ISO 9001:1994
(Main)Quality systems — Model for quality assurance in design, development, production, installation and servicing
Quality systems — Model for quality assurance in design, development, production, installation and servicing
Systèmes qualité — Modèle pour l'assurance de la qualité en conception, développement, 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 concevoir et fournir un produit conforme 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 conception jusqu'aux prestations associées. La présente Norme internationale est applicable lorsque a) de la conception est exigée et les exigences relatives au produit sont formulées principalement en termes de résultats ou lorsqu'il est nécessaire d'établir ces exigences, et b) la confiance dans la conformité du produit peut être obtenue par une démonstration adéquate des aptitudes d'un fournisseur en matière de conception, développement, production, installation et prestations associées. NOTE 1 Pour les références informatives, voir annexe A.
Sistemi kakovosti - Model zagotavljanja kakovosti v razvoju, proizvodnji, vgradnji in servisiranju
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL
IS0
STANDARD
9001
Second edition
1994-07-01
Quality systems - Model for quality
assurance in design, development,
production, installation and servicing
Sys tkmes qualit L Mod&/e pour /‘assurance de la qualit6 en conception,
dheloppement, production, installation et prestations associ6es
Reference number
IS0 9001 :1994(E)
---------------------- Page: 1 ----------------------
IS0 9001:1994(E)
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
4
*.*.,.,.,.
4.5 Document and data control
5
4.6 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
,.,. 5
4.7 Control of customer-supplied product
6
.,.,,,.,,.*.,.
4.8 Product identification and traceability
6
,,,.,.,,.,,,,.,.,,.,,,.,,.,.,,,,,.,.*.
4.9 Process control
,,.,.,.,,.,.,.,. 6
4.10 Inspection and testing
, . . . . . . . . 7
Control of inspection, measuring and test equipment
4.11
8
. . . .~.~.~~~.~~~~.~~~~.~.~.
4.12 Inspection and test status
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.13 Control of nonconforming product
8
,.,.,.,.,.
4.14 Corrective and preventive action
. . . . . 9
4.15 Handling, storage, packaging, preservation and delivery
9
4.16 Control of quality records .,.,,.~.,.
9
.,.,,.,.,.
4.17 Internal quality audits
10
4.18 Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
10
4.19 Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
4.20 Statistical techniques
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
---------------------- Page: 2 ----------------------
Q IS0
IS0 9001:1994(E)
Annex
A Bibliography 11
*****~~~***.*=.,,.,.,.*~
---------------------- Page: 3 ----------------------
43 IS0
IS0 9001:1994(E)
I 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 9001 was prepared by Technical Committee
lSO/rC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
This second edition cancels and replaces the first edition
(IS0 9001:1987), which has been technically revised.
Annex A of this International Standard is for information only.
iv
---------------------- Page: 4 ----------------------
0 IS0
IS0 9001:1994(E)
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 servicing
- 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-
due tion, ins talla tion and servicing
- for use when conformance to specified requirements is to be as-
sured by the supplier during production, installation and servicing.
.
1. r* I l
c) IS0 9003, Quality systems - Model for quallry assurance In TInal rn-
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 9002 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.
---------------------- Page: 5 ----------------------
This page intentionally left blank
---------------------- Page: 6 ----------------------
INTERNATIONAL STANDARD 0 IS0 IS0 9001:1994(E)
- Model for quality assurance in
Quality systems
design, development, production, installation and
servicing
IS0 8402:1994, Quality management and quality as-
1 Scope
surance - Vocabulary.
This International Standard specifies quality system
requirements for use where a supplier’s capability to
3 Definitions
design and supply conforming product needs to be
demonstrated.
For the purposes of this International Standard, the
definitions given in IS0 8402 and the following defi-
The requirements specified are aimed primarily at
nitions apply.
achieving customer satisfaction by preventing non-
conformity at all stages from design through to ser-
3.1 product: Result of activities or processes.
vicing.
NOTES
This International Standard is applicable in situations
when
2 A product may include service, hardware, processed
materials, software or a combination thereof.
a) design is required and the product requirements
3 A product can be tangible (e.g. assemblies or processed
are stated principally in performance terms, or
materials) or intangible (e.g. knowledge or concepts), or a
they need to be established, and
combination thereof.
b) confidence in product conformance can be at-
4 For the purposes of this International Standard, the term
tained by adequate demonstration of a supplier’s
“product” applies to the intended product offering only and
capabilities in design, development, production,
not to unintended “by-products” affecting the environment.
installation and servicing.
This differs from the definition given in IS0 8402.
NOTE 1 For informative references, see annex A.
3.2 tender: Offer made by a supplier in response to
an invitation to satisfy a contract award to provide
product.
3.3 contract: Agreed requirements between a sup-
2 Normative reference
plier and customer transmitted by any means.
The following standard contains provisions which,
through reference in this text, constitute provisions
4 Quality system requirements
of this International Standard. At the time of publi-
cation, the edition indicated was valid. All standards
4.1 Management responsibility
are subject to revision, and parties to agreements
based on this International Standard are encouraged
to investigate the possibility of applying the most re- Quality policy
4.1 .l
cent edition of t le standard indicated below. Mem-
bers of IEC and IS0 maintain registers of currently The supplier’s management with executive responsi-
valid lnternationa bility shall define and document its policy for quality,
Standards.
1
---------------------- Page: 7 ----------------------
Q IS0
IS0 9001:1994(E)
NOTE 5 The responsibility of a management represen-
including objectives for quality and its commitment to
tative may also include liaison with external parties on mat-
quality. The quality policy shall be relevant to the
ters relating to the supplier’s quality system.
supplier’s organizational goals and the expectations
and needs of its customers. The supplier shall ensure
4.1.3 Management review
that this policy is understood, implemented and
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
4.2.1 General
freedom and authority to:
The supplier shall establish, document and maintain
initiate action to prevent the occurrence of any
a)
a quality system as a means of ensuring that product
nonconformities relating to the product, process
conforms to specified requirements. The supplier
and quality system;
shall prepare a quality manual covering the require-
ments of this International Standard. The quality
b) identify and record any problems relating to the
manual shall include or make reference to the quality
product, process and quality system;
system procedures and outline the structure of the
documentation used in the quality system.
initiate, recommend or provide solutions through
d
designated channels;
NOTE 6 Guidance on quality manuals is given in
IS0 10013.
verify the implementation of solutions;
4
4.2.2 Quality system procedures
control further processing, delivery or installation
e)
of nonconforming product until the deficiency or
The supplier shall
unsatisfactory condition has been corrected.
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
b) effectively implement the quality system and its
provide adequate resources, including the assignment
documented procedures.
of trained personnel (see 4.18), for management,
performance of work and verification activities includ-
For the purposes of this International Standard, the
ing internal quality audits.
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
work instructions that define how an activity is performed.
bilities, shall have defined authority for
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.
---------------------- Page: 8 ----------------------
0 IS0
IS0 9oot1994(E)
The supplier shall give consideration to the following verbal means, the supplier shall ensure that the
order requirements are agreed before their ac-
activities, as appropriate, in meeting the specified re-
quirements for products, projects or contracts: ceptance;
the preparation of quality plans; b) any differences between the contract or order re-
a)
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
test equipment), fixtures, resources and skills that tract or order requirements.
may be needed to achieve the required quality;
4.3.3 Amendment to a contract
ensuring the compatibility of the design, the pro-
d
duction process, installation, servicing, inspection The supplier shall identify how an amendment to a
contract is made and correctly transferred to the
and test procedures and the applicable documen-
functions concerned within the supplier’s organiz-
tation;
ation.
the updating, as necessary, of quality control, in-
d)
spection and testing techniques, including the
4.3.4 Records
development of new instrumentation;
Records of contract reviews shall be maintained (see
the identification of any measurement require-
e) 4.16).
ment involving capability that exceeds the known
NOTE 9 Channels for communication and interfaces with
state of the art, in sufficient time for the needed
the customer’s organization in these contract matters
capability to be developed;
should be established.
the identification of suitable verification at appro-
f 1
priate stages in the realization of product; 4.4 Design control
the clarification of standards of acceptability for
4.4.1 General
9)
all features and requirements, including those
which contain a subjective element; The supplier shall establish and maintain documented
procedures to control and verify the design of the
the identification and preparation of quality rec-
h)
product in order to ensure that the specified require-
ords (see 4.16).
ments are met.
NOTE 8 The quality plans referred to [see 4.2.3a)] may
4.4.2 Design and development planning
be in the form of a reference to the appropriate documented
procedures that form an integral part of the supplier’s qual-
The supplier shall prepare plans for each design and
ity system.
development activity. The plans shall describe or ref-
erence these activities, and define responsibility for
4.3 Contract review
their implementation. The design and development
activities shall be assigned to qualified personnel
4.3.1 General equipped with adequate resources. The plans shall be
updated as the design evolves.
The supplier shall establish and maintain documented
procedures for contract review and for the coordi-
4.4.3 Organizational and technical interfaces
nation of these activities.
Organizational and technical interfaces between dif-
ferent groups which input into the design process
4.3.2 Review
shall be defined and the necessary information docu-
mented, transmitted and regularly reviewed.
Before submission of a tender, or the acceptance of
a contract or order (statement of requirement), the
4.4.4 Design input
tender, contract or order shall be reviewed by the
supplier to ensure that:
Design input requirements relating to the product, in-
cluding applicable statutory and regulatory require-
a) the requirements are adequately defined and
ments, shall be identified, documented and their
documented; where no written statement of re-
selection reviewed by the supplier for adequacy. In-
quirement is available for an order received by
3
---------------------- Page: 9 ----------------------
0 IS0
IS0 9001:1994(E)
4.4.8 Design validation
complete, ambiguous or conflicting requirements shall
be resolved with those responsible for imposing
Design validation shall be performed to ensure that
these requirements.
product conforms to defined user needs and/or re-
Design input shall take into consideration the results
quirements.
of any contract review activities.
NOTES
Design validation follows successful design verification
11
4.4.5 Design output
(see 4.4.7).
Design output shall be documented and expressed in 12 Validation is normally performed under defined operat-
ing conditions.
terms that can be verified and validated against design
input requirements.
13 Validation is normally performed on the final product,
but may be necessary in earlier stages prior to product
Design output shall:
completion.
a) meet the design input requirements;
14 Multiple validations may be performed if there are dif-
ferent intended uses.
b) contain or make reference to acceptance criteria;
c) identify those characteristics of the design that
4.4.9 Design changes
are crucial to the safe and proper functioning of
the product (e.g. operating, storage, handling,
All design changes and modifications shall be identi-
maintenance and disposal requirements).
fied, documented, reviewed and approved by author-
ized personnel before their implementation.
Design output documents shall be reviewed before
release.
4.5 Document and data control
4.4.6 Design review
4.5.1 General
At appropriate stages of design, formal documented
The supplier shall establish and maintain documented
reviews of the design results shall be planned and
procedures to control all documents and data that re-
conducted. Participants at each design review shall
late to the requirements of this International Standard
include representatives of all functions concerned
including, to the extent applicable, documents of ex-
with the design stage being reviewed, as well as
ternal origin such as standards and customer
other specialist personnel, as required. Records of
drawings.
such reviews shall be maintained (see 4.16).
NOTE 15 Documents and data can be in the form of any
type of media, such as hard copy or electronic media.
4.4.7 Design verification
At appropriate stages of design, design verification
4.5.2 Document and data approval and issue
shall be performed to ensure that the design stage
output meets the design stage input requirements.
The documents and data shall be reviewed and ap-
The design verification measures shall be recorded
proved for adequacy by authorized personnel prior to
(see 4.16) .
issue. A master list or equivalent document control
procedure identifying the current revision status of
NOTE 10 In addition to con ducting design reviews (see
documents shall be established and be readily avail-
4.4.61, design verification may activities such as
include
the use of invalid and/or obsolete
able to preclude
documents.
- performing alternative calculations,
This control shall ensure that:
- comparing the new design with a similar proven design,
if available,
a) the pertinent issues of appropriate documents are
available at all locations where operations essen-
- undertaking tests and demonstrations, and
tial to the effective functioning of the quality sys-
- reviewing the design stage documents before release. tem are performed;
4
---------------------- Page: 10 ----------------------
0 IS0
IS0 9001:1994(E)
b) invalid and/or obsolete documents are promptly a) the type, class, grade or other precise identifi-
removed from all points of issue or use, or other- cation;
wise assured against unintended use;
b) the title or other positive identification, and appli-
c) any obsolete documents retained for legal and/or cable issues of specifications, drawings, process
knowledge-preservation purposes are suitably requirements, inspection instructions and other
relevant technical data, including requirements for
identified.
approval or qualification of product, procedures,
process equipment and personnel;
4.5.3 Document and data changes
c) the title, number and issue of the quality system
Changes to documents and data shall be reviewed
standard to be applied.
and approved by the same functions/organizations
that performed
...
NORME
IS0
INTERNATIONALE
9001
Deuxi&me bdition
1994-07-01
Systhmes qualit - Modhle pour
I’assurance de la qualit en conception,
dbveloppement, production, installation et
prestations associbes
Quality systems
- Model for quality assurance in design, development,
production, installation and servicing *
Numbro de rhfhrence
IS0 3001 :I 994(F)
---------------------- Page: 1 ----------------------
IS0 9001:1994(F)
Sommaire
Page
1
1 Domaine d’application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 Reference normative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1
3 Definitions . . . . . . .*.
4 Exigences en matiere de systeme qualite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Responsabilite de la direction . 2
41 .
2
42 . Systeme qualite .
43 . Revue de contrat . 3
3
44 . MaRrise de la conception .
45 . Mai’trise des documents et des donnees . 5
Achats . 5
46 .
................................... 6
47 . Maitrise du produit fourni par le client
48 . Identification et tracabilite du produit . 6
.......................................................... 6
49 . Maltrise des processus
4.10 Controles et essais . 7
7
4.11 Maitrise des equipements de controle, de mesure et d’essai
4.12 ttat des controles et des essais . 8
....................................... 8
4.13 Maitrise du produit non conforme
4.14 Actions correctives et preventives . 9
4.15 Manutention, stockage, conditionnement, preservation et
9
livraison .
10
4.16 Maitrise des enregistrements relatifs a la qualite .
4.17 Audits qualite internes . 10
10
4.18 Formation .
Prestations associees . 10
4.19
4.20 Techniques statistiques . 11
0 IS0 1994
Droits de reproduction reserves. Sauf prescription differente, aucune partie de cette publi-
cation ne peut etre 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 I’editeur.
Organisation internationale de normalisation
Case Postale 56 l CH-1211 Geneve 20 l Suisse
Imprime en Suisse
ii
---------------------- Page: 2 ----------------------
0 IS0 IS0 9001:1994(F)
Annexe
12
A Bibliographie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
---------------------- Page: 3 ----------------------
0 IS0
IS0 9001:1994(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 confiee aux
comites techniques de I’ISO. Chaque comite membre interesse par une
etude a le droit de faire partie du comite technique tree 8 cet effet. Les
organisations internationales, gouvernementales et non gouvernemen-
tales, en liaison avec I’ISO participent egalement aux travaux. L’ISO colla-
bore etroitement avec la Commission electrotechnique internationale (CEI)
en ce qui concerne la normalisation electrotechnique.
Les projets de Normes internationales adopt& par les comites techniques
sont soumis aux comites membres pour vote. Leur publication comme
Normes internationales requiert I’approbation de 75 % au moins des co-
mites membres votants.
La Norme internationale IS0 9001 a ete elaboree par le comite technique
lSO/TC 176, Management et assurance de la qua/it& sous-comite SC 2,
SystGmes qua/it&
Cette deuxieme edition annule et remplace la premiere edition
(IS0 9001:1987), dont elle constitue une revision technique.
L’annexe A de la presente Norme internationale est donnee uniquement
a titre d’information.
IV
---------------------- Page: 4 ----------------------
43 IS0
IS0 9001:1994(F)
Introduction
La presente Norme internationale fait par-tie d’une serie de trois Normes
internationales sur les exigences en mat&e de systeme qualite qui peu-
vent etre utilisees dans le cadre de I’assurance externe de la qualite. Les
modeles pour /‘assurance de la qualite, definis dans les trois Normes
internationales mentionnees ci-dessous, decrivent trois formes distinctes
d’exigences en mat&e 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, Systdmes qua/it6 - Modhle pour I’assurance de la qualit
en conception, dheloppemen t, production, ins talla tion et pres ta tions
associ6es
- a 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, Systhmes qua/it& - Mod&le pour I’assurance de la qualit
en production, ins talla tion et pres ta tions associ6es
- a utiliser lorsque la conformite a des exigences specifiees est a
assurer par le fournisseur pendant la production, I’installation et les
prestations associees.
c) IS0 9003, Systbmes qua/it6 - ModdIe pour I’assurance de la qualitb
en contrdle et essais finals
- 8 utiliser lorsque la conformite a des exigences specifiees est 8
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 9002 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 cauvre 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 system0 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 l’assurance
de la qualite, a savoir IS0 9001, IS0 9002 ou IS0 9003.
V
---------------------- Page: 5 ----------------------
This page intentionally left blank
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE 0 IS0
IS0 9001:1994(F)
SystGmes qualit - Modde pour I’assurance de la
qualit en conception, dbveloppement, production,
installation et prestations associbes
rechercher la possibilite d’appliquer l’edition la plus
1 Domaine d’application
recente de la norme indiquee ci-apres. Les membres
de la CEI et de I’ISO possedent le registre des Nor-
La presente Norme internationale specific des exi-
mes internationales en vigueur a un moment don&.
gences en matiere de systeme qualite a utiliser lors-
que I’aptitude d’un fournisseur a concevoir et fournir
IS0 8402:1994, Management de la qua/it& et assu-
un produit conforme doit etre demontree.
rance de la qua/it6 - Vocabulaire.
Les exigences specifiees visent en premier lieu la sa-
tisfaction du client, par la prevention des non-
conformites a tous les stades, depuis la conception
3 Dbfinitions
jusqu’aux prestations associees.
Pour les besoins de la presente Norme internationale,
La presente Norme internationale est applicable lors-
les definitions donnees dans I’ISO 8402 et les defini-
we
tions suivantes s’appliquent.
a) de la conception est exigee et les exigences rela-
3.1 produit: Resultat d’activites ou de processus.
tives au produit sont formulees principalement en
termes de resultats ou lorsqu’il est necessaire
NOTES
d’etablir ces exigences, et
2 Le terme produit peut inclure les services, les matkriels,
b) la confiance dans la conformite du produit peut
les produits issus de processus 2 caract&e continu, les lo-
etre obtenue par une demonstration adequate des
giciels, ou une combinaison des deux.
aptitudes d’un fournisseur en mat&e de concep-
3 Un produit peut &re materiel (par exemple, assem-
tion, developpement, production, installation et
blages ou produits issus de processus B caracthe continu)
prestations associees.
ou immatkiel (par exemple, connaissances ou concepts),
ou une combinaison des deux.
NOPE1 Pour les Gfkrences informatives, voir
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 diff&e de la definition donnee dans
I’ISO 8402.
2 R6fkrence normative
3.2 offre: Une offre est faite par un fournisseur en
La norme suivante contient des dispositions qui, par
suite de la reference qui en est faite, constituent des reponse a un appel d’offre en vue de I’attribution d’un
contrat de fourniture d’un produit.
dispositions valables pour la presente Norme interna-
tionale. Au moment de la publication, l’edition indi-
quee etait en vigueur. Toute norme est sujette 8 3.3 contrat: Exigences ayant fait I’objet d’un accord
revision et les parties prenantes des accords fond& entre un fournisseur et un client et transmises par un
sur la presente Norme internationale sont invitees a moyen quelconque.
1
---------------------- Page: 7 ----------------------
IS0 9001:1994(F)
0 IS0
d’autres res ponsabi lit&, doit avoir une autorite definie
4 Exigences en matike de systhme
pour
qualit
a) assurer qu’un systeme qualite est defini, mis en
4.1 Responsabilit6 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 l’amelioration du sys-
tiere de qualite, y compris ses objectifs et son enga-
teme qualite.
gement en la mat&e. La politique qualite doit etre
NOTE 5
pertinente par rapport aux objectifs generaux du four- La responsabilith du representant de la direction
peut bgalement comprendre les relations avec des parties
nisseur et aux attentes et besoins de ses clients. Le
exthieures en ce qui concerne les sujets relatifs au sys-
fournisseur doit assurer que cette politique est com-
t&me 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 Responsabilit6 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).
a) declencher des actions permettant de prevenir
I’apparition de toute non-conformite relative au
4.2 Systhme qualit
produit, au processus et au systeme qualite;
4.2.1 GhSralit6s
b) identifier et enregistrer tout probleme relatif au
produit, au processus et au systeme qualite;
Le fournisseur doit etablir, consigner par ecrit et
entretenir un systeme qualite en tant que moyen pour
c) declencher, recommander ou fournir des solutions
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
d ) verifier la mise en oeuvre des solutions;
internationale. Le manuel qualite doit comprendre les
e ) maltriser la poursuite des operations relatives au procedures du systeme qualite ou y faire reference,
produit non conforme, sa livraison ou son instal- et exposer la structure de la documentation utilisee
dans le cadre du systeme qualite.
lation jusqu’a ce que la deficience ou la situation
non satisfaisante ait ete corrigee.
NOTE 6 L’ISO 10013 fournit des conseils relatifs 3 Ma-
boration des manuels qualitk
4.1.2.2 Moyens
Le fournisseur doit identifier les exigences relatives
4.2.2 Proc6dures du systhme 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
La direction du fournisseur, qui a pouvoir de decision, b) mettre reellement en oeuvre le systeme qualite
doit nommer un de ses membres qui, nonobstant et ses procedures &rites.
2
---------------------- Page: 8 ----------------------
0 IS0
IS0 9001:1994(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 appropribes
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 taches, 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.
4.3.1 Gtin6ralit6s
NOTE 7 Les procedures &rites peuvent faire reference
a des instructions de travail qui definissent comment une
Le fournisseur doit etablir et tenir a jour des procedu-
t&he est realisee.
res &rites de revue de contrat et de coordination de
ces activites.
4.2.3 Planification de la qualit
4.3.2 Revue
Le fournisseur doit definir et consigner par ecrit com-
ment satisfaire les exigences pour la qualite. La pla-
Avant soumission d’une offre ou acceptation d’un
nification de la qualite doit etre coherente avec
contrat ou d’une commande (formulation des exi-
I’ensemble des exigences du systeme qualite du
gence& l’offre, le contrat ou la commande doit Qtre
fournisseur et doit etre consignee sous une forme
revu(e) par le fournisseur afin d’assurer que
adaptee aux methodes de travail du fournisseur. Ce
dernier doit porter toute son attention sur les activites
a) les exigences sont definies et documentees de
suivantes, s’il y a lieu, pour satisfaire aux exigences
facon adequate; lorsqu’il n’existe pas d’exigences
specifiees pour les produits, les projets ou les con-
&rites pour une commande verbale, le fournis-
trats:
seur doit assurer que les exigences de cette
commande ont bien fait I’objet d’un accord avant
l’etablissement de plans qualite;
a)
d’etre acceptees;
I’identification et I’acquisition de tous moyens de
b)
b) toute difference entre les exigences d’un contrat
maTtrise des activites, processus, equipements (y
ou d’une commande et celles de l’offre a fait
compris les equipements de contrdle et d’essai),
I’objet d’une solution;
dispositifs, ensemble des moyens et compe-
tences qui peuvent etre necessaires pour obtenir
c) le fournisseur presente I’aptitude 8 satisfaire aux
la qualite requise;
exigences du contrat ou de la commande.
I’assurance de la compatibilite de la conception,
d
du processus de production, de I’installation, des 4.3.3 Avenant au contrat
prestations associees, des procedures de contrble
Le fournisseur doit definir comment un avenant a un
et d’essai et de la documentation applicable;
contrat est trait6 et comment il le transmet correc-
la mise a jour, autant que necessaire, des techni-
d) 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-
4.3.4 Enregistrements
velle instrumentation;
Des enregistrements de ces revues de contrat doi-
I’identification, en temps voulu, de toute exigence
e)
vent etre consewes (voir 4.16).
en mat&e de mesurage mettant en jeu une apti-
tude qui depasse les possibilites actuelles de
II convient de constituer des circuits de com-
NOTE 9
l’etat de I’art, afin de developper I’aptitude neces-
munication et des interfaces avec le client en matiere de
contrat.
saire;
I’identification des verifications adequates aux
4.4 Maitrise de la conception
phases appropriees de la realisation du produit;
la clarification des normes d’acceptation pour 4.4.1 G6n6ralitbs
toutes les caracteristiques et exigences, y com-
pris celles qui contiennent un element subjectif; Le fournisseur doit etablir et tenir a jour des procedu-
res &rites pour mai’triser et verifier la conception du
I’identification et la preparation d’enregistrements produit afin d’assurer que les exigences specifiees
h)
relatifs a la qualite (voir 4.16). sont satisfaites.
3
---------------------- Page: 9 ----------------------
IS0 9001:1994(F) 0 IS0
4.4.2 Planification de la conception et du Les documents relatifs aux donnees de sortie de la
dkveloppement conception doivent etre revus avant leur mise en cir-
culation.
Le fournisseur doit elaborer des plans pour chaque
activite de conception et de developpement. Ces
4.4.6 Revue de conception
plans decrivent ces activites ou y font reference, et
definissent les responsabilites pour leur mise en
Des revues formelles et consignees par ecrit des re-
oeuvre. Les activites de conception et de develop-
su!tats de la conception doivent etre planifiees et
pement doivent etre affectees 8 du personnel qualifie
conduites a des phases appropriees de la conception.
dote de moyens adequats. Les plans doivent etre mis
Les participants a chacune de ces revues doivent
a jour au fur et 8 mesure de l’evolution de la concep-
comprendre des representants de toutes les fonc-
tion.
tions concernees par la phase de conception, objet
de la revue, ainsi que tout autre expert, comme re-
quis. Des enregistrements de ces revues doivent etre
Interfaces organisationnelles et techniques
4.4.3
conserves (voir 4.16).
Les interfaces organisationnelles et techniques entre
4.4.7 Wrification de la conception
les differents groupes, qui contribuent au processus
de conception, doivent etre definies et les infor-
La verification de la conception doit etre effect&e a
mations necessaires doivent etre consignees par
des phases appropriees de la conception afin d’assu-
ecrit, transmises et revues regulierement.
rer que les donnees de sortie de chacune de ces
phases satisfont aux exigences des donnees d’entree
Donnbes d’entree de la conception
4.4.4
de cette meme phase. Les actions de verification de
la conception doivent etre enregistrees (voir 4.16).
Les exigences concernant le produit relatives aux
NOTE 10 En plus des revues de conception (voir 4.4.6),
donnees d’entree de la conception et comprenant les
la verification de la conception peut comprendre des taches
exigences legales et reglementaires applicables doi-
telles que
vent etre identifiees et consignees par ecrit, et leur
selection doit etre revue par le fournisseur quant 8
- I’execution de calculs par d’autres methodes,
leur adequation. II faut apporter une solution aux exi-
gences incompletes, ambigijes ou incompatibles avec
- la comparaison de la nouvelle conception avec une
ceux qui les ont imposees.
conception similaire elle existe,
eprouvee si
Les donnees d’entree de la conception doivent pren-
- la realisation d’essais et de modeles de demonstration,
dre en compte les resultats de toutes les activites de
et
revue de contrat.
- la revue des documents relatifs aux differentes phases
de la conception avant leur mise en circulation.
Donnbes de sortie de la conception
4.4.5
4.4.8 Validation de la conception
Les donnees de sortie de la conception doivent etre
consignees par ecrit et exprimees de facon 8 pouvoir
La validation de la conception doit etre effect&e pour
etre verifiees et validees par rapport aux donnees
assurer que le produit est conforme aux besoins
d’entree de la conception.
et/au aux exigences definis de I’utilisateur.
Les donnees de sortie de la conception doivent
NOTES
a) satisfaire aux exigences des donnees d’entree de
11 Cette validation fait suite a une verification satisfaisante
la conception; de la conception (voir 4.4.7).
12 La validation est effect&e normalement dans des
b) contenir ou faire reference a des criteres d’ac-
conditions de fonctionnement definies.
ceptation;
13 La validation est effectuee normalement sur le produit
c) identifier les caracteristiques de conception criti-
final, mais peut etre necessaire a des phases anterieures a
ques pour le fonctionnement correct et en toute
l’achevement du produit.
securite du produit (par exemple, les exigences
en mat&e d’exploitation, de stockage, de manu-
14 Des validations multiples peuvent etre executees si
differentes utilisations sont prevues.
tention, de maintenance et de mise hors service).
4
---------------------- Page: 10 ----------------------
Q IS0
IS0 9001:1994(F)
4.4.9 Modifications de la conception Les fonctions/organismes design& doivent avoir ac-
ces 8 toutes informations appropriees sur lesquelles
Tous les changements et toutes les modifications de
ils peuvent fonder leur revue et leur approbation.
la conception doivent etre identifies, consign& par
Lorsque cela est realisable, la nature de la modifica-
ecrit, revus et approuves par des personnes habilitees
tion doit etre identifiee dans le document ou dans les
avant d’etre mis en ceuvre.
annexes appropriees.
4.5 Maltrise des documents et des donnkes
4.6 Achats
4.5.1 Gknkralit&
4.6.1 Ghn&alit&
Le fournisseur doit etablir et tenir a jour des procedu-
Le fournisseur doit etablir et tenir a jour des procedu-
res &rites pour maitriser tous les documents et don-
res &rites pour assurer que le produit achete (voir
nees relatifs aux exigences de la presente Norme
3.1) est conforme aux exigences specifiees.
internationale, y compris, dans les limites de ce qui
est applicable, des documents d’origine exterieure
4.6.2 Evaluation des sous-contractants
tels que les normes et les plans du client.
NOTE 15 Les documents et les donnbes peuvent se Le fournisseur doit
presenter sur tout support, tel que support papier ou sup-
port informatique.
a) evaluer et selectionner les sous-contractants sur
la base de leur aptitude a satisfaire aux exigences
de la sous-commande, y compris les exigences
4.52 Approba tion et d iff usio n des docu ments et
de systeme qualite et toutes exigences specifi-
des donnbes
ques d’assurance de la qualite;
Avant leur diffusion, les documents et les donnees
b) definir le type et l’etendue de la maltrise exercee
doivent etre revus et approuves en ce qui concerne
par le fournisseur sur ses sous-contractants.
leur adequation, par des personnes habilitees. Une
Celle-ci doit dependre du type de produit com-
liste de reference ou toute procedure de ma7trise de
mande au sous-contractant, de I’incidence de ce
documents equivalente indiquant la revision en vi-
produit sur la qualite du produit final et, lorsque
gueur des documents doit etre etablie et etre faci-
cela est applicable, des rapports d’audits qualite
lement accessible pour empecher I’utilisation de
et/au des enregistrements relatifs aux aptitudes
documents non valables et/au perimes.
et performances dont le sous-contractant a fait la
Cette mai;trise doit assurer que
demonstration precedemment;
a) les editions pertinentes des documents appro- c) etablir, tenir a jour et conserver des enregis-
pries sont disponibles 8 tous les endroits 00 des
trements relatifs a la qualite des sous-contractants
operations essentielles au fonctionnement effi-
acceptables (voir 4.16).
cace du systeme qualite sont effect&es;
4.6.3 Donnees d’achat
b) les documents non valables et/au perimes sont
aussitot retires de tous les points de diffusion ou
Les documents d’achat doivent contenir des donnees
d’utilisation, ou sinon qu’ils ne peuvent pas etre
decrivant clairement le produit command6 et com-
utilises de facon non intentionnelle;
prenant, lorsque cela est applicable
a) le type, la categoric, la classe ou toute autre
identification precise;
le titre ou toute autre identification formelle et
b)
4.5.3 Modifications des documents et des I’edition applicable des specifications, plans, exi-
gences en mat&e de processus, instructions de
donnQes
controle et autres donnees techniques perti-
Les modifications des documents et des donnees nentes, y compris les exigences pour I’approba-
doivent etre revues et approuvees par les memes tion ou la qualification du produit, des procedures,
fonctions/organismes qui les ont revus et approuves de I’equipement et du personnel relatifs au pro-
a I’origine, a moins qu’il n’en soit specific autrement. cessus;
5
---------------------- Page: 11 ----------------------
IS0 9001:1994(F) 0 IS0
c) le titre, le numero et l’edition de la norme de Lorsque et dans la mesure ou la tracabilite est une
systeme qualite 8 appliquer. exigence specifiee, le fournisseur doit etablir et tenir
a jour des procedures &rites pour I’identification
Le fournisseur doit revoir et approuver les documents
specifique de produits ou de lots particuliers. Cette
d’achat en ce qui concerne I’adequation des exi-
identification doit etre enregistree (voir 4.16).
gences specifiees avant de les diffuser.
4.9 Maitrise des processus
4.6.4 Vbrification du produit achetb
Le fournisseur doit identifier et planifier les processus
4.6.4.1 Wrification par le fournisseur chez le
de production, d’installation et les processus relatifs
sous-contractant
aux prestations associees qui ont une incidence di-
recte sur la qualite, et il doit aussi assurer que ces
Lorsque le fournisseur a I’intention de verifier le pro-
processus sont mis en ceuvre dans des conditions
duit achete chez le sous-contractant, il doit specifier
maTtrisees. Ces dernieres doivent comprendre
dans les documents d’achat les dispositions a prendre
pour la verification et les modalites de mise a dispo-
des procedures &rites definissant les pratiques
a)
sition du produit.
de production, d’installation et les pratiques rela-
tives aux prestations associees lorsque I’absence
4.6.4.2 Vbrification par le client du produit
de ces procedures pourrait avoir une incidence
sous-contract6
nefaste sur la qualite;
Lorsque cela est specific dans le contrat, le client du I’utilisation d’equipements adequats pour la pro-
b)
fournisseur ou son representant doit avoir le droit de
duction, l’installation et les prestations associees,
verifier dans les locaux du sous-contractant et du
ainsi qu’un environnement de travail approprie;
fournisseur que le produit sous-contracte est
conforme aux exigences specifiees. Cette verification la conformite aux normes et codes de reference,
cl
ne doit pas Qtre utilisee par le fournisseur comme aux plans qualite et/au aux procedures &rites;
preuve de la maRrise effective de la qualite par le
le pilotage et la maRrise des parametres des pro-
d)
sous-contractant.
cessus et des caracteristiques du produit appro-
La verification par le client ne doit pas decharger le
pries;
fournisseur de sa responsabilite de fournir un produit
acceptable, ni empecher un rejet ulterieur du produit
I’approbation des processus et de l’equipement,
e)
par le client.
s’il y a lieu;
les criteres d’execution qui doivent etre prescrits
f 1
4.7 Maitrise du produit fourni par le client
le plus clairement possible (par exemple au
moyen de normes &rites, d’echantillons repre-
Le fournisseur doit etablir et tenir a jour des procedu-
sentatifs ou d’illustrations);
res &rites pour la verification, le stockage et la pre-
servation du produit fourni par le client pour etre
la maintenance appropriee de l’equipement de
incorpore dans les fournitures ou pour des activites
maniere a assurer en permanence I’aptitude des
qui y sont liees. Tout produit de cette nature perdu,
processus.
endommage ou encore impropre a I’utilisation doit
etre enregistre et le client doit en etre informe (voir
Quand les resultats des processus ne p
...
SLOVENSKI SIST ISO 9001
druga izdaja
STANDARD
junij 1995
Sistemi kakovosti - Model zagotavljanja kakovosti v razvoju,
proizvodnji, vgradnji in servisiranju (identi~en z ISO 9001:1994)
Quality sistems - Model for quality assurance in design, development,
production, installation and servicing
Systèmes qualité - Modèle pour l’assurance de la qualité en conception,
devéloppement, production, installation et prestations associées
Qualitaetssicherungssysteme - Modell zur Darlegung des
Qualitaetsmanagementsystems in Design/Entwicklung, Produktion, Montage
und Wartung
Deskriptorji: zagotavljanje kakovosti, program zagotavljanja kakovosti, sistemi
zagotavljanja kakovosti, razvoj, (delo), proizvodnja, vgradnja, poprodajne
storitve, referen~ni modeli
Referen~na {tevilka
ICS 03.120.10 SIST ISO 9001:1995 (sl, en)
Nadaljevanje na straneh od 2 do 32
© 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 9001 : 1995
UVOD
Standard SIST ISO 9001, Sistemi kakovosti - Model zagotavljanja kakovosti v razvoju,
proizvodnji, vgradnji in servisiranju, druga izdaja, 1995, ima status slovenskega standarda in
je identi~en mednarodnemu standardu ISO 9001, Quality sistems - Model for quality
assurance in design, development, production, installation and servicing, second edition, 1994-
07-01.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 9001:1994 je pripravil tehni~ni odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje kakovosti in zagotavljanje kakovosti. Slovenski standard
SIST ISO 9001:1995 je prevod angle{kega besedila mednarodnega standarda ISO 9001:1994.
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 9002:1995 idt ISO 9002:1994
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 9002:1995 Sistemi kakovosti - Model zagotavljanja kakovosti v proizvodnji,
vgradnji in servisiranju (identi~en z ISO 9002:1994)
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)
*
V pripravi
2
---------------------- Page: 2 ----------------------
SIST ISO 9001 : 1995
PREDHODNE IZDAJE
- SLS ISO 9001:1992
OSNOVA ZA IZDAJO STANDARDA
- Prevzem standarda ISO 9001:1994, druga izdaja
OPOMBE:
- Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, pomeni to
v SIST ISO 9001:1995 “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 9001:1995 je identi~en tudi standardu EN ISO 9001:1994.
3
---------------------- Page: 3 ----------------------
SIST ISO 9001 : 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.16
podatkov.16
4.6 Nabava.17 4.6 Purchasing.17
4.7 Obvladovanje proizvodov, ki 4.7 Control of customer-supplied
jih dobavi odjemalec.19 product.19
4.8 Identifikacija in sledljivost 4.8 Product identification and
proizvodov.19 traceability.19
4.9 Obvladovanje procesa.20 4.9 Process control.20
4.10 Kontrola in presku{anje.21 4.10 Inspection and testing.21
4.11 Obvladovanje kontrolne, 4.11 Control of inspection, measuring
merilne in preskusne opreme.23 and test equipment.23
4.12. Status kontroliranja in 4.12 Inspection and test status.25
presku{anja.25
4.13 Obvladovanje neskladnih 4.13 Control of nonconforming
proizvodov.25 product.25
4.14 Korektivni in preventivni ukrepi.26 4.14 Corrective and preventive action.26
4.15 Ravnanje, skladi{~enje, 4.15 Handling, storage, packaging,
pakiranje, za{~ita in dostava.27 preservation and delivery.27
4.16 Obvladovanje zapisov o 4.16 Control of quality records.28
kakovosti.28
4.17 Notranje presoje kakovosti.29 4.17 Internal quality audits.29
4.18 Usposabljanje.30 4.18 Training.30
4.19 Servisiranje.30 4.19 Servicing.30
4.20 Statisti~ne metode.30 4.20 Statistical techniques.30
Dodatek Annex
A Bibliografija.31 A Bibliography.31
4
---------------------- Page: 4 ----------------------
SIST ISO 9001 : 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 9001 je pripravil International Standard ISO 9001 was
tehni~ni odbor ISO/TC 176 Vodenje prepared by Technical Committee
kakovosti in zagotavljanje kakovosti, ISO/TC 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 9001:1987), ki je bila tehni~no the first edition (ISO 9001:1987), 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 9001 : 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 9002 in ISO Standard, ISO 9002 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
6
---------------------- Page: 6 ----------------------
SIST ISO 9001 : 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. ISO 9001, ISO 9002
ali ISO 9003, vsebuje standard ISO 9000-1. or ISO 9003.
7
---------------------- Page: 7 ----------------------
SIST ISO 9001 : 1995
Sistemi kakovosti - Model Quality system - Model for
zagotavljanja kakovosti v quality assurance in design,
razvoju, proizvodnji, vgradnji development, production,
in servisiranju installation and 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, da je sposoben supplier's capability to design and supply
razviti in dobaviti skladen proizvod. conforming product 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 razvoja do servisiranja. from design through to servicing.
Ta mednarodni standard se uporablja: This International Standard is applicable in
situations when
a) kadar je zahtevan razvoj in so zahteve a) design is required and the product
za proizvod podane predvsem z requirements are stated principally in
opisom lastnosti ali jih je treba {ele performance terms, or they need to
ugotoviti, in be established, 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
razvoju, proizvodnji, vgradnji in capabilities in design, development,
servisiranju. 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 to investigate the possibility of
se priporo~a, naj razi{~ejo mo`nost uporabe applying the most recent edition of the
najnovej{e izdaje spodaj navedenega standard indicated below. Members of IEC
standarda. ^lani IEC in ISO vzdr`ujejo and ISO maintain registers of currently valid
register veljavnih mednarodnih standardov. International Standards.
ISO 8402:1994, Vodenje kakovosti in ISO 8402:1994, Quality management and
zagotavljanje kakovosti - Slovar quality assurance - Vocabulary
8
---------------------- Page: 8 ----------------------
SIST ISO 9001 : 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 between
dobaviteljem in odjemalcem, sporo~ene na a supplier and customer transmitted by any
kakr{enkoli na~in. 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.
9
---------------------- Page: 9 ----------------------
SIST ISO 9001 : 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.
10
---------------------- Page: 10 ----------------------
SIST ISO 9001 : 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
sistema kakovosti ali se nanje sklicevati in the quality system procedures and outline
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.
11
---------------------- Page: 11 ----------------------
SIST ISO 9001 : 1995
Opomba 7: V pisnih postopkih se lahko sklicujemo NOTE 7 Documented procedures may make
na navodila za delo, ki dolo~ajo, kako reference to work instructions that define
se 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, design, the production process,
servisiranja, postopkov kontroliranja in installation, servicing, inspection and
presku{anja ter uporabljene test 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 NOTE 8 The quality plans referred to [see
4.2.3a)] 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.
12
---------------------- Page: 12 ----------------------
SIST ISO 9001 : 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 z
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.