present
posebnih primerih z dodajanjem ali form, but on occasions they may need to
odvzemanjem dolo~enih zahtev za sistem be tailored by adding or deleting certain
kakovosti lahko prilagodijo specifi~nim quality system requirements for specific
pogodbenim situacijam. Vodila za take contractual situations. ISO 9000-1 provides
prilagoditve kakor tudi navodila za izbiro guidance on such tailoring as well as on
ustreznega modela zagotavljanja kakovosti, selection of the appropriate quality
to je izbiro standarda ISO 9001, ISO 9002 assurance model, viz ISO9001, ISO 9002
ali ISO 9003, vsebuje standard ISO 9000-1. or ISO 9003.
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SIST ISO 9002 : 1995
Sistemi kakovosti - Model Quality systems - Model for
zagotavljanja kakovosti v quality assurance in
proizvodnji, vgradnji in production, installation and
servisiranju servicing
1 Predmet 1 Scope
Ta mednarodni standard specificira zahteve This International Standard specifies quality
za sistem kakovosti. Uporablja se, kadar system requirements for use where a
mora dobavitelj dokazati sposobnost, da supplier's capability to supply conforming
dobavlja `e v razvoju osvojen proizvod. product to an established design needs to
be demonstrated.
Navedene zahteve so namenjene predvsem The requirements specified are aimed
doseganju zadovoljstva odjemalca tako, da primarily at achieving customer satisfaction
se neskladnosti prepre~ujejo v vseh fazah by preventing nonconformity at all stages
od proizvodnje do servisiranja. from production through to servicing.
Ta mednarodni standard se uporablja: This International Standard is applicable in
situations when
a) ko so zahtevane lastnosti proizvoda a) the specified requirements for product
izra`ene z `e sprejeto dokumentacijo are stated in terms of an established
razvoja ali specifikacijo in design or specification, and
b) kadar je mogo~e dose~i zaupanje v b) confidence in product conformance
skladnost proizvoda s primernim can be attained by adequate
prikazom zmo`nosti dobavitelja v demonstration of a supplier's
proizvodnji, vgradnji in servisiranju. capabilities in production, installation
and servicing.
Opomba 1: Informativne reference glej v dodatku A. NOTE 1 For informative references, see annex A.
2 Zveza z drugimi standardi 2 Normative reference
Spodaj navedeni standard vsebuje dolo~ila, The following standard contains provisions
ki v povezavi s tem besedilom tvorijo which, through reference in this text,
dolo~ila tega mednarodnega standarda. V constitute provisions of this International
~asu objave je bila veljavna spodaj Standard. At the time of publication, the
navedena izdaja. Vsi standardi se revidirajo edition indicated was valid. All standards
in strankam, ki sklenejo pogodbo, are subject to revision, and parties to
zasnovano na tem mednarodnem standardu, agreements based on this International
se priporo~a, naj razi{~ejo mo`nost uporabe Standard are encouraged to investigate the
najnovej{e izdaje spodaj navedenega possibility of applying the most recent
standarda. ^lani IEC in ISO vzdr`ujejo edition of the standard indicated below.
register veljavnih mednarodnih standardov. Members of IEC and ISO maintain registers
of currently valid International Standards.
ISO 8402:1994, Vodenje kakovosti in ISO 8402:1994, Quality management and
zagotavljanje kakovosti - Slovar quality assurance - Vocabulary
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SIST ISO 9002 : 1995
3 Definicije 3 Definitions
V tem mednarodnem standardu se For the purposes of this International
uporabljajo definicije, podane v standardu Standard, the definitions given in ISO 8402
ISO 8402, in naslednje definicije: and the following definitions apply.
3.1 Proizvod: Rezultat aktivnosti ali 3.1 product: Result of activities or
procesov. processes.
Opombe: 2 Proizvod je lahko storitev, strojna NOTES 2A product may include service,
oprema, predelani materiali, programska hardware, processed materials, software
oprema ali njihova kombinacija. or a combination thereof.
3 Proizvod je lahko materialen (na primer 3 A product can be tangible (e.g.
sestavi ali predelani materiali) ali assemblies or processed materials) or
nematerialen (na primer znanje ali intangible (e.g. knowledge or concepts),
zamisli) ali kombinacija obeh. or a combination thereof.
4 V tem mednarodnem standardu se izraz 4 For the purposes of this International
“proizvod” nana{a samo na namerni Standard, the term “product” applies to
ponujeni proizvod, ki se nudi, in ne na the intended product offering only and
nenamerne "stranske" proizvode, ki not to unintended “by-products” affecting
vplivajo na okolje. V tem je razlika v the environment. This differs from the
primerjavi z definicijo proizvoda, podano definition given in ISO 8402.
v standardu ISO 8402.
3.2 Ponudba na razpis (tender): Ponudba, 3.2 tender: Offer made by a supplier in
ki jo pripravi dobavitelj kot odgovor na response to an invitation to satisfy a
povabilo za izpolnitev pogodbenih dolo~il contract award to provide product.
za dobavo proizvoda.
3.3 Pogodba: Dogovorjene zahteve med 3.3 contract: Agreed requirements
dobaviteljem in odjemalcem, sporo~ene na between a supplier and customer
kakr{enkoli na~in. transmitted by any means.
4 Zahteve za sistem kakovosti 4 Quality system requirements
4.1 Odgovornost vodstva 4.1 Management responsibility
4.1.1 Politika kakovosti 4.1.1 Quality policy
Vodstvo dobavitelja z izvr{ilno odgovornostjo The supplier's management with executive
mora dolo~iti in dokumentirati svojo politiko responsibility shall define and document its
kakovosti, vklju~no s cilji kakovosti in s policy for quality, including objectives for
svojo zavezanostjo za kakovost. Politika quality and its commitment to quality. The
kakovosti mora biti primerna dobaviteljevim quality policy shall be relevant to the
organizacijskim ciljem ter pri~akovanjem in supplier's organizational goals and the
potrebam njegovih odjemalcev. Dobavitelj expectations and needs of its customers.
mora zagotoviti, da politiko kakovosti The supplier shall ensure that this policy is
razumejo, izvajajo in vzdr`ujejo na vseh understood, implemented and maintained at
ravneh organizacije. all levels of the organization.
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SIST ISO 9002 : 1995
4.1.2 Organizacija 4.1.2 Organization
4.1.2.1 Odgovornosti in pooblastila 4.1.2.1 Responsibility and authority
Odgovornosti, pooblastila in medsebojni The responsibility, authority and the
odnos osebja, ki vodi, izvaja in overja delo, interrelation of personnel who manage,
ki vpliva na kakovost, morajo biti dolo~eni perform and verify work affecting quality
in dokumentirani, {e posebej za tisto shall be defined and documented,
osebje, ki potrebuje organizacijsko svobodo particularly for personnel who need the
in pooblastila za: organizational freedom and authority to:
a) uvajanje ukrepov, s katerimi se a) initiate action to prevent the
prepre~uje pojavljanje neskladnosti pri occurrence of any nonconformities
proizvodih, v procesih in v sistemih relating to the product, process and
kakovosti; quality system;
b) identificiranje in zapisovanje vseh b) identify and record any problems
problemov, povezanih s proizvodom, relating to the product, process and
procesom in sistemom kakovosti; quality system;
c) uvajanje, priporo~anje ali omogo~anje c) initiate, recommend or provide
izvedbe re{itev po ustaljenih poteh; solutions through designated channels;
d) overjanje izvajanja re{itev; d) verify the implementation of solutions;
e) nadzor nadaljnje obdelave, dostave ali e) control further processing, delivery or
vgradnje neskladnega proizvoda, installation of nonconforming product
dokler pomanjkljivost ali nezadovoljivo until the deficiency or unsatisfactory
stanje ni odpravljeno. condition has been corrected.
4.1.2.2 Viri 4.1.2.2 Resources
Dobavitelj mora identificirati zahteve v zvezi The supplier shall identify resource
z viri in zagotoviti primerne vire, vklju~no z requirements and provide adequate
imenovanjem usposobljenega osebja (glej resources, including the assignment of
4.18) za vodenje, izvajanje dela in trained personnel (see 4.18), for
overitvene aktivnosti, vklju~no z notranjimi management, performance of work and
presojami kakovosti. verification activities including internal quality
audits.
4.1.2.3 Predstavnik vodstva 4.1.2.3 Management representative
Dobaviteljevo vodstvo z izvr{ilno The supplier's management with executive
odgovornostjo mora imenovati ~lana responsibility shall appoint a member of the
dobaviteljevega lastnega vodstva, ki mora supplier's own management who,
imeti ne glede na druge odgovornosti irrespective of other responsibilities, shall
dolo~ena pooblastila za: have defined authority for
a) zagotavljanje, da je sistem kakovosti a) ensuring that a quality system is
vzpostavljen, da se izvaja in vzdr`uje established, implemented and
v skladu s tem mednarodnim maintained in accordance with this
standardom, in International Standard, and
b) poro~anje o delovanju sistema b) reporting on the performance of the
kakovosti dobaviteljevemu vodstvu za quality system to the supplier's
pregled in kot osnovo za izbolj{anje management for review and as a
sistema kakovosti. basis for improvement of the quality
system.
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SIST ISO 9002 : 1995
Opomba 5: Odgovornost predstavnika vodstva lahko NOTE 5 The responsibility of a management
vklju~uje tudi sodelovanje z zunanjimi representative may also include liaison
strankami v zadevah, povezanih z with external parties on matters relating
dobaviteljevim sistemom kakovosti. to the supplier's quality system.
4.1.3 Pregled s strani vodstva 4.1.3 Management review
Dobaviteljevo vodstvo z izvr{ilno The supplier's management with executive
odgovornostjo mora pregledovati sistem responsibility shall review the quality system
kakovosti v dolo~enih ~asovnih presledkih, at defined intervals sufficient to ensure its
zadostnih da sta zagotovljeni stalna continuing suitability and effectiveness in
ustreznost in u~inkovitost v izpolnjevanju satisfying the requirements of this
zahtev tega mednarodnega standarda ter International Standard and the supplier's
izra`eni politika in cilji kakovosti dobavitelja stated quality policy and objectives (see
(glej 4.1.1). Vzdr`evati se morajo zapisi o 4.1.1). Records of such reviews shall be
pregledih (glej 4.16). maintained (see 4.16).
4.2 Sistem kakovosti 4.2 Quality system
4.2.1 Splo{no 4.2.1 General
Dobavitelj mora vzpostaviti, dokumentirati in The supplier shall establish, document and
vzdr`evati sistem kakovosti, s katerim maintain a quality system as a means of
zagotavlja, da je proizvod skladen s ensuring that product conforms to specified
specificiranimi zahtevami. Dobavitelj mora requirements. The supplier shall prepare a
izdelati poslovnik kakovosti, ki pokriva quality manual covering the requirements of
zahteve tega mednarodnega standarda. this International Standard. The quality
Poslovnik kakovosti mora vsebovati postopke manual shall include or make reference to
the quality system procedures and outline
sistema kakovosti ali se nanje sklicevati in
povzeti strukturo dokumentacije, ki se the structure of the documentation used in
uporablja v sistemu kakovosti. the quality system.
Opomba 6: Napotki za poslovnik kakovosti so NOTE 6 Guidance on quality manuals is given in
podani v standardu ISO 10013. ISO 10013.
4.2.2 Postopki sistema kakovosti 4.2.2 Quality system procedures
Dobavitelj mora: The supplier shall
a) izdelati dokumentirane postopke, a) prepare documented procedures
skladne z zahtevami tega consistent with the requirements of
mednarodnega standarda in izra`eno this International Standard and the
politiko kakovosti dobavitelja, in supplier's stated quality policy, and
b) u~inkovito izvajati sistem kakovosti in b) effectively implement the quality
njegove dokumentirane postopke. system and its documented
procedures.
Za namene tega mednarodnega standarda For the purposes of this International
morajo biti obseg in podrobnosti postopkov, Standard, the range and detail of the
ki so sestavni del sistema kakovosti, odvisni procedures that form part of the quality
od zahtevnosti dela in uporabljenih metod system shall be dependent upon the
ter od potrebnih ve{~in in usposobljenosti complexity of the work, the methods used,
osebja, ki aktivnosti izvaja. and the skills and training needed by
personnel involved in carrying out the
activity.
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SIST ISO 9002 : 1995
Opomba 7: V pisnih postopkih se lahko sklicuje na NOTE 7 Documented procedures may make
navodila za delo, ki dolo~ajo, kako se reference to work instructions that define
aktivnost izvede. how an activity is performed.
4.2.3 Planiranje kakovosti 4.2.3 Quality planning
Dobavitelj mora opredeliti in dokumentirati, The supplier shall define and document
kako bodo zahteve za kakovost izpolnjene. how the requirements for quality will be
Planiranje kakovosti mora biti usklajeno z met. Quality planning shall be consistent
vsemi drugimi zahtevami dobaviteljevega with all other requirements of a supplier's
sistema kakovosti in mora biti quality system and shall be documented in
dokumentirano v obliki, primerni a format to suit the supplier's method of
dobaviteljevemu na~inu dela. operation.
Dobavitelj mora pri izpolnjevanju The supplier shall give consideration to the
specificiranih zahtev za proizvode, projekte following activities, as appropriate, in
ali pogodbe upo{tevati naslednje dejavnosti, meeting the specified requirements for
~e je to primerno: products, projects or contracts:
a) pripravo planov kakovosti; a) the preparation of quality plans;
b) identifikacijo potreb in preskrbo b) the identification and acquisition of
krmilne opreme, procesov, opreme any controls, processes, equipment
(vklju~no s kontrolno in preskusno (including inspection and test
opremo), pripomo~kov, virov in ve{~in, equipment), fixtures, resources and
ki bi lahko bile potrebne za skills that may be needed to achieve
doseganje zahtevane kakovosti; the required quality;
c) zagotavljanje usklajenosti razvoja, c) ensuring the compatibility of the
proizvodnega procesa, vgradnje, production process, installation,
servisiranja, postopkov kontroliranja in servicing, inspection and test
presku{anja ter uporabljene procedures and the applicable
dokumentacije; documentation;
d) potrebno posodabljanje metod d) the updating, as necessary, of quality
obvladovanja kakovosti ter tehnik control, inspection and testing
kontroliranja in presku{anja, vklju~no z techniques, including the development
razvojem novih orodij; of new instrumentation;
e) pravo~asno identifikacijo vseh zahtev e) the identification of any measurement
za merjenja, ki presegajo obstoje~e requirement involving capability that
mo`nosti in za katera je potreben exceeds the known state of the art, in
dolo~en ~as za razvoj; sufficient time for the needed
capability to be developed;
f) identifikacijo ustreznih overjanj na f) the identification of suitable verification
primernih stopnjah v izvedbi at appropriate stages in the realization
proizvoda; of product;
g) raz~i{~evanje kriterijev sprejemljivosti g) the clarification of standards of
za vse zna~ilnosti in zahteve, vklju~no acceptability for all features and
s takimi, ki vsebujejo subjektivne requirements, including those which
elemente; contain a subjective element;
h) identifikacija in priprava zapisov o h) the identification and preparation of
kakovosti (glej 4.16). quality records (see 4.16).
Opomba 8: Na omenjene plane kakovosti [glej 4.2.3 NOTE 8 The quality plans referred to [see
a)] se lahko sklicuje v ustreznih 4.2.3a)] may be in the form of a
dokumentiranih postopkih, ki tvorijo reference to the appropriate documented
celoto dobaviteljevega sistema kakovosti. procedures that form an integral part of
the supplier's quality system.
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SIST ISO 9002 : 1995
4.3 Pregled pogodbe 4.3 Contract review
4.3.1 Splo{no 4.3.1 General
Dobavitelj mora izdelati in vzdr`evati The supplier shall establish and maintain
dokumentirane postopke za pregled documented procedures for contract review
pogodbe in za usklajevanje teh dejavnosti. and for the coordination of these activities.
4.3.2 Pregled 4.3.2 Review
Pred predlo`itvijo ponudbe na razpis Before submission of a tender, or the
(tenderja) ali prevzema pogodbe ali naro~ila acceptance of a contract or order
(izjava z zahtevami) mora dobavitelj (statement of requirement), the tender,
ponudbo na razpis (tender), p
...
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