ISO 10013:1995
(Main)Guidelines for developing quality manuals
Guidelines for developing quality manuals
Provides guidelines for the development, preparation and control of quality manuals tailored to the specific needs of the user. Does not cover detailed work instructions, quality plans, brochures and other quality system related documents.
Lignes directrices pour l'élaboration des manuels qualité
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IS0 10013:1995(E)
Contents
Page
1
1 Scope .
1
2 Normative reference .
3 Definitions . 1
1
4 Documentation of quality systems .
5 Process of preparing a quality manual . 3
6 Process of quality manual approval, issue and control . 3
7 What to include in a quality manual . 4
Annexes
A Typical quality system document hierarchy . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
8
B Example of a possible format for a section of a quality manual
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
C Example of a section of a quality manual
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
D Bibliography
0 IS0 1995
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, in&ding photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
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0 IS0
IS0 10013:1995(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
technical committees. Each member body interested in a subject for
which a technical committee has been established has the right to be
represented on that committee. International organizations, governmental
and non-governmental, in liaison with ISO, also take part in the work. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an International
Standard requires approval by at least 75 % of the member bodies casting
a vote.
International Standard IS0 10013 was prepared by Technical Committee
ISO/TC 176, Quality management and quality assurance, Subcommittee
SC 3, Supporting technologies.
Annexes A, B, C and D of this International Standard are for information
only.
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0 IS0
IS0 10013:1995(E)
Introduction
The IS0 9000 family of International Standards includes requirements for
quality systems which can be used to achieve common interpretation,
development, implementation and application of quality management and
quality assurance.
The IS0 9000 family of International Standards requires the development
and implementation of documented quality systems, including the prep-
aration of quality manuals.
IS0 8402:1994, Quality management and quality assurance -
Vocabulary, defines a quality manual as a document stating the quality
policy and describing the quality system of an organization. This may relate
to an organization’s total activities or to a selected part of those activities;
for example, specified requirements depending upon the nature of prod-
ucts or services, processes, contractual requirements, governing regu-
lations or the organization itself.
It is important that the requirements and content of the quality system and
quality manual address the quality standard they are intended to satisfy.
This International Standard provides guidelines for developing such quality
manuals.
iv
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INTERNATIONAL STANDARD 0 IS0 IS0 10013:1995(E)
Guidelines for developing quality manuals
dent on that organization’s circumstances, but usually
1 Scope
starts with development of the organzation’s quality
policy and objectives.
This International Standard provides guidelines for the
development, preparation and control of quality man-
uals tailored to the specific needs of the user. The
4.1 Documented quality system procedures
resultant quality manuals will reflect documented
quality system procedures required by the IS0 9000 Documented quality system procedures should form
family of International Standards. Detailed work in- the basic documentation used for the overall planning
structions, quality plans, brochures and other quality and administration of activities which impact on qual-
system related documents are not covered by this
ity. In accordance with the IS0 9000 family, these
International Standard. (See annex A, level C.)
documented procedures should cover all the appli-
cable elements of the quality system standard. They
NOTE 1 This International Standard may be used to de-
should describe (to the degree of detail required for
velop quality manuals relating to quality system standards
adequate control of the activities concerned) the re-
other than the IS0 9000 family.
sponsibilities, authorities and interrelationships of the
personnel who manage, perform, verify or review
work affecting quality, how the different activities are
2 Normative reference
to be performed, the documentation to be used and
The following standard contains provisions which, the controls to be applied. (See annex A.)
through reference in this text, constitute provisions
4.1 .I Procedural scope
of this International Standard. At the time of publi-
cation, the edition indicated was valid. All standards
Each documented procedure should cover a logically
are subject to revision, and parties to agreements
separable part of the quality system, such as a com-
based on this International Standard are encouraged
plete quality system element or part thereof, or a se-
to investigate the possibility of applying the most re-
quence of interrelated activities connected with more
cent edition of the standard indicated below. Mem-
than one quality system element. The quantity of
bers of IEC and IS0 maintain registers of currently
documented procedures, the volume of each and the
valid International Standards.
nature of their format and presentation are to be de-
IS0 8402: 1994, Quality management and quality as- termined by the user of this International Standard;
each usually reflects the complexity of the facility, or-
surance - Vocabulary.
ganization and nature of business. Documented qual-
ity system procedures should not, as a rule, enter into
3 Definitions
purely technical details of the type normally docu-
mented in detailed work instructions.
For the purposes of this International Standard, the
definitions given in IS0 8402 apply.
4.1.2 Consistent approach
By arranging each documented procedure in the same
4 Documentation of quality systems
structure and format, the users will become familiar
with the consistent approach applied to each require-
Annex A describes a typical quality system doc-
umentation hierarchy. The order of development of ment and so improve the likelihood of systematic
this hierarchy in an individual organization is depen- compliance with the standard.
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IS0 10013:1995(E) 0 IS0
4.2.2 Structure and format
4.2 Quality manuals
Although there is no required structure or format for
A quality manual should consist of, or refer to, the
a quality manual, it should convey accurately, com-
documented quality system procedures intended for
pletely and concisely the quality policy, objectives and
the overall planning and administration of activities
governing documented procedures of the organization
which impact on quality within an organization. A
(see clause 6). One of the methods of assuring that
quality manual should cover all the applicable ele-
the subject matter is adequately addressed and lo-
ments of the quality system standard required for an
cated would be to key the sections of the quality
organization. It should describe, in adequate detail,
manual to the quality elements of the governing
the same control aspects mentioned in subclause 4.1.
quality system standard. Other approaches, such as
In some situations, the related documented quality
structuring the manual to reflect the nature of the or-
system procedures and some sections of the quality
ganization, are equally acceptable.
manual may be identical. However, some degree of
tailoring is usually required to ensure that only appro-
NOTE 3 For system clarity and assessment purposes,
priate documented procedures (or sections thereof)
the intentional omission of any quality system element from
are selected for the specific purposes of the quality
the quality manual compared to the governing quality sys-
manual being developed. The contents of quality
tem standard should be explained.
manuals are addressed in detail in clause 7. Docu-
mented procedures related to the quality system, not
dealt with in the selected quality system standard but
4.2.3 Derivation of a quality manual
necessary for the adequate control of the activities,
should be added to the quality manual or be refer-
A quality manual may:
enced as necessary. (See annex B.)
a) be a direct compilation of documented quality
NOTE 2 Inclusion of proprietary information is at the dis-
system procedures;
cretion of the organization.
b) be a grouping or section of the documented qual-
ity system procedures;
4.21 Purposes of quality manuals
c) be a series of documented procedures for specific
Quality manuals may be developed and used by an
facilities or applications;
organization for purposes including, but not limited to,
d) be more than one document or level;
the following:
e) have a common core with tailored appendices;
a) communicating the organization’s quality policy,
procedures and requirements;
f) stand alone or otherwise;
b) describing and implementing an effective quality
g) have other numerous possible derivations based
system;
upon organizational need.
c) providing improved control of practices and facili-
tating assurance activities;
4.2.4 Special applications of quality manuals
d) providing the documented bases for auditing the
The simple term “quality manual” is used when the
quality system;
same manual is employed for both quality manage-
ment and quality assurance purposes. This usage is
e) providing continuity of the quality system and its
the most common application of a quality manual.
requirements during changing circumstances;
However, in situations where an organization believes
that a distinction of content or usage is needed, it is
f) training personnel in the quality system require-
essential that manuals describing the same quality
ments and methods of compliance;
system are not in conflict.
g) presenting the quality system for external pur-
Any quality manual should identify the management
poses, such as demonstrating compliance with
functions, address or reference the documented
IS0 9001, 9002 or 9003;
quality system and procedures and briefly cover all the
applicable requirements of the quality system stan-
h) demonstrating compliance of the quality system
dard selected by the organization.
with quality requirements in contractual situations.
2
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0 IS0 IS0 10013:1995(E)
5.3 Accuracy and completeness
5 Process of preparing a quality manual
The delegated competent body should be responsible
for assuring the accuracy and completeness of the
quality manual draft, as well as for the continuity and
5.1 Responsibil ity for preparation
contents of the document.
Once the manage nent decision has been made to
6 Process of quality manual approval,
document a quality system in a quality manual, the
issue and control
actual process should begin with assignment of the
coordination task to a management-delegated com-
petent body, which may be an individual or a group
6.1 Final review and approval
of individuals from one or more functional organiz-
ations.
Prior to issuing the manual, the document should be
subjected to review by responsible individuals to en-
The actual writing activity should be performed and
sure clarity, accuracy, suitability and proper structure.
controlled from within the delegated competent body
The intended users should also have the opportunity
or from within various individual functional units, as
to assess and comment on the usability of the docu-
appropriate. The use of existing documents and ref-
ment. Release of the new quality manual should be
erences can significantly shorten the quality manual
approved by the management responsible for its im-
development time, as well as being an aid to identi-
plementation. Each copy should bear evidence of this
fying those areas where quality system inadequacies
release authorization. Electronic or other methods of
need to be addressed and corrected.
release of the manual are acceptable, if evidence of
approval is retained.
The competent body may initiate the following actions
as applicable:
6.2 Distribution of the manual
a) establish and list existing applicable quality sys-
The method of distribution of the authorized manual,
objectives and documented pro-
tem policies,
whether in total or by sections, should provide assur-
cedures, or develop plans for such;
ance that all users have appropriate access. Proper
distribution and control can be aided, for example, by
decide which quality system elements apply ac-
serialization of copies for recipients. Management
cording to the quality system standard selected;
should ensure that individuals are familiar with those
contents of the manual appropriate to each user
obtain data about the existing quality system and
within the organization.
practices by various means, such as question-
naires and interviews;
6.3 Incorporation of changes
request and obtain additional source documenta-
d
tion or references from operational units; A method of providing for the initiation, development,
review, control and incorporation of changes to the
determine the structure and format for the in-
e) manual should be provided. This task should be as-
tended manual;
signed to an appropriate document control function.
The same review and approval process used in de-
classify existing documents in accordance with
f )
veloping the basic manual should apply when pro-
the intended structure and format;
cessing changes.
use any other method suitable within the organiz-
9)
6.4 Issue and change control
ation to complete the quality manual draft.
Document issue and change control are essential to
ensure that the content of the manual is properly
authorized. The authorized content should be readily
identifiable. Various methods may be considered for
5.2 Use of references
facilitating the physical process of making changes.
To ensure that each manual is kept up to date, a
Wherever appropriate, and to avoid unnecessary doc-
method is needed to assure that all changes are re-
ument volume, reference to existing recognized stan-
ceived by each manual holder and incorporated into
dards or documents available to the quality manual
each manual. A table of contents, a separate
user should be incorporated.
3
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0 ES0
IS0 10013:1995(E)
define the application of the quality system elements.
revision-status page or other suitable means may be
To ensure clarity and avoid confusion, the use of dis-
used to assure the users that they have the author-
claimers (e.g. what is not covered by a quality manual
ized manual.
and situations where it should not be applied) may
also be appropriate. Some or all of this information
may also be located on the title page.
6.5 Uncontrolled copies
For the purposes of pro
...
NORME
IS0
INTERNATIONALE
10013
Premihre kdition
1995-03-I 5
Lignes directrices pour Maboration des
manuels qualit
Guidelines for developing quality manuals
Numbro de rkfbence
IS0 10013: 1995(F)
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IS0 10013:1995(F)
Sommaire
Page
1
1 Domaine d’application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
2 Reference normative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
3 Definitions , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
4 Documentation des systemes qualite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Processus d’etablissement d’un manuel qualite . . . . . . . . . . . . . . . . . . . . . . 3
Processus d’approbation, de diffusion et de maltrise du manuel
6
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
qualite
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
7 Contenu d’un manuel qualite
Annexes
. . . . . . . . . . . . 7
A Hierarchic type des documents d’un systeme qualite
B Exemple de presentation possible d’un chapitre d’un manuel
8
qualite . . . . . . . . . . . . . . .*.
. . . . . . . .I. IO
C Exemple de chapitre d’un manuel qualite
12
D Bibliographie . .
0 IS0 1995
Droits de reproduction r&e&s. Sauf prescription diffkente, aucune partie de cette publi-
cation ne peut etre reproduite ni utilisee sous quelque forme que ce soit et par aucun pro-
&d& electronicye ou mkcanique, y compris la photocopie et les microfilms, sans I’accord
hrit de I’kditeur.
Organisation internationale de normalisation
Case Postale 56 0 CH-1211 Get-he 20 l Suisse
Imprime en Suisse
ii
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63 IS0
IS0 10013:1995(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 inter-es& par une
etude a le droit de faire pat-tie du comite technique tree a cet effet. Les
organisations internationales, gouvernementales et non gouvernemen-
tales, en liaison avec I’ISO participent egalement aux travaux. L’ISO colla-
bore etroitement avec la Commission electrotechnique internationale (CEI)
en ce qui concerne la normalisation electrotechnique.
Les projets de Normes internationales adopt& par les comites techniques
sont soumis aux comites membres pour vote. Leur publication comme
Normes internationales requiert I’approbation de 75 % au moins des co-
mites membres votants.
La Norme internationale IS0 10013 a ete elaboree par le comite technique
lSO/TC 176, Management et assurance de /a qua/it& sous-comite SC 3,
Techniques de soutien.
Les annexes A, B, C et D de la presente Norme internationale sont don-
nees uniquement a titre d’information.
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0 IS0
IS0 10013:1995(F)
Introduction
Les Normes internationales de la famille IS0 9000 dkfinissent les exi-
gences de systemes qualit qui peuvent &re utilisbes pour parvenir 3 une
interprktation, une conception, une mise en oeuvre et une application
communes du management et de I’assurance de la qualit&
Les normes internationales de la famille IS0 9000 relatives aux systkmes
qualiti! exigent I’klaboration et la mise en wvre de systkmes qualit
consign& par krit, comprenant Etablissement de manuels qualit&
L’ISO 8402:1994, Management de la qua/it6 et assurance de la
qua/it6 - Vocabulaire, dkfinit le manuel qualiti: comme un document
honGant la politique qualit et dkrivant le systkme qualiti! d’un orga-
nisme. II peut se rapporter A I’ensemble des activitks d’un organisme ou
A une partie determihe de celles-ci; par exemple, des exigences spkci-
fi6es selon la nature des produits ou des services, des processus, des
exigences contractuelles, des reglements en vigueur ou de I’organisme
lui-meme.
II est important que les exigences et le contenu du syst&me qualit et du
manuel qualiti, rkpondent ZI la norme de qualit qu’ils sont cens& satis-
faire. La pksente Norme internationale fournit des lignes directrices pour
IWaboration de manuels qualiti: de ce type.
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NORME INTERNATIONALE 0 IS0
IS0 10013:1995(F)
Lignes directrices pour Naboration des manuels
qualit
1 Domaine d’application 4 Documentation des systkmes qualiti!
La presente Norme internationale fournit des lignes L’annexe A presente une hierarchic type des docu-
ments relatifs aux systemes qualite. L’ordre d’elabo-
directrices pour I’elaboration, la preparation et la ma?-
ration de cette hierarchic, dans un organisme
trise des manuels qualite, adaptees aux besoins spe-
particulier, depend de son environnement, mais de-
cifiques de I’organisme utilisateur. Les manuels
qualite obtenus seront le reflet des procedures &rites bute generalement par I’elaboration de la politique et
exigees par les Normes internationales de la famille des objectifs qualite de I’organisme.
IS0 9000. La presente Norme internationale ne traite
pas des instructions de travail detaillees, des plans
4.1 Procbdures &rites du systeme qualit
qualite, des brochures et autres documents relatifs a
un systeme qualite. (Voir annexe A, niveau C.)
II est recommande que les procedures &rites du
systeme qualite constituent la documentation de base
La pr-6sente Norme internationale peut &re utili-
NOTE 1
pour la planification et la gestion g&&r-ales des activi-
ske pour I’klaboration de manuels qualit relevant d’autres
tes ayant une incidence sur la qualite. Conformement
normes de systGmes qualit que celles de la famille
a la famille IS0 9000, il est recommande que ces
IS0 9000.
procedures &rites traitent tous les elements applica-
bles de la norme de systeme qualite. II est recom-
mande qu’elles decrivent (avec le degre de details
2 Rbfbrence normative
requis permettant une ma?trise adequate des activites
concernees) les responsabilites, les liaisons hierarchi-
La norme suivante contient des dispositions qui, par
ques et les relations mutuelles des personnes char-
suite de la reference qui en est faite, constituent des
gees du management, de I’execution, de la
dispositions valables pour la presente Norme interna-
verification et de la revue des taches ayant une inci-
tionale. Au moment de la publication, I’edition indi-
-dence sur la qualite, la man&e dont les differentes
q&e etait en vigueur. Toute norme est sujette a
activites doivent etre executees, la documentation a
revision et les parties prenantes des accords fond&
utiliser et la man&e de la ma’itriser. (Voir annexe A.)
sur la presente Norme internationale sont invitees a
rechercher la possibilite d’appliquer I’edition la plus
4.1.1 Objet des procbdures
recente de la norme indiquee ci-apres. Les membres
de la CEI et de I’ISO possedent le registre des Nor-
II est recommande que chaque procedure traite une
mes internationales en vigueur a un moment donne.
par-tie logiquement separable du systeme qualite, telle
qu’un element complet de systeme qualite ou une
IS0 8402:1994, Management de la qua/it6 et assu-
partie de cet element, ou encore une suite d’activites
rance de la qua/it6 - Vocabulaire.
liees entre elles a plus d’un element de systeme
qualite. Le nombre de procedures &rites, le volume
de chacune d’elles et la nature de leur structure et de
leur presentation doivent etre determines par l’utili-
3 Dhfinitions
sateur de la presente Norme internationale; les pro-
cedures refletent generalement la complexite de
Pour les besoins de la presente Norme internationale,
I’organisation ou la nature des activi-
les definitions donnees dans I’ISO 8402 s’appliquent. l’instal lation, de
1
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IS0 10013:1995(F) 0 IS0
t& traitkes. II est recommandi! que les prockdures b) dkrire et mettre en ceuvre un systkme qualit
&rites relatives aux systkmes qualitk n’entrent pas, effectif;
en principe, dans des details exclusivement techni-
c) fournir une maTtrise amblioree des pratiques et
ques, tels que ceux normalement consign& dans les
faciliter les activit& d’assurance de la qualitb;
instructions de travail dbtailkes.
d) fournir les bases documentaires pour auditer le
syst&me qualitk;
4.12 Approche homogene
e) assurer la continuiti3 du systgme qualitk et de ses
L’organisation de chaque procedure selon la meme
exigences en cas de modification des circonstan-
structure et la meme presentation permettra aux uti-
ces;
lisateurs de se familiariser avec la cohkence de I’ap-
proche utilisbe pour chaque exigence et d’amkliorer
f) former le personnel aux exigences de systeme
ainsi la possibilite d’une conformit systbmatique
qualite et aux mkthodes relatives 5 la conformitk;
avec la norme.
g) p&enter son systeme qualitk pour des usages
externes, tels que la dbmonstration de sa confor-
Manuel qualit mitb 5 I’ISO 9001, I’ISO 9002 ou I’ISO 9003;
42 .
h) dbmontrer la conformit de son systkme qualit
recommandG qu’un manuel qualitk comprenne
II est
aux exigences relatives A la qualite dans des si-
les procedures &rites du systeme qualitk pr&ues
tuations contractuelles.
pour la planification et I’administration des activitgs
ayant une incidence sur la qualitk dans le cadre d’un
organisme, ou qu’il s’y rkf&e. II est recommandk
4.2.2 Structure et prbsentation
qu’un manuel qualitk traite tous les 6kments applica-
bles de la norme relative au systkme qualite exigbe
Bien qu’aucune structure ou prksentation ne soit exi-
pour un organisme. II convient de dkrire, avec des
gke pour un manuel qualit& il est recommandk que
dktails adequats, les m$mes aspects de maltrise
celui-ci expose, de man&e prkise, concise et com-
mentionnks au paragraphe 4.1. Dans certaines si-
PI&e la politique q&lit& les objectifs et les procedu-
tuations, les prockdures &rites correspondantes du
res &rites applicables de I’organisme (voir article 6).
systeme qualit et certaines parties du manuel qualiti!
Une des methodes permettant de s’assurer que le
peuvent &tre identiques. Cependant, un certain degrk
sujet est correctement traiti! et localisk devrait &re
d’adaptation est g&Walement exig8 pour assurer que
de relier les chapitres du manuel aux Mments qualit
seules les prochdures &rites adbquates (ou certaines
de la norme relative au systeme qualitk appliquk
parties de celles-ci) sont sklectionnbes pour rkpondre
D’autres approches, telles que la structuration du
aux besoins spkcifiques du manuel qualit en tours
manuel de man&-e A refkter la nature de I’organisme,
d’klaboration. Le contenu des manuels qualitk est
sont hgalement acceptables.
trait6 de man&e dktaillke B I’article 7. II convient
NOTE 3 II convient d’expliquer, a des fins de clarification
d’ajouter au manuel qualit& ou le cas 6cheant d’y
et d’kvaluation, pourquoi un Mment du systkme qualit a
mentionner en rbfl!rence, les procbdures &rites rela-
&l! omis intentionnellement du manuel qualit& en compa-
tives au systeme qualit& non traitbes dans la norme
raison avec la norme du systhme rkgissant la qualit&
choisie relative aux syst&mes qualit& mais nkessai-
res pour une maTtrise adequate des activitbs. (Voir
annexe B.) 4.2.3 Variantes d’un manuel qualit
NOTE 2 L’introduction d’informations confidentielles est
Un manuel qualitk peut
A la discrktion de l’organisme.
a) etre une simple compilation des procbdures
&rites du systeme qualitk;
4.2.1 Objets des manuels qualit
b) etre un regroupement ou une pat-tie des procedu-
Les manuels qualiti! peuvent etre klaborks et utilis&
res &rites du systeme qualitk;
par un organisme pour repondre aux objectifs sui-
vants, cette Iiste n%tant pas exhaustive: c) etre une s&ie de procedures &rites relatives 2
des installations ou 8 des applications spkifiques;
a) communiquer la politique, les procedures et les
exigences qualiti! de I’organisme; d) cornporter plusieurs documents ou niveaux;
2
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0 IS0
IS0 10013:1995(F)
e) cornporter un document principal commun et des plicables au systkme qualiti! ou d&elopper les
annexes modulkes; plans correspondants;
f) se suffire 5 lui-meme ou non; b) dkcider des Mments de systeme qualit qui
s’appliquent en fonction de la norme de systhme
presenter de nombreuses autres variantes &en-
qualiti! choisie;
9)
tuelles en fonction des besoins de I’organisme.
c) se procurer des donn6es sur le systkme qualiti:
et les pratiques existants par divers moyens, tels
4.2.4 Applications particulihres des manuels
que des questionnaires et des entretiens;
qualit
d) demander et obtenir aupres des unit& opbration-
Le simple terme de ({manuel qualit& est utilisk lors-
nelles une documentation ou des @fi!rences ad-
que le meme manuel est employ6 8 la fois pour le
ditionnelles prises ZI la source;
management de la qualiti! et I’assurance de la qualit&
Cet usage correspond G I’application la plus commune
e) ditterminer la structure et la prhsentation du ma-
d’un manuel qualit& Cependant, lorsqu’un organisme
nuel envisag6;
juge qu’il est nkessaire de faire une distinction selon
le contenu, ou selon I’usage, il est indispensable que
classer les documents existants conform6ment A
f)
les manuels dkrivant le m6me systkme qualit ne
la structure et a la pnkentation envisagkes;
soient pas contradictoires.
) utiliser toute autre m6thode appropriee dans le
II est recommand6 que tout manuel qualit identifie
cadre de I’organisme pour achever le projet de
les fonctions de management, d&rive ou fasse r6f6-
manuel qualit&
rence aux proc6dures &rites du systkme qualiti: et
traite bri&vement toutes les exigences applicables de
la norme de systeme qualiti! choisie par I’organisme.
5.2 Utilisation des rhfkences
Le cas itcheant, et pour 6viter un volume inutile de
5 Processus d’htablissement d’un
documents, il convient d’inclure les renvois aux nor-
manuel qualit
mes ou docufients existants reconnus et ti la dispo-
sition de I’utilisateur du manuel qualit&
5.1 Responsabilitb de I’&ablissement
5.3 Exactitude et exhaustivitk
D&s que la dkision de consigner par 6crit un sys &me
qualit dans un manuel qualit a 6t6 prise par a di-
II est recommandi! que I’entitk compbtente mandatke
rection, il est recommandi! que le processus pro-
veille B assurer que le projet de manuel qualiti! est
prement dit commence par I’attribution de la t&t e de
exact et complet et que le contenu du document est
coordination ZI une entit6 compktente mandat6e par
homog&ne.
la direction qui peut 6tre soit un individu, soit un
groupe d’individus appartenant 2 un ou plusieurs or-
6 Processus d’approbation, de diffusion
ganismes fonctionnels.
et de maitrise du manuel qualit
II est recommand6 que la redaction proprement dite
soit effect&e et maitrisite au sein de I’entiti! comp&
6.1 Revue finale et approbation
tente dGgu6e ou au sein de diffi!rentes unit& fonc-
tionnelles individuelles, selon ce qui convient le
Avant la diffusion du manuel, il convient de soumettre
mieux. L’utilisation des documents et des r6f6rences
le document 2 une revue effect&e par les responsa-
existants peut reduire de manikre significative la du-
bles afin de s’assurer de la clart6, de I’exactitude, de
ke d’6laboration du manuel qualit& ainsi qu’aider a
la pertinence et de la structure appropri6e du manuel.
identifier les domaines oti des insuffisances du sys-
II est recommande 6galement que les utilisateurs
t&me qualit doivent 6tre prises en compte et corri-
prkvus aient eux aussi I’occasion d’6valuer et de
gites.
commenter la facilitk d’utilisation du document. II est
recommandi! que Emission du nouveau manuel
L’entitk compbtente peut, le cas Bchbant, entrepren-
qualit soit approuke par la direction responsable de
dre les actions suivantes:
sa mise en ceuvre. II est recommand6 que chaque
a) &ablir une liste des directives politiques, des ob- copie Porte la preuve de cette autorisation d%mission.
jectifs et des proc6dures &rites, existants et ap- Les methodes Blectroniques ou autres d%mission du
3
---------------------- Page: 7 ----------------------
IS0 10013:1995(F)
ma nuel sont acceptables, i cond ition que la preuve
7 Contenu d’un manuel qualit
de I’approbation soit conse n&e.
6.2 Diffusion du manuel 7.1 GhGkalit&
II est recommande que le mode de diffusion du ma- II convient qu’un manuel qualite contienne en general
nuel autorise, en totalite ou en partie, donne I’assu- les Mments suivants:
rance que tous les utilisateurs y ont un acces
un titre, un objet et un domaine d’application;
approprie. Une diffusion et une maRrise correctes a)
peuvent etre facilitees, par exemple, par une nume-
b) un sommaire;
rotation des copies a I’usage des destinataires. II est
recommande que la direction s’assure que chaque
des pages introductives relatives
d 5 I’organisme
wtilisateur h l’int&ieur de l’organisme est familiaris
concerne et au manuel lui-meme;
avec la partie du manuel qui est de son ressort.
la politique et les objectifs qualit de I’organisme;
d)
6.3 Introduction des modifications
e) une description de l’organisation, des responsa-
bilites et des liaisons hierarchiques;
II convient de prevoir une methode de declen-
chement, d’elaboration, de revue, de maltrise et d’in-
f) une description des 6l6ments du systkme qualit
troduction des modifications dans le manuel. II
et tout renvoi aux procedures &rites du systeme
convient d’attribuer cette t&he 8 une fonction appro-
qualite;
price de maCtrise des documents. II convient d’appli-
quer aux modifications le meme processus de revue
un chapitre de definitions, s’il y a lieu;
et d’approbation que ceux qui ont ete utilises pour
Maboration du manuel de base.
un guide du manuel qualite, s’il y a lieu;
une a
...
SLOVENSKI SIST ISO 10013
druga izdaja
STANDARD
avgust 1997
Smernice za izdelavo poslovnikov kakovosti
(istoveten ISO 10013:1995)
Guidelines for developing quality manuals
Lignes directrices pour l'élaboration des manuels qualité
Leitfaden für das Erstellen von Qualitätsmanagement-Handbüchern
Deskriptorji: kakovost, vodenje kakovosti, zagotavljanje kakovosti, sistemi zagotavljanja
kakovosti, dokumenti, priro~niki, priprava, splo{ni pogoji
Referen~na {tevilka
ICS 03.120.10 SIST ISO 10013:1997 (sl,en)
Nadaljevanje na straneh od 2 do 28
© 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 10013 : 1997
UVOD
Standard SIST ISO 10013 (sl,en), Smernice za izdelavo poslovnikov kakovosti, druga izdaja,
1997, ima status slovenskega standarda in je istoveten mednarodnemu standardu ISO 10013,
Guidelines for developing quality manuals, prva izdaja, 1995.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 10013:1995 je pripravil tehni~ni odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje in zagotavljanje kakovosti. Slovenski standard
SIST ISO 10013:1997, druga izdaja, je prevod angle{kega besedila mednarodnega standarda
ISO 10013:1995, First edition. 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 VZK Vodenje in zagotavljanje kakovosti.
Ta slovenski standard je dne 1997-07-02 odobril direktor USM.
ZVEZE S STANDARDI
SIST EN ISO 8402:1997 (sl,en,de,fr) Vodenje in zagotavljanje kakovosti - Slovar
PREDHODNE IZDAJE
- SIST ISO 10013:1996 (en)
OSNOVA ZA IZDAJO STANDARDA
- Prevzem standarda ISO 10013:1995
OPOMBE
- Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v
SIST ISO 10013:1997 to pomeni “slovenski standard”.
- Uvod in nacionalni predgovor nista sestavni del standarda.
- Slovenski standard SIST ISO 10013:1997 je istoveten standardu ISO 10013:1995.
2
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SIST ISO 10013 : 1997
VSEBINA Stran Contents Page
Predgovor.4 Foreword.4
Uvod.5 Introduction.5
1 Predmet standarda.6 1 Scope.6
2 Zveza z drugimi standardi.6 2 Normative reference.6
3 Definicije.6 3 Definitions.6
4 Dokumentacija sistemov kakovosti.7 4 Documentation of quality systems.7
5 Proces izdelave poslovnika kakovosti.10 5 Process of preparing a quality manual.10
6 Proces odobritve, izdaje in nadzora 6 Process of quality manual approval,
poslovnika kakovosti.12 issue and control.12
7 Kaj vklju~iti v poslovnik kakovosti.13 7 What to include in a quality manual.13
Dodatki Annexes
A Zna~ilna hierarhija dokumentov sistema A Typical quality system document
kakovosti.20 hieararchy.21
B Primer oblike poglavja iz poslovnika B Example of possible format for a section
kakovosti.22 of quality manual.23
C Primer poglavja v poslovniku C Example of section of a
quality manual.26
kakovosti.24
D Bibliography.28
D Bibliografija.28
3
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SIST ISO 10013 : 1997
PREDGOVOR FOREWORD
ISO (Mednarodna organizacija za standardi- ISO (the International Organization for Stan-
zacijo) je svetovna zveza nacionalnih dardization) is a worldwide federation of
organov za standarde (~lanov ISO). national standards bodies (ISO member
Mednarodne standarde ponavadi pripravljajo bodies). The work of preparing International
tehni~ni odbori ISO. Vsak ~lan, ki `eli Standards is normally carried out through
sodelovati na dolo~enem podro~ju, za katero ISO technical committees. Each member
je ustanovljen tehni~ni odbor, ima pravico body interested in a subject for which a
biti zastopan v tem odboru. Pri delu sode- technical committee has been established
lujejo tudi vladne in nevladne mednarodne has the right to be represented on that
organizacije, povezane z ISO. V vseh zade- committee. International organizations, go-
vah, ki so povezane s standardizacijo na vernmental and non-governmental, in liaison
podro~ju elektrotehnike, ISO tesno sodeluje with ISO, also take part in the work. ISO
z Mednarodno elektrotehni{ko komisijo (IEC). collaborates closely with the International
Electrotechnical Commission (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 med- member bodies for voting. Publication as an
narodnega standarda je treba pridobiti so- International Standard requires approval by
glasje najmanj 75 odstotkov ~lanic, ki se at least 75% of the member bodies casting
udele`ijo glasovanja. a vote.
Mednarodni standard ISO 10013 je pripravil International standard ISO 10013 was pre-
tehni~ni odbor ISO/TC 176, Vodenje in pared by Technical Committee ISO/TC 176,
Quality management and quality assurance,
zagotavljanje kakovosti, pododbor SC 3,
Podporne tehnologije. Subcommittee SC, Supporting technologies.
Dodatki A, B, C in D tega mednarodnega Annexes A, B, C and D of this International
standarda slu`ijo samo za informacijo. Standard are for the information only.
4
---------------------- Page: 4 ----------------------
SIST ISO 10013 : 1997
UVOD INTRODUCTION
Skupina mednarodnih standardov ISO 9000 The ISO 9000 family of International Stan-
vklju~uje zahteve za sisteme kakovosti, ki se dards includes requirements for quality sys-
lahko uporabijo za doseganje enotne razla- tems which can be used to achieve com-
ge, razvoja, izvedbe in uporabe vodenja mon interpretation, development, implemen-
kakovosti in zagotavljanja kakovosti. tation and application of quality management
and quality assurance.
Skupina mednarodnih standardov ISO 9000 The ISO 9000 family of International Stan-
zahteva razvoj in izvedbo dokumentiranih dards requires the development and imple-
sistemov kakovosti, vklju~no s pripravo mentation of documented quality systems,
poslovnikov kakovosti. including the preparation of quality manuals.
ISO 8402:1994, Vodenje in zagotavljanje ISO 8402:1994, Quality management and
kakovosti - Slovar dolo~a poslovnik kakovosti quality assurance - Vocabulary, defines a
kot dokument, ki podaja politiko kakovosti in quality manual as a document stating the
opisuje sistem kakovosti v organizaciji. quality policy and describing the quality
Lahko se nana{a na vse aktivnosti v system of an organization. This may relate
organizaciji ali na izbrani del teh aktivnosti, to an organization's total activities or to a
na primer na specificirane zahteve v selected part of those activities; for exam-
odvisnosti od narave proizvodov ali storitev, ple, specified requirements depending upon
procesov, pogodbenih zahtev, upravnih the nature of products or services, proc-
predpisov ali na samo organizacijo. esses, contractual requirements, governing
regulations or the organization itself.
Pomembno je, da se zahteve in vsebina It is important that the requirements and
sistema kakovosti in poslovnika kakovosti content of the quality system and quality
nana{ajo na tisti standard kakovosti, ki naj manual address the quality standard they
bi ga zadovoljile. Ta mednarodni standard are intended to satisfy. This International
dolo~a smernice za izdelavo tak{nega Standard provides guidelines for developing
sistema kakovosti. such quality system.
5
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SIST ISO 10013 : 1997
Smernice za izdelavo poslov- Guidelines for developing
nikov kakovosti quality manuals
1 Predmet standarda 1 Scope
Ta mednarodni standard dolo~a smernice za This International Standard provides guide-
izdelavo, pripravo in nadzor nad poslovniki lines for the development, preparation and
kakovosti, ki so prikrojeni posebnim potre- control of quality manuals tailored to the
bam uporabnika. Tako izdelani poslovniki specific needs of the user. The resultant
kakovosti bodo odra`ali dokumentirane quality manuals will reflect documented
postopke sistema kakovosti, ki jih zahteva quality system procedures required by the
skupina mednarodnih standardov ISO 9000. ISO 9000 family of International Standards.
Ta mednarodni standard ne obravnava Detailed work instructions, quality plans,
podrobnih delovnih navodil, planov kako- brochures and other quality system related
vosti, bro{ur in drugih dokumentov, ki se documents are not covered by this Interna-
nana{ajo na sistem kakovosti. (Glej dodatek tional Standard. (See annex A, level C.)
A, nivo C)
Opomba 1: Ta mednarodni standard se lahko uporabi NOTE 1 This International Standard may be used
za izdelavo poslovnikov kakovosti, ki se to develop quality manuals relating to
nana{ajo na druge standarde za sisteme quality system standards other than the
kakovosti in ne le na skupino ISO 9000. ISO 9000 family.
2 Zveza z drugimi standardi 2 Normative references
Spodaj navedeni standard vsebuje dolo~ila, The following standard contains provisions
ki v povezavi s tem besedilom tvorijo which, through reference in this text, con-
dolo~ila tega mednarodnega standarda. V stitute provisions of this International Stan-
~asu objave je bila veljavna spodaj dard. At the time of publication, the edition
navedena izdaja. Vsi standardi se obi~ajno indicated was valid. All standards are sub-
revidirajo. Strankam, ki sklenejo pogodbo, ject to revision, and parties to agreements
zasnovano na tem mednarodnem standardu, based on this International Standard are
se priporo~a, da razi{~ejo mo`nost uporabe encouraged to investigate the possibility of
najnovej{e izdaje spodaj navedenega applying the most recent edition of the
standarda. ^lani IEC in ISO vzdr`ujejo reg- standard indicated below. Members of IEC
ister veljavnih mednarodnih standardov. and ISO maintain registers of currently valid
International Standards.
ISO 8402:1994, Vodenje in zagotavljanje ISO 8402:1994, Quality management and
kakovosti - Slovar quality assurance - Vocabulary.
3 Definicije 3 Definitions
V tem mednarodnem standardu se uporab- For the purposes of this International Stan-
ljajo definicije, podane v standardu dard, the definitions given in ISO 8402 ap-
ISO 8402. ply.
6
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SIST ISO 10013 : 1997
4 Dokumentacija sistemov 4 Documentation of quality
kakovosti systems
Dodatek A prikazuje tipi~no hierarhijo Annex A describes a typical quality system
dokumentacije sistema kakovosti. Vrstni red documentation hierarchy. The order of de-
izdelave te hierarhije v posamezni velopment of this hierarchy in an individual
organizaciji je odvisen od razmer v organization is dependent on that organiza-
organizaciji, vendar se ponavadi za~ne z tion's circumstances, but usually starts with
dolo~itvijo njene politike kakovosti in ciljev. development of the organization's quality
policy and objectives.
4.1Dokumentirani postopki sistema 4.1Documented quality system
kakovosti procedures
Dokumentirani postopki sistema kakovosti naj Documented quality system procedures
tvorijo osnovno dokumentacijo, ki se upo- should form the basic documentation used
rablja za celotno planiranje in administriranje for the overall planning and administration of
aktivnosti, ki vplivajo na kakovost. V skladu activities which impact on quality. In accor-
s standardi skupine ISO 9000 naj ti dance with the ISO 9000 family, these
dokumentirani postopki obravnavajo vse documented procedures should cover all
primerne elemente standarda za sistem applicable elements of the quality system
kakovosti. Opisujejo naj (tako podrobno, kot standard. They should describe (to the de-
je potrebno za ustrezen nadzor obravnavanih gree of detail required for adequate control
aktivnosti) odgovornosti, pooblastila in med- of the activities concerned) the responsibili-
sebojne povezave osebja, ki vodi, izvaja, ties, authorities and interrelationships of the
preverja ali pregleduje delo, ki vpliva na personnel who manage, perform, verify or
kakovost; na~in izvedbe razli~nih aktivnosti; review work affecting quality, how the differ-
dokumentacijo, ki naj bo uporabljena, in ent activities are to be performed, the
nadzor, ki naj bo izveden. (Glej dodatek A) documentation to be used and the controls
to be applied. (See annex A.)
4.1.1 Vsebina postopkov 4.1.1 Procedural scope
Vsak dokumentiran postopek naj obravnava Each documented procedure should cover a
logi~no lo~ljiv del sistema kakovosti, kot na logically separable part of the quality sys-
primer celoten element sistema kakovosti ali tem, such as a complete quality system
le njegov del, ali zaporedje medsebojno element or part thereof, or a sequence of
povezanih aktivnosti, ki jih povezuje ve~ kot interrelated activities connected with more
en element sistema kakovosti. [tevilo than one quality system element. The quan-
dokumentiranih postopkov, obseg vsakega tity of documented procedures, the volume
izmed njih ter njihovo obliko in vrsto pred- of each and the nature of their format and
stavitve dolo~i uporabnik tega mednarodnega presentation are to be determined by the
standarda. Vse navedeno ponavadi odra`a user of this International Standard; each
kompleksnost procesa, organizacije in vrste usually reflects the complexity of the facility,
poslovanja. Dokumentirani postopki sistema organization and nature of business. Docu-
kakovosti naj praviloma ne vsebujejo popol- mented quality system procedures should
noma tehni~nih podrobnosti take vrste, ki so not, as a rule, enter into purely technical
ponavadi dokumentirane v podrobnih delov- details of the type normally documented in
nih navodilih. detailed work instructions.
7
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SIST ISO 10013 : 1997
4.1.2 Dosleden pristop 4.1.2 Consistent approach
Z uporabo vedno enake oblike in zgradbe By arranging each documented procedure in
dokumentiranih postopkov bodo uporabniki the same structure and format, the users
spoznali dosleden pristop, uporabljen pri will become familiar with the consistent ap-
vsaki zahtevi, in tako pove~ali verjetnost proach applied to each requirement and so
sistemati~ne skladnosti s standardom. improve the likelihood of systematic compli-
ance with the standard.
4.2 Poslovniki kakovosti 4.2 Quality manuals
Poslovnik kakovosti naj vsebuje oziroma se A quality manual should consist of, or refer
sklicuje na dokumentirane postopke sistema to, the documented quality system proce-
kakovosti, ki so namenjeni za celotno plani- dures intended for the overall planning and
ranje in administriranje aktivnosti, ki vplivajo administration of activities which impact on
na kakovost v organizaciji. Poslovnik kako- quality within organization. A quality manual
vosti naj obravnava vse primerne elemente should cover all the applicable elements of
tistega standarda za sistem kakovosti, ki je the quality system standard required for an
zahtevan za organizacijo. Do primerne organization. It should describe, in adequate
podrobnosti naj opisuje nadzorne vidike, ki detail, the same control aspects mentioned
so zapisani v podpoglavju 4.1. V nekaterih in subclause 4.1. In some situations, the
okoli{~inah so lahko dolo~eni deli poslovnika related documented quality system proce-
kakovosti popolnoma enaki pripadajo~im dures and some sections of the quality
dokumentiranim postopkom sistema kako- manual may be identical. However, some
vosti. Vsekakor je ponavadi potrebna degree of tailoring is usually required to
dolo~ena stopnja prikrojitve, da se izberejo ensure that only appropriate documented
samo primerni dokumentirani postopki (ali procedures (or sections thereof) are selected
njihovi deli) za specifi~ne namene poslovnika for the specific purposes of the quality
kakovosti, ki se izdeluje. Vsebina poslov- manual being developed. The contents of
nikov kakovosti je podrobno opisana v po- quality manuals are addressed in detail in
glavju 7. Po potrebi naj se poslovniku kako- clause 7. Documented procedures related to
vosti dodajo dokumentirani postopki ali naj the quality system, not dealt with in the
se sklicujejo na dokumentirane postopke, ki selected quality system standard but neces-
so povezani s sistemom kakovosti in kljub sary for the adequate control of the activi-
temu, da so nujni za primerno obvladovanje ties, should be added to the quality manual
aktivnosti, niso vklju~eni v izbranem stan- or be referenced as necessary. (See annex
dardu za sistem kakovosti. (Glej dodatek B) B.)
Opomba 2: Organizacija se lahko sama odlo~i o NOTE 2 Inclusion of proprietary information is at
uporabi zaupnih poslovnih informacij. the discretion of organization.
4.2.1 Namen poslovnikov kakovosti 4.2.1 Purposes of quality manuals
Poslovnike kakovosti lahko organizacija Quality manuals may be developed and
izdela in uporabi za namene, ki vklju~ujejo used by an organization for purposes in-
naslednje, niso pa na to omejeni: cluding, but not limited to, the following:
a) sporo~anje politike kakovosti organi- a) communicating the organization's qual-
zacije ity policy;
b) opisovanje in izvedbo u~inkovitega b) describing and implementing an effec-
sistema kakovosti tive quality system;
8
---------------------- Page: 8 ----------------------
SIST ISO 10013 : 1997
c) zagotavljanje obvladovanja izbolj{av v c) providing improvement control of prac-
praksi in pospe{evanje aktivnosti za tices and facilitating assurance activi-
zagotavljanje kakovosti ties;
d) zagotavljanje dokumentirane osnove za d) providing the documented bases for
presojo sistema kakovosti auditing the quality system;
e) zagotavljanje stalnosti sistema kako- e) providing continuity of quality system
vosti in njegovih zahtev tudi v spre- and its requirements during changing
minjajo~ih se razmerah, circumstances;
f) usposabljanje osebja s podro~ja zahtev f) training personnel in the quality system
sistema kakovosti in metod za requirements and methods of compli-
skladnost ance;
g) predstavitev sistema kakovosti za g) presenting the quality system for ex-
zunanje namene, kot na primer doka- ternal purposes, such as demonstrating
zovanje skladnosti z ISO 9001, 9002 compliance with ISO 9001, 9002 or
ali 9003 9003;
h) dokazovanje skladnosti sistema kako- h) demonstrating compliance of the qual-
vosti z zahtevami kakovosti v pogod- ity system with quality requirements in
benih razmerah. contractual situations.
4.2.2 Zgradba in oblika 4.2.2 Structure and format
^eprav struktura poslovnika kakovosti ni Although there is no required structure for
predpisana, naj le-ta natan~no, popolno in quality manual, it should convey accurately,
jedrnato izra`a politiko kakovosti, cilje in completely and concisely the quality policy,
dolo~a glavne dokumentirane postopke v objectives and governing documented pro-
organizaciji (glej poglavje 6). Ena izmed cedures of the organization (see clause 6).
metod, ki zagotavlja, da je dolo~ena tema One of the methods of assuring that the
primerno obravnavana in ume{~ena, je subject matter is adequately addressed and
prilagoditev poglavij v poslovniku kakovosti located would be to key the sections of the
elementom kakovosti glavnega standarda za quality manual to the quality elements of
sistem kakovosti. Enako sprejemljivi so tudi the governing quality system standard. Other
drugi pristopi, kot na primer tak{no strukturi- approaches, such as structuring the manual
ranje poslovnika, ki odra`a naravo organi- to reflect the nature of the organization, are
zacije. equally acceptable.
Opomba 3: Zaradi jasnosti sistema in njegovega NOTE 3 For system clarity and assessment pur-
ocenjevanja naj bo razlo`eno vsako poses, the intentional omission of any
namerno izpu{~anje kateregakoli ele- quality system element from the quality
menta sistema kakovosti iz poslovnika manual compared to the governing quality
kakovosti v primerjavi z glavnim stan- system standard should be explained.
dardom za sistem kakovosti.
4.2.3 Izvor poslovnika kakovosti 4.2.3 Derivation of a quality manual
Poslovnik kakovosti je lahko: A quality manual may:
a) neposredno sestavljen iz dokumentira- a) be a direct compilation of documented
nih postopkov sistema kakovosti quality system procedures;
b) razvrstitev ali del dokumentiranih b) be a grouping or section of the
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SIST ISO 10013 : 1997
postopkov sistema kakovosti documented quality system procedures;
c) niz dokumentiranih postopkov za c) be a series of documented procedures
specifi~ne prilo`nosti in uporabe for specific facilities or applications;
d) ve~ kot en dokument ali nivo d) be more than one document or level;
e) tak{en, da ima skupno jedro s pri- e) have a common core with tailored
lagojenimi dodatki appendices;
f) samostojen ali ne f) stand alone or otherwise;
g) tak{en, da ima vrsto drugih mogo~ih g) have other numerous possible deriva-
izpeljav, glede na potrebe organizacije. tions based upon organizational need.
4.2.4 Posebne uporabe poslovnika 4.2.4 Special applications of quality
kakovosti manual
Preprost izraz "poslovnik kakovosti" je upo- The simple term "quality manual" is used
rabljen, kadar se isti poslovnik uporablja when the same manual is employed for
tako za vodenje kot za zagotavljanje kako- both quality management and quality assur-
vosti. To je najpogostej{a uporaba poslov- ance purposes. This usage is the most
nika kakovosti. Kadar pa je po mnenju or- common application of a quality manual.
ganizacije potrebna porazdelitev vsebine ali However, in situations where an organization
uporabe, je zagotovo zelo pomembno, da si believes that a distinction of content or us-
poslovniki, ki opisujejo isti sistem kakovosti, age is needed, it is essential that manuals
ne nasprotujejo. describing the same quality system are not
in conflict.
Vsak poslovnik kakovosti naj dolo~i vodilne Any quality manual should identify the man-
funkcije, obravnava ali se sklicuje na agement functions, address or reference the
dokumentiran sistem kakovosti in postopke documented quality system and procedures
ter na kratko obdela vse ustrezne zahteve and briefly cover all the applicable require-
standarda, ki si ga za sistem kakovosti ments of the quality system standard se-
izbere organizacija. lected by the organization.
5 Proces izdelave poslovnika 5 Process of preparing a quality
kakovosti manual
5.1 Odgovornost za izdelavo 5.1 Responsibility for preparation
Ko vodstvo sprejme odlo~itev, da bo sistem Once the management decision has been
kakovosti dokumentiran v poslovniku kako- made to document a quality system in a
vosti, naj se za~ne dejanski proces tako, da quality manual, the actual process should
vodstvo zadol`i pristojno telo za koordini- begin with assignment of the coordination
ranje. To je lahko posameznik ali skupina task to a management-delegated competent
posameznikov iz ene ali ve~ funkcionalnih body, which may be an individual or a
enot. group of individuals from one or more func-
tional organizations.
Dejansko pisanje naj izvaja in nadzira, kot The actual writing activity should be per-
je to primerno: poobla{~eno pristojno telo formed and controlled from within the dele-
ali razli~ne posamezne funkcionalne enote. gated competent body or from within vari-
Uporaba obstoje~ih dokumentov in referenc ous individual functional units, as appropri-
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SIST ISO 10013 : 1997
lahko bistveno skraj{a ~as izdelave poslov- ate. The use of existing documents and ref-
nika kakovosti, prav tako je v pomo~ pri erences can significantly shorten the quality
dolo~anju tistih podro~ij, na katerih je manual development time, as well as being
potrebno obravnavati in odpraviti neus- an aid to identifying those areas where
treznosti v sistemu kakovosti. quality system inadequacies need to be ad-
dressed and corrected.
Pristojno telo lahko spodbudi naslednje ak- The competent body may initiate the fol-
cije, ~e so te primerne: lowing actions as applicable:
a) urediti in izdelati seznam obstoje~ih a) establish and list existing applicable
uporabnih politik sistema kakovosti, quality system policies, objectives and
ciljev in dokumentiranih postopkov ozi- documented procedures, or develop
roma izdelati plane zanje plans for such;
b) odrediti, kateri elementi sistema kako- b) decide which quality system elements
vosti so primerni glede na izbran apply according to the quality system
standard za sistem kakovosti standard selected;
c) na razli~ne na~ine (na primer z c) obtain data about the existing quality
vpra{alniki ali pogovori) priskrbeti system and practices by various
podatke o obstoje~em sistemu kako- means, such as questionnaires and
vosti in praksah interviews;
d) od operacijskih enot zahtevati ali d) request and obtain additional source
priskrbeti dodatno izvorno documentation or references from op-
dokumentacijo ali sklicevanje erational units;
e) dolo~iti zgradbo in obliko pred- e) determine the structure and format for
videnega poslovnika the intended manual;
f) razporediti obstoje~e dokumente glede f) classify existing documents in accor-
na predvideno zgradbo in obliko dance with the intended structure and
format;
g) uporabiti katerokoli drugo primerno g) use any other method suitable within
metodo v organizaciji za dokon~anje the organization to complete the qual-
osnutka poslovnika kakovosti. ity manual draft.
5.2 Uporaba referenc 5.2 Use of references
Kjerkoli je to primerno in zaradi Wherever appropriate, and to avoid unnec-
prepre~evanja nepotrebne obse`nosti essary document volume, reference to ex-
dokumenta naj se vklju~i sklicevanje na ob- isting recognized standards or documents
stoje~e priznane standarde ali dokumente, ki available to the quality manual user should
so dostopni uporabniku poslovnika kakovosti. be incorporated.
5.3 Natan~nost in popolnost 5.3 Accuracy and completeness
Poobla{~eno telo naj bo odgovorno za The delegated competent body should be
zagotavljanje natan~nosti in popolnosti responsible for assuring the accuracy and
osnutka poslovnika kakovosti kakor tudi za completeness of the quality manual draft, as
stalnost in vsebino dokumentov. well as for the continuity and contents of
documents.
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SIST ISO 10013 : 1997
6 Proces odobritve, izdaje in 6 Process of quality manual
nadzora poslovnika kakovosti approval, issue and control
6.1 Kon~ni pregled in odobritev 6.1 Final review and approval
Poslovnik naj pred izdajo pregledajo odgo- Prior to issuing the manual, the document
vorni posamezniki, da se zagotovijo jasnost, should be subject to review by responsible
natan~nost, ustreznost in primernost individuals to ensure clarity, accuracy, suit-
zgradbe. Predvideni uporabniki poslovnika ability and proper structure. The intended
naj imajo mo`nost, da ga ocenijo in dajo users should also have the opportunity to
pripombe o njegovi uporabnosti. Za~etek assess and comment on the usability of the
uporabe novega poslovnika kakovosti naj document. Release of the new quality man-
odobri vodstvo, ki je odgovorno za njegovo ual should be approved by the management
izvajanje. Vsaka kopija naj nosi dokaz o responsible for its implementation. Each
odobritvi za za~etek uporabe. Elektronske ali copy should bear evidence of this release
druge metode izdaje poslovnika so spre- authorization. Electronic or other methods of
jemljive, ~e ohranjajo dokaz o odobritvi. release of the manual are acceptable, if
evidence of approval is retained.
6.2 Razdeljevanje poslovnika 6.2 Distribution of the manual
Metoda za razdeljevanje odobrenega poslov- The method of distribution of the authorized
nika, pa naj gre za celotnega ali njegove manual, whether in total or by sections,
dele, mora zagotavljati, da imajo vsi upo- should provide assurance that all users have
rabniki ustrezen dostop. Pri ustreznem appropriate access. Proper distribution and
razdeljevanju in nadzoru je lahko, na primer, control can be aided, for example, by seri-
v pomo~ o{tevil~enje kopij, ki se izdajajo alization of copies for recipients. Manage-
prejemnikom. Vodstvo naj zagotovi, da so ment should ensure that individuals are fa-
posamezni uporabniki znotraj organizacije miliar with those contents of the manual
seznanjeni s tistimi deli poslovnika, ki so appropriate to each user within the organi-
zanje primerni. zation.
6.3 Vklju~evanje sprememb 6.3 Incorporation of changes
Zagotovljena naj bo metoda za spodbuditev, A method of providing for the initiation, de-
izdelavo, pregled, nadzor in vklju~evanje velopment, review, control and incorporation
sprememb v poslovnik. Ta naloga naj bo of changes to the manual should be pro-
dodeljena ustrezni funkciji za nadzor vided. This task should be assigned to an
dokumentov. Pri obdelavi sprememb je treba appropriate document control function. The
uporabiti enak proces p
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