SIST ISO 9001:1995
(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
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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)
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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
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Q IS0
IS0 9001:1994(E)
Annex
A Bibliography 11
*****~~~***.*=.,,.,.,.*~
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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
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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.
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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
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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.
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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
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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
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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
...
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.
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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
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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
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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
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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.
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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
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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.
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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
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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.
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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.
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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.
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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.
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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
...
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