SIST ISO 10005:1998
(Main)Quality management -- Guidelines for quality plans
Quality management -- Guidelines for quality plans
Provides guidelines to assist suppliers in the preparation, review, acceptance and revision of quality plans. These guidelines are not intended to be used as a checklist for compliance with requirements. Applicable where a quality plan is to be used for a particular product, project or contract.
Management de la qualité -- Lignes directrices pour les plans qualité
Vodenje kakovosti - Smernice za plane kakovosti
General Information
Relations
Buy Standard
Standards Content (Sample)
INTERNATIONAL IS0
STANDARD 10005
First edition
1995-09-15
Quality management - Guidelines for
quality plans
Management de la qua/it6 - Lignes directrices pour /es plans qua/it6
----lu/yyh__
- -
-
-
-
-
-
tISOi
~~~
Reference number
IS0 10005:1995(E)
---------------------- Page: 1 ----------------------
PSO 10005:1995(E)
Contents
Page
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 Scope
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.
2 Normative reference
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Definitions
2
4 Preparation, review, acceptance and revision of the quality plan
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Preparation
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Review and acceptance
3
4.3 Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Contents of the quality plan
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 Management responsibilities
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.2 Quality plan and quality system
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.3 Contract review
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.4 Design control
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.5 Document and data control
4
5.6 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.7 Control of customer-supplied product
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.8 Product identification and traceability
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.9 Process control
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.10 Inspection and testing
. . . . . . . . . 5
5.11 Control of inspection, measuring and test equipment
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.12 Inspection and test status
6
5.13 Control of nonconforming product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.14 Corrective and preventive action
. . . . . 6
5.15 Handling, storage, packaging, preservation and delivery
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.16 Control of quality records
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.17 Quality audits
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, 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
---------------------- Page: 2 ----------------------
0 IS0
IS0 10005:1995(E)
5.18 Training . 6
5.19 Servicing . 6
5.20 Statistical techniques . 7
Annexes
A Simplified examples of formats for the presentation of quality
plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
B Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
---------------------- Page: 3 ----------------------
0 IS0
IS0 10005:1995(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 10005 was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
Annexes A and B of this International Standard are for information only.
IV
---------------------- Page: 4 ----------------------
0 IS0
IS0 10005:1995(E)
Introduction
This International Standard was prepared to address the need for a
mechanism to relate generic requirements on quality system elements to
the specific requirements of a particular product, project or contract.
Its provisions should be considered advisory and not requirements.
A quality plan may be used within an organization to ensure that specific
requirements for quality are being appropriately planned and addressed for
identified products during production. A quality plan may be used to indi-
cate the specific application of a quality system to a given development
project, whether for a marketable product or for an in-house facility.
A quality plan may also be used by the supplier in a contractual situation
to demonstrate to the customer how the specific requirements for quality
of a particular contract will be met. In many cases, it may be beneficial to
obtain customer input to the development of the quality plan.
The quality plan should be compatible with other plans that may be pre-
pared.
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IS0 10005:1995(E)
INTERNATIONAL STANDARD 0 ISo
Quality management - Guidelines for quality plans
for compliance with requirements. A quality plan may
1 Scope
also be used where a documented quality system
does not exist, in which case procedures may need
1 .I This International Standard provides guidelines
to be developed to support the quality plan.
to assist suppliers in the preparation, review, accept-
ance and revision of quality plans.
NOTE 1 Annex B contains a bibliography of International
Standards which provide information that may prove helpful
It is intended for use in two situations:
to those involved in the preparation and review of quality
plans.
as guidance to a supplier organization in meeting
a)
the requirements of IS0 9001, IS0 9002 or
IS0 9003 relative to the preparation of a quality
plan; or
2 Normative reference
b) as guidance to a supplier organization in preparing
The following standard contains provisions which,
a quality plan when the supplier does not have
through reference in this text, constitute provisions
such a quality system.
of this International Standard. At the time of publi-
cation, the edition indicated was valid. All standards
In both situations, the quality plan is supplemental to
are subject to revision, and parties to agreements
the supplier’s generic quality system documentation
based on this International Standard are encouraged
and should not duplicate the generic documentation.
to investigate the possibility of applying the most re-
For convenience in situations of type b), this Inter-
cent edition of the standard indicated below. Mem-
national Standard includes features that are covered
bers of IEC and IS0 maintain registers of currently
in the generic requirements of IS0 9001, IS0 9002
valid International Standards.
and IS0 9003.
IS0 8402: 1994, Quality management and quality as-
Quality plans provide a mechanism to tie specific re-
surance - Vocabulary.
quirements of the product, project or contract to ex-
isting generic quality system procedures. They do not
require the development of a comprehensive set of
procedures or instructions over and above those al-
3 Definitions
ready existing, although some additional documented
procedures may be necessary.
For the purposes of this International Standard, the
definitions given in IS0 8402, together with the fol-
1.2 This International Standard is applicable where lowing definitions, apply. Terms which are repeated
a quality plan is to be used for a particular product, here for clarity but have been defined in other Inter-
project or contract. A quality plan may be applicable national Standards are identified by the placement of
to any product of the generic product categories the number of the standard after the term being de-
(hardware, software, processed materials and ser-
fined.
vices) or industry/economic sectors.
3.1 contract: Agreed requirements between a sup-
A quality plan may be used to monitor and assess
plier and customer transmitted by any’means.
adherence to the requirements for quality, but these
guidelines are not intended to be used as a checklist [ISO 90011
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0 IS0
IS0 10005:1995(E)
3.7 quality plan: Document setting out the specific
3.2 project: Unique process consisting of a set of
coordinated and controlled activities with start and quality practices, resources and sequence of activities
finish dates, undertaken to achieve an objective con- relevant to a particular product, project or contract.
forming to specific requirements, including the con-
NOTES
straints of time, cost and resources.
11 A quality plan usually makes reference to the parts of
NOTES
the quality ma nual applicable to th e specific case.
2 An in dividual p reject may form part of a larger project
12 Depending on the scope of the plan, a qualifier may be
structure
used, for example, “quality assurance plan”, “quality man-
agement plan “.
3 In some types of projects, the objectives are refined and
the project characteristics defined progressively as the pro-
[ISO 84021
ject proceeds.
3.8 quality system: Organizational structure, pro-
4 The outco ime of a p reject may be one or several
cedures, processes and resources needed to imple-
of a product.
ment quality management.
3.3 type test: Test or series of tests directed
NOTES
towards approval of a design conducted to determine
that it is capable of meeting the requirements of the
comprehensive as
13 The quality system should be as
product specification.
the quality objectives.
needed to meet
3.4 witness testing: Testing of a product in the 14 The quality system of an organization is designed pri-
marily to satisfy the internal managerial needs of the or-
presence of the customer’s representative or a third
ganization. It is broader than the requirements of a particular
party.
customer who evaluates only the relevant part of the quality
system.
.
35 procedure: Specified way to perform an activity.
15 For contractual or mandatory quality assessment pur-
NOTES
poses, demonstration of the implementation of identified
quality system elements may be required.
5 In many cases, procedure s are documented (e.g. quality
m procedures).
syste
[ISO 84021
6 When a procedure is to be documented, the term
“written procedure” or “documented procedure” is fre-
4 Preparation, review, acceptance
quently used.
and revision of the quality plan
7 A written or documented procedure usually contains the
purpose and scope of an activity; what shall be done and
4.1 Preparation
by whom; when, where and how it shall be done; what
materials, equipment and documents shall be used; and
When preparing a quality plan, quality activities appli-
how it shall be controlled and recorded.
cable to the situation should be defined and docu-
mented.
[ISO 84021
Much of the generic documentation needed may be
3.6 product: Result of activities or processes.
contained in the supplier’s quality manual and docu-
mented procedures. This documentation may need to
NOTES
be selected, adapted and/or supplemented. The qual-
8 A product may include service, hardware, processed ity plan shows how the supplier’s generic docu-
materi als, software, or a combination thereof.
mented procedures are related to and applied to any
necessary additional procedures peculiar to the prod-
9 A product can be tangible (e.g. assemblies or processed
uct, project or contract in order to attain specified
materials) or intangible (e.g. knowledge or concepts), or a
quality objectives.
combination thereof.
The quality plan should indicate, either directly or by
10 A product can be either intended (e.g. offering to cus-
reference to appropriate documented procedures or
tomers) or unintended (e.g. polluant or unwanted effects).
other documents, how the required activities are to
[ISO 84021 be carried out.
2
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0 IS0
IS0 10005:1995(E)
stages, the supplier should submit the quality plan for
The format and level of detail in the plan should be
consistent with any agreed customer requirement, each stage to the customer prior to the start of that
the supplier’s method of operation and the complexity stage.
of the activities to be performed. The plan should be
Procedures referenced in the plan should be made
as brief as possible, consistent with meeting the pro-
available to the customer, where agreed in the con-
visions of this International Standard. (Simplified
tract.
examples of alternative presentations of quality plans
are contained in annex A.)
4.3 Revision
A quality plan may be a stand-alone document when
a supplier does not have a documented quality sys- The supplier should revise the plan, when appropriate,
tem. A quality plan may also be included as part of to reflect changes that have been made to the prod-
another document or documents (e.g. product or pro-
uct, project or contract, changes to the manner in
ject plan), depending on such things as customer re-
which the product is produced or the service is pro-
quirements or the business practices of a specific
vided, or changes in quality assurance practices.
supplier. It may be necessary to develop a quality plan
Changes to the quality plan should be reviewed for
that consists of a number of parts, each of which re-
impact and adequacy by the same authorized group
presents a plan for a distinct stage, such as for de-
which conducted the review of the original quality
sign, purchasing, production, or inspection and test,
plan.
or for particular activities such as the dependability
plan.
Subject to the specific requirements of a contract,
proposed changes to the plan should be submitted to
NOTE 16 When drafting a textural quality plan, the fol-
the customer for review and acceptance before they
lowing conventions may be used:
are implemented.
- “shall ” to express a provision that is binding between
two 0
r more par-tie s;
5 Contents of the quality plan
- “will” to express a declaration of purpose or intent by
one party;
a) Structure
- “should” to express a recommendation among other
The contents of the quality plan should be based on
possibilities;
this International Standard and the supplier’s docu-
- “may” to indicate a course
of action permissible within mented quality system. It is not essential that the
the limits of the q ua lity plan
quality plan follow the structure and numbering of any
IS0 9000 standards and the alignment of the para-
graphs in this International Standard is only intended
4.2 Review and acceptance
to ease use and understanding.
The quality plan should be reviewed for adequacy and
The elements described in the following subclauses
formally approved by an authorized group that in-
should be addressed, where relevant to the require-
cludes representatives from all affected functions
ments of the product, project or contract.
within the supplier’s organization.
b) Scope of the quality plan
In contractual situations, a quality plan may be sub-
mitted to the customer by the supplier for review and
The scope of the quality plan should be defined and
acceptance, either as part of the precontract award-
should include, but not be limited to:
bidding process or after the contract has been
awarded.
- the product or project to which it is to be ap-
If the plan is submitted as part of the bidding process plied;
and a contract is subsequently awarded, the plan
- the scope of the contract to which it is to be
should be reviewed and, where appropriate, revised
applied;
to reflect any changes in requirements that may have
oc
...
SLOVENSKI STANDARD
SIST ISO 10005:1998
01-oktober-1998
Vodenje kakovosti - Smernice za plane kakovosti
Quality management -- Guidelines for quality plans
Management de la qualité -- Lignes directrices pour les plans qualité
Ta slovenski standard je istoveten z: ISO 10005:1995
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST ISO 10005:1998 sl,en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST ISO 10005:1998
---------------------- Page: 2 ----------------------
SIST ISO 10005:1998
INTERNATIONAL IS0
STANDARD 10005
First edition
1995-09-15
Quality management - Guidelines for
quality plans
Management de la qua/it6 - Lignes directrices pour /es plans qua/it6
----lu/yyh__
- -
-
-
-
-
-
tISOi
~~~
Reference number
IS0 10005:1995(E)
---------------------- Page: 3 ----------------------
SIST ISO 10005:1998
PSO 10005:1995(E)
Contents
Page
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1 Scope
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~.~.
2 Normative reference
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Definitions
2
4 Preparation, review, acceptance and revision of the quality plan
2
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.1 Preparation
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.2 Review and acceptance
3
4.3 Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
3
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5 Contents of the quality plan
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 Management responsibilities
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.2 Quality plan and quality system
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.3 Contract review
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.4 Design control
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.5 Document and data control
4
5.6 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.7 Control of customer-supplied product
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.8 Product identification and traceability
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.9 Process control
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.10 Inspection and testing
. . . . . . . . . 5
5.11 Control of inspection, measuring and test equipment
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.12 Inspection and test status
6
5.13 Control of nonconforming product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.14 Corrective and preventive action
. . . . . 6
5.15 Handling, storage, packaging, preservation and delivery
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.16 Control of quality records
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.17 Quality audits
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, 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
---------------------- Page: 4 ----------------------
SIST ISO 10005:1998
0 IS0
IS0 10005:1995(E)
5.18 Training . 6
5.19 Servicing . 6
5.20 Statistical techniques . 7
Annexes
A Simplified examples of formats for the presentation of quality
plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
B Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
---------------------- Page: 5 ----------------------
SIST ISO 10005:1998
0 IS0
IS0 10005:1995(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 10005 was prepared by Technical Committee
lSO/TC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
Annexes A and B of this International Standard are for information only.
IV
---------------------- Page: 6 ----------------------
SIST ISO 10005:1998
0 IS0
IS0 10005:1995(E)
Introduction
This International Standard was prepared to address the need for a
mechanism to relate generic requirements on quality system elements to
the specific requirements of a particular product, project or contract.
Its provisions should be considered advisory and not requirements.
A quality plan may be used within an organization to ensure that specific
requirements for quality are being appropriately planned and addressed for
identified products during production. A quality plan may be used to indi-
cate the specific application of a quality system to a given development
project, whether for a marketable product or for an in-house facility.
A quality plan may also be used by the supplier in a contractual situation
to demonstrate to the customer how the specific requirements for quality
of a particular contract will be met. In many cases, it may be beneficial to
obtain customer input to the development of the quality plan.
The quality plan should be compatible with other plans that may be pre-
pared.
---------------------- Page: 7 ----------------------
SIST ISO 10005:1998
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---------------------- Page: 8 ----------------------
SIST ISO 10005:1998
IS0 10005:1995(E)
INTERNATIONAL STANDARD 0 ISo
Quality management - Guidelines for quality plans
for compliance with requirements. A quality plan may
1 Scope
also be used where a documented quality system
does not exist, in which case procedures may need
1 .I This International Standard provides guidelines
to be developed to support the quality plan.
to assist suppliers in the preparation, review, accept-
ance and revision of quality plans.
NOTE 1 Annex B contains a bibliography of International
Standards which provide information that may prove helpful
It is intended for use in two situations:
to those involved in the preparation and review of quality
plans.
as guidance to a supplier organization in meeting
a)
the requirements of IS0 9001, IS0 9002 or
IS0 9003 relative to the preparation of a quality
plan; or
2 Normative reference
b) as guidance to a supplier organization in preparing
The following standard contains provisions which,
a quality plan when the supplier does not have
through reference in this text, constitute provisions
such a quality system.
of this International Standard. At the time of publi-
cation, the edition indicated was valid. All standards
In both situations, the quality plan is supplemental to
are subject to revision, and parties to agreements
the supplier’s generic quality system documentation
based on this International Standard are encouraged
and should not duplicate the generic documentation.
to investigate the possibility of applying the most re-
For convenience in situations of type b), this Inter-
cent edition of the standard indicated below. Mem-
national Standard includes features that are covered
bers of IEC and IS0 maintain registers of currently
in the generic requirements of IS0 9001, IS0 9002
valid International Standards.
and IS0 9003.
IS0 8402: 1994, Quality management and quality as-
Quality plans provide a mechanism to tie specific re-
surance - Vocabulary.
quirements of the product, project or contract to ex-
isting generic quality system procedures. They do not
require the development of a comprehensive set of
procedures or instructions over and above those al-
3 Definitions
ready existing, although some additional documented
procedures may be necessary.
For the purposes of this International Standard, the
definitions given in IS0 8402, together with the fol-
1.2 This International Standard is applicable where lowing definitions, apply. Terms which are repeated
a quality plan is to be used for a particular product, here for clarity but have been defined in other Inter-
project or contract. A quality plan may be applicable national Standards are identified by the placement of
to any product of the generic product categories the number of the standard after the term being de-
(hardware, software, processed materials and ser-
fined.
vices) or industry/economic sectors.
3.1 contract: Agreed requirements between a sup-
A quality plan may be used to monitor and assess
plier and customer transmitted by any’means.
adherence to the requirements for quality, but these
guidelines are not intended to be used as a checklist [ISO 90011
---------------------- Page: 9 ----------------------
SIST ISO 10005:1998
0 IS0
IS0 10005:1995(E)
3.7 quality plan: Document setting out the specific
3.2 project: Unique process consisting of a set of
coordinated and controlled activities with start and quality practices, resources and sequence of activities
finish dates, undertaken to achieve an objective con- relevant to a particular product, project or contract.
forming to specific requirements, including the con-
NOTES
straints of time, cost and resources.
11 A quality plan usually makes reference to the parts of
NOTES
the quality ma nual applicable to th e specific case.
2 An in dividual p reject may form part of a larger project
12 Depending on the scope of the plan, a qualifier may be
structure
used, for example, “quality assurance plan”, “quality man-
agement plan “.
3 In some types of projects, the objectives are refined and
the project characteristics defined progressively as the pro-
[ISO 84021
ject proceeds.
3.8 quality system: Organizational structure, pro-
4 The outco ime of a p reject may be one or several
cedures, processes and resources needed to imple-
of a product.
ment quality management.
3.3 type test: Test or series of tests directed
NOTES
towards approval of a design conducted to determine
that it is capable of meeting the requirements of the
comprehensive as
13 The quality system should be as
product specification.
the quality objectives.
needed to meet
3.4 witness testing: Testing of a product in the 14 The quality system of an organization is designed pri-
marily to satisfy the internal managerial needs of the or-
presence of the customer’s representative or a third
ganization. It is broader than the requirements of a particular
party.
customer who evaluates only the relevant part of the quality
system.
.
35 procedure: Specified way to perform an activity.
15 For contractual or mandatory quality assessment pur-
NOTES
poses, demonstration of the implementation of identified
quality system elements may be required.
5 In many cases, procedure s are documented (e.g. quality
m procedures).
syste
[ISO 84021
6 When a procedure is to be documented, the term
“written procedure” or “documented procedure” is fre-
4 Preparation, review, acceptance
quently used.
and revision of the quality plan
7 A written or documented procedure usually contains the
purpose and scope of an activity; what shall be done and
4.1 Preparation
by whom; when, where and how it shall be done; what
materials, equipment and documents shall be used; and
When preparing a quality plan, quality activities appli-
how it shall be controlled and recorded.
cable to the situation should be defined and docu-
mented.
[ISO 84021
Much of the generic documentation needed may be
3.6 product: Result of activities or processes.
contained in the supplier’s quality manual and docu-
mented procedures. This documentation may need to
NOTES
be selected, adapted and/or supplemented. The qual-
8 A product may include service, hardware, processed ity plan shows how the supplier’s generic docu-
materi als, software, or a combination thereof.
mented procedures are related to and applied to any
necessary additional procedures peculiar to the prod-
9 A product can be tangible (e.g. assemblies or processed
uct, project or contract in order to attain specified
materials) or intangible (e.g. knowledge or concepts), or a
quality objectives.
combination thereof.
The quality plan should indicate, either directly or by
10 A product can be either intended (e.g. offering to cus-
reference to appropriate documented procedures or
tomers) or unintended (e.g. polluant or unwanted effects).
other documents, how the required activities are to
[ISO 84021 be carried out.
2
---------------------- Page: 10 ----------------------
SIST ISO 10005:1998
0 IS0
IS0 10005:1995(E)
stages, the supplier should submit the quality plan for
The format and level of detail in the plan should be
consistent with any agreed customer requirement, each stage to the customer prior to the start of that
the supplier’s method of operation and the complexity stage.
of the activities to be performed. The plan should be
Procedures referenced in the plan should be made
as brief as possible, consistent with meeting the pro-
available to the customer, where agreed in the con-
visions of this International Standard. (Simplified
tract.
examples of alternative presentations of quality plans
are contained in annex A.)
4.3 Revision
A quality plan may be a stand-alone document when
a supplier does not have a documented quality sys- The supplier should revise the plan, when appropriate,
tem. A quality plan may also be included as part of to reflect changes that have been made to the prod-
another document or documents (e.g. product or pro-
uct, project or contract, changes to the manner in
ject plan), depending on such things as customer re-
which the product is produced or the service is pro-
quirements or the business practices of a specific
vided, or changes in quality assurance practices.
supplier. It may be necessary to develop a quality plan
Changes to the quality plan should be reviewed for
that consists of a number of parts, each of which re-
impact and adequacy by the same authorized group
presents a plan for a distinct stage, such as for de-
which conducted the review of the original quality
sign, purchasing, production, or inspection and test,
plan.
or for particular activities such as the dependability
plan.
Subject to the specific requirements of a contract,
proposed changes to the plan should be submitted to
NOTE 16 When drafting a textural quality plan, the fol-
the customer for review and acceptance before they
lowing conventions may be used:
are implemented.
- “shall ” to express a provision that is binding between
two 0
r more par-tie s;
5 Contents of the quality plan
- “will” to express a declaration of purpose or intent by
one party;
a) Structure
- “should” to express a recommendation among other
The contents of the quality plan should be based on
possibilities;
this International Standard and the supplier’s docu-
- “may” to indicate a course
of action permissible within mented quality system. It is not essential that the
the limits of the q ua lity plan
quality plan follow the structure and numbering of any
IS0 9000 standards and the alignment of the para-
graphs in this International Standard is only intended
4.2 Review and acceptance
to ease use and understanding.
The quality plan should be reviewed for adequacy and
The elements described in the following subclauses
formally approved by an authorized group that in-
should be addressed, where relevant to the require-
cludes representatives from all affected functions
ments of the product, project or contract.
within the supplier’s organization.
b) Scope of the quality plan
In contractual situations, a quality plan may be sub-
mitted to the customer by the supplier for review and
The scope of the quality plan should be de
...
NORME
IS0
INTERNATIONALE
10005
Premibe kdition
1995-09-I 5
Management de la qualit - Lignes
directrices pour les plans qualit
Quality management - Guidelines for quality plans
Num6ro de ri3f6rence
IS0 10005: 1995(F)
---------------------- Page: 1 ----------------------
IS0 10005:1995(F)
Sommaire
Page
1
1 Domaine d’application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2 Reference normative
2
3 Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
. . . . . . 3
4 Preparation, revue, acceptation et revision du plan qualite
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4.1 Preparation
3
4.2 Revue et acceptation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4.3 Revision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
4
5 Contenu du plan qualite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.1 Responsabilites de la direction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Plan qualite et systeme qualite . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.2
4
5.3 Revue de contrat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . .~. 4
5.4 Ma’itrise de la conception
MaTtrise des documents et des donnees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
5.5
5.6 Achats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.7 Ma*itrise du produit fourni par le client . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.8 Identification et tracabilite du produit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5.9 Maltrise des processus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
5
5.10 Controles et essais . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
6
5.11 MaTtrise des equipements de controle, de mesure et d’essai
6
5.12 ctat des controles et des essais . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.13 MaTtrise du produit non conforme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.14 Actions correctives et preventives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Manutention, stockage, conditionnement, preservation et
5.15
livraison . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
5.16 MaTtrise des enregistrements relatifs a la qualite . . . . . . . . . . . . . . . . 6
0 IS0 1995
Droits de reproduction reserves. Sauf prescription differente, aucune partie de cette publi-
cation ne peut Qtre reproduite ni utilisee sous quelque forme que ce soit et par aucun pro-
cede, electronique ou mecanique, y compris la photocopie et les microfilms, sans I’accord
ecrit de I’editeur.
Organisation internationale de normalisation
Case Postale 56 l CH-1211 Geneve 20 l Suisse
Imprime en Suisse
ii
---------------------- Page: 2 ----------------------
0 IS0
IS0 10005:1995(F)
5.17 Audits qualit
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 7
5.18 Formation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
5.19 Prestations associkes 7
5.20 Techniques statistiques . .~.~. 7
Annexes
dB Exemples simplifiks de prksentation des plans qualit . . . . . . . . . . 8
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
IB Bibliographie
. . .
III
---------------------- Page: 3 ----------------------
Q IS0
IS0 10005:1995(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 interesse par une
etude a le droit de faire par-tie du comite technique tree 8 cet effet. Les
organisations internationales, gouvernementales et non gouvernemen-
tales, en liaison avec I’ISO participent egalement aux travaux. L’ISO colla-
bore etroitement avec la Commission electrotechnique internationale (CEI)
en ce qui concerne la normalisation electrotechnique.
Les projets de Normes internationales adopt& par les comites techniques
sont soumis aux comites membres pour vote. Leur publication comme
Normes internationales requiert I’approbation de 75 % au moins des co-
mites membres votants.
La Norme internationale IS0 10005 a ete elaboree par le comite technique
lSO/TC 176, Management et assurance de /a qua/it& sous-comite SC 2,
Sys t&mes qua/it&
Le s annexes A et B de la presente Norme intern ationale sont donnees
un iquement a titre d’info rmation.
---------------------- Page: 4 ----------------------
0 IS0
IS0 10005:1995(F)
Introduction
La presente Norme internationale a ete elaboree pour repondre au besoin
d’appliquer une methode particuliere pour relier des exigences generiques
d’elements de systeme qualite aux exigences specifiques d’un produit,
projet ou contrat particulier. II convient de considerer ses dispositions
comme des conseils et non pas des exigences.
Un plan qualite peut etre utilise dans un organisme pour s’assurer que des
exigences specifiques relatives a la qualite sont convenablement planifiees
et prises en compte pour des produits identifies en tours de production.
Un plan qualite peut etre utilise pour indiquer I’application specifique d’un
systeme qualite a un projet de developpement don&, soit pour un produit
commercialisable, soit pour commodite interne. Un plan qualite peut
egalement etre applique par le fournisseur dans une situation contractuelle
pour demontrer au client de quelle maniere les exigences specifiques re-
latives a la qualite d’un contrat particulier seront satisfaites. Dans un grand
nombre de cas, il peut etre avantageux d’obtenir des donnees d’entrees
du client pour le developpement de ce plan qualite.
II est souhaitable q ue le plan qualite soit compatible avec les autres plans
pouvanf etre elabo res.
---------------------- Page: 5 ----------------------
This page intentionally left blank
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE 0 IS0
IS0 10005:1995(F)
Lignes directrices pour
Management de la qualit -
les plans qualit
peut etre applicable a n’importe quelle categoric ge-
1 Domaine d’application
nerique de produit (materiel, logiciel, produit issu de
processus a caractere continu et service) ou de sec-
1.1 La presente Norme internationale fournit des Ii-
teurs industriels/economiques.
gnes directrices pour aider les fournisseurs dans la
preparation, la revue, I’acceptation et la revision de
Un plan qualite peut etre utilise pour tenir sous
plans qualite.
controle et evaluer I’adhesion aux exigences de la
qualite, mais ces lignes directrices ne sont pas desti-
Elle est prevue pour etre utilisee dans deux cas:
nees a etre utilisees comme liste de controle de
conformite aux exigences. Un plan qualite peut
a) en tant que guide pour un organisme fournisseur
egalement etre utilise chaque fois qu’un systeme
pour satisfaire les exigences de I’ISO 9001,
qualite fonde sur des documents n’existe pas et, dans
I’ISO 9002 ou I’ISO 9003 relatives a I’elaboration
ce cas, il peut etre utile de developper des procedures
d’un plan qualite; ou
pour servir de base a ce plan qualite.
b) en tant que guide pour un organisme fournisseur
NOTE 1 L’annex B contient une bibliographic des Nor-
pour I’elaboration d’un plan qualite lorsque le
mes internationales qui fournissent des informations pou-
fournisseur ne possede pas un tel systeme qua-
- , vant s’avkrer utiles aux personnes chargkes de la
ljte .
prkparation et de la revue des plans qualit&
Dans les deux cas, le plan qualite vient en supplement
a la documentation du systeme qualite generique du
fournisseur, qu’il convient de ne pas dupliquer. Pour
commodite dans le cas de type b), la presente Norme
internationale comprend des caracteristiques qui sont
couvertes dans les exigences generiques de 2 Rkfbence normative
I’ISO 9001, I’ISO 9002 et I’ISO 9003.
La norme suivante contient des dispositions qui, par
Les plans qualite fournissent une methode particuliere
suite de la reference qui en est faite, constituent des
pour mettre en relation les exigences specifiques du
dispositions valables pour la presente Norme inter-
produit, projet ou contrat avec les procedures generi-
nationale. Au moment de la publication, I’edition indi-
ques de systeme qualite existantes. lls ne necessitent
quee etait en vigueur. Toute norme est sujette a
pas le developpement d’un ensemble complet de
revision et les parties prenantes des accords fond&
procedures ou d’instructions couvrant ou se
sur la presente Norme internationale sont invitees a
substitant a celles deja existantes, bien que des pro-
rechercher la possibilite d’appliquer I’edition la plus
cedures &rites supplementaires puissent s’averer
recente de la norme indiquee ci-apres. Les membres
necessaires.
de la CEI et de I’ISO possedent le registre des Nor-
mes internationales en vigueur a un moment donne.
1.2 La presente Norme internationale est applicable
IS0 8402:1994, Management de la qua/it6 et assu-
chaque fois qu’un plan qualite doit etre utilise pour un
rance de la qua126 - Vocabulaire.
produit, projet ou contrat particulier. Un plan qualite
1
---------------------- Page: 7 ----------------------
IS0 10005:1995(F) 0 IS0
quels matkriels, equipements et
documents doivent &re
3 Dbfinitions
utilisk, et comment cela doit &re
maltrisk et enregistrk
Pour les besoins de la presente Norme internationale,
[ISO 84021
les definitions donnees dans I’ISO 8402 et les dbfini-
tions suivantes s’appliquent. Les termes repris ici
36 . produit: R6sultat d’activiths ou de processus.
pour des raisons de clart6, mais d6jA definis dans
d’autres Normes internationales, sont identifih par la
NOTES
mention du num&o de la norme, aprh la dkfinition.
8 Le terme ((produit)) peut inclure les services, les mat&
riels, les produits issus de processus A caracthre continu,
3.1 contrat: Exigences ayant fait I’objet d’un accord
les logiciels, ou une combinaison de ceux-ci.
entre un fournisseur et un client, et transmises par
un moyen quelconque.
9 Un produit peut &re matkriel (par exemple, assemblage
ou produits issus de processus A caracthre continu) ou im-
[ISO 90011
matbrie (par exemple, connaissances ou concepts), ou une
combinaison des deux.
3.2 projet: Processus spkifique consistant en un
10 Un produit peut etre soit intentionnel (par exemple, une
ensemble d’activites coordonnkes et maTtrikes avec
offre aux clients), soit non intentionnel (par exemple, un
dates de d6but et de fin, entreprises pour atteindre
polluant ou des effets indhirables).
un objectif conforme aux exigences spkifiques,
comprenant les containtes de temps, cotits et
[ISO 84021
moyens.
3.7 plan qualit& Document honGant les pratiques,
NOTES
les moyens et la sequence des activitks likes 5 la
qualiti! spkcifiques 5 un produit, projet ou contrat
peut We une par-tie d’une structure
2 Un projet individuel
particulier.
de projet plus large.
NOTES
3 Pour certains types de projets, les objectifs sont affinh
et les caracthistiques du projet sont dbfinies au fur et A
11 Un plan qualitk fait g& halement rbfhence aux parties
mesure de I’avancement du projet.
du manuel q ualite applicab les sphifiquement.
4 Le ksultat d’un projet peut &re une ou plusieurs unit&
12 Selon I’objet du plan, un qualificatif peut etre utilise, par
d’un produit.
exemple ((plan assurance qualit& ((plan management de la
qualit&.
3.3 essai de type: Essai ou shie d’essais visant
I’approbation d’une conception conduite pour dkter- [ISO 84021
miner sa capacitk 8 r6pondre aux exigences de la
3.8 systkme qualit& Ensemble de I’organisation,
spkcification du produit.
des prockdures, des processus et des moyens n&
cessaires pour mettre en ceuvre le management de la
3.4 essai tbmoin: Essai d’un produit effect& en
qualit&
prhence d’un reprksentant du client ou d’une tierce
partie.
NOTES
3.5 procedure: Man&e spkifike d’accomplir une
13 II convient que le systbme qualiti! ne soit pas plus
activitk &endu qu’il n’est besoin pour atteindre les objectifs relatifs
h la qualit&
NOTES
14 Le systeme qualit d’un organisme est conCu essen-
5 Dans de nombreux cas, les procbdures sont exprimkes tiellement pour satisfaire les besoins internes de
par des documents (par exemple, prockdures d’un systhme management de I’organisme. II va au-dela des exigences
qualit@. d’un client particulier, qui n’kvalue que la partie du systeme
qualit qui le concerne.
squ’une procbdure est exprimke par un
6 Lor document, le
((proc&dure &rite)) est 15 Pour les besoins d’une &valuation qualit contractuelle
terme souvent utilisk
ou obligatoire, la dbmonstration de la mise en ceuvre d’&-
7 Une prockdure &rite comporte ghhalement I’objet et
ments identifih du systkme qualitk peut &tre exigbe.
le domaine d’application d’une activitb; ce qui doit &re fait
et qui doit le faire; quand, oh et comment cela doit Mre fait; [ISO 84021
---------------------- Page: 8 ----------------------
0 IS0
IS0 10005:1995(F)
- ((iI convient de imer une recommandatio
2) pour expr
4 IPrkparation, revue, acceptation
parmi d’autres
possibilit&;
et rbvision du plan qualit
- ((peut)) pour indiqu er une skquence d’action s permises
dans les limites du plan qualit&
4.1 Prkparation
En preparant un plan qualite, il convient de definir et
de consigner par ecrit les activites relatives a la qualite
4.2 Revue et acceptation
applicables.
II convient que le plan qualite soit revu pour adequa-
Une grande partie de la documentation generique ne-
tion et formellement approuve par un groupe autorise
cessaire peut etre contenue dans le manuel qualite
qui comprend les representants de toutes les fonc-
et les procedures &rites du fournisseur. II peut etre
tions concernees au sein de I’organisme du fournis- ’
necessaire que cette documentation soit choisie,
seur.
adaptee et/au completee. Le plan qualite montre
comment les procedures &rites generiques du four-
En situations contractuelles, un plan qualite peut etre
nisseur sont reliees et appliquees a toutes procedures
soumis au client par le fournisseur pour revue et ac-
supplementaires necessaires specifiques au produit,
ceptation, soit en tant que par-tie du processus d’offre
projet ou contrat dans le but d’atteindre les objectifs
avant contrat, soit apres que le contrat a ete attribue.
specifies relatifs a la qualite.
Si le plan est presente en tant que partie du proces-
II convient que le plan qualite indique, soit direc-
sus d’offre et si un contrat est par la suite attribue, il
tement, soit en se refer-ant aux procedures &rites
convient de faire une revue de ce plan et, si neces-
appropriees ou a d’autres documents, comment les
saire, de reviser ce plan pour qu’il reflete les modifi-
activites requises doivent etre executees.
cations des exigences pouvant etre inter-venues suite
aux negotiations ayant precede le contrat.
II convient que la forme et le niveau de detail du plan
soient compatibles avec toute exigence convenue du
Lorsqu’un plan qualite est exige par un contrat, il
client, le mode de fonctionnement du fournisseur et
convient normalement qu’il soit presente avec le
la complexite des activites 21 accomplir. II convient que
commencement des activites requises. Chaque fois
le plan soit aussi bref que possible, et compatible
que le contrat se deroule en plusieurs phases, il
avec la satisfaction aux dispositions de la pr&ente
convient que le fournisseur soumette le plan qualite
Norme internationale. (L’annexe A comporte des
au client avant le commencement de chacune des
exemples simplifies de plusieurs presentations possi-
phases.
bles de plans qualite.)
II convient que les procedures auxquelles on se refer-e
Un plan qualite peut etre un document autonome,
dans un plan soient a la disposition du client, si cela
lorsqu’un fournisseur ne dispose pas d’un systeme
a ete convenu dans le contrat.
qualite documente par ecrit. Un plan qualite peut aussi
faire par-tie d’un autre document ou de documents
(comme un plan pour un produit ou pour un projet)
4.3 Rhision
dependant d’elements tels que les exigences d’un
client ou les pratiques professionnelles d’un fournis-
II convient que le fournisseur revise le plan, chaque
seur specifique. II peut etre necessaire de developper
fois que cela est necessaire, pour tenir compte des
un plan qualite qui consiste en un nombre de parties,
modifications apportees au produit, projet ou contrat,
chacune d’entre elles representant un plan pour une
des modifications sur la man&-e dont le produit est
phase distincte telle que conception, achat, produc-
fabrique, le service fourni ou des modifications dans
tion, ou controle et essais, ou activites particulieres
les pratiques de I’assurance de la qualite.
telles que le plan de skete de fonctionnement.
II convient que les modifications du plan qualite soient
NOTE 16 Lors de la rkdaction du plan qualit& les
revues pour impact et adequation par le meme groupe
conventions suivantes peuvent &re utilisbes:
autorise qui a conduit la revue du plan qualite original.
-’
((doit )) pour exprimer une disposition qui est prise entre
Suivant les exigences specifiques d’un contrat, il
deux ou plusieurs parties;
convient que des modifications du plan proposees
soient soumises a la revue et a I’acceptation du client
- le futur pour exprimer une dklaration d’objectif ou
d’ intentio n par une pat-tie avant d’etre mises en oeuvre.
---------------------- Page: 9 ----------------------
0 IS0
IS0 10005:1995(F)
e) de ma’itriser les actions correctives (voir 5.14).
5 Contenu du plan qualit
a) Structure
5.2 Plan qualit et systkme qualit
II convient que le contenu du plan qualite soit fonde
La plus grande par-tie de la documentation du plan
sur la presente Norme internationale et sur le sys-
qualite existera en principe deja en tant que par-tie de
teme qualite documente du fournisseur. II n’est pas
la documentation du systeme qualite. II est seulement
primordial que le plan qualite suive la structure et la
necessaire que le plan qualite se refere i cette docu-
num6rotation d’une norme IS0 9000 et l’alignement
mentation et demontre comment elle doit etre appli-
des paragraphes de la presente Norme internationale
quee a la situation particuliere concernee. Lorsqu’un
n’est destine qu’a faciliter son utilisation et sa
element d’une telle documentation n’existe pas en-
comprehention.
core mais est necessaire, it convient que le plan qua-
lite I’identifie ainsi que quand, comment et par qui il
II convient que les elements decrits dans les paragra-
sera prepare et approuve.
phes suivants repondent aux exigences du produit,
projet ou contrat chaque fois qu’il est pertinent de le
5.3 Revue de contrat
faire.
II
...
SLOVENSKI SIST ISO 10005
druga izdaja
STANDARD
november 1998
Vodenje kakovosti - Smernice za plane kakovosti
(enakovreden ISO 10005:1995)
Quality management - Guidelines for quality plans
Management de la qualité - Lignes directrices pour les plans qualité
Qualitätsmanagement - Leitfaden für Qualitätsmanagementpläne
Deskriptorji: vodenje kakovosti, zagotavljanje kakovosti, sistemi zagotavljanja kakovosti,
komponente, splo{ni pogoji
Referen~na {tevilka
ICS 03.120.10 SIST ISO 10005:1998 (sl,en)
Nadaljevanje na straneh od 2 do 34
© 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 10005 : 1998
UVOD
Standard SIST ISO 10005 (sl,en), Vodenje kakovosti - Smernice za plane kakovosti, druga
izdaja, 1998, ima status slovenskega standarda in je enakovreden mednarodnemu standardu
ISO 10005, Quality management - Guidelines for quality plans, prva izdaja, 1995.
NACIONALNI PREDGOVOR
Mednarodni standard ISO 10005:1995 je pripravil tehni~ni odbor Mednarodne organizacije za
standardizacijo ISO/TC 176 Vodenje in zagotavljanje kakovosti. Slovenski standard
SIST ISO 10005:1998 je prevod angle{kega besedila mednarodnega standarda
ISO 10005:1995. 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 in potrdil tehni~ni odbor USM/TC VZK Vodenje in zagotavljanje kakovosti.
Ta slovenski standard je dne 1998-10-05 odobril direktor USM.
ZVEZE S STANDARDI
S prevzemom tega mednarodnega standarda velja naslednja zveza:
SIST EN ISO 8402:1997 (sl,en,de,fr) Vodenje in zagotavljanje kakovosti - Slovar (istoveten
EN ISO 8402:1995)
PREDHODNA IZDAJA
- SIST ISO 10005:1996 (en)
OSNOVA ZA IZDAJO STANDARDA
- Prevzem standarda ISO 10005:1995.
OPOMBE
- Povsod, kjer se v besedilu standarda uporablja izraz “mednarodni standard”, v
SIST ISO 10005 to pomeni “slovenski standard”.
- Uvod in nacionalni predgovor nista sestavni del standarda.
- Slovenski standard SIST ISO 10005:1998 (sl,en) je enakovreden mednarodnemu
standardu ISO 10005:1995.
2
---------------------- Page: 2 ----------------------
SIST ISO 10005 : 1998
VSEBINA Stran Contents Page
Predgovor.4 Foreword.4
Uvod.5 Introduction.5
1 Predmet standarda.6 1 Scope.6
2 Zveza z drugimi standardi.7 2 Normative refernce.7
3 Definicije.7 3 Definitions.7
4 Priprava, pregled, sprejem in revizija 4 Preparation, review, acceptance and
plana kakovosti.9 revision of the quality plan.9
4.1 Priprava.9 4.1 Preparation.9
4.2 Pregled in sprejem.11 4.2 Review and acceptance.11
4.3 Revizija.11 4.3 Revision.11
5 Vsebina plana kakovosti.12 5 Contents of the quality plan.12
5.1 Odgovornosti vodstva.12 5.1 Management responsibilities.12
5.2 Plan kakovosti in sistem kakovosti.13 5.2 Quality plan and quality system.13
5.3 Pregled pogodbe.13 5.3 Contract review.13
5.4 Obvladovanje na~rtovanja.13 5.4 Design control.13
5.5 Obvladovanje dokumentov in 5.5 Document and data control.14
podatkov.14
5.6 Nabava.14
5.6 Purchasing.14
5.7 Obvladovanje proizvoda, ki ga dobavi
5.7 Control of customer-supplied
odjemalec.15
product.15
5.8 Identifikacija in sledljivost proizvoda.15
5.8 Product identification and traceability.15
5.9 Obvladovanje procesa.15
5.9 Process control.15
5.10 Kontrola in presku{anje.16
5.10 Inspection and testing.16
5.11 Obvladovanje kontrolne, merilne in
5.11 Control of inspection, measuring and
preskusne opreme.17
test equipment.17
5.12 Status kontrole in presku{anja.17
5.12 Inspection and test status.17
5.13 Obvladovanje neskladnega
5.13 Control of nonconforming product.17
proizvoda.17
5.14 Korektivni in preventivni uktrepi.18
5.14 Corrective and preventive action.18
5.15 Ravnanje, skladi{~enje, pakiranje,
5.15 Handling, storage, packaging,
za{~ita in dostava.18
preservation and delivery.18
5.16 Obvladovanje zapisov kakovosti.19
5.16 Control of quality records.19
5.17 Presoje kakovosti.19
5.17 Quality audits.19
5.18 Usposabljanje.20
5.18 Training.20
5.19 Servisiranje.20
5.19 Servicing.20
5.20 Statisti~ne tehnike.20
5.20 Statistical techniques.20
Dodatek A - Poenostavljeni primeri oblik
Annex A - Simplified examples of formats
za predstavitev planov kakovosti.21
for the presentation of quality plans.21
Dodatek B - Bibliografija.33
Annex B - Bibliography.34
3
---------------------- Page: 3 ----------------------
SIST ISO 10005 : 1998
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 ponavadi bodies). The work of preparing International
pripravljajo tehni~ni odbori ISO. Vsak ~lan, Standards is normally carried out through
ki `eli sodelovati na dolo~enem podro~ju, za ISO technical committees. Each member
katerega 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
sodelujejo tudi vladne in nevladne has the right to be represented on that
mednarodne organizacije, povezane z ISO. V committee. International organizations,
vseh zadevah, ki so povezane s governmental and non-governmental, in
standardizacijo na podro~ju elektrotehnike, liaison with ISO, also take part in the work.
ISO tesno sodeluje z Mednarodno ISO collaborates closely with the
elektrotehni{ko komisijo (IEC). 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 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 casting
udele`ijo glasovanja. a vote.
Mednarodni standard ISO 10005 je pripravil International Standard was prepared by
tehni~ni odbor ISO/TC 176 Vodenje in Technical Commitee ISO/TC 176, Quality
zagotavljanje kakovosti, pododbor SC 2 management and quality assurance,
Sistemi kakovosti. Subcommitee SC 2, Quality systems.
Dodatka A in B tega mednarodnega Annexes A and B of this International
standarda sta podana samo kot informacija. Standard are for information only.
4
---------------------- Page: 4 ----------------------
SIST ISO 10005 : 1998
Uvod Introduction
Mednarodni standard je bil pripravljen zaradi This International Standard was prepared to
potrebe po mehanizmu, ki bi povezal address the need for a mechanism to relate
splo{ne zahteve za elemente sistema generic requirements in quaity system
kakovosti in specifi~ne zahteve dolo~enega elements to the specific requirements of a
proizvoda, projekta ali pogodbe. Dolo~ila so particular product, project or contract. Its
samo svetovalnega zna~aja in niso zahteve. provisions should be considered advisory
and not requirements.
Plan kakovosti se lahko uporablja v A quality plan may be used within an
organizaciji, da se zagotovi ustrezno organization to ensure that specific
planiranje in naslavljanje identificiranih requirements for quality are being
proizvodov med izdelavo, v skladu s appropriately planned and addressed for
specifi~nimi zahtevami kakovosti. Plan identified products during production. A
kakovosti se lahko uporablja kot pokazatelj quality plan may be used to indicate the
specifi~ne uporabe sistema kakovosti na specific application of a quality system to a
dolo~enem razvojnem projektu za prodajni given development project, whether for a
proizvod ali za pripomo~ke, ki bodo marketable product or for an in-house
uporabljeni znotraj hi{e. Dobavitelj lahko v facility. A quality plan may also be used by
pogodbenem razmerju uporabi plan the supplier in a contractual situation to
kakovosti za prikaz, kako bo izpolnil demonstrate to the customer how the
specifi~ne zahteve za kakovost, ki so specific requirements for quality of a
dolo~ene v pogodbi. Mnogokrat je lahko particular contract will be met. In many
ugodno, ~e dobavitelj lahko pri razvoju cases, it may be beneficial to obtain
plana kakovosti pridobi odjemal~eve customer input to the development of the
pripombe. quality plan.
Plan kakovosti naj bo zdru`ljiv z drugimi The quality plan should be compatible with
plani, ki so morda `e pripravljeni. other plans that may be prepared.
5
---------------------- Page: 5 ----------------------
SIST ISO 10005 : 1998
Vodenje kakovosti - Smernice Quality management -
za plane kakovosti Guidelines for quality plans
1 Predmet standarda 1 Scope
1.1 Ta mednarodni standard dolo~a 1.1 This International Standard provides
smernice, ki bodo v pomo~ dobaviteljem pri guidelines to assist suppliers in the
pripravi, pregledu, sprejemu in reviziji planov preparation, review, acceptance and revision
kakovosti. of quality plans.
Uporablja se lahko v dveh primerih: It is intended for use in two situations:
a) kot vodilo dobaviteljevi organizaciji pri a) as guidance to a supplier organisation
izpolnjevanju zahtev ISO 9001, in meeting the requrements of ISO
ISO 9002 ali ISO 9003 za pripravo 9001, ISO 9002 or ISO 9003 relative
plana kakovosti; ali to the preparation of a quality plan;
or
b) kot vodilo dobaviteljevi organizaciji pri b) as guidance to a supplier organization
pripravi plana kakovosti, v primeru, da in preparing a quality plan when the
dobavitelj {e nima tak{nega sistema supplier does not have such a quality
kakovosti. system.
V obeh primerih je plan kakovosti le In both situations, the quality plan is
dodatek splo{ne dokumentacije supplemental to the supplier’s generic
dobaviteljevega sistema kakovosti in naj je quality system documentation and should
ne podvaja. Zaradi primernosti pri uporabi not duplicate the generic documentation. For
tipa b), vklju~uje ta mednarodni standard convenience in situations of type b), this
zna~ilnosti, ki so zajete v splo{nih zahtevah International Standard includes features that
standardov ISO 9001, ISO 9002 in are covered in the generic requirements of
ISO 9003. ISO 9001, ISO 9002 and
ISO 9003.
Plani kakovosti zagotavljajo mehanizem, ki Quality plans provide a mechanism to tie
povezuje specifi~ne zahteve proizvoda, specific requirements of the product, project
projekta ali pogodbe z obstoje~imi splo{nimi or contract to existing generic quality
postopki sistema kakovosti. Plani kakovosti system procedures. They do not require the
ne zahtevajo razvoja mno`ice dodatnih development of a comprehensive set of
postopkov ali navodil, ~eprav so lahko procedures or instructions over and above
potrebni dodatni dokumentirani postopki. those already existing, although some
additional documented procedures may be
necessary.
1.2 Ta mednarodni standard je primeren, 1.2 This International Standard is applicable
kadar se plan kakovosti uporablja za where a quality plan is to be used for a
dolo~en proizvod, projekt ali pogodbo. Plan particular product, project or contract. A
kakovosti se lahko uporablja pri vsaki izvorni quality plan may be applicable to any
vrsti proizvoda (strojna in programska product of the generic product categories
oprema, predelani materiali in storitve) ali v (hardware, software, processed materials and
industrijskih/ekonomskih sektorjih. services) or industry/economic sectors.
6
---------------------- Page: 6 ----------------------
SIST ISO 10005 : 1998
Plan kakovosti se lahko uporabi za nadzor A quality plan may be used to monitor and
in ocenjevanje skladnosti z zahtevami asses adherence to the requirements for
kakovosti, vendar te smernice niso seznam quality, but these guidelines are not
to~k za preverjanje skladnosti z zahtevami. intended to be used as a checklist for
Plan kakovosti se lahko uporabi tudi, ~e ne compliance with requirements. A quality plan
obstaja dokumentiran sistem kakovosti, may also be used where a documented
vendar so v takem primeru potrebni quality system does not exist, in which case
postopki za podporo plana kakovosti. procedures may need to be developed to
support the quality plan.
Opomba: 1. Dodatek B vsebuje seznam mednarodnih NOTE 1 Annex B contains a bibliography of
standardov, ki lahko dajo informacije in International Standards which provide
so v pomo~ vsem vklju~enim v pripravo information that may prove helpful to
in pregled planov kakovosti. those involved in the preparation and
review of quality plans.
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 ponavadi edition indicated was valid. All standards are
revidirajo. Strankam, ki sklenejo pogodbo, subject to revision, and parties to
zasnovano na tem mednarodnem standardu, agreements based on this International
se priporo~a, naj razi{~ejo mo`nost uporabe Standard are encouraged to investigate the
najnovej{e izdaje spodaj navedenega possibility of applying the most recent
standarda. ^lani IEC in ISO vzdr`ujejo edition of the standard indicated below.
register veljavnih mednarodnih standardov. Members of IEC and ISO mantain registers
of currently valid International Standards.
ISO 8402:1994, Vodenje in zagotavljanje
kakovosti - Slovar. ISO 8402:1994, Quality management and
quality assurance - Vocabulary.
SIST EN ISO 8402:1995, Vodenje in
zagotavljanje kakovosti - Slovar.
3 Definicije 3 Definitions
V tem mednarodnem standardu so For the purposes of this International
uporabljene definicije, podane v standardu Standard, the definitions given in ISO 8402,
ISO 8402, skupaj s spodaj navedenimi together with the following definitions, apply.
definicijami. Izrazi, ki so tukaj ponovljeni Terms which are repeated here for clarity
zaradi jasnosti, definirani pa so bili v drugih but have been defined in other International
mednarodnih standardih, imajo navedeno Standards are identified by the placement of
oznako standarda za definicijo izraza. the number of the standard after the term
being defined.
3.1 Pogodba: Dogovorjene zahteve med 3.1 Contract: Agreed requirements between
dobaviteljem in odjemalcem, sporo~ene na a supplier and customer transmitted by any
kakr{enkoli na~in. means.
(ISO 9001) (ISO 9001)
7
---------------------- Page: 7 ----------------------
SIST ISO 10005 : 1998
3.2 Projekt: Enkraten proces, sestavljen iz 3.2 project: Unique process consisting of a
mno`ice usklajenih in obvladovanih aktivnosti set of coordinated and controlled activities
z za~etnim in kon~nim datumom, ki se with start and finish dates, undertaken to
izvajajo, da bi se dosegel cilj, ki je v achieve an objective conforming to specific
skladu s posebnimi zahtevami, vklju~ujo~ requirements, including the constraints of
omejitev ~asa, stro{kov in virov. time, cost and resources
Opombe: 2. Posamezen projekt je lahko del ve~je NOTES 2 An individual project may form a part of
projektne strukture. a larger project structure.
3. Pri nekaterih tipih projektov se vzporedno 3 In some types of projects, the objectives
z napredovanjem projekta izbolj{ujejo cilji are refined and the project characteristics
in se postopoma definirajo zna~ilnosti defined progressively as the project
projekta. proceeds.
4. Rezultat projekta je lahko ena ali ve~ 4 The outcome of a project may be one or
enot proizvoda. several units of a product.
3.3 Tipski preskus: Preskus ali zaporedje 3.3 type test: Test or series of tests
preskusov, ki so usmerjeni k odobritvi directed towards approval of a design
na~rtovanja in se izvajajo zato, da se conducted to determine that it is capable of
ugotovi ali se lahko zadovoljijo zahteve meeting the requirements of the product
specifikacije proizvoda. specification.
3.4 Presku{anje v prisotnosti pri~e: 3.4 witness testing: Testing of a product
Presku{anje proizvoda v prisotnosti in the presence of the customer’s
naro~nikovega predstavnika ali tretje stranke. representative or a third party.
3.5 Postopek: Specificiran na~in izvajanja 3.5 procedure: Specified way to perform an
neke aktivnosti. activity.
Opombe: 5.V {tevilnih primerih so postopki NOTES 5 In many cases, procedures are
dokumentirani (na primer postopki documented (e.g. quality system
sistema kakovosti). procedures).
6.Kadar je postopek dokumentiran, se 6 When a procedure is documented, the
pogosto uporablja izraz “pisni postopek” term “written procedure” or “documented
ali “dokumentirani postopek”. procedure” is frequently used.
7.Pisni ali dokumentirani postopek 7 A written or documented procedure
ponavadi vsebuje: namen in podro~je usually contains the purpose and scope
aktivnosti; kaj naj se naredi in kdo naj of an activity; what shall be done and
to naredi; kdaj, kje in kako naj se to by whom; when, where and how it shall
naredi; katere materiale, opremo in be done; what materials, equipment and
dokumente naj se uporabi; kako je treba documents shall be used; and how it
aktivnost obvladovati in zapisati. shall be controlled and recorded.
(ISO 8402) (ISO 8402)
3.6 Proizvod: Rezultat aktivnosti ali 3.6 product: Result of activities or
procesov. processes.
Opombe: 8. Proizvod lahko vklju~uje storitev, strojno NOTES 8 A product may include service, hardware,
opremo, predelane materiale, programsko processed materials, software or a
opremo ali njihove kombinacije. combination thereof.
9. Proizvod je lahko materialen (na primer 9 A product can be tangible (e.g. assemblies or
sestavljeni ali predelani materiali) ali processed materials) or intangible (e.g.
nematerialen (na primer znanje ali zamisli) ali knowledge or concepts), or a combination
kombinacija obeh. thereof.
8
---------------------- Page: 8 ----------------------
SIST ISO 10005 : 1998
10.Proizvod je lahko nameren (na primer 10 A product can be either intended (e.g.
ponudba odjemalcem) ali nenameren (na offering to customers) or unintended
primer onesna`evalne snovi ali (e.g. polluant or unwanted effects).
neza`eleni u~inki).
(ISO 8402) (ISO 8402)
3.7 Plan kakovosti: Dokument, ki 3.7 quality plan: Document setting out the
opredeljuje ustrezne specifi~ne tehnike dela, specific quality practices, resources and
vire in zaporedje ukrepov za kakovost za sequence of activities relevant to particular
dolo~en proizvod, projekt ali pogodbo. product, project or contract.
Opombe: 11.Plan kakovosti se ponavadi sklicuje na NOTES 11 A quality plan usually makes reference
tiste dele poslovnika kakovosti, ki se to the parts of the quality manual
nana{ajo na dolo~en primer. applicable to the specific case.
12.Naslov dokumenta se lahko oblikuje 12 Depending on the scope of the plan, a
glede na namen plana, na primer “plan qualifier may be used, for example,
zagotavljanja kakovosti” ali “plan vodenja “quality assurance plan”, “quality
kakovosti”. management plan”.
(ISO 8402) (ISO 8402)
3.8 Sistem kakovosti: Organizacijska 3.8 quality system: Organizational structure,
struktura, postopki, procesi in viri, potrebni procedures, processes and resources
za izvajanje vodenja kakovosti. needed to implement quality management.
Opombe: 13.Sistem kakovosti naj bo tako obse`en, NOTES 13The quality system should be as
kolikor je potrebno za izpolnitev ciljev comprehensive as needed to meet the
kakovosti. quality objectives.
14.Sistem kakovosti organizacije je 14The quality system of an organization is
zasnovan predvsem zato, da zadovolji designed primarily to satisfy the internal
notranje potrebe vodenja organizacije in managerial needs of the organization. It
je {ir{i od zahtev dolo~enega odjemalca, is broader than the requirements of a
ki ovrednoti samo tisti del sistema particular customer who evaluates only
kakovosti, ki se nana{a nanj. the relevant part of the quality system.
15.Za pogodbene namene ali za namene 15For contractual or mandatory quality
obvezne ocenitve kakovosti se lahko assesment purposes, demonstration of
zahteva dokaz izvajanja dolo~enih the implementation of identified quality
elementov sistema kakovosti. system elements may be required.
(ISO 8402) (ISO 8402)
4 Priprava, pregled, sprejem in 4 Preparation, review, acceptance
revizija plana kakovosti and revision of the quality plan
4.1 Priprava 4.1 Preparation
Ob pripravljanju plana kakovosti naj bodo When preparing a quality plan, quality
definirane in dokumentirane razmeram activities applicable to the situation should
primerne aktivnosti kakovosti. be defined and documented.
Velik del potrebne splo{ne dokumentacije je Much of the generic documentation needed
lahko `e v dobaviteljevem poslovniku may be contained in the supplier’s quality
kakovosti in dokumentiranih postopkih, manual and documented procedures. This
vendar jo je treba izbrati, prilagoditi in/ali documentation may need to be selected,
dopolniti. Plan kakovosti ka`e, kako so adapted and/or supplemented. The quality
dobaviteljevi splo{ni dokumentirani postopki plan shows how the supplier’s generic
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povezani s potrebnimi dodatnimi postopki, ki documented procedures are related to and
so odvisni od proizvoda, projekta ali applied to any necessary additional
pogodbe, in kako so v njih uporabljeni za procedures peculiar to the product, project
doseganja dolo~enih ciljev kakovosti. or contract in order to attain specified
quality objectives.
Plan kakovosti naj neposredno ali s The quality plan should indicate, either
sklicevanjem na ustrezne dokumentirane directly or by reference to appropriate
postopke ali druge dokumente navaja, kako documented procedures or other documents,
naj bodo izpeljane zahtevane aktivnosti. how the required activities are to be carried
out.
Oblika in stopnja podrobnosti v planu naj The format and level of detail in the plan
bosta v skladu z dogovorjenimi zahtevami should be consistent with any agreed
odjemalca, dobaviteljevimi metodami dela in customer requirement, the supplier’s method
obse`nostjo aktivnosti, ki bodo izvedene. of operation and the complexity of the
Plan naj bo ~im kraj{i, vendar skladen z activities to be performed. The plan should
dolo~ili tega mednarodnega standarda. be as brief as possible, consistent with
(Poenostavljeni primeri nekaterih mogo~ih meeting the provisions of this International
predstavitev planov kakovosti so v dodatku Standard. (Simplified examples of alternative
A.) presentations of quality plans are contained
in annex A.)
Plan kakovosti je lahko samostojen A quality plan may be a stand-alone
dokument kadar dobavitelj nima document when a supplier does not have a
dokumentiranega sistema kakovosti. Plan documented quality system. A quality plan
kakovosti je lahko tudi vklju~en v del may also be included as part of another
drugega dokumenta ali dokumentov (na document or documents (e.g. product or
primer plan proizvoda ali projekta), odvisno project plan), depending on such things as
od, na primer zahtev odjemalca ali na~ina customer requrements or the business
poslovanja posameznega dobavitelja. Lahko, practices of a specific supplier. It may be
da je treba razviti plan kakovosti, ki je necessary to develop a quality plan that
sestavljen iz mno`ice delov, od katerih vsak consists of a number of parts, each of
predstavlja plan za dolo~eno stopnjo, na which represents a plan for a distinct stage,
primer za na~rtovanje, nabavo, proizvodnjo, such as for design, purchasing, production,
kontrolo in presku{anje, ali za posebne or inspection and test, or for particular
aktivnosti, kot je plan odvisnosti. activities such as the dependability plan.
Opomba: 16. Ko se pripravlja plan kakovosti, se lahko NOTE 16 When drafting a textural quality plan, the
uporabijo naslednja poimenovanja: following conventions may be used:
- “bodo”, da se izrazi dolo~ilo, ki - “shall” to express a provision that is
obvezuje dve ali ve~ strani; binding between two or more parties;
- “bo”, da se izrazi pripravljenost ali - “will” to express a declaration of
namen ene strani; purpose or intent by one party;
- “naj”, da se izrazi priporo~ilo med - “should” to express a recommendation
ve~ mo`nostmi; among other possibilities;
- “lahko”, da se naka`e potek ukrepa, - “may” to indicate a course of action
ki je dopusten znotraj plana permissible within the limits of the
kakovosti. quality plan.
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SIST ISO 10005 : 1998
4.2 Pregled in sprejem 4.2 Review and acceptance
Da bi ugotovili ustreznost plana kakovosti, The quality plan should be reviewed for
naj ga pregleda in formalno potrdi adequacy and formally approved by an
poobla{~ena skupina, sestavljena iz authorized group that includes
predstavnikov vseh vklju~enih funkcij representatives from all affected functions
dobaviteljeve organizacije. within the supplier’s organisation.
Pri pogodbi lahko dobavitelj po{lje In contractual situations, a quality plan may
odjemalcu plan kakovosti v presojo, da ga be submitted to the customer by the
pregleda in sprejme. To se lahko zgodi `e supplier for review and acceptance, either
v postopku sprejemanja ponudb ali potem, as part of the precontract award-bidding
ko je bila pogodba `e sklenjena. process or after the contract has been
awarded.
^e je plan predan odjemalcu `e v postopku If the plan is submmited as part of the
sprejemanja ponudb in je bila zatem bidding process and a contract is
sklenjena pogodba, je treba plan, po subsequently awarded, the plan should be
potrebi, pregledati in popraviti, da se reviewed and, where apropriate, revised to
vklju~ijo vse spremembe zahtev, ki so lahko reflect any chages in requirements that may
rezultat pogajanj pred sklenitvijo pogodbe. have occured as a result of precontract
negotiations.
^e pogodba zahteva plan kakovosti, naj bo When a quality plan is required by a
predlo`en pred za~etkom zahtevanih contract, it should normally be submitted
aktivnosti. ^e se pogodba izvaja po prior to the start of the required activities.
stopnjah, naj dobavitelj plan kakovosti za Where the contract is conducted in stages,
vsako stopnjo po{lje v presojo odjemalcu the supplier should submit the quality plan
pred za~etkom te stopnje. for each stage to the customer prior to the
start of that stage.
Postopki, na katere se sklicuje plan, naj Procedures referenced in the plan should be
bodo na voljo odjemalcu, ~e je bilo tako made available to the customer, where
dogovorjeno v pogodbi. agreed in the contract.
4.3 Revizija 4.3 Revision
Dobavitelj naj po potrebi spremeni plan, The supplier should revise the plan, when
tako da bo kazal spremembe, ki so nastale appropriate, to reflect changes that have
na proizvodu, projektu ali v pogodbi, been made to the product, project or
spremembe pri na~inu izdelave proizvoda ali contract, changes to the manner in which
izvedbi storitve, ali spremembe pri the product is produced or the service is
zagotavljanju kakovosti. provided, or changes in quality assurance
practices.
Vpliv in ustreznost sprememb plana Changes to the quality plan should be
kakovosti naj pregleda ista poobla{~ena reviewed for impact and adequacy by the
skupina, kot je pregledala izvorni plan same authorized group which conducted the
kakovosti. review of the original quality plan.
V skladu s specifi~nimi zahtevami pogodbe Subject to the specific requirements of a
naj odjemalec predlagane spremembe plana contract, proposed changes to the plan
pregleda in sprejme preden so uvedene. should be submitted to the customer for
review and acceptance before
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