SIST ISO 9000-2:1998
(Main)Quality management and quality assurance standards -- Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003
Quality management and quality assurance standards -- Part 2: Generic guidelines for the application of ISO 9001, ISO 9002 and ISO 9003
Normes pour le management de la qualité et l'assurance de la qualité -- Partie 2: Lignes directrices génériques pour l'application de l'ISO 9001, l'ISO 9002 et l'ISO 9003
Standardi za vodenje in zagotavljanje kakovosti - 2. del: Splošne smernice za uporabo standardov ISO 9001, ISO 9002 in ISO 9003
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INTERNATIONAL
IS0
STANDARD
9000-2
Second edition
1997-06-I 5
Quality management and quality assurance
standards -
Part 2:
Generic guidelines for the application of
IS0 9001, IS0 9002 and IS0 9003
Normes pour le management de la qua/M et / ‘assurance de la qua/it& -
Parfie 2: Lignes directrices ghkriques pour I ’applica tion de / ‘/SO 900 1,
/ ‘/SO 9002 et IWO 9003
Reference number
IS0 9000-2: 1997(E)
---------------------- Page: 1 ----------------------
IS0 9000=2:1997(E)
Page
Contents
1
................................................................................................
1 Scope
1
Normative references .
2
2
Definitions .
3
2
............................................................
4 Quality system requirements
2
..............................................................
41 0 Management responsibility
5
..................................................................................
42 0 Quality system
6
................................................................................
43 0 Contract review
.................................................................................. 8
44 l Design control
13
...............................................................
45 l Document and data control
15
46 . Purchasing .
.............................................. 16
47 l Control of customer-supplied product
17
..............................................
48 0 Product identification and traceability
18
49 Process control .
....................................................................... 19
4 ’10 Inspection and testing
...................... 21
4 ’11 Control of inspection, measuring and test equipment
21
4 ’12 Inspection and test status .
................................................... 22
4 ’13 Control of nonconforming product
23
Corrective and preventive action .
4 ’14
25
.................
4 ’15 Handling, storage, packaging, preservation and delivery
26
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 ’16 Control of quality records
27
.......................................................................
4 ’17 Internal quality audits
29
4 ’18 Training .
29
4 ’19 Servicing .
30
4 ’a 20 Statistical techniques .
32
Annex A Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 IS0 1997
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
1ntemet:centra.l @iso.ch
X.400: c=ch; a=4OOnet; p=iso; o=isocs; s=central
Printed in Switzerland
ii
---------------------- Page: 2 ----------------------
@ IS0 IS0 9000=2:1997(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 9000-2 was prepared by Technical Committee ISO/TC 176,
Quality management and quality assurance, Subcommittee SC 2, Quality systems.
This second edition cancels and replaces the first edition (IS0 9000-2: 1993), which has
been technically revised.
IS0 9000 consists of the following parts, under the general title Quality management
and quality assurance standards
- Part 1: Guidelines for selection and use
- Part 2: Generic guidelines for the application of IS0 9001, IS0 9002 and IS0 9003
-
Part 3: Guidelines for the application of IS0 9001 to the development, supply and
maintenance of software
- Part 4: Guide to dependability management
Annex A of this part of IS0 9000 is for information only.
. . .
111
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IS0 9000=2:1997(E)
Introduction
This part of IS0 9000 gives guidance for the application of IS0 9001, IS0 9002 and
IS0 9003. To facilitate cross-reference to those standards, this part of IS0 9000 has the
same clause structure as IS0 9001, IS0 9002 and IS0 9003.
In general, the number and scope of the quality system elements and procedures
required for quality assurance are greatest in IS0 9001 and least in IS0 9003. For all
clauses, the guidelines of this part of IS0 9000 should be applied in a manner consistent
with the scope and requirements of the corresponding clause, if present, in the standard
involved (i.e. IS0 9001, IS0 9002 or IS0 9003). Reference should be made to
subclause 8.3 of IS0 9000-l : 1994 for guidance on the appropriate extent and degree of
demonstration.
IS0 9000-l gives an overview of the IS0 9000 series of International Standards, and
explains the use of the entire series. IS0 9004-l gives guidance for designing and
installing a quality management system.
This part of IS0 9000 does not duplicate the guidance to users that is given in other IS0
guidance standards such as IS0 9000-1, IS0 9000-3, IS0 9004-l and IS0 9004-2.
iv
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IS0 9000-2: 1997(E)
INTERNATIONAL STANDARD @ Iso
Quality management and quality assurance standards -
Part 2:
Generic guidelines for the application of IS0 9001, IS0 9002 and
IS0 9003
1 Scope
This part of IS0 9000 gives guidance on the application of the 1994 versions of IS0 9001,
IS0 9002 and IS0 9003.
It does not add to, or otherwise change, the requirements of IS0 9001, IS0 9002 or IS0 9003.
In the case of conflicting interpretations of IS0 9001, IS0 9002 or IS0 9003 on the one
hand, and IS0 9000-2 on the other, the interpretation of the text in IS0 9001, IS0 9002 or
IS0 9003 takes precedence. The use of ‘should’ in this part of IS0 9000 does not weaken the
requirements expressed as ‘shall’ in IS0 9001, IS0 9002 and IS0 9003.
This part of IS0 9000 gives guidance for the following users:
a) suppliers involved in applications of IS0 9001, IS0 9002 or IS0 9003;
b) customers and third parties.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute
provisions of this part of IS0 9000. At the time of publication, the editions indicated were
valid. All standards are subject to revision, and parties to agreements based on this part of
IS0 9000 are encouraged to investigate the possibility of applying the most recent editions of
the standards indicated below. Members of IEC and IS0 maintain registers of currently valid
International Standards.
IS0 8402: 1994, Quality management and quality assurance - Vocabulary.
Model for quality assurance in design, development,
IS0 9001: 1994, Quality systems -
production, installation and servicing.
IS0 9002: 1994, Quality systems - Model for quality assurance in production, installation
and servicing.
Model for quality assurance injinal inspection and test.
IS0 9003: 1994, Quality systems -
1
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@ IS0
IS0 9000=2:1997(E)
3 Definitions
For the purposes of this part of IS0 9000, the definitions given in IS0 8402 and the following
apply*
contract: Agreed requirements between a supplier and customer transmitted by any
31 .
means.
[ISO 90011
product: Result of activities or processes.
32 .
NOTE 1 A product may include service, hardware, processed materials, software or a combination
thereof.
ies or processed materials) or in .tangi ble (e.g.
NOTE 2 A product can be tangible (e.g. assembl
knowledge or concepts), or a combination thereof.
NOTE 3 For the purposes of this International Standard, the term ‘product’ applies to the intended
product offering only and not to unintended ‘by-products’ affecting the environment. This differs
from the definition given in IS0 8402.
[ISO 90011
33 0 specified requirements
Product requirements prescribed by the customer and agreed by the supplier.
1)
Requirements prescribed by the supplier that are perceived as satisfying a market
2)
need.
34 tender: Offer made by a supplier in response to an invitation to satisfy a contract
aL.rd to provide product.
[ISO 900 l]
4 Quality system requirements
41 a Management responsibility
4.1.1 Quality policy
The supplier ’s management with executive responsibility (see 4.1.2.1) is required to develop
and define its quality policy, quality objectives and commitment in (a) recorded statement(s).
This is required to be relevant to its organizational goals, and the expectations and needs of
its customers. The statement(s) should be published throughout the organization and be seen
to be fully supported by the management.
2
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@ IS0 IS0 9000=2:1997(E)
All employees, including newly hired, part-time and temporary employees, should be trained
so that they understand the objectives of the organization and the commitment required to
achieve these objectives. The policy should be expressed in language that is easy to
understand and the objectives should be achievable, planned and periodically reviewed.
Management should continuously demonstrate visible commitment to the quality policy by
activities which may include, but not be limited to, the following:
ensuring that the organization ’s personnel understand and implement the quality
policy;
ensuring that the organization ’s personnel have quality objectives consistent with
the organization ’s overall objectives;
initiating, managing and following up on the implementation of the quality
policy, including implementation and maintenance of the quality system;
not accepting deviations from the quality policy in any part or aspect of the
organization;
providing adequate resources and training to support quality system development
and implementation. (See 4.1.2.2.)
4.1.2 Organization
4.1.2.1 Responsibility and authority
Management with executive responsibility is that person or group of persons within an
organization with the necessary level of authority for making policy and setting objectives,
planning their implementation, reviewing achievement and taking corrective action. The
supplier should clearly identify those persons having such executive responsibility.
In particular the personnel having the responsibility and authority to make decisions that
control all the elements of the quality system and processes should be identified and the job
requirements defined and documented (see 4.18).
4.1.2.2 Resources
Consideration needs to be given by the supplier ’s management to the identification and
provision of adequate resources needed to implement its quality policy and achieve its
objectives as well as to satisfy customer needs and expectations. The following should be
considered:
personnel to plan, manage, perform work, control and carry out verification
activities;
awareness of standards, procedures and other documented practices that are
needed;
3
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@ IS0
ISO9000=2:1997(E)
I
training and qualifications (see 4.18);
planning design, development and production activities to allow sufficient time to
perform the work;
equipment and processes, including acquisition of new equipment or technology;
means to access quality records.
4.1.2.3 Management representative
Within the supplier ’s organization, a management representative with delegated authority is
required to be appointed for arranging and overseeing the working of the quality system. This
management representative is required to be appointed by management with executive
responsibility.
The functions of the management representative may be totally related to quality system
activities or be in conjunction with other functions and responsibilities within the
organization. If the management representative has other functions to perform, there should
be no conflict of interest between the responsibilities for the other functions and those for the
quality system. The management representative should have the authority to ensure that the
requirements of IS0 9001, IS0 9002 or IS0 9003 are satisfied and that compliance is
maintained, together with the responsibility to ensure that they are operated throughout the
organization.
The defined role should include reporting on the suitability and effectiveness of the quality
system as a basis for improvement, management review, and liaison, as necessary, with
customers, subcontractors and any other external parties on quality matters.
4.1.3 Management review
The supplier ’s management with executive responsibility, should review the quality system.
This may include, but not be limited to, the following:
the adequacy of the organizational structure, including its staffing and other
resources;
conformity to IS0 900 1, IS0 9002 or IS0 9003, and effective implementation of
the quality system;
compliance with quality policy;
I
information based on customer feedback, internal feedback (such as results of
internal audits), process performance and product performance, as well as
corrective and preventive ictions taken.
The intervals between reviews shoul d be carefully planned and periodically reviewed to
ensure the continuing suitability and effectiveness of the quality system. The management
4
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@ IS0 IS0 9000=2:1997(E)
review process, frequency of reviews and levels of inputs will depend on the individual
circumstance. Some organizations have found that annual management reviews are
acceptable.
Management should focus on trends that may indicate problems. Chronic problem areas
should receive special attention. Actions that are required following changes to the quality
system determined during management review should be implemented in a timely manner.
The effectiveness of any changes should be evaluated. Records of such reviews should be
maintained (see 4.16).
42 0 Quality system
4.2.1 General
The implementation of a quality system by the supplier is most effective when those in the
organization understand its intention and how it functions, in particular, in the area of their
responsibility and its interface with other parts of the system. The quality manual has an
important role in this regard, for both internal and external parties. To give a coherent view
of the quality system, the quality manual should include the quality policy, a description of
the organization, and identify the quality system procedures with appropriate cross-references
to more detailed documentation. The quality manual could, for example, be one document
supported by several levels of other documents, each level becoming progressively more
detailed. There may also be an overall system manual, one or more specific procedural
manuals, work instructions and reference documents. Together, these documents define the
quality system. Further guidance on development of quality manuals is given in IS0 100 13.
4.2.2. Quality system procedures
Documented quality system procedures are required for applicable requirements of IS0
9001, IS0 9002 and IS0 9003 and should be consistent with the supplier ’s quality policy. It
is important to recognise that the structure and level of detail required in these procedures
should be tailored to the needs of the organization ’s personnel, which will depend upon
methods used and the training requirements, skills and qualifications of such personnel, as
indicated in 4.18.
A documented procedure usually specifies the purpose and scope of an activity:
what shall be done by whom;
I
when, where, and how it shall be done;
-
what materials, equipment and documents shall be used; and
how an activity shall be controlled and recorded.
Documented procedures may make reference to work instructions that define how an activity
is performed.
5
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@ IS0
ISO9000=2:1997(E)
4.2.3 Quality planning
The supplier needs to show that planning activities have been performed, and that they
establish the means by which the requirements for quality will be met. Planning should
include the application of the quality system elements, and how the product quality
requirements will be met.
This may require the following.
a) For managerial and operational planning, preparing the application of the quality
system.
b) For product planning, setting out in a quality plan or in any other documented
procedures the specific quality practices, resources and sequence of activities
relevant to a particular product, project or contract.
More guidance on quality plans is given in IS0 10005.
43 a Contract review
4.3.1 General
In the situation where a tender is offered or a contract or order is to be established between a
supplier and a customer, the means of achieving satisfaction lies in the contract review
process.
Contract review is one of the supplier ’s primary interfaces with its customers. The
documented procedures should include a review of customer requirements (whether
expressed in a tender, contract or order, which may be written or verbal) and how customer
requirements are reviewed and communicated within the organization.
The contract review is prior to accepting a contract or an order.
4.3.2 Review
The importance of a thorough understanding of the customer ’s needs, from initial contact,
through tendering or receiving verbal orders, to the formulation of the contract, or order and
in all subsequent stages cannot be overstated. Often, dialogue will be necessary to achieve
this understanding, that should clearly establish the customer ’s requirements as to the product,
delivery and other critical factors. Where a verbal statement of requirement is received from
the customer, the supplier should ensure that an order (statement of requirements) is
understood, adequately documented and agreed to by the customer.
Contract review is a process that includes the following:
a) review of the requirement; this may be appropriate at the tendering or order entry
stage and at subsequent stages prior to acceptance of the contract or the order;
6
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@ IS0 IS0 9000=2:1997(E)
b) agreement within the supplier ’s organization that
I
the requirements have been defined,
I
the requirements are understood,
I
the supplier has the capability to meet the requirements of the contract, by going
through a defined process to verify that the necessary resources and facilities are
available to fulfil all the requirements of the contract;
resolution of any differences with the customer;
cl
d) contract review of a standard product (e.g. “off-the-shelf’ items, a “commodity
item ”, a catalogue item with published specification, etc.) can be as simple as
verifying the accuracy of the information on the order;
e) the requirements of the contract, where appropriate, may be translated into the
terminology, tolerances, and other necessary information for designing,
purchasing and process control;
f) preliminary quality plan or documented procedures, where appropriate, may be
developed to give an understanding of how to implement the contract
successfully and support the contract review process.
It is beneficial for the supplier to adopt a contract or order review procedure that has the
following features:
affected parties have an opportunity and adequate time to review the contract;
I
a checklist or some other means (e.g. a standard form) is available for reviewers
to verify and record that they have reviewed and understood the requirements of
the contract or order;
a method is available for reviewers to question the requirements of the contract or
order, to have their questions considered and to have differences with other
affected parties resolved.
4.3.3 Amendment to contract
When customer requirements change, consideration should be given to repeating the contract
review procedure (see 4.3.2). It is beneficial for the supplier to have a procedure for reviews
by the same departmental functions that reviewed the original contract or accepted order.
Before such changes come into effect, there should be methods available to ensure that all
relevant changes are communicated to those affected.
4.3.4 Records
In all cases, it should be sufficient to retain records that the review has been performed (see
4.16). For internal purposes, however, records of the evaluation associated with the contract
7
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@ IS0
ISO9000=2:1997(E)
review may be retained in cases such as complex or critical projects. These records should
give objective evidence for audits, and facilitate the following:
post-delivery project review;
process improvement; and
the generation of proposals for future projects.
44 0 Design control
4.4.1 General
The essential quality aspects and the regulatory requirements such as safety, performance, and
dependability of a product are established during the design and development phase.
Deficient design can be a major cause of quality problems.
In considering design control, it is important to note that the design process may apply to
various activities in differing styles and timescales. Such aspects are related to products, as
well as the process associated with product design. The supplier should consider all phases of
the design associated with product design and all phases of the design process for which
controlled procedures are necessary.
4.4.2 Design and development planning
The supplier should establish procedures for design and development planning and, where
appropriate,include the following:
identification, scope and objectives;
sequential and parallel work schedules;
timing, frequency, and nature of design verification and validation activities;
evaluation of the safety, performance and dependability incorporated in the
product design;
I
methods of product measurement, test and acceptance criteria;
assignment of responsibilities.
Design and development plans should be integrated with any other plans and verification
procedures related to the product and plans should be updated as necessary.
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IS0 9000=2:1997(E)
@ IS0
The supplier should clearly assign responsibilities for specific design leadership and other
design work functions to qualified personnel. The personnel in these functions should have
access to information and the resources to complete the work.
Design activities should be defined to the level of detail necessary for carrying out the design
process.
4.4.3 Organizational and technical interfaces
When input to the design is from a variety of sources, the inter-relationships and interfaces, as
well as the pertinent responsibilities and authorities, should be defined, documented,
coordinated, and controlled.
Many organizational functions, both internal and external, may contribute to the design
process; examples are as follows:
research and development;
marketing and sales;
purchasing;
quality assurance and quality management;
engineering;
materials technology;
production/manufacturing;
service groups;
facilities management;
warehousing/transportation/logistics;
communications;
information systems.
They should also establish, but not limit themselves to, the following:
what information should be received and transmitted;
identification of sending and receiving groups;
the purpose of the information transmitted;
identification of transmittal methods;
document transmittal and records maintenance.
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@ IS0
ISO9000=2:1997(E)
4.4.4 Design input
User needs (through marketing) or customer requirements (through contract) should be
established during contract review (see 4.3) that, together with relevant statutory legislation,
will form the design input requirements.
Design inputs are typically in the form of product requirement specifications and/or product
description with specifications relating to configuration, composition, incorporated elements,
and other design features.
All pertinent design inputs (such as performance, functional, descriptive, environmental,
safety and regulatory requirements) should be defined, reviewed and recorded by the supplier.
The design inputs should describe all requirements to the greatest possible extent; they lay
the foundation and provide a unified approach to the design. Details agreed between
customer and supplier on how customer, statutory and regulatory requirements will be met
should be included.
The record of the design inputs should also include the resolutions of any
incomplete, ambiguous or conflicting requirements that have been identified at the contract
review and/or design verification stages or related design control activities.
materials, and processes requiring
The design inputs should identify design criteria,
development and analysis, including prototype testing to verify their adequacy. Design inputs
should be prepared in a way that facilitates periodic updates. They should indicate ‘when’ or
‘what criteria’ will cause the inputs to be updated, who is responsible for the update, and under
what circumstances the customer will get a copy. Design inputs prepared in this way serve as
the definitive up-to-date reference document as the design progresses to completion.
4.4.5 Design output
Throughout the design process, the requirements contained in the design description are
translated by the supplier into outputs. Design outputs should be documented in terms that
can be verified and validated against design input requirements and need to contain or make
reference to acceptance criteria; examples of these can be found in the following:
drawings and parts list;
specifications (including process and materials specifications);
instructions;
I
software;
I
servicing procedures.
Design outputs are the product requirements used for purchasing, production, installation,
inspection and testing, and servicing. Because of their impact on follow-on activities, it is
important that the outputs are reviewed and approved before release.
10
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@ IS0 ISO9000=2:1997(E)
4.4.6 Design review
Design reviews should be planned. In order to achieve a degree of objectivity, they need to
involve all functions, both internal and external, concerned with the design stage being
reviewed. Design staff and other specialist personnel should also participate as required.
Design review may be a regulatory requirement for certain types of product. The timing and
frequency of these reviews will be influenced by the maturity, complexity and cost of the
product being designed. Records of such reviews should be maintained (see 4.16).
The competence of the participants in the design reviews should be adequate to permit them
to examine designs and their implications. Design reviews may consider questions such as
the following.
Do designs satisfy all specified requirements for the product?
Are product design and processing capabilities compatible?
Are safety considerations considered?
Do designs meet functional and operational requirements, for example,
performance and dependability objectives?
Have appropriate materials and/or facilities been selected?
e)
Is there adequate compatibility of materials, components and/or service elements?
f)
Is the design satisfactory for all anticipated environmental and load conditions?
g)
Are components or service elements standardized and do they provide for
h)
reliability, availability and maintainability?
Is there a provision in tolerances, and/or configuration, for interchangeability and
0
replacement?
.
Are plans for implementing the design technically feasible (e.g. purchasing,
J)
production, installation, inspection and testing)?
Where computer software has been used in design computations, modelling or
k)
analyses, has the software been appropriately validated, authorized, verified and
placed under configuration control?
Have the inputs to such software, and the outputs, been appropriately verified and
1)
documented?
Are the assumpti
...
SLOVENSKI STANDARD
SIST ISO 9000-2:1998
01-avgust-1998
Standardi za vodenje in zagotavljanje kakovosti - 2. del: Splošne smernice za
uporabo standardov ISO 9001, ISO 9002 in ISO 9003
Quality management and quality assurance standards -- Part 2: Generic guidelines for
the application of ISO 9001, ISO 9002 and ISO 9003
Normes pour le management de la qualité et l'assurance de la qualité -- Partie 2: Lignes
directrices génériques pour l'application de l'ISO 9001, l'ISO 9002 et l'ISO 9003
Ta slovenski standard je istoveten z: ISO 9000-2:1997
ICS:
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
SIST ISO 9000-2:1998 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST ISO 9000-2:1998
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SIST ISO 9000-2:1998
INTERNATIONAL
IS0
STANDARD
9000-2
Second edition
1997-06-I 5
Quality management and quality assurance
standards -
Part 2:
Generic guidelines for the application of
IS0 9001, IS0 9002 and IS0 9003
Normes pour le management de la qua/M et / ‘assurance de la qua/it& -
Parfie 2: Lignes directrices ghkriques pour I ’applica tion de / ‘/SO 900 1,
/ ‘/SO 9002 et IWO 9003
Reference number
IS0 9000-2: 1997(E)
---------------------- Page: 3 ----------------------
SIST ISO 9000-2:1998
IS0 9000=2:1997(E)
Page
Contents
1
................................................................................................
1 Scope
1
Normative references .
2
2
Definitions .
3
2
............................................................
4 Quality system requirements
2
..............................................................
41 0 Management responsibility
5
..................................................................................
42 0 Quality system
6
................................................................................
43 0 Contract review
.................................................................................. 8
44 l Design control
13
...............................................................
45 l Document and data control
15
46 . Purchasing .
.............................................. 16
47 l Control of customer-supplied product
17
..............................................
48 0 Product identification and traceability
18
49 Process control .
....................................................................... 19
4 ’10 Inspection and testing
...................... 21
4 ’11 Control of inspection, measuring and test equipment
21
4 ’12 Inspection and test status .
................................................... 22
4 ’13 Control of nonconforming product
23
Corrective and preventive action .
4 ’14
25
.................
4 ’15 Handling, storage, packaging, preservation and delivery
26
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
4 ’16 Control of quality records
27
.......................................................................
4 ’17 Internal quality audits
29
4 ’18 Training .
29
4 ’19 Servicing .
30
4 ’a 20 Statistical techniques .
32
Annex A Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 IS0 1997
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
1ntemet:centra.l @iso.ch
X.400: c=ch; a=4OOnet; p=iso; o=isocs; s=central
Printed in Switzerland
ii
---------------------- Page: 4 ----------------------
SIST ISO 9000-2:1998
@ IS0 IS0 9000=2:1997(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 9000-2 was prepared by Technical Committee ISO/TC 176,
Quality management and quality assurance, Subcommittee SC 2, Quality systems.
This second edition cancels and replaces the first edition (IS0 9000-2: 1993), which has
been technically revised.
IS0 9000 consists of the following parts, under the general title Quality management
and quality assurance standards
- Part 1: Guidelines for selection and use
- Part 2: Generic guidelines for the application of IS0 9001, IS0 9002 and IS0 9003
-
Part 3: Guidelines for the application of IS0 9001 to the development, supply and
maintenance of software
- Part 4: Guide to dependability management
Annex A of this part of IS0 9000 is for information only.
. . .
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Introduction
This part of IS0 9000 gives guidance for the application of IS0 9001, IS0 9002 and
IS0 9003. To facilitate cross-reference to those standards, this part of IS0 9000 has the
same clause structure as IS0 9001, IS0 9002 and IS0 9003.
In general, the number and scope of the quality system elements and procedures
required for quality assurance are greatest in IS0 9001 and least in IS0 9003. For all
clauses, the guidelines of this part of IS0 9000 should be applied in a manner consistent
with the scope and requirements of the corresponding clause, if present, in the standard
involved (i.e. IS0 9001, IS0 9002 or IS0 9003). Reference should be made to
subclause 8.3 of IS0 9000-l : 1994 for guidance on the appropriate extent and degree of
demonstration.
IS0 9000-l gives an overview of the IS0 9000 series of International Standards, and
explains the use of the entire series. IS0 9004-l gives guidance for designing and
installing a quality management system.
This part of IS0 9000 does not duplicate the guidance to users that is given in other IS0
guidance standards such as IS0 9000-1, IS0 9000-3, IS0 9004-l and IS0 9004-2.
iv
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SIST ISO 9000-2:1998
IS0 9000-2: 1997(E)
INTERNATIONAL STANDARD @ Iso
Quality management and quality assurance standards -
Part 2:
Generic guidelines for the application of IS0 9001, IS0 9002 and
IS0 9003
1 Scope
This part of IS0 9000 gives guidance on the application of the 1994 versions of IS0 9001,
IS0 9002 and IS0 9003.
It does not add to, or otherwise change, the requirements of IS0 9001, IS0 9002 or IS0 9003.
In the case of conflicting interpretations of IS0 9001, IS0 9002 or IS0 9003 on the one
hand, and IS0 9000-2 on the other, the interpretation of the text in IS0 9001, IS0 9002 or
IS0 9003 takes precedence. The use of ‘should’ in this part of IS0 9000 does not weaken the
requirements expressed as ‘shall’ in IS0 9001, IS0 9002 and IS0 9003.
This part of IS0 9000 gives guidance for the following users:
a) suppliers involved in applications of IS0 9001, IS0 9002 or IS0 9003;
b) customers and third parties.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute
provisions of this part of IS0 9000. At the time of publication, the editions indicated were
valid. All standards are subject to revision, and parties to agreements based on this part of
IS0 9000 are encouraged to investigate the possibility of applying the most recent editions of
the standards indicated below. Members of IEC and IS0 maintain registers of currently valid
International Standards.
IS0 8402: 1994, Quality management and quality assurance - Vocabulary.
Model for quality assurance in design, development,
IS0 9001: 1994, Quality systems -
production, installation and servicing.
IS0 9002: 1994, Quality systems - Model for quality assurance in production, installation
and servicing.
Model for quality assurance injinal inspection and test.
IS0 9003: 1994, Quality systems -
1
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SIST ISO 9000-2:1998
@ IS0
IS0 9000=2:1997(E)
3 Definitions
For the purposes of this part of IS0 9000, the definitions given in IS0 8402 and the following
apply*
contract: Agreed requirements between a supplier and customer transmitted by any
31 .
means.
[ISO 90011
product: Result of activities or processes.
32 .
NOTE 1 A product may include service, hardware, processed materials, software or a combination
thereof.
ies or processed materials) or in .tangi ble (e.g.
NOTE 2 A product can be tangible (e.g. assembl
knowledge or concepts), or a combination thereof.
NOTE 3 For the purposes of this International Standard, the term ‘product’ applies to the intended
product offering only and not to unintended ‘by-products’ affecting the environment. This differs
from the definition given in IS0 8402.
[ISO 90011
33 0 specified requirements
Product requirements prescribed by the customer and agreed by the supplier.
1)
Requirements prescribed by the supplier that are perceived as satisfying a market
2)
need.
34 tender: Offer made by a supplier in response to an invitation to satisfy a contract
aL.rd to provide product.
[ISO 900 l]
4 Quality system requirements
41 a Management responsibility
4.1.1 Quality policy
The supplier ’s management with executive responsibility (see 4.1.2.1) is required to develop
and define its quality policy, quality objectives and commitment in (a) recorded statement(s).
This is required to be relevant to its organizational goals, and the expectations and needs of
its customers. The statement(s) should be published throughout the organization and be seen
to be fully supported by the management.
2
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SIST ISO 9000-2:1998
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All employees, including newly hired, part-time and temporary employees, should be trained
so that they understand the objectives of the organization and the commitment required to
achieve these objectives. The policy should be expressed in language that is easy to
understand and the objectives should be achievable, planned and periodically reviewed.
Management should continuously demonstrate visible commitment to the quality policy by
activities which may include, but not be limited to, the following:
ensuring that the organization ’s personnel understand and implement the quality
policy;
ensuring that the organization ’s personnel have quality objectives consistent with
the organization ’s overall objectives;
initiating, managing and following up on the implementation of the quality
policy, including implementation and maintenance of the quality system;
not accepting deviations from the quality policy in any part or aspect of the
organization;
providing adequate resources and training to support quality system development
and implementation. (See 4.1.2.2.)
4.1.2 Organization
4.1.2.1 Responsibility and authority
Management with executive responsibility is that person or group of persons within an
organization with the necessary level of authority for making policy and setting objectives,
planning their implementation, reviewing achievement and taking corrective action. The
supplier should clearly identify those persons having such executive responsibility.
In particular the personnel having the responsibility and authority to make decisions that
control all the elements of the quality system and processes should be identified and the job
requirements defined and documented (see 4.18).
4.1.2.2 Resources
Consideration needs to be given by the supplier ’s management to the identification and
provision of adequate resources needed to implement its quality policy and achieve its
objectives as well as to satisfy customer needs and expectations. The following should be
considered:
personnel to plan, manage, perform work, control and carry out verification
activities;
awareness of standards, procedures and other documented practices that are
needed;
3
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ISO9000=2:1997(E)
I
training and qualifications (see 4.18);
planning design, development and production activities to allow sufficient time to
perform the work;
equipment and processes, including acquisition of new equipment or technology;
means to access quality records.
4.1.2.3 Management representative
Within the supplier ’s organization, a management representative with delegated authority is
required to be appointed for arranging and overseeing the working of the quality system. This
management representative is required to be appointed by management with executive
responsibility.
The functions of the management representative may be totally related to quality system
activities or be in conjunction with other functions and responsibilities within the
organization. If the management representative has other functions to perform, there should
be no conflict of interest between the responsibilities for the other functions and those for the
quality system. The management representative should have the authority to ensure that the
requirements of IS0 9001, IS0 9002 or IS0 9003 are satisfied and that compliance is
maintained, together with the responsibility to ensure that they are operated throughout the
organization.
The defined role should include reporting on the suitability and effectiveness of the quality
system as a basis for improvement, management review, and liaison, as necessary, with
customers, subcontractors and any other external parties on quality matters.
4.1.3 Management review
The supplier ’s management with executive responsibility, should review the quality system.
This may include, but not be limited to, the following:
the adequacy of the organizational structure, including its staffing and other
resources;
conformity to IS0 900 1, IS0 9002 or IS0 9003, and effective implementation of
the quality system;
compliance with quality policy;
I
information based on customer feedback, internal feedback (such as results of
internal audits), process performance and product performance, as well as
corrective and preventive ictions taken.
The intervals between reviews shoul d be carefully planned and periodically reviewed to
ensure the continuing suitability and effectiveness of the quality system. The management
4
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SIST ISO 9000-2:1998
@ IS0 IS0 9000=2:1997(E)
review process, frequency of reviews and levels of inputs will depend on the individual
circumstance. Some organizations have found that annual management reviews are
acceptable.
Management should focus on trends that may indicate problems. Chronic problem areas
should receive special attention. Actions that are required following changes to the quality
system determined during management review should be implemented in a timely manner.
The effectiveness of any changes should be evaluated. Records of such reviews should be
maintained (see 4.16).
42 0 Quality system
4.2.1 General
The implementation of a quality system by the supplier is most effective when those in the
organization understand its intention and how it functions, in particular, in the area of their
responsibility and its interface with other parts of the system. The quality manual has an
important role in this regard, for both internal and external parties. To give a coherent view
of the quality system, the quality manual should include the quality policy, a description of
the organization, and identify the quality system procedures with appropriate cross-references
to more detailed documentation. The quality manual could, for example, be one document
supported by several levels of other documents, each level becoming progressively more
detailed. There may also be an overall system manual, one or more specific procedural
manuals, work instructions and reference documents. Together, these documents define the
quality system. Further guidance on development of quality manuals is given in IS0 100 13.
4.2.2. Quality system procedures
Documented quality system procedures are required for applicable requirements of IS0
9001, IS0 9002 and IS0 9003 and should be consistent with the supplier ’s quality policy. It
is important to recognise that the structure and level of detail required in these procedures
should be tailored to the needs of the organization ’s personnel, which will depend upon
methods used and the training requirements, skills and qualifications of such personnel, as
indicated in 4.18.
A documented procedure usually specifies the purpose and scope of an activity:
what shall be done by whom;
I
when, where, and how it shall be done;
-
what materials, equipment and documents shall be used; and
how an activity shall be controlled and recorded.
Documented procedures may make reference to work instructions that define how an activity
is performed.
5
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ISO9000=2:1997(E)
4.2.3 Quality planning
The supplier needs to show that planning activities have been performed, and that they
establish the means by which the requirements for quality will be met. Planning should
include the application of the quality system elements, and how the product quality
requirements will be met.
This may require the following.
a) For managerial and operational planning, preparing the application of the quality
system.
b) For product planning, setting out in a quality plan or in any other documented
procedures the specific quality practices, resources and sequence of activities
relevant to a particular product, project or contract.
More guidance on quality plans is given in IS0 10005.
43 a Contract review
4.3.1 General
In the situation where a tender is offered or a contract or order is to be established between a
supplier and a customer, the means of achieving satisfaction lies in the contract review
process.
Contract review is one of the supplier ’s primary interfaces with its customers. The
documented procedures should include a review of customer requirements (whether
expressed in a tender, contract or order, which may be written or verbal) and how customer
requirements are reviewed and communicated within the organization.
The contract review is prior to accepting a contract or an order.
4.3.2 Review
The importance of a thorough understanding of the customer ’s needs, from initial contact,
through tendering or receiving verbal orders, to the formulation of the contract, or order and
in all subsequent stages cannot be overstated. Often, dialogue will be necessary to achieve
this understanding, that should clearly establish the customer ’s requirements as to the product,
delivery and other critical factors. Where a verbal statement of requirement is received from
the customer, the supplier should ensure that an order (statement of requirements) is
understood, adequately documented and agreed to by the customer.
Contract review is a process that includes the following:
a) review of the requirement; this may be appropriate at the tendering or order entry
stage and at subsequent stages prior to acceptance of the contract or the order;
6
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SIST ISO 9000-2:1998
@ IS0 IS0 9000=2:1997(E)
b) agreement within the supplier ’s organization that
I
the requirements have been defined,
I
the requirements are understood,
I
the supplier has the capability to meet the requirements of the contract, by going
through a defined process to verify that the necessary resources and facilities are
available to fulfil all the requirements of the contract;
resolution of any differences with the customer;
cl
d) contract review of a standard product (e.g. “off-the-shelf’ items, a “commodity
item ”, a catalogue item with published specification, etc.) can be as simple as
verifying the accuracy of the information on the order;
e) the requirements of the contract, where appropriate, may be translated into the
terminology, tolerances, and other necessary information for designing,
purchasing and process control;
f) preliminary quality plan or documented procedures, where appropriate, may be
developed to give an understanding of how to implement the contract
successfully and support the contract review process.
It is beneficial for the supplier to adopt a contract or order review procedure that has the
following features:
affected parties have an opportunity and adequate time to review the contract;
I
a checklist or some other means (e.g. a standard form) is available for reviewers
to verify and record that they have reviewed and understood the requirements of
the contract or order;
a method is available for reviewers to question the requirements of the contract or
order, to have their questions considered and to have differences with other
affected parties resolved.
4.3.3 Amendment to contract
When customer requirements change, consideration should be given to repeating the contract
review procedure (see 4.3.2). It is beneficial for the supplier to have a procedure for reviews
by the same departmental functions that reviewed the original contract or accepted order.
Before such changes come into effect, there should be methods available to ensure that all
relevant changes are communicated to those affected.
4.3.4 Records
In all cases, it should be sufficient to retain records that the review has been performed (see
4.16). For internal purposes, however, records of the evaluation associated with the contract
7
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SIST ISO 9000-2:1998
@ IS0
ISO9000=2:1997(E)
review may be retained in cases such as complex or critical projects. These records should
give objective evidence for audits, and facilitate the following:
post-delivery project review;
process improvement; and
the generation of proposals for future projects.
44 0 Design control
4.4.1 General
The essential quality aspects and the regulatory requirements such as safety, performance, and
dependability of a product are established during the design and development phase.
Deficient design can be a major cause of quality problems.
In considering design control, it is important to note that the design process may apply to
various activities in differing styles and timescales. Such aspects are related to products, as
well as the process associated with product design. The supplier should consider all phases of
the design associated with product design and all phases of the design process for which
controlled procedures are necessary.
4.4.2 Design and development planning
The supplier should establish procedures for design and development planning and, where
appropriate,include the following:
identification, scope and objectives;
sequential and parallel work schedules;
timing, frequency, and nature of design verification and validation activities;
evaluation of the safety, performance and dependability incorporated in the
product design;
I
methods of product measurement, test and acceptance criteria;
assignment of responsibilities.
Design and development plans should be integrated with any other plans and verification
procedures related to the product and plans should be updated as necessary.
---------------------- Page: 14 ----------------------
SIST ISO 9000-2:1998
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@ IS0
The supplier should clearly assign responsibilities for specific design leadership and other
design work functions to qualified personnel. The personnel in these functions should have
access to information and the resources to complete the work.
Design activities should be defined to the level of detail necessary for carrying out the design
process.
4.4.3 Organizational and technical interfaces
When input to the design is from a variety of sources, the inter-relationships and interfaces, as
well as the pertinent responsibilities and authorities, should be defined, documented,
coordinated, and controlled.
Many organizational functions, both internal and external, may contribute to the design
process; examples are as follows:
research and development;
marketing and sales;
purchasing;
quality assurance and quality management;
engineering;
materials technology;
production/manufacturing;
service groups;
facilities management;
warehousing/transportation/logistics;
communications;
information systems.
They should also establish, but not limit themselves to, the following:
what information should be received and transmitted;
identification of sending and receiving groups;
the purpose of the information transmitted;
identification of transmittal methods;
document transmittal and records maintenance.
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SIST ISO 9000-2:1998
@ IS0
ISO9000=2:1997(E)
4.4.4 Design input
User needs (through marketing) or customer requirements (through contract) should be
established during contract review (see 4.3) that, together with relevant statutory legislation,
will form the design input requirements.
Design inputs are typically in the form of product requirement specifications and/or product
description with specifications relating to configuration, composition, incorporated elements,
and other design features.
All pertinent design inputs (such as performance, functional, descriptive, environmental,
safety and regulatory requirements) should be defined, reviewed and recorded by the supplier.
The design inputs should describe all requirements to the greatest possible extent; they lay
the foundation and provide a unified approach to the design. Details agreed between
customer and supplier on how customer, statutory and regulatory requirements will be met
should be included.
The record of the design inputs should also include the resolutions of any
incomplete, ambiguous or conflicting requirements that have been identified at the contract
review and/or design verification stages or related design control activities.
materials, and processes requiring
The design inputs should identify design criteria,
development and analysis, including prototype testing to verify their adequacy. Design inputs
should be prepared in a way that facilitates periodic updates. They should indicate ‘when’ or
‘what criteria’ will cause the inputs to be updated, who is responsible for the update, and under
what circumstances the customer will get a copy. Design inputs prepared in this way serve as
the definitive up-to-date reference document as the design progresses to completion.
4.4.5 Design output
Throughout the design process, the requirements contained in the design description are
translated by the supplier into outputs. Design outputs should be documented in terms that
can be verified and validated against design input requirements and need to contain or make
reference to acceptance criteria; examples of these can be found in the following:
drawings and parts list;
specifications (including process and materials specifications);
instructions;
I
software;
I
servicing procedures.
Design outputs are the product requirements used for purchasing, production, installation,
inspection and testing, and servicing. Because of their impact on follow-on activities, it is
important that the outputs are reviewed and approved before release.
10
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SIST ISO 9000-2:1998
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4.4.6 Design review
Design reviews should be planned. In order to achieve a degree of objectivity, they need to
involve all functions, both internal and external, concerned with the design stage being
reviewed. Design staff and other specialist personnel should also participate as required.
Design review may be a regulatory requirement for certain types of product. The timing and
frequency of these reviews will be influenced by the maturity, complexity and cost of the
product being designed. Records of such reviews should be maintained (see 4.16).
The competence of the participants in the design reviews should be adequate to permit them
to examine designs and their implications. Desi
...
IS0
NORME
9000-2
INTERNATIONALE
Deuxihme bdition
1997006- 15
Normes pour le management de la qualit
et I’assurance de la qualit -
Partie 2:
Lignes directrices ghbiques pour
I’application de I’ISO 9001 y I’ISO 9002 et
I’ISO 9003
Quality management and quality assurance standards -
Part 2: Generic guidelines for the application of IS0 9001, /SO 9002 and
IS0 9003
Num&o de reference
IS0 9000-2: 1997(F)
---------------------- Page: 1 ----------------------
IS0 9000=2:1997(F)
Sommaire
............................................................................................................................................ 1
1 Domaine d’application
........................................................................................................................................... 1
2 References normatives
2
3 Definitions .
2
4 Exigences en matiere de systeme qualite .
2
4.1 Responsabilite de la direction .
4
4.2 Systeme qualite .
................................................................................................................................................... 5
4.3 Revue de contrat
4.4 Maiitrise de la conception . 6
......................................................................................................... 11
4.5 Maltrise des documents et des donnees
.................................................................................................................................................................. 12
4.6 Achats
............................................................................................................. 13
4.7 Maitrise du produit fourni par le client
.............................................................................................................. 14
4.8 Identification et traqabilite du produit
14
4.9 Ma’itrise des processus .
15
4.10 Controles et essais .
17
4.11 Maitrise des equipements de controle, de mesure et d’essai .
..................................................................................................................... 17
4.12 Etat des controles et des essais
.................................................................................................................. 18
4.13 Maitrise du produit non conforme
18
4.14 Actions correctives et preventives .
20
4.15 Manutention, stockage, conditionnement, preservation et livraison .
4.16 Maitrise des enregistrements relatifs a la qualite . 21
4.17 Audits qualite internes 22
.....................................................................................................................................
23
4.18 Formation .
24
4.19 Prestations associees .
24
4.20 Techniques statistiques .
Annexe A (informative) Bibliographie . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
0 IS0 1997
Droits de reproduction reserves. Sauf prescription differente, aucune partie de cette publication ne peut etre reproduite ni utilisee sous quelque
forme que ce soit et par aucun procede, Qlectronique 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
Internet: central @ iso.ch
x.400: c=ch; a=400net; p=iso; o=isocs; s=central
Imprime en Suisse
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0 IS0
IS0 9000-2: 1997(F)
Avant-propos
L’ISO (Organisation internationale de normalisation) est une federation mondiale d’organismes nationaux de
normalisation (comites membres de I’ISO). L’elaboration des Normes internationales est en general confide aux
comites techniques de I’ISO. Chaque comite membre interesse par une etude a le droit de faire partie du comite
technique tree a cet effet. Les organisations internationales, gouvernementales et non gouvernementales, en
liaison avec I’ISO patticipent Qgalement aux travaux. L’ISO collabore 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 comites
membres votants.
La Norme internationale IS0 9000-2 a ete elaboree par le comite technique lSO/TC 176, Management et assurance
de /a qua/it&, sous-comite SC 2, Syst&mes qua/it&
Cette deuxieme edition annule et remplace la premiere edition (IS0 9000-2:1993), dont elle constitue une revision
technique.
L’ISO 9000 comprend les parties suivantes, presentees sous le titre general Normes pour /e management de /a
qua/it& et /‘assurance de la qua/it&:
- Parfie 1: Ligne directrices pour leur shlection et utilisation
- Partie 2: Lignes directrices pour /‘application de IWO 900 1, MO 9002 et IWO 9003
- Partie 3: Lignes directrices pour /‘application de I’ISO 900 1: 1994 au dbveloppement, A la mise & disposition, A
/‘installation et A la maintenance de logiciel
- Partie 4: Guide de gestion du programme de &ret6 de fonctionnement
L’annexe A de la presente partie de I’ISO 9000 est donnee uniquement a titre d’information.
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0 IS0
IS0 9000-2: 1997(F)
Introduction
La presente partie de I’ISO 9000 donne des recommandations pour I’application de I’ISO 9001, I’ISO 9002 et
I’ISO 9003. Pour faciliter la reference croisee a ces normes, la presente partie de I’ISO 9000 a la meme structure
d’atticles que I’ISO 9001, I’ISO 9002 et I’ISO 9003.
En general, le domaine d’application et le nombre des elements et procedures du systeme qualite exiges pour
I’assurance qualite sont plus developpes dans I’ISO 9001 et le sont moins dans I’ISO 9003. Pour tous les articles, il
convient d’appliquer les lignes directrices de la presente partie de I’ISO 9000 de facon coherente avec les objectifs
et les exigences de I’article correspondant, a supposer qu’il existe, dans la norme concernee (c’est-a-dire
I’ISO 9001, I’ISO 9002 ou I’ISO 9003). II est important de se referer au paragraphe 8.3 de I’ISO 9000-l :1994 pour
les recommandations relatives au degre et a I’etendue appropries de la demonstration.
L’ISO 9000-l fournit un apercu general des Normes internationales de la serie IS0 9000 et explique I’utilisation de
la serie dans son ensemble. L’ISO 9004-l fournit des recommandations permettant de developper et de mettre en
ceuvre un systeme de management de la qualite.
La presente partie de I’ISO 9000 ne fait pas double emploi avec les recommandations aux utilisateurs qui sont
fournies dans d’autres Normes internationales de recommandations telles que I’ISO 9000-1, I’ISO 9000-3,
I’ISO 9004-l et I’ISO 9004-2.
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NORME INTERNATIONALE o IS0
IS0 9000-2: 1997(F)
Normes pour le management de la qualit et I’assurance de
la qualit -
Partie 2:
Lignes directrices pour I’application de US0 9001 9 I’ISO 9002 et
I’ISO 9003
1 Domaine d’application
La presente partie de I’ISO 9000 donne des recommandations sur I’application des editions 1994 de I’ISO 9001,
I’ISO 9002 et I’ISO 9003.
La presente partie de I’ISO 9000 n’ajoute pas d’exigences, ni ne change les exigences de I’ISO 9001, de I’ISO 9002
ou de I’ISO 9003. En cas d’interpretation conflictuelle de I’ISO 9001, I’ISO 9002 ou I’ISO 9003 d’une part, et de
I’ISO 9000-2 d’autre part, I’interpretation du texte de I’ISO 9001, I’ISO 9002 ou I’ISO 9003 fait autorite. L’utilisation de
“il convient que” dans la presente partie de I’ISO 9000 n’affaiblit pas les exigences exprimees en “doit” de
I’ISO 9001, I’ISO 9002 et I’ISO 9003.
La presente partie de I’ISO 9000 donne des recommandations aux utilisateurs suivants:
a) fournisseurs concern& par les applications de I’ISO 9001, I’ISO 9002 ou I’ISO 9003;
b) clients et tierce parties.
2 References normatives
Les normes suivantes contiennent des dispositions qui, par suite de la reference qui en est faite, constituent des
dispositions valables pour la presente pattie de I’ISO 9000. Au moment de la publication, les editions indiquees
etaient en vigueur. Toute norme est sujette a revision et les parties prenantes des accords fond& sur la presente
par-tie de I’ISO 9000 sont invitees & rechercher la possibilite d’appliquer les editions les plus recentes des normes
indiquees ci-apres. Les membres de la CEI et de I’ISO possedent le registre des Normes internationales en vigueur
a un moment donne.
IS0 8402:1994, Management de la qua/it6 et assurance de la qua/it& - Vocabulaire.
IS0 9001 :1994, Systhmes qua/it6 - Mod&/e pour /‘assurance de la qua/it6 en conception, d&eloppement,
production, installation et pres ta tions associhes.
IS0 9002: 1994, SystGmes qua/it6 - Mod&/e pour /‘assurance de la qua/it6 en production, installation et prestations
associkes.
Mod&le pour I’assurance de la qualit en contr6le et essais finals.
IS0 9003: 1994, Syst&mes qua/it6 -
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3 Definitions
Pour Oes besoins de la presente par-tie de IWO 9000, les definitions donnees dans IWO 8402 et les definitions
suivantes s’appliquent.
3.1 contrat
Exigences ayant fait I’objet d’un accord entre un fournisseur et un client et transmises par un moyen quelconque.
[ISO 90011
3.2 produit
R&ultat d’activitbs ou de processus.
NOTE 1 Le terme produit peut inclure les services, les mat&iels, les produits issus de processus A caracthre continu, les
logiciels, ou une combinaison des deux.
NOTE 2 Un produit peut Qtre materiel a r exemple, assem iblages ou produits issus de processus & caracthre continu) ou
(P
immat&iel (par exemple, connaissances ou concepts), ou une combinaison des deux.
NOTE 3 Dans le cadre de la prksente partie de I’ISO 9000, le terme “produit” s’applique au produit intentionnel et ne
s’applique pas aux sous-produits non intentionnels affectant I’environnement. Ceci diffhre de la definition donhe dans
I’ISO 8402.
[ISO 90011
3.3 exigences sp6cif i6es
1) Exigences prescrites par le client et ayant fait I’objet d’un accord avec le fournisseur.
2) Exigences prescrites par le fournisseur, et qui sont percues comme satisfaisant un besoin du march&
3.4 offre
Une offre est faite par un fournisseur en reponse a un appel d’offre en vue de I’attribution d’un contrat de fourniture
d’un produit.
[ISO 90011
4 Exigences en matihe de systkme qualit
4.1 ResponsabilM de la direction
4.1 .l Politique qualit
II est necessaire que la direction du fournisseur, qui a pouvoir de decision (voir 4.1.2.1), developpe et definisse sa
politique qualite, ses objectifs qualite et son engagement dans une (des) declaration(s) &rite(s). II est necessaire
que ceci soit pertinent par rapport aux objectifs generaux et aux besoins et attentes de ses clients. II convient que la
(les) declaration(s) soit (soient) publiee(s) dans I’ensemble de I’organisme et soit (soient) assimilee(s) pour etre
pleinement appuyee(s) par la direction.
II convient que tous les employ&, y compris les nouveaux embauches, les personnes a temps partiel ou
temporaires, soient form& de sotte qu’ils comprennent les objectifs de I’organisme et I’engagement necessaire
pour atteindre ces objectifs. II convient que la politique soit exprimee dans un langage facile a comprendre et que
les objectifs soient realisables, planifies et periodiquement revus.
II convient que la direction manifeste de facon continue et visible son engagement en faveur de la politique qualite
par des actions qui peuvent inclure, de facon non limitative, ce qui suit:
- s’assurer que le personnel de I’organisme comprend bien et met en oeuvre la politique qualite;
2
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- s’assurer que le personnel de I’organisme a des objectifs qualite coherents avec les objectifs generaux de
I’organisme;
- lancer, pilokr et suivre la mise en ceuvre de la politique qualite, y compris la mise en oeuvre et le maintien du
systeme qualite;
ne pas accepter d&arts par rapport a la politique qualite dans aucun domaine ni aspect de I’organisme;
- fournir des ressources et une formation appropriees pour appuyer le developpement et la mise en oeuvre du
systeme qualite. (Voir 4.1.2.2.)
4.1.2 Organisation
4.1.2.1 Responsabilit6 et autorite
La direction ayant pouvoir de decision est la personne ou le groupe de personnes appattenant a I’organisme qui
possede le niveau d’autorite necessaire pour definir la politique et etablir les objectifs, planifier leur mise en oeuvre,
faire la revue de leur realisation et declencher des actions correctives. II convient que le fournisseur identifie
clairement ces personnes ayant un tel pouvoir de decision.
En particulier, il convient d’identifier le personnel ayant la responsabilite et I’autorite de prendre les decisions
permettant la maitrise de tous les elements du systeme qualite et des processus, et de definir et consigner par ecrit
les exigences du travail (voir 4.18).
4.1.2.2 Moyens
II convient que la direction du fournisseur identifie et fournisse des moyens adequats necessaires pour mettre en
oeuvre sa politique qualite et atteindre ses objectifs ainsi que pour satisfaire aux besoins et attentes du clients. II
convient de prendre en consideration ce qui suit:
- le personnel pour planifier, gerer, faire le travail, maitriser et executer les activites de verification;
la connaissance des normes, des procedures et autres pratiques documentees qui sont necessaires;
- la formation et les qualifications (voir 4.18);
- la planification des activites de conception, de developpement et de production afin d’allouer un temps suffisant
pour faire le travail;
- les equipements et processus, y compris I’acquisition d’un nouvel equipement ou d’une nouvelle technologie;
les moyens d’acces aux enregistrements relatifs a la qualite.
4.1.2.3 Repksentant de la direction
II est necessaire que soit nomme un representant de la direction ayant delegation de I’autorite, au sein de
I’organisme du fournisseur, pour gerer et superviser le travail relatif au systeme qualite. II est necessaire que ce
representant de la direction soit designe par la direction ayant pouvoir de decision.
Les fonctions du representant de la direction peuvent etre completement consacrees aux activites du systeme
qualite ou etre conjointes avec d’autres fonctions ou responsabilites au sein de I’organisme. Si le representant de la
direction a d’autres fonctions a assumer, il convient qu’il n’y ait aucun conflit d’interet entre ses responsabilites
relatives a ces autres fonctions et celles relatives au systeme qualite. II convient que le representant de la direction
ait I’autorite pour assurer que les exigences de I’ISO 9001, I’ISO 9002 ou I’ISO 9003 sont satisfaites et que leur
conformite est maintenue et qu’il ait la responsabilite de s’assurer de leur application dans I’ensemble de
I’organisme.
II convient que la definition de son role inclue le rapport sur le bien-fond8 et I’efficacite du systeme qualite comme
la revue de direction et la liaison, tant que necessaire, avec les clients, les sous-
base pour I’amelioration,
contractants et toutes les autres parties externes ayant trait a la qualite.
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IS0 9000-2: 1997(F) 0 IS0
4.1.3 Revue de direction
II convient que la direction du fournisseur ayant pouvoir de decision effectue la revue du systeme qualite. Cejje-ci
peut inclure, de facon non limitative, ce qui suit:
- I’adequation de la structure organisationnelle, y compris le personnel et les moyens;
- la conformite a I’ISO 9001, I’ISO 9002 ou I’ISO 9003, et la mise en ceuvre efficace du systeme qualite;
- la conformite avec la politique qualite;
- l’information issue du retour client, des retours internes (tels que les resultats d’audits internes), de la
performance du processus, de la performance du produit, ainsi que les actions correctives et preventives
prises.
II convient que les intervalles entre les revues soient soigneusement planifies et periodiquement revus pour assurer
la continuite de la conformite et de I’efficacite du systeme qualite. Le processus de revue de direction, sa frequence
et le niveau des donnees d’entree dependront de chaque circonstance. Certains organismes ont trouve acceptable
des revues de direction planifiees sur une base annuelle.
II convient que la direction se concentre sur des tendances qui peuvent reveler des problemes. II convient que des
domaines presentant des problemes chroniques recoivent une attention particuliere. II convient que des actions
necessaires, suite a des modifications du systeme qualite lors d’une revue de direction, soient mises en oeuvre de
facon appropriee dans le temps. II convient d’evaluer I’efficacite de toute modification. II convient de consetver des
enregistrements de telles revues (voir 4.16).
4.2 Systkme qualit
4.2.1 G6nCraMs
La mise en oeuvre d’un systeme qualite par le fournisseur est plus efficace lorsque les personnes travaillant dans
I’organisme comprennent bien ses objectifs et son fonctionnement, en particulier dans le cadre de leur
responsabilite, et ses interfaces avec les autres parties du systeme. Le manuel qualite a un role important a cet
egard, a la fois pour les parties internes et externes. Afin de donner une vue coherente du systeme qualite, il
convient que le manuel qualite inclue la politique qualite, une description de I’organisme et identifie les procedures
du systeme qualite avec les references croisees appropriees par rapport a des documents plus detail&s. Le manuel
qualite pourrait, par exemple, etre un document unique, s’appuyant sur plusieurs niveaux d’autres documents,
chacun d’eux devenant progressivement plus detail16 II peut egalement y avoir un manuel general du systeme, un
ou plusieurs manuel(s) specifique(s) de procedures, des instructions de travail et des documents de reference.
Ensemble, ces documents definissent le systeme qualite. D’autres recommandations sur I’elaboration des manuels
qualite sont donnees dans I’ISO 10013.
4.2.2 Proc6dures du syst&me qualit
Des procedures &rites du systeme qualite sont necessaires pour les exigences applicables de I’ISO 9001,
I’ISO 9002 et I’ISO 9003, et il convient qu’elles soient coherentes avec la politique qualite du fournisseur. II est
important de reconnaitre la necessite que la structure et le niveau de detail exiges dans ces procedures soient
adapt& aux besoins du personnel de I’organisme. Cette adaptation dependra des methodes utilisees et des
exigences de formation, de I’experience et des qualifications de ce personnel, comme indique en 4.18.
Une procedure &rite specific generalement I’objectif et le domaine d’application d’une activite:
- ce qui doit Qtre fait et par qui;
quand, oh et comment cela doit Qtre fait;
-
- quels materiaux, equipements et documents doivent etre utilises; et
- comment une activite doit Qtre maitrisee et enregistree.
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IS0 9000-2: 1997(F)
Les procedures &rites peuvent faire reference a des instructions de travail qui definissent comment une activite est
realisee.
4.2.3 Planification de la qualit
Le fournisseur a besoin de montrer que les activites de planification ont ete executees et qu’elles etablissent les
moyens par lesquels les exigences pour la qualite seront satisfaites. II convient que la planification inclue
I’application des elements du systeme qualite et la maniere dont les exigences de la qualite du produit seront
satisfaites.
Ceci peut necessiter ce qui suit.
Pour la planification du management et des operations, preparation de I’application du systeme qualite.
b) Pour la planification lice au produit, etablissement dans un plan qualite ou dans toute autre procedure &rite,
des pratiques specifiques de la qualite, des moyens et de la sequence d’activites relatives a un produit, projet
ou contrat particulier.
D’autres recommandations sur les plans qualite sont donnees dans I’ISO 10005.
4.3 Revue de contrat
4.3.1 Gh&alMs
Dans une situation ou une offre, un contrat ou une commande doit Qtre etabli(e) entre un fournisseur et un client,
les moyens d’obtention de la satisfaction se trouvent dans le processus de revue de contrat.
La revue de contrat est une des principales interfaces du fournisseur avec ses clients. II convient que les
procedures &rites comprennent une revue des exigences du client (exprimees dans une offre, un contrat ou une
commande, qui peuvent etre ecrits ou verbaux) et comment les exigences du client sont revues et communiquees
au sein de I’organisme.
La revue de contrat est prealable a I’acceptation d’un contrat ou d’une commande.
4.3.2 Revue
On ne dira jamais assez a quel point il est important de comprendre les besoins du client, des le premier contact,
que ce soit au travers d’un appel d’offre ou de la reception de commandes verbales, jusqu’a la formulation du
contrat, ou de la commande ainsi que dans toutes les phases ulterieures. Souvent, il importe d’etablir un dialogue
pour acquerir cette comprehension des exigences du client en ce qui concerne le produit, la livraison et les autres
facteurs importants. Lorsqu’une declaration verbale d’exigences est recue d’un client, il convient que le fournisseur
s’assure qu’une commande (declaration d’exigences) est comprise, documentee de facon adequate et recoit
I’accord du client.
Une revue de contrat est un processus qui comprend ce qui suit:
a) la revue des exigences; elle peut se justifier a partir de la phase d’appel d’offre ou d’entree de commande et
aux phases ulterieures, prealables a I’acceptation du contrat ou de la commande;
I’accord au sein de I’organisme du fournisseur que
b)
- les exigences ont ete definies,
les exigences sont comprises,
- le fournisseur a I’aptitude de satisfaire aux exigences du contrat, en mettant en oeuvre un processus defini
pour verifier que les moyens et equipements necessaires sont disponibles pour satisfaire I’ensemble des
exigences du contrat;
c) la resolution de toute divergence avec le client;
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IS0 9000-2: 1997(F) 0 IS0
d) la revue de contrat d’un produit standard (par exemple un “produit sur etagere”, une “piece detach&‘, un
catalogue d’articles avec la publication des specifications, etc.) peut etre aussi simple que la verification de
I’exactitude de I’information donnee sur la commande;
les exigences du contrat, si cela est approprie, peuvent etre traduites sous forme de terminologie, de
e)
tolerances ou toute autre information necessaire pour la conception, les achats ou la maitrise du processus;
f) un plan qualite preliminaire ou des procedures &rites peuvent etre elabores, si cela est approprie, pour
permettre de comprendre comment mettre en oeuvre avec succes le contrat et piloter le processus de revue de
contrat.
.
Le fournisseur a inter& a adopter une procedure de revue de ou de commande presente les
W’
caracteristiques suivantes:
- toutes les parties concernees ont I’occasion et le temps suffisant de revoir le contrat;
- une liste de verification ou tout autre moyen (par exemple un formulaire standard) est a la disposition des
personnes en charge de la revue de contrat pour verifier et enregistrer qu’elles ont revu et compris les
exigences du contrat ou de la commande;
- les personnes en charge de la revue de contrat disposent d’une methode leur permettant de remettre en
question les exigences du contrat ou de la commande, d’obtenir les eclaircissements necessaires et de
resoudre les divergences avec les autres parties concernees.
4.3.3 Avenant au contrat
Lorsque les exigences d’un client changent, il convient de bien faire attention a ce que la procedure de revue de
contrat soit repetee (voir 4.3.2). II est benefique pour le fournisseur d’avoir une procedure pour les revues par les
memes fonctions que celles ayant effect& la revue du contrat initial ou de la commande acceptee. Avant que de
telles modifications prennent effet, il convient de disposer de methodes afin d’assurer que I’ensemble des
modifications appropriees sont communiquees aux personnes concernees.
4.3.4 Enregistrements
Dans la plupatt des cas, il peut etre suffisant de ne conserver que les enregistrements sur la realisation de la revue
(voir 4.16). Cependant, pour des objectifs internes, des enregistrements de I’evaluation lies a la revue de contrat
peuvent etre conserves dans certains cas, tels que des projets critiques ou complexes. II convient que ces
enregistrements donnent une preuve objective pour les audits et facilitent ce qui suit:
- revue du projet apres livraison;
- amelioration des processus; et
- I’elaboration de propositions pour des projets futurs.
4.4 Maitrise de la conception
4.4.1 G&Walit&
Les aspects essentiels de la qualite et les exigences reglementaires telles que la securite, la performance et la
surete de fonctionnement d’un produit sont determines durant la phase de conception et de developpement. Toute
conception defectueuse peut etre une cause majeure de problemes de qualite.
Lorsqu’on considere’ la maitrise de la conception, il est important de noter que le processus de conception peut
s’appliquer a diverses activites selon des modes et des echelles de temps differents. Ceci est fonction du produit
ainsi que du processus associe a la conception du produit. II convient que le fournisseur considere toutes les
phases de la conception associees a la conception du produit ainsi que toutes les phases du processus de
conception pour lesquelles des procedures maitrisees sont necessaires.
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4.4.2 Planification de la conception et du d6veloppement
II convient que le fournisseur etablisse des procedures pour la planification de la conception et du developpement
qui, lorsque cela est approprie, incluent ce qui suit:
- I’identification, le domaine d’application et les objectifs;
- des programmes de travail sequentiels et paralleles;
- la duree, la frequence et la nature des activites de verification et de validation de la conception;
- I’evaluation de la securite, de la performance et de la surete de fonctionnement integrees dans la conception
du produit;
- des methodes de mesure, d’essai et des criteres d’acceptation du produit;
- I’aff ectation des responsabilites.
II convient que les plans de conception et de developpement soient integres a d’autres plans et procedures de
verification relatives au produit et que ces plans soient mis a jour autant que necessaire.
II convient que le fournisseur affecte clairement a un personnel qualifie des responsabilites specifiques de
leadership en conception et autres fonctions relatives aux travaux de conception. II convient que ce personnel ait
acces aux informations et moyens necessaires pour realiser les travaux.
II convient que les activites de conception soient definies selon le niveau de detail necessaire pour permettre de
mener a terme le processus de conception.
4.4.3 Interfaces organisationnelles et techniques
Lorsque les donnees d’entree de la conception proviennent de diverses sources, il convient que les relations et
interfaces ainsi que les responsabilites et autorites appropriees, soient definies, documentees, coordonnees et
maitrisees.
De nombreuses fonctions de I’organisme, a la fois internes et externes, peuvent contribuer au processus de
conception, avec par exemple ce qui suit:
- la recherche et le developpement;
- la mercatique et les ventes;
- les achats;
- I’assurance de la qualite et le management de la qualite;
- I’ingenierie;
- la technologie des materiaux;
- la production/la fabrication;
- les services internes;
- la gestion des installations;
- I’emmagasinageAe transport/la logistique;
- la communication;
- les systemes d’information.
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