PSIST ISO 9004-1:1995

INTERNATIONAL
Is0
STANDARD
9004-I
First edition
1994-07-01
Quality management and quality system
elements -
Part 1:
Guidelines
Management de la qualit et &ments de systhme qua/it6 -
Par-tie 1: Lignes directrices
Reference number
IS0 9004-I :1994(E)

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IS0 9004~1:1994( E)
Contents
Page
1
1 Scope .
1
.....................................................................
2 Normative references
1
.................................................................................
3 Definitions
....................................................... 2
4 Management responsibility
.......................................................... 3
5 Quality system elements
.............................. 7
6 Financial considerations of quality systems
8
7 Quality in marketing .
........................................... 9
8 Quality in specification and design
12
9 Quality in purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
14
10 Quality of processes .
15
.............................................................
11 Control of processes
16
12 Product verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
, . . . . . . . . 16
13 Control of inspection, measuring and test equipment
17
14 Control of nonconforming product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
15 Corrective action
19
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
16 Post-production activities
,.,.,.,,,.,,.,.,. 19
17 Quality records
20
18 Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.
21
19 Product safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
22
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20 Use of statistical methods
Annex
23
A Bibliography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
0 IS0 1994
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case Postale 56 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland

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0 IS0
IS0 9004=1:1994(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 9004-l was prepared by Technical Committee
ISOflC 176, Quality management and quality assurance, Subcommittee
SC 2, Quality systems.
This first edition of IS0 9004-l cancels and replaces IS0 9004:1987, and
has been prepared as a result of comments received on IS0 9004:1977.
IS0 requires that all its standards be reviewed every five years and, as
IS0 9004 has been expanded into a series of standards, it was considered
that the revision to the 1987 edition of IS0 9004 should become the first
part in the series, i.e. IS0 9004-l.
Comments adopted by Working Group 12 of lSO/TC 176/SC 2 during the
review were based on the following considerations.
a) IS0 9004 is a document for internal use by an organization. It is not
intended as guidance to IS0 9001, IS0 9002 or IS0 9003, for which
IS0 9000-2 is available.
b) For editorial reasons, the 1987 document structure was retained in the
1994 edition. The structure of all four standards IS0 9001, IS0 9002,
IS0 9003 and IS0 9004 will be changed and aligned with each other
in the next five-year major revision.
c) This edition is essentially an editorial revision to align terminology with
IS0 8402 and to reflect the need to serve better not only manufac-
turing but also process and service industries.
d) This edition also introduces some newer general quality management
concepts, such as that all activities can be considered as processes,
with input and output.
e) More emphasis has been placed on planning and preventive action.
For this reason, activities such as handling, identification and packag-
ing processes are now additionally dealt with under Quality in specifi-
. . .
III

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43 IS0
IS0 9004=1:1994(E)
cation and design (clause 8), Quality of processes (clause 10) and
Control of processes (clause 11).
f) Figure 1 has been updated to reflect quality activities in the life cycle
of a product.
g) New methods for the financial reporting of quality management ef-
fectiveness have been introduced.
IS0 9004 consists of the following parts, under the general title Quality
management and quality system elements:
- Part 1: Guidelines
- Part 2: Guidelines for sewices
- Part 3: Guidelines for processed materials
- Part 4: Guidelines for quality improvement
- Part 5: Guidelines for quality plans
- Part 6: Guidelines on quality assurance for project management
- Part 7: Guidelines for configuration management
- Part 8: Guidelines on quality principles and their application to man-
agement practices
Annex A of this part of IS0 9004 is for information only.

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0 IS0
IS0 9004=1:1994(E)
Introduction
0.1 General
This part of IS0 9004 and all other International Standards in the IS0 9000
family are generic and independent of any specific industry or economic
sector. Collectively they provide guidance for quality management and
models for quality assurance.
The International Standards in the IS0 9000 family describe what el-
ements quality systems should encompass, but not how a specific or-
ganization should implement these elements. Because the needs of
organizations vary, it is not the purpose of these International Standards
to enforce uniformity of quality systems. The design and implementation
of a quality system will be influenced by the particular objectives, prod-
ucts, processes and individual practices of the organization.
A primary concern of any organization should be the quality of its products.
(See 3.5 for the definition of “product” which includes service.)
In order to be successful, an organization should offer products that:
a) meet a well-defined need, use or purpose;
b) satisfy customers’ expectations;
c) comply with applicable standards and specifications;
d) comply with requirements of society (see 3.3);
e) reflect environmental needs;
f) are made available at competitive prices;
g) are provided economically.
0.2 Organizational goals
In order to meet its objectives, an organization should ensure that the
technical, administrative and human factors affecting the quality of its
products will be under control, whether hardware, software, processed
materials or services. All such control should be oriented towards the re-
duction, elimination and, most importantly, prevention of nonconformities.
A quality system should be developed and implemented for the purpose
of accomplishing the objectives set out in the organization’s quality policy.
Each element (or requirement) in a quality system varies in importance
from one type of activity to another and from one product to another.

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@a IS0
IS0 9004=1:1994(E)
In order to achieve maximum effectiveness and to satisfy customer ex-
pectations, it is essential that the quality system be appropriate to the type
of activity and to the product being offered.
0.3 Meeting customer/organization needs and expectations
A quality system has two interrelated aspects, as follows.
a) The customer’s needs and expectations
For the customer, there is a need for confidence in the ability of the
organization to deliver the desired quality as well as the consistent
maintenance of that quality.
The organization’s needs and interests
b)
For the organization, there is a business need to attain and to
maintain the desired quality at an optimum cost; the fulfilment of
this aspect is related to the planned and efficient utilization of the
technological, human and material resources available to the or-
ganization.
Each of the above aspects of a quality system requires objective evidence
in the form of information and data concerning the quality of the system
and the quality of the organization’s products.
0.4 Benefits, costs and risks
Benefit, cost and risk considerations have great importance for both the
organization and customer. These considerations are inherent aspects of
most products. The possible effects and ramifications of these consider-
ations are given in a) to c).
a) Benefit considerations
For the customer, consideration has to be given to reduced costs,
improved fitness for use, increased satisfaction and growth in confi-
dence.
For the organization, consideration has to be given to increased prof-
itability and market share.
Cost considerations
b)
For the customer, consideration has to be given to safety, acquisition
cost, operating, maintenance, downtime and repair costs, and possible
disposal costs.
For the organization, consideration has to be given to costs due to
marketing and design deficiencies, including unsatisfactory product,
rework, repair, replacement, reprocessing, loss of production, warran-
ties and field repair.
c) Risk considerations
For the customer, consideration has to be given to risks such as those
pertaining to the health and safety of people, dissatisfaction with
product, availability, marketing claims and loss of confidence.
For the organization, consideration has to be given to risks related to
deficient products which lead to loss of image or reputation, loss of
market, complaints, claims, liability and waste of human and financial
resources.
vi

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63 IS0
IS0 9004=1:1994(E)
0.5 Conclusions
An effective quality system should be designed to satisfy customer needs
and expectations while serving to protect the organization’s interests. A
well-structured quality system is a valuable management resource in the
optimization and control of quality in relation to benefit, cost and risk con-
siderations.
vii

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IS0 900&1:1994(E)
INTERNATIONAL STANDARD 0 IS0
Quality management and quality system elements -
Part 1:
Guidelines
NOTES
1 Scope
1 For further guidance, see IS0 9004-Z and IS0 9004-3.
This part of IS0 9004 provides guidance on quality
2 For informative references, see annex A.
management and quality system elements.
2 Normative references
The quality system elements are suitable for use in
the development and implementation of a compre- The following standards contain provisions which,
hensive and effective in-house quality system, with a
through reference in this text, constitute provisions
view to ensuring customer satisfaction.
of this part of IS0 9004. 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 9004 are encouraged to investigate the
This part of IS0 9004 is not intended for contractual,
possibility of applying the most recent editions of the
regulatory or certification use. Consequently, it is not
standards indicated below. Members of IEC and IS0
a guideline for the implementing of IS0 9001,
maintain registers of currently valid International
IS0 9002 and IS0 9003. IS0 9000-2 should be used
Standards.
for that purpose.
IS0 8402:1994, Quality management and quality as-
surance - Vocabulary.
The selection of appropriate elements contained in
IS0 9000-l : 1994, Quality management and quality
this part of IS0 9004 and the extent to which these
assurance standards - Part 1: Guidelines for selec-
elements are adopted and applied by an organization
tion and use.
depends upon factors such as the market being
served, nature of the product, production processes,
and customer and consumer needs.
3 Definitions
This revision of IS0 9004 has improved the
References in this part of IS0 9004 to a “product”
harmonization of terminology with other International
should be interpreted as applicable to the generic
Standards in the IS0 9000 family. Table 1 shows the
product categories of hardware, software, processed
supply chain terminology used in these International
materials or service (in accordance with the definition
Standards.
of “product” in IS0 8402).

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IS0 9004=1:1994(E)
fJ IS0
3.4 quality plan: Document setting out the specific
Table 1 quality practices, resources and sequence of activities
- Relationships of organizations in the
relevant to a particular product, project or contract.
supply chain
. /
Sub-
supplier or
NOTES
IS0 9000-1 customer
supplier + organization +
9 A quality plan usually makes reference to the parts of
IS0 9001,
Sub-
the quality manual applicable to the specific case.
IS0 9002, supplier + customer
contractor +
IS0 9003
I I
10 Depending on the scope of the plan, a qualifier may be
used, for example, “quality assurance plan”, “quality man-
1 IS0 9004-I / co$iitor + organization + customer 1
agement plan”.
3.5 product: Result of activities or processes.
Thus, the term “subcontractor” is used rather than
the term “supplier” in this part of IS0 9004 to avoid
NOTES
confusion with the meaning of the term “supplier”, in
IS0 9000 and IS0 9001. See IS0 9000-l for a fuller
11 A product may include service, hardware, processed
explanation of the basis for usage of these terms.
materials, software or a combination thereof.
For the purposes of this part of IS0 9004, the defi- 12 A product can be tangible (e.g. assemblies or pro-
cessed materials) or intangible (e.g. knowledge or con-
nitions given in IS0 8402 apply.
cepts), or a combination thereof.
For the convenience of users of this part of IS0 9004,
13 A product can be either intended (e.g. offering to cus-
the following definitions are quoted from IS0 8402.
tomers) or unintended (e.g. pollutant or unwanted effects).
3.1 organization: Company, corporation, firm, en-
3.6 service: Result generated by activities at the
terprise or institution, or part thereof, whether incor-
interface between the supplier and the customer and
porated or not, public or private, that has its own
by supplier internal activities to meet the customer
functions and administration.
needs.
NOTES
3.2 customer: Recipient of a product provided by
the supplier.
14 The supplier or the customer may be represented at
the interface by personnel or equipment.
NOTES
15 Customer activities at the interface with the supplier
3 In a contractual situation, the customer is called the
may be essential to the service delivery.
“purchaser”.
16 Delivery or use of tangible products may form part of
4 The customer may be, for example, the ultimate con-
the service delivery.
sumer, user, beneficiary or purchaser.
17 A service may be linked with the manufacture and
5 The customer can be either external or internal to the
supply of tangible product.
organization.
3.3 requirements of society: Obligations resulting
from laws, regulations, rules, codes, statutes and
4 Management responsibility
other considerations.
NOTES
4.1 General
6 “Other considerations” include notably protection of the
environment, health, safety, security, conservation of en- The responsibility for and commitment to a quality
ergy and natural resources.
policy belongs to the highest level of management.
Quality management encompasses all activities of the
7 All requirements of society should be taken into account
overall management function that determine the
when defining the requirements for quality.
quality policy, objectives and responsibilities, and im-
plement them by means such as quality planning,
8 Requirements of society include jurisdictional and regu-
quality control, quality assurance and quality improve-
latory requirements. These may vary from one jurisdiction
to another. ment within the quality system.
2

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4.2 Quality policy
5 Quality system elements
The management of an organization should define and
5.1 Extent of application
document its quality policy. This policy should be
consistent with other policies within the organization.
Management should take all necessary measures to
5.1.1 The quality system typically applies to, and
ensure that its quality policy is understood, im-
interacts with, all activities pertinent to the quality of
plemented and reviewed, at all levels of the organiz-
a product. It will involve all phases in the life cycle of
ation.
a product and processes, from initial identification of
market needs to final satisfaction of requirements.
Typical phases are:
4.3 Quality objectives
marketing and market research;
4.3.1 Management should document objectives and
commitments pertaining to key elements of quality,
b) product design and development;
such as fitness for use, performance, safety and de-
pendability.
process planning and development;
cl
4.3.2 The calculation and evaluation of costs associ-
d) purchasing;
ated with all quality elements and objectives should
always be an important consideration, with the ob-
e) production, or provision of services;
jective of minimizing quality losses.
f) verification;
4.3.3 Appropriate levels of management should
g) packaging and storage;
document specific quality objectives consistent with
quality policy as well as other objectives of the or-
h) sales and distribution;
ganization.
installation and commissioning;
i)
4.4 Quality system
j) technical assistance and servicing;
4.4.1 A quality system is the organizational struc-
ture, procedures, processes and resources needed to k) after sales;
implement quality management.
disposal or recycling at the end of useful life.
1)
4.4.2 The organization’s management should de-
NOTE 18 Figure 1 gives a schematic representation of
velop, establish and implement a quality system to
the typical life-cycle phases of a product.
accomplish the stated policies and objectives.
5.1.2 In the context of interacting activities within
4.4.3 The quality system should be structured and
an organization, marketing and design should be em-
adapted to the organization’s particular type of busi-
phasized as especially important for
ness and should take into account the appropriate el-
ements outlined in this part of IS0 9004.
- determining and defining customer needs, expec-
tations and other product requirements, and
4.4.4 The quality system should function in such a
manner as to provide confidence that:
- providing the concepts (including supporting data)
for producing a product to documented specifi-
the system is understood, implemented, main-
a)
cations at optimum cost.
tained and effective;
b) the products actually do satisfy customer needs
5.2 Structure of the quality system
and expectations;
5.2.1 General
the needs of both society and the environment
d
have been addressed;
Input from the market should be used to improve new
and existing products and to improve the quality sys-
d) emphasis is placed on problem prevention rather
tem.
than dependence on detection after occurrence.

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0 IS0
IS0 9004-I : 1994(E)
Management should determine the level of com-
Management is ultimately responsible for establishing
the quality policy and for decisions concerning the in- petence, experience and training necessary to ensure
itiation, development, implementation and mainten- the capability of personnel (see clause 18).
ance of the quality system.
Management should identify quality-related factors
affecting market position and objectives relative to
5.2.2 Responsibility and authority
products, processes or associated services, in order
to allocate organization resources on a planned and
Activities contributing to quality, whether directly or
timely basis.
indirectly, should be defined and documented, and
the following actions taken.
Programmes and schedules covering these resources
and skills should be consistent with the organization’s
a) General and specific quality-related responsi-
overall objectives.
bilities should be explicitly defined.
b) Responsibility and authority delegated to each ac-
5.2.5 Operational procedures
tivity contributing to quality should be clearly es-
tablished. Responsibility, organizational freedom
The quality system should be organized in such a way
and authority to act should be sufficient to attain
that adequate and continuous control is exercised
the assigned quality objectives with the desired
over all activities affecting quality.
efficiency.
The quality system should emphasize preventive ac-
Interface control and coordination measures be-
cl
tions that avoid occurrence of problems, while main-
tween different activit ies should be defined.
taining the ability to respond to and correct failures
should they occur.
d) In organizing a well-structured and effective qual-
ity system, emphasis should be placed on the
Documented operational procedures coordinating dif-
identification of potential or actual quality prob-
ferent activities with respect to an effective quality
lems and the implementation of preventive or
system should be developed, issued and maintained
corrective action (see clauses 14 and 15).
to implement the quality policy and objectives. These
documented procedures should specify the objectives
5.2.3 Organizational structure
and performance of the various activities having an
impact on quality (see figure 1).
Functions related to the quality system should be
clearly established within the overall organizational All documented procedures should be stated simply,
structure. The lines of authority and communication unambiguously and understandably, and should indi-
should be defined. cate methods to be used and criteria to be satisfied.
5.2.4 Resources and personnel
5.2.6 Configuration management
Management should identify resource requirements,
The quality system should include documented pro-
and provide sufficient and appropriate resources es-
cedures for configuration management to the extent
sential to the implementation of the quality policy and
appropriate. This discipline is initiated early in the de-
the achievement of quality objectives. For example,
sign phase and continues through the whole life cycle
these resources can include:
of a product. It assists in the operation and control of
design, development, production and use of a prod-
a) human resources and specialized skills;
uct, and gives management visibility of the state of
documentation and product during its life-time.
b) design and development equipment;
Configuration management can include: configuration
c) manufacturing equipment;
identification, configuration control, configuration sta-
tus accounting and configuration audit. It relates to
d) inspection, test and examination equipment;
several of the activities described in this part of
IS0 9004.
e) instrumentation and computer software.

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IS0 9004=1:1994(E)
Product design
and development
Process planning
Disposal or recycling and development
at the end of useful life
Purchasing
Typical life-cycle
Technical assistance
phases of a product
and servicing
Production or
provision of service
Installation and
Sales and distribution
l-- Packaging and storage
Figure 1 - Main activities having an impact on quality
5.3.2.3 Documented procedures should be estab-
5.3 Documentation of the quality system
lished for making changes, modifications, revisions or
additions to the contents of a quality manual.
5.3.1 Quality policies and procedures
5.3.2.4 Supporting the quality manual are documen-
All the elements, requirements and provisions
ted quality system procedures (e.g. design, purchas-
adopted by an organization for its quality system
ing and process work instructions). These
should be documented in a systematic, orderly and
documented procedures can take various forms, de-
understandable manner in the form of policies and
pending on
procedures. However, care should be taken to limit
documentation to the extent pertinent to the appli-
- the size of the organization,
cation.
- the specific nature of the activity, and
The quality system should include adequate provision
for the proper identification, distribution, collection
- the intended scope and structure of the quality
and maintenance of all quality documents.
manual.
Documented procedures may apply to one or more
5.3.2 Quality system documentation
parts of the organization.
5.3.2.1 The typical form of the main document used
5.3.3 Quality plans
to demonstrate or describe a documented quality
system is a “quality manual”. For further guidance,
For any product or process, management should en-
see IS0 10013.
sure that documented quality plans are prepared and
maintained. These should be consistent with all other
5.3.2.2 The primary purpose of a quality manual is requirements of the organization’s quality system, and
to define an outline structure of the quality system should ensure that specified requirements for a prod-
while serving as a permanent reference in the im- uct, project or contract are met. A quality plan may
plementation and maintenance of that system. be a part of a larger overall plan. A quality plan is par-
5

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0 IS0
IS0 9004-l : 1994(E)
ation’s quality system comply with planned arrange-
titularly necessary for a new product or process, or
ments, and to determine the effectiveness of the
when there is significant change to an existing prod-
quality system. All elements should be internally au-
uct or process.
dited and evaluated on a regular basis, considering the
Quality plans should define:
status and importance of the activity to be audited.
For this purpose, an appropriate audit programme
a) the quality objectives to be attained (e.g. charac-
should be established and implemented by the or-
teristics or specifications, uniformity, effective-
ganization’s management.
ness, aesthetics, cycle time, cost, natural
resources, utilization, yield and dependability);
b) the steps in the processes that constitute the op- 5.4.2 Audit programme
erating practice of the organization (a flowchart or
similar diagram can be used to demonstrate the The audit programme should cover:
elements of the process);
a) planning and scheduling the specific activities and
c) the specific allocation of responsibilities, authority areas to be audited;
and resources during the different phases of the
b) assignment of personnel with appropriate quali-
project;
fications to conduct audits;
) the specific documented procedures and in-
c) documented procedures for carrying out audits,
structions to be applied;
including recording and reporting the results of
) suitable testing, inspection, examination and audit the quality audit and reaching agreement on
programmes at appropriate stages (e.g. design timely corrective actions on the deficiencies found
and development); during the audit.
Apart from planned and systematic audits, other fac-
f) a documented procedure for changes and modifi-
tors necessitating audits can be organizational
cations in a quality plan as projects proceed;
changes, market feedback, nonconformity reports and
g) a method for measuring the achievement of the
surveys.
quality objectives;
other actions necessary to meet the objectives.
h)
5.4.3 Extent of audits
Quality plans may be included or referenced in the
quality manual, as appropriate. Objective evaluations of quality system activities by
competent personnel should include the following
To facilitate achievement of the objectives of a quality
activities or areas:
plan, documented operational control as described in
...