HB 90.0-2000 the ISO 9001 Comparison - 2000 vs 1994 the ISO 9001 Comparison - 2000 vs 1994

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The ISO 9001 Comparison 2000 vs 1994


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The ISO 9001 Comparison

2000 vs 1994

COPYRIGHT

Standards Australia/Standards New ZealandAll rights are reserved. No part of this work may be reproduced or copied in any form or by anymeans, electronic or mechanical, including photocopying, without the written permission of the

publisher.

Jointly published by Standards Australia International Ltd, GPO Box 5420, Sydney, NSW 2001and Standards New Zealand, Private Bag 2439, Wellington 6020

ISBN 0 7337 3696 3


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PREFACE

This Handbook, HB 90.0, has been prepared to provide assistance to those who wish to get an understanding

of the differences between the 2000 and the 1994 versions of ISO 9001.

In the Handbook, the clauses of the 1994 version are mapped against the relevant clause(s) of the 2000

version. Because of the differences in the structure of the two versions of the standard, some of the clauses

(or parts of the clauses) of the 1994 version are mapped against two or more clauses of the 2000 version.

This Handbook replaces the interim version, HB 150(Int):2000 which compared ISO/DIS 9001:2000 with

ISO 9001:1994.


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CONTENTS

Page

HOW TO READ THIS HANDBOOK ........................................................................................5

MAJOR CHANGES ...................................................................................................................7

DETAILED COMPARISON OF

ISO 9001:2000, Quality management systems Requirements

WITH

ISO 9001:1994, Quality systems Model for quality assurance in design,

development, production, installation and servicing ............................................................9

FOREWORD..............................................................................................................................9

0 INTRODUCTION..................................................................................................................11

0.1 General...........................................................................................................................11

0.2 Process approach............................................................................................................12

0.3 Relationship with ISO 9004 ...........................................................................................14

0.4 Compatibility with other management systems ..............................................................15

1 SCOPE...................................................................................................................................16

1.1 General...........................................................................................................................16

1.2 Application.....................................................................................................................17

2 NORMATIVE REFERENCE.................................................................................................18

3 TERMS AND DEFINITIONS ...............................................................................................19

4 QUALITY MANAGEMENT SYSTEM.................................................................................20

4.1 General requirements .....................................................................................................20

4.2 Documentation requirements..........................................................................................21

5 MANAGEMENT RESPONSIBILITY...................................................................................25

5.1 Management commitment ..............................................................................................25

5.2 Customer focus ..............................................................................................................26

5.3 Quality policy.................................................................................................................27

5.4 Planning .........................................................................................................................28

5.5 Responsibility, authority and communication.................................................................30

5.6 Management review .......................................................................................................32

6 RESOURCE MANAGEMENT..............................................................................................33

6.1 Provision of resources ....................................................................................................33

6.2 Human resources ............................................................................................................33

6.3 Infrastructure..................................................................................................................34

6.4 Work environment..........................................................................................................34


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7 PRODUCT REALIZATION ..................................................................................................35

7.1 Planning of product realization.......................................................................................35

7.2 Customer-related processes ............................................................................................37

7.3 Design and development ................................................................................................39

7.4 Purchasing......................................................................................................................43

7.5 Production and service provision....................................................................................46

7.6 Control of monitoring and measuring devices ................................................................51

8 MEASUREMENT, ANALYSIS AND IMPROVEMENT......................................................53

8.1 General...........................................................................................................................53

8.2 Monitoring and measurement.........................................................................................53

8.3 Control of nonconforming product .................................................................................57

8.4 Analysis of data..............................................................................................................588.5 Improvement ..................................................................................................................58

ANNEXES

A CORRESPONDENCE BETWEEN ISO 9001:2000 AND ISO 14001:1996........................60

B CORRESPONDENCE BETWEEN ISO 9001:2000 AND ISO 9001:1994 ..........................64

BIBLIOGRAPHY .....................................................................................................................68


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HOW TO READ THIS HANDBOOK

Throughout this Handbook, the following abbreviations are used:

The 1994 version refers to ISO 9001:1994;

The 2000 version refers to ISO 9001:2000.

SECTION 1 gives a broad outline of the concepts behind the current revisions and a broad outline of the

major changes that have occurred as a result.

SECTION 2 is where the detailed comparisons are given. Because (as described in Section 1) there has been

a major structural change, the full text of the clauses from each of the standards is given.

The text of each clause of the 2000 version is given first and the relevant clause(s) (or part of the clause)

from the 1994 version alongside, followed by a COMMENT. (See Example below.)

EXAMPLE

2000 version 1994 version

C-Txt

I-S

PLUS

4.2.2 Quality Manual

The organization shall establish and maintain a

quality manual that includes

a) the scope of the quality management system,

including details of andjustification for any

exclusions (see 1.2),

b) the documented procedures established for the

quality management system, or reference to them,

and

c) a description of the interaction between the

processes of the quality management system.

4.2.1 General

The supplier shall establish, document andmaintain a quality system as a means ofensuring that product conforms to specifiedrequirements. The supplier shall prepare aquality manual covering the requirements of thisInternational Standard. The quality manual shallinclude or make reference to the quality systemprocedures and outline the structure of thedocumentation used in the quality system.

NOTE 6 Guidance on quality manuals is givenin ISO 10013.

!The greyed text is dealt with in clause4.1 of the 2000 version.

COMMENT

The 2000 version goes beyond the requirements of the 1994 version in that the organization now needs

to address how to achieve customer satisfaction.

__________________________________________________________________________________

HOW CHANGES ARE SHOWN

In the example above, a set of indicators is used to give a quick picture of the correlation and these are

located on the left of the 2000 version clause. The indicators are given in Table 1, but in the example, the

indicators are

C-Txt = Changed Text;

I-S = Intent is the same;

PLUS = some new requirements.

Any new requirements in the 2000 version are shown in bold as per the example.

Where, in the clause in the 1994 version, only part of the text is relevant to the clause being considered in the

2000 version, the non-relevant text is shown in grey.The ! icon is used to provide additional information; in the example it shows where else in the 2000

version, the greyed text is dealt with.


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Table 1 Details of indicators used to show the comparison between

the clauses of the 2000 version and the 1994 version

Correlation

Indicator

Description

S-TxtThe text is essentially the same in each standard (there may be minor

word changes which do not affect the meaning or intent).

S-Txt

PLUS

The text is essentially the same in each standard (there may be minor

word changes which do not affect the meaning or intent)

but there are some new requirements. The new requirements are shown

in bold.

C-Txt

I-S

The text in AS/NZS ISO 9001:2000 has changed from that of ISO

9001:1994. However the intent has not altered.

C-TxtI-S

PLUS

The text in AS/NZS ISO 9001:2000 has changed from that of ISO

9001:1994. However the intent has not altered,but there are some additional new requirements. The new requirements

are shown in bold.

NEWThis is a new requirement and there is no equivalent in ISO 9001:1994.

N/ENo equivalent in ISO 9001:1994 but the text in ISO 9001:2000 is

editorial and does not provide requirements to be met.

!!!! This icon is used to provide additional information, e.g. only part of aclause is relevant and the remainder is dealt with elsewhere.


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MAJOR CHANGES

There are a number of fundamental changes that have taken place during the current revision process. The

major changes are

Process approach

A process model approach has been used to develop the 2000 version of ISO 9001. As a result the old 20

clause structure of the 1994 version has gone and the standard structure is now more closely aligned to

business working practices.

While at first glance, it would appear that the 2000 version has been completely rewritten, what has actually

happened is that the most of the content of the 1994 version has been redistributed into the new process

model structure. In doing so, the text may have been changed but in many cases the intent of the clause has

not. However it is true that new requirements have been added and the major ones are discussed briefly here

and in more detail in Section 2.

One beneficial outcome of this approach is that the weighting given to the content via a main clause and

subclause structure is more appropriate to business needs. In the old 20 clause approach the clause

numbering gave undue weight to some aspects of relatively minor importance.

One standard for certification

ISO 9001:2000 is now the only standard on which certification can be based. ISO 9002 and ISO 9003 have

been withdrawn.1

Provision has been made for those who had certification to ISO 9002 or ISO 9003. This

has been done through a permissible exclusions approach which is detailed in clause 1.2 on page 17.

Terminology

The standard now uses the relationship of supplier organization customer which is in line with

normal business practice. (This replaces the subcontractor supplier customer terminology of the 1994

version.) The term subcontractor is no longer appears in the standard and can be used in the normal context

of usage.

Continual improvement

Organizations are now required to have a process of continual improvement built into their quality

management system. This means that when justifiable opportunities for improvement arise, they should be

implemented.

Customer satisfaction

The 2000 version now requires an organization to have a much stronger customer focus and to monitor

information on customer perceptions about how well your organization has met the customers requirements.

This is one of the means to be used in evaluating the performance of the quality management system.

Internal communication

There is now a requirement for an organization to have an internal communication process to provideinformation on the quality management system and its effectiveness.

Competence

In assessing human resources and in training, the issue of competence has been introduced and will need to

be addressed within the organization.

Less documented procedures demanded

The standard has shifted the emphasis on the need for documentation of procedures from the standard to the

organization. The standard now requires only six documented procedures.

The organization itself will need to decide what other documentation is needed for it to control its operations

and processes.

1 ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 are available as superseded standards from

www.ISO9000-2000.com


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Interaction between processes

The standard now more clearly defines that the production processes and the resultant product(s) are part of

the quality management system. There is a requirement for the organization to describe its processes and

how they interact.

OutsourcingThe standard now recognizes that organizations do outsource activities and has a requirement that the

organization has to exercise control over the outsourced processes.

Other changes

There are a number of other changes, which are either a new requirement within a clause or an extension of

the requirement(s) of the 1994 version.

These are indicated within each of the clauses of the 2000 version by one or more of the methods detailed in

How to read this Handbook.


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DETAILED COMPARISON OF

ISO 9001:2000, Quality management systems Requirements

WITH

ISO 9001:1994, Quality systems Model for quality assurance in

design, development, production, installation and servicing

2000 Version 1994 Version

S-Txt

PLUS

Foreword

ISO (the International Organization for

Standardization) is a worldwide federation of

national standards bodies (ISO member bodies).

The work of preparing International Standards is

normally carried out through ISO 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. ISO

collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters

of electrotechnical standardization.

International Standards are drafted in accordance

with the rules given in the ISO/IEC Directives,

Part 3.

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.

Attention is drawn to the possibility that some of

the elements of this International Standard may be

the subject of patent rights. ISO shall not be held

responsible for identifying any or all such patent

rights.

International Standard, ISO 9001was prepared by

Technical Committee ISO/TC 176, Quality

management and quality assurance, Subcommittee

SC 2, Quality systems.

This third edition of ISO 9001 cancels and

replaces the second edition (ISO 9001:1994)together with ISO 9002:1994 and ISO 9003:1994.

It constitutes a technical revision of these

documents. Those organizations which have used

Foreword

ISO (the International Organization forStandardization) is a worldwide federationof national standards bodies (ISO mmemberbodies). The work of preparing InternationalStandards is normally carried out throughISO technical committees. Each member bodyinterested in a subject for which a technicalcommittee has been established has the right tobe represented on that committee. Internationalorganizations, governmental and non-governmental, in liaison with ISO, can also takepart in the work. ISO collaborates closely withthe International Electrotechnical Commission(IEC) on all matters of electrotechnicalstandardization.

Draft International Standards adopted by thetechnical committees are circulated to themember bodies for voting. Publication as anInternational Standard requires approval by atleast 75% of the member bodies casting a vote.

International Standard ISO 9001 was preparedby Technical Committee ISO/TC 176, Qualitymanagement and quality assuraance,Subcommittee SC 2,Quality systems.

This second edition cancels and replaces thefirst edition (ISO 9001:1987), which has beentechnically revised.

Annex A of this International Standard is for

information only.


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ISO 9002:1994 and ISO 9003:1994 in the past

may use this International Standard by excluding

certain requirements in accordance with 1.2.

The title of ISO 9001 has been revised in thisedition and no longer includes the term Quality

assurance. This reflects the fact that the quality

management system requirements specified in this

edition of ISO 9001, in addition to quality

assurance of product, also aim to enhance

customer satisfaction.

Annexes A and B of this International Standard

are for information only.

COMMENT

The Foreword describes the first major change in the 2000 version, in that ISO 9002 and ISO 9003 willbe incorporated into the revision of ISO 9001. However, the way this change has been implemented still

allows those whose systems are based on either ISO 9002 or ISO 9003 to continue on a similar basis.

How this is achieved is contained in clause 1.2,Application.

The other major change noted is in the title, which actually indicates the emphasis of this revision,

concentrating on the performance of the quality management system and the achievement of its

objectives. The other major objective of the standard is the enhancement of customer satisfaction.

There has been no change in the text that outlines how ISO standards are produced.


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C-Txt

I-S

0 Introduction

0.1 General

The adoption of a quality management systemshould be a strategic decision of the organization.

The design and implementation of an

organization's quality management system is

influenced by varying needs, particular objectives,

the products provided, the processes employed and

the size and structure of the organization. It is not

the intent of this International Standard to imply

uniformity in the structure of quality management

systems or uniformity of documentation.

The quality management system requirements

specified in this International Standard arecomplementary to technical requirements for

products. Information marked NOTE is for

guidance in understanding or clarifying the

associated requirement.

This International Standard can be used by internal

and external parties, including certification bodies,

to assess the organizations ability to meet

customer, regulatory and the organization's own

requirements.

The quality management principles stated in

ISO 9000 and ISO 9004 have been taken intoconsideration during the development of this

International Standard.

Introduction

This International Standard is one of threeInternational Standards dealing with qualitysystem requirements that can be used for

external quality assurance purposes. Thequality assurance models, set out in the threeInternational Standards listed below, representthree distinct forms of quality systemrequirements suitable for the purpose of asupplier demonstrating its capability, and for theassessment of the capability of a supplier byexternal parties.

a) ISO 9001, Quality systemsModel forquality assurance in design, development,production, installation and servicing

or use when conformance to specifiedrequirements is to be assured by thesupplier during design, development,production, installation and servicing.

b) ISO 9002, Quality systemsModel forquality assurance in production, installationand servicing

for use when conformance to specifiedrequirements is to be assured by thesupplier during production, installation andservicing.

c) ISO 9003, Quality systemsModel forquality assurance in final inspection and test

for use when conformance to specifiedrequirements is to be assured by the

supplier solely at final inspection and test.It is emphasized that the quality systemrequirements specified in this InternationalStandard, ISO 9002 and ISO 9003 arecomplementary (not alternative) to the technical(product) specified requirements. They specifyrequirements which determine what elementsquality systems have to encompass, but it is notthe purpose of these International Standards toenforce uniformity of quality systems. They aregeneric and independent of any specific industryor economic sector. The design and implemen-tation of a quality system will be influenced bythe varying needs of an organization, its

particular objectives, the products and servicessupplied, and the processes and specificpractices employed.

It is intended that these International Standardswill be adopted in their present form, but onoccasions they may need to be tailored byadding or deleting certain quality systemrequirements for specific contractual situations.ISO 9000-1 provides guidance on such tailoringas well as on selection of the appropriate qualityassurance model, i.e. ISO 9001, ISO 9002 orISO 9003.

!The issue of tailoring is addressed in

the clause 1 Scope (1994 version).


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COMMENT

This section of the Introduction covers the same ground as the 1994 version. However since ISO 9002

and ISO 9003 have been incorporated into the 2000 version, reference to these has been deleted.

As in the 1994 version, the design of an organizations quality management system and the associated

documentation needs to meet the requirements of the organization. ISO Committee TC 176 is not

recommending that the structure of the quality management system and/or documentation has to be in

any particular format to comply with the requirements of the standard. The decision on how the 2000

version is implemented is up to each individual organization.


N/E

0.2 Process approach

This International Standard promotes the adoption

of a process approach when developing,

implementing and improving the effectiveness of aquality management system, to enhance the

customer satisfaction by meeting customer

requirements.

For an organization to function effectively, it has

to identify and manage numerous linked activities.

An activity using resources and managed in order

to enable the transformation of inputs into outputs,

can be considered as a process. Often the output

from one process directly forms the input to the

next.

The application of a system of processes within anorganization, together with the identification and

interactions of these processes, and their

management, can be referred to as the process

approach.

An advantage of the process approach is the

ongoing control that it provides over the linkage

between the individual processes within the

system of processes, as well as over their

combination and interaction.

When used within a quality management system,

such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of

added value,

c) obtaining results of process performance and

effectiveness, and

d) continual improvement of processes based on

objective measurement.

The model of a process-based quality management

system shown in Figure 1 illustrates the process

linkages presented in clauses 4 to 8. This

illustration shows that customers play a significant

role in defining requirements as inputs. Monitoring

of customer satisfaction requires the evaluation of

!There is no equivalent to this part ofthe Introduction.


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information relating to customer perception as to

whether the organization has met the customer

requirements. The model shown in Figure 1 covers

all the requirements of this International Standard,

but does not show processes at a detailed level.

NOTE In addition, the methodology known as

Plan-Do-Check-Act (PDCA) can be applied to all

processes. PDCA can be briefly described as

follows:

Plan: establish the objectives and processes

necessary to deliver results in accordance

with customer requirements and the

organization's policies;

Do: implement the processes;

Check: monitor and measure processes and productagainst policies, objectives and

requirements for the product and report the

results;

Act: take actions to continually improve process

performance.

Figure 1 Model of a process-based quality

management system

COMMENT

This section of the Introduction is new and describes a major change in approach in the 2000 version.

The quality management system is now based on a process model as described in 0.2 Process approach

and further discussed in ISO 9000:2000, Quality management systemsFundamentals and vocabulary

and ISO 9004:2000, Quality management systemsGuidelines for performance improvements.

It is not intended to cover the concepts of the process model here since they are adequately dealt with in

the two references given above.

However, the change to a process model has meant that the structure of the standard needed to be

substantially revised. As a consequence, the 2000 version has moved away from the 20 element

structure of the 1994 version. While the content of the 1994 version has been carried over into the 2000

version structure, the text has been modified to a large extent to either present the requirements more

succinctly or more clearly without altering the intent to any great extent.


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The other problem that existed as a result of the structure of the 1994 version was that all clauses in the

4.1 to 4.20 group carried the same weight. In restructuring the 2000 version, it has been possible to place

the emphasis where it is needed.


N/E

0.3 Relationship with ISO 9004

The present editions of ISO 9001 and ISO 9004

have been developed as a consistent pair of quality

management system standards which have been

designed to complement each other, but can also

be used independently. Although the two

International Standards have different scopes, they

have similar structures in order to assist their

application as a consistent pair.

ISO 9001 specifies requirements for a quality

management system that can be used for internal

application by organizations, or for certification,

or for contractual purposes. It focuses on the

effectiveness of the quality management system in

meeting customer requirements.

ISO 9004 gives guidance on a wider range of

objectives of a quality management system than

does ISO 9001, particularly for the continual

improvement of an organizations overall

performance and efficiency, as well as its

effectiveness. ISO 9004 is recommended as a

guide for organizations whose top management

wishes to move beyond the requirements of ISO

9001, in pursuit of continual improvement of

performance. However, it is not intended for

certification or for contractual purposes.


COMMENT

The companion standard, ISO 9004, which gives guidance on the improvement of the performance of a

quality management system, has now been aligned in clause structure with ISO 9001:2000, which

specifically details the requirements.

ISO 9004 is intended to be used by those who wish to go beyond the requirements of ISO 9001 and seek

further improvement of their quality management system. ISO 9004 is not a guide to the implementation

to ISO 9001.


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N/E

0.4 Compatibility with other managementsystems

This International Standard has been aligned withISO 14001:1996 in order to enhance the

compatibility of the two standards for the benefit

of the user community.

This International Standard does not include

requirements specific to other management

systems, such as those particular to environmental

management, occupational health and safety

management, financial management or risk

management. However, this International Standard

enables an organization to align or integrate its

own quality management system with relatedmanagement system requirements. It is possible

for an organization to adapt its existing

management system(s) in order to establish a

quality management system that complies with the

requirements of this International Standard.


COMMENT

Alignment with other management systems is becoming an important issue for many organizations.

While the only other published International Management System standard is ISO 14001 on

environmental management systems, there may be more published in the future and it may be necessary

to consider any such future systems. Alignment of the two standards has been undertaken to assist thoseorganizations who wish to integrate their management systems.


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C-TxtI-S

PLUS

1 Scope

1.1 GeneralThis International Standard specifies

requirements for a quality management system

where an organization

a) needs to demonstrate its ability to

consistently provide product that meets

customer and applicable regulatory

requirements, and

b) aims to enhance customer satisfaction

through the effective application of the

system, including processes for continual

improvement of the system and the

assurance of conformity to customer and

applicable regulatory requirements.

NOTE In this International Standard, the term

product applies only to the product intended for,

or required by, a customer.

1 Scope

This International Standard specifies quality

system requirements for use where a supplier'scapability to design and supply conformingproduct needs to be demonstrated.

The requirements specified are aimed primarilyat achieving customer satisfaction by preventingnonconformity at all stages from design through

to servicing.

This International Standard is applicable insituations when

a) design is required and the productrequirements are stated principally inperformance terms, or they need to beestablished, and

b) confidence in product conformance can beattained by adequate demonstration of asupplier's capabilities in design,development, production, installation andservicing.

NOTE 1 For information references, see

annex A

COMMENT

In the 2000 version, a major change has been to introduce the concept of enhancing customer

satisfaction through effective application of the system, including processes for continualimprovement of the system. (This is a significant extension, particularly the need for continual

improvement.) It also now places emphasis on both assurance of conformity and meeting any regulatory

requirements that apply to the product as additional means of enhancing customer satisfaction.

The standard has taken a positive approach requiring assurance of conformity of product rather than the

negative approach of prevention of nonconformity.


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HB 90.0:2000, The ISO 9001 Comparison - 2000 vs1994 The ISO 9001 Comparison - 2000 vs 1994
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HB 90.0-2000 the ISO 9001 Comparison - 2000 vs 1994 the ISO 9001 Comparison - 2000 vs 1994

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