ISO9000 Informação2

ISO 9000
Quality management principles

The following text is an integral reproduction of the content of the document
"Quality Management Principles".
Introduction
This document introduces the eight quality management principles on which the
quality management system standards of the revised ISO 9000:2000 series are
based. These principles can be used by senior management as a framework to
guide their organizations towards improved performance. The principles are derived
from the collective experience and knowledge of the international experts who
participate in ISO Technical Committee ISO/TC 176, Quality management and
quality assurance, which is responsible for developing and maintaining the ISO
9000 standards.
The eight quality management principles are defined in ISO 9000:2000, Quality
management systems Fundamentals and vocabulary, and in ISO 9004:2000,
Quality management systems Guidelines for performance improvements.
This document gives the standardized descriptions of the principles as they appear
in ISO 9000:2000 and ISO 9004:2000. In addition, it provides examples of the
benefits derived from their use and of actions that managers typically take in
applying the principles to improve their organizations' performance.
Principle 1 Customer focus
Principle 2 Leadership
Principle 3 Involvement of people
Principle 4 Process approach
Principle 5 System approach to management
Principle 6 Continual improvement
Principle 7 Factual approach to decision making
Principle 8 Mutually beneficial supplier relationships
The next step
Key benefits:
Increased revenue and market share obtained through flexible and fast
responses to market opportunities.
Increased effectiveness in the use of the organization's resources to enhance
customer satisfaction.
Principle 1 Customer focus
Organizations depend on their customers and therefore should understand current
and future customer needs, should meet customer requirements and strive to
exceed customer expectations.
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Improved customer loyalty leading to repeat business.
Applying the principle of customer focus typically leads to:
Researching and understanding customer needs and expectations.
Ensuring that the objectives of the organization are linked to customer needs
and expectations.
Communicating customer needs and expectations throughout the
organization.
Measuring customer satisfaction and acting on the results.
Systematically managing customer relationships.
Ensuring a balanced approach between satisfying customers and other
interested parties (such as owners, employees, suppliers, financiers, local
communities and society as a whole).
Key benefits:
People will understand and be motivated towards the organization's goals and
objectives.
Activities are evaluated, aligned and implemented in a unified way.
Miscommunication between levels of an organization will be minimized.
Applying the principle of leadership typically leads to:
Considering the needs of all interested parties including customers, owners,
employees, suppliers, financiers, local communities and society as a whole.
Establishing a clear vision of the organization's future.
Setting challenging goals and targets.
Creating and sustaining shared values, fairness and ethical role models at all
levels of the organization.
Establishing trust and eliminating fear.
Providing people with the required resources, training and freedom to act with
responsibility and accountability.
Inspiring, encouraging and recognizing people's contributions.
Key benefits:
Motivated, committed and involved people within the organization.
Innovation and creativity in furthering the organization's objectives.
People being accountable for their own performance.
People eager to participate in and contribute to continual improvement.
Applying the principle of involvement of people typically leads to:
Principle 2 Leadership
Leaders establish unity of purpose and direction of the organization. They should
create and maintain the internal environment in which people can become fully
involved in achieving the organization's objectives.
Principle 3 Involvement of people
People at all levels are the essence of an organization and their full involvement
enables their abilities to be used for the organization's benefit.
People understanding the importance of their contribution and role in the
organization.
People identifying constraints to their performance.
People accepting ownership of problems and their responsibility for solving
them.
People evaluating their performance against their personal goals and
objectives.
People actively seeking opportunities to enhance their competence,
knowledge and experience.
People freely sharing knowledge and experience.
People openly discussing problems and issues.
Key benefits:
Lower costs and shorter cycle times through effective use of resources.
Improved, consistent and predictable results.
Focused and prioritized improvement opportunities.
Applying the principle of process approach typically leads to:
Systematically defining the activities necessary to obtain a desired result.
Establishing clear responsibility and accountability for managing key
activities.
Analysing and measuring of the capability of key activities.
Identifying the interfaces of key activities within and between the functions of
the organization.
Focusing on the factors such as resources, methods, and materials that will
improve key activities of the organization.
Evaluating risks, consequences and impacts of activities on customers,
suppliers and other interested parties.
Key benefits:
Integration and alignment of the processes that will best achieve the desired
results.
Ability to focus effort on the key processes.
Providing confidence to interested parties as to the consistency, effectiveness
and efficiency of the organization.
Applying the principle of system approach to management typically leads to:
Structuring a system to achieve the organization's objectives in the most
effective and efficient way.
Understanding the interdependencies between the processes of the system.
Principle 4 Process approach
A desired result is achieved more efficiently when activities and related resources
are managed as a process.
Principle 5 System approach to management
Identifying, understanding and managing interrelated processes as a system
contributes to the organization's effectiveness and efficiency in achieving its
objectives.
Structured approaches that harmonize and integrate processes.
Providing a better understanding of the roles and responsibilities necessary
for achieving common objectives and thereby reducing cross-functional
barriers.
Understanding organizational capabilities and establishing resource
constraints prior to action.
Targeting and defining how specific activities within a system should operate.
Continually improving the system through measurement and evaluation.
Key benefits:
Performance advantage through improved organizational capabilities.
Alignment of improvement activities at all levels to an organization's strategic
intent.
Flexibility to react quickly to opportunities.
Applying the principle of continual improvement typically leads to:
Employing a consistent organization-wide approach to continual improvement
of the organization's performance.
Providing people with training in the methods and tools of continual
improvement.
Making continual improvement of products, processes and systems an
objective for every individual in the organization.
Establishing goals to guide, and measures to track, continual improvement.
Recognizing and acknowledging improvements.
Key benefits:
Informed decisions.
An increased ability to demonstrate the effectiveness of past decisions
through reference to factual records.
Increased ability to review, challenge and change opinions and decisions.
Applying the principle of factual approach to decision making typically leads to:
Ensuring that data and information are sufficiently accurate and reliable.
Making data accessible to those who need it.
Analysing data and information using valid methods.
Making decisions and taking action based on factual analysis, balanced with
experience and intuition.
Principle 6 Continual improvement
Continual improvement of the organization's overall performance should be a
permanent objective of the organization.
Principle 7 Factual approach to decision making
Effective decisions are based on the analysis of data and information
Principle 8 Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial
relationship enhances the ability of both to create value
Key benefits:
Increased ability to create value for both parties.
Flexibility and speed of joint responses to changing market or customer needs
and expectations.
Optimization of costs and resources.
Applying the principles of mutually beneficial supplier relationships typically leads
to:
Establishing relationships that balance short-term gains with long-term
considerations.
Pooling of expertise and resources with partners.
Identifying and selecting key suppliers.
Clear and open communication.
Sharing information and future plans.
Establishing joint development and improvement activities.
Inspiring, encouraging and recognizing improvements and achievements by
suppliers.
The next step:
This document provides a general perspective on the quality management principles
underlying the ISO 9000:2000 series. It gives an overview of these principles and
shows how, collectively, they can form a basis for performance improvement and
organizational excellence.
There are many different ways of applying these quality management principles.
The nature of the organization and the specific challenges it faces will determine
how to implement them. Many organizations will find it beneficial to set up quality
management systems based on these principles.
The requirements of quality management systems and supporting guidelines are
given in the ISO 9000 - Selection and use.
Further information on the ISO 9000 standards is available from ISO's national
member institutes or from the ISO Central Secretariat ISO 9000 enquiry service.
Sales enquiries should also be directed to the ISO members or to the ISO Central
Secretariat sales department.
ISO publishes the bimonthly ISO Management Systems, which provides updates on
these families of standards and news on their implementation around the world. A
Spanish-language edition is published by the Spanish national standards institute,
AENOR.

ISO | ISO name and logo | Privacy policy

Selection and use

Selection and Use of the ISO 9000:2000 family of
standards
The following text is an integral reproduction of the content of the brochure"ISO
9000 - Selection and use". Hard copies of the brochure are available from
sales@iso.org.
The ISO 9000 family of international quality management standards and guidelines
has earned a global reputation as the basis for establishing quality management
systems.
This brochure has been developed by ISO Technical Committee ISO/TC 176, Quality
management and quality assurance, which is responsible for developing and
maintaining the ISO 9000 family. The brochure has been updated to take into
account the revisions of several of the core series standards in the ISO 9000 family
which were published on 15 December 2000 by ISO (International Organization for
Standardization). These revised standards are identified by the "2000" in their
designation.
The purpose of this brochure is to provide you with a general perspective on the
ISO 9000 family of standards with emphasis on the features of the revised versions.
It presents an overview of the standards and demonstrates how, collectively, they
form a basis for continual improvement and business excellence. In particular, you
will see how to distinguish between the various documents in the ISO 9000 family
and how they may be utilized to your maximum benefit.
The familiar three standards ISO 9001, ISO 9002 and ISO 9003 have been
integrated into the new ISO 9001:2000. This brochure provides you with general
information on how to use the revised standard together with other documents in
the ISO 9000 family to meet your specific requirements.
ISO 9001:2000 specifies requirements for a quality management system for any
organization that needs to demonstrate its ability to consistently provide product
that meets customer and applicable regulatory requirements and aims to enhance
customer satisfaction.ISO 9001:2000 has been organized in a user-friendly format
with terms that are easily recognized by all business sectors. The standard is used
for certification/registration and contractual purposes by organizations seeking
recognition of their quality management system.
The greatest value is obtained when you use the entire family of standards in an
integrated manner. It is suggested that, beginning with ISO 9000:2000, you adopt
ISO 9001:2000 to achieve a first level of performance. The practices described in
ISO 9004:2000 may then be implemented to make your quality management
system increasingly effective in achieving your own business goals. ISO 9001:2000
and ISO 9004:2000 have been formatted as a consistent pair of standards to
facilitate their use. Using the standards in this way will also enable you to relate
them to other management systems (e.g. environmental), many sector specific
requirements (such as ISO/TS/16949 in the automotive industry) and will assist in
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gaining recognition through national award programmes.
This brochure provides you with:
Examples of typical applications of the documents;
A step-by-step process to implement a quality management system;
A brief view of the future evolution of the ISO 9000 family.

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ISO 9000

The ISO 9000:2000 series - implementation and
transition
The revised core series of the ISO 9000 family of International Standards for quality
management was published on 15 December 2000.
In addition to developing the revisions, ISO/TC 176, Quality management and
quality assurance - the ISO technical committee responsible for the ISO 9000
family - has also developed supporting documents to assist users in
implementing the ISO 9000:2000 series and making the transition to ISO
9001:2000, which is now the only ISO 9000 certification standard, from the 1994
versions of ISO 9001, ISO 9002 and ISO 9003.
Transition deadline: ISO and the International Accreditation Forum (IAF)
jointly agreed on a policy to ensure a smooth transition to the ISO 9000:2000
series. Under this, organizations certified to 1994 versions of ISO 9001, ISO
9002 or ISO 9003 were given a three-year deadline from the publication of
the revised standards to migrate to ISO 9001:2000. Therefore, from 15
December 2003, certificates to the 1994 versions will lose their
accredited status by the IAF and its national accreditation body members.
The IAF confirmed at its 16th annual meeting on 21-26 September 2002 that
the deadline will not be extended.
The most recent versions of these documents are posted below. The supporting
documents are the work of ISO/TC 176's Subcommittee 2, which is responsible for
revising ISO 9001 and ISO 9004, and which has its own Web site
Frequently Asked Questions (FAQs)
The Year 2000 Revisions of ISO 9001 and ISO 9004
Transition Planning Guidance for ISO 9001:2000
Introduction and support package
Guidance on 'Outsourced Processes'
Guidance on ISO 9001:2000 clause 1.2 "Application"
Guidance on the Documentation Requirements of ISO 9001:2000
Guide to the Terminology used in ISO 9000:2000 family of Standards
Guidance on the Concept and Use of the Process Approach for management
systems
Last modified: 2004-01-27
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The ISO Survey of ISO 9000 and ISO 14000 Certificates - Tenth cycle 1

The ISO Survey of ISO 9000 and ISO 14000 Certificates

Tenth cycle: up to and including 31 December 2000
______________________________________________________________________________________

1 Introduction

ISO does not itself issue certificates of conformity to ISO 9000 or ISO 14000. This is carried out
independently of ISO by certification bodies in different countries. Therefore, there is no official central
database of ISO 9000 and ISO 14000 certificates. However, ISO 9000 and ISO 14000 are two of our best
known families of standards and ISO constantly receives requests for information on their implementation
worldwide, which is what led ISO to undertake this regular survey as an information service.

2 General remarks

This survey does not claim to be exhaustive and the reader should consider the data reported in this survey
with care, keeping in mind the remarks below.

2.1 A number of joint assessment arrangements are in operation and these have been taken into account
where known, but a small amount of double counting no doubt occurs. When this comes to light, totals
are adjusted, which explaims the lower figures for some countries in the 2000 survey. The figures
shown in this survey are those which have been provided by the certification bodies, and the Central
Secretariat is very grateful for all their help.

2.2 Efforts have been made to maintain consistency between approaches for all ten cycles and, in some
cases, estimates have been made. However, it is quite likely that in some cases, undercounting has
occurred.

2.3 No attempt has been made to distinguish between accredited and non-accredited certificates.
Consequently, accredited and non-accredited certificates are added together without distinction. Also,
the certificates mentioned may either cover single site or multiple site certifications; again, no
distinction has been made.

2.4 We introduced worldwide figures by industrial sectors for the first time in the eighth cycle and we have
continued to give this information in the present cycle. Due to public demand, a CD-ROM is available
showing the number of certificates per country by industrial sector. This electronic product is available
from the Central Secretariat for a fee.

2 The ISO Survey of ISO 9000 and ISO 14000 Certificates Tenth cycle
3 Key findings on ISO 9000

3.1 A country-by-country breakdown is shown in Annex A and you will find the key findings highlighted below.

3.2 The success of the ISO 9000 family of standards is still growing, and the number of countries where
ISO 9000 is being implemented has increased. Up to the end of December 2000, at least 408 631 ISO 9000
certificates had been awarded in 158 countries worldwide. This is an increase of 64 988 ISO 9000
certificates over the end of December 1999, when the total stood at 343 643 for 150 countries.

3.3 Looking at the different regions of the world, Europe, with 220 127 certificates awarded, is still increasing
rapidly with 29 879 more certificates than last year, while the Far East with 81 919 certificates awarded,
showing a 25 271 increase, confirms the growing interest of the region's industries in the ISO 9000
certification process.

Cut-off date for each cycle

Regional
share
expressed in
percent

C
y
c
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e

1

1
9
9
3
-
0
1
-
3
1

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2

1
9
9
3
-
0
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3

1
9
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4
-
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6
-
3
0

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4

1
9
9
5
-
0
3
-
3
1

C
y
c
l
e

5

1
9
9
5
-
1
2
-
3
1

C
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c
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e

6

1
9
9
6
-
1
2
-
3
1

C
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c
l
e

7

1
9
9
7
-
1
2
-
3
1

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c
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e

8

1
9
9
8
-
1
2
-
3
1

C
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c
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e

9

1
9
9
9
-
1
2
-
3
1

C
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l
e

1
0

2
0
0
0
-
1
2
-
3
1

Africa/West
Asia
3,42 2,73 2,64 2,75 2,65 3,79 3,88 4,47 5,04 4.94
Europe 83,02 81,12 78,73 75,61 72,72 67,58 64,34 61,16 55,36 53.87
Central and
South Americas
0,10 0,30 0,68 0,77 0,96 1,05 1,34 1,92 2,61 2.64
North America 4,32 5,61 6,99 7,77 8,15 10,44 11,25 12,34 13,14 11.82
Far East
countries
2,46 3,40 4,39 6,29 7,26 11,31 13,38 13,95 16,48 20.05
Australia/New-
Zealand
6,69 6,84 6,58 6,81 8,27 5,83 5,80 6,16 7,36 6.68
3.4 With 10 548 and 9 298 new ISO 9000 certificates respectively, China and Italy show the highest annual
growth. Japan with over 6 700 new certificates comes in third position and the Republic of Korea shows
3 891 new certificates, the Far East displaying very consistent growth.

3.5 The following appear for the first time:

Albania Nepal Uganda
Chad Papua New Guinea Uzbekistan
Kyrgyzstan Suriname

3.6 Key certificate milestones

The following countries have passed key certification milestones:

1 000 5 000 10 000 15 000 20 000 30 000 60 000
Romania Israel Spain Korea,
Republic of
China Italy
Russia Japan
Philippines

3.7 As time passes, certificates are withdrawn for a variety of reasons. At the end of 2000, some 15 886
certificates had been withdrawn.

Organization discontinued because:
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Afghanistan 2 5 3
Argentina 2 1 2 3 6 13
Austria 2 3 201 1 9
Australia 3 70 96 14 84
Bahamas 2
Belgium 3 2 11 33 3
Bhutan 15
Bosnia and Herzegovina 2
Brazil 90 31 23
Brunei Darussalam 13 1 46 37
Bulgaria 2
Canada 29 2 21 835 126 41
Chile 1
China 128 1 1 277 1
Hong Kong, China 2 1 257
Taipei, Chinese 14 34 2 19 8 10
Colombia 6 7 3 20
Croatia 1 1 43 5 2
Cuba 1
Cyprus 3
Czech Republic 6 1 1 3
Denmark 1 282
Dominica 1
Egypt 1 5 3
Estonia 3 3
Finland 2 91
France 1 1 169 3 3
Germany 53 44 63 160 66 44
Greece 20 74 1 15
Grenada 1
Hungary 22 13 8 84 24 42
India 45 13 35
Indonesia 1 4
Iran, Islamic Republic of 1
Ireland 21 100 392 42 160
Israel 14 15 6 43 11 12
Italy 12 3 1 193 11 37
Japan 452 1 7 238 42 69
Jordan 6 7 1
Korea, Democratic People's
Republic of
26

3 8
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Korea, Republic of 1 1 120 30 76
Latvia 3 1
Lithuania 1
Luxembourg 10
Malaysia 4 1 2 2
Mauritius 2
Mexico 86 4 5
Monaco 2
Morocco 5
Namibia 1 4 1 1
Netherlands 4 68 2 17 11
New Zealand 45 317 5 6
Norway 3 1 29 12 11
Oman 2
Pakistan 1
Philippines 1 9 1
Poland 20 9 2
Portugal 49 24 27 70 27 74
Puerto Rico 1
Romania 1 6 1 5
Russia 1 23 1 3
Singapore 26 3 1 37 27 10
Slovenia 2 2 3 5
South Africa 13 4 7 779 84 123
Spain 511 512 3 5
Sweden 145 5 80 11 6
Switzerland 12 3 8 7 6
Syrian Arab Republic 1
Thailand 4 9
Tunisia 1 1
Turkey 121 1 118 72 14 27
Ukraine 3
United Kingdom 435 58 54 274 65 192
United States of America 17 30 9 2 236 96 78
Uruguay 1 5 6 2
Venezuela 2 61 2 61
Vietnam 2
Yugoslavia 49 2
Zimbabwe 3 2
TOTAL: 2 168 335 562 10 520 910 1 391

3.8 ISO 9000 by industrial sectors

Although the response was better this year than last, there are still many certification bodies who cannot
supply us with figures for industrial sectors.

EAC
Code
Nos.
ISO 9000 BY
INDUSTRIAL SECTORS
1998 1999 2000
EAC
Code
Nos.
ISO 9000 BY
INDUSTRIAL
SECTORS
1998 1999 2000
1 Agriculture, fishing 610 678 1 745 21 Aerospace 1 052 4 131 924
2 Mining and quarrying 1 052 1 791 2 028 22
Other transport
equipment
3 040 7 656 9 072
3
Food products, beverages
and tobacco
7 347 8 746 11 440 23
Manufacturing not
elsewhere classified
2 106 4 844 5 534
4 Textiles and textile products 2 835 3 673 5 178 24 Recycling 1 001 1 765 932
5 Leather and leather products 2 313 2 093 926 25 Electricity supply 860 932 979
6 Wood and wood products 2 218 1 967 2 225 26 Gas supply 390 558 531
7
Pulp, paper and paper
products
1 316 3 279 4 785 27 Water supply 505 799 1 242
8 Publishing companies 363 354 445 28 Construction 19 768 25 273 32 389
9 Printing companies 1 998 2 939 3 299 29
Wholesale & retail
trade; repairs of
motor vehicles,
motorcycles &
personal &
household goods
16 451 13 803 18 530
10
Manufacture of coke &
refined petroleum products
1 009 1 669 1 929 30
Hotels and
restaurants
865 1 794 1 187
11 Nuclear fuel 279 220 115 31
Transport, storage
and communication
11 738 11 366 13 181
12
Chemicals, chemical
products & fibres
11 803 12 615 14 790 32
Financial
intermediation, real
estate, rental
4 690 3 218 4 367
13 Pharmaceuticals 1 160 1 105 1 451 33
Information
technology
5 826 6 706 11 067
14 Rubber and plastic products 6 277 13 575 18 036 34
Engineering
Services
8 064 9 201 11 451
15
Non-metallic mineral
products
2 328 3 571 4 209 35 Other Services 13 088 12 150 13 160
16
Concrete, cement, lime,
plaster, etc.
4 998 7 107 6 467 36 Public administration 689 2 086 1 404
17
Basic metal & fabricated
metal products
28 885 28 972 40 713 37 Education 1 833 3 996 4 282
18 Machinery and equipment 20 275 19 827 23 027 38
Health and social
work
1 250 2 871 3 820
19
Electrical and optical
equipment
36 653 40 035 38 148 39 Other social services 2 513 2 005 1 529
20 Shipbuilding 398 4 670 589
TOTAL 229 846 274 040 317 126


4 Key findings on ISO 14000

The first of the ISO 14000 family of standards for environmental management were published in September
1996 and are rapidly becoming well known and used, which can be seen in the data received for 2000
shown in Annex B.

4.1 The total number of certificates awarded at the end of 2000 was 22 897, compared to 14 106 at the end
of December 1999, showing a very significant rise of 8 791.

4.2 As noted in the previous surveys, Europe and the Far East experienced a very significant growth in
2000, bringing them to an combined overall total of 18 902 certificates, compared to the other regions
where ISO 14000 appears to be slower in taking off.

Cut-off date for each cycle
Regional share
expressed in
percent
Cycle 5
1995-12-31
Cycle 6
1996-12-31
Cycle 7
1997-12-31
Cycle 8
1998-12-31
Cycle 9
1999-12-31
Cycle 10
2000-12-31
Africa/West Asia 0,39 0,67 1,65 1,75 2,39 2,84
Europe 87,94 63,58 59,24 53,94 52,21 48,13
Central and South
Americas
1,17 1,01 2,21 1,83 2,19 2,43
North America 0,39 2,88 2,64 5,50 6,91 7,32
Far East countries 9,73 28,10 30,59 32,10 30,84 34,42
Australia/New-
Zealand
0,39 3,76 3,68 4,88 5,46 4,86


4.3 Up to the end of 2000, 22 897 environmental certificates were held in 98 countries. During that period,
ISO 14000 was implemented in 14 additional countries, Africa/West Africa, the Americas and Europe
each implementing ISO 14000 in 4 of additional countries. Once again, Japan shows the highest
increase with 2 541 new certificates awarded. The United Kingdom follows for the second time with an
increase of 1 042 and Sweden comes in third position (again for the second time running) with an
increase of 519 certificates.


4.4 The following appear for the first time:

Andorra Kenya Palestine
Bolivia Korea, Democratic People's
Republic of
Paraguay
Brunei Darussalam Latvia Russian Federation
Dominican Republic Malta Sri Lanka
Honduras Nigeria

4.5 Key certificate milestones

The following countries have passed key certification milestones:

100 500 1 000 5 000
Argentina China Australia Japan
Belgium Denmark Germany
Czech Republic Finland Sweden
Hong Kong, China France USA
Mexico Italy
Singapore Korea, Republic of
South Africa Netherlands

4.6 Below is a table showing the number of withdrawn ISO 14000 certificates per country and, as already
mentioned for ISO 9000 certificates, the reasons for these withdrawals. A total of 262 certificates were
withdrawn.

Country
O
r
g
a
n
i
z
a
t
i
o
n

f
a
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t
i
f
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o
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t

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t
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n

o
n

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s
t
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n
t

w
a
s

i
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s
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f
f
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t

N
o

b
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s
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n
e
s
s

a
d
v
a
n
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e

O
t
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r

r
e
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/

r
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o
n

u
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k
n
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w
n

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r
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a
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a
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n

c
h
a
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e
d

c
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r
t
i
f
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c
a
t
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o
n

b
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y

O
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a
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i
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a
t
i
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n

c
e
a
s
e
d

a
c
t
i
v
i
t
i
e
s

Austria 5 1
Belgium 1
Brazil 30
Canada 9 2
Hong Kong, China 1 1
Croatia 1
Czech Republic 1
Denmark 6
Estonia 1
France 7
Germany 2 6 4 1
Hungary 1
Japan 41 40 21
Korea, Republic of 2 8
Mexico 1
Netherlands 1 3 1 3
New Zealand 1 1
Norway 1
Poland 4
Portugal 3
South Africa 3
Spain 7 7
Sweden 3 1
Switzerland 1 1 3
Turkey 1 1 3
United States of America 19 2
TOTAL: 10 3 9 115 97 28

4.7 ISO 14000 Industrial Sectors

As in the case of ISO 9000 certificates, not all respondents were able to provide us with their data according
to the EAC codes.

EAC
Code
Nos.
ISO 14001 BY
INDUSTRIAL
SECTORS
1998 1999 2000
EAC
Code
Nos.
ISO 14001 BY
INDUSTRIAL
SECTORS
1998 1999 2000
1 Agriculture, fishing 16 85 205 21 Aerospace 49 309 391
2 Mining and quarrying 88 122 181 22
Other transport
equipment
312 445 589
3
Food products,
beverages and tobacco
272 390 834 23
Manufacturing not
elsewhere classified
70 118 272
4
Textiles and textile
products
91 100 219 24 Recycling 109 333 463
5
Leather and leather
products
22 94 41 25 Electricity supply 298 258 462
6 Wood and wood products 34 109 212 26 Gas supply 36 68 82
7
Pulp, paper and paper
products
209 232 520 27 Water supply 47 107 191
8 Publishing companies 12 29 44 28 Construction 298 500 1 035
9 Printing companies 63 132 118 29
Wholesale & retail trade;
repairs of motor vehicles,
motorcycles & personal &
household goods
129 340 452
10
Manufacture of coke &
refined petroleum
products
106 114 252 30 Hotels and restaurants 105 51 66
11 Nuclear fuel 6 10 16 31
Transport, storage and
communication
144 345 565
12
Chemicals, chemical
products & fibres
693 1 073 1 737 32
Financial intermediation,
real estate, rental
13 80 95
13 Pharmaceuticals 42 54 106 33 Information technology 22 147 139
14
Rubber and plastic
products
193 380 666 34 Engineering services 106 139 321
15
Non-metallic mineral
products
88 121 234 35 Other services 212 450 799
16
Concrete, cement, lime,
plaster, etc.
105 251 359 36 Public administration 21 78 193
17
Basic metal & fabricated
metal products
294 458 1 105 37 Education 15 46 72
18
Machinery and
equipment
569 699 1 071 38 Health and social work 38 44 43
19
Electrical and optical
equipment
2 147 2 233 3 100 39 Other social services 29 89 209
20 Shipbuilding 9 248 17
TOTAL 7 112 10 881 17 476


Annex A: ISO 9000 Certifications Worldwide:
Growth from 1995 to end of 2000
Countries Jan. Sept. June March Dec. Dec. Dec. Dec Dec, Dec
Africa/West Asia 1993 1993 1994 1995 1995 1996 1997 1998 1999 2000
Afghanistan 1 1 1 1 1 3
Algeria 2 4 9
Bahrain 1 5 9 20 30 31 31 33
Bangladesh 1 1 4 25 25
Botswana 1 4 4 4 6
Cameroon 1 5 5 5 8
Chad 2
Congo 1 2 2 2 2
Egypt 9 16 45 166 344 385 649 468
Gabon 2 3 5
Ghana 1 1 2 2 2 2 3 3
Guinea 1 2 2
India 8 73 328 585 1 023 1 665 2 865 3 344 5 200 5 682
Iran 2 97 131 224 259 433
Israel 110 170 279 497 526 1 709 2 303 3 700 4 600 6 140
Ivory Coast 3 4 8 8 10
Jordan 2 2 8 35 169 257 336
Kenya 1 1 11 28 416 419 173
Kuwait 1 9 15 28 62 67 74
Lebanon 6 15 37 66 86
Libyan Arab
Jamihiriya
1
1
1 1
Madagascar 1 1
Malawi 1 1 1
Maldives 1 1 1
Mali 4 5 5 5 5
Mauritius 3 4 59 72 92 92 131
Morocco 2 6 9 34 60 71 77 86
Mozambique 1 3 3
Namibia 5 6 11 2 14 19 24
Nigeria 1 1 4 3 20 20 20
Oman 2 5 20 26 53 70 82 66
Pakistan 1 3 7 22 56 145 194 611
Palestine 5 14 23
Qatar 1 1 5 7 20 20 20 55
Saudi Arabia 4 10 30 53 98 159 211 280 324 610
Senegal 1 1 4 8
Seychelles 1 2 2 5 5
Sierra Leone 1 1 1 1 1
South Africa 824 1 007 1 161 1 369 1 454 1 882 1 915 2 166 3 316 3 454
Sri Lanka 1 1 1 1 7 22 38 59 82 82
Sudan 1 1 1 1
Suriname 1
Swaziland 1 2 2 3 2 6 7 8
Syrian Arab Rep. 6 7 13 93 128
Tanzania 1 2 4
Tunisia 1 1 2 3 13 25 51 70 163 196
Uganda 32
United Arab Emirates 3 9 35 45 104 139 314 632 1 045 1 007
Yemen 1 2 2 8 12 12
Zaire 1 1 1 1 1 1 1
Zambia 1 1 1 3 3 3 4 4 4
Zimbabwe 12 23 44 49 60 112 103
Africa/West Asia 951 1 272 1 855 2 619 3 378 6 162 8 668 12 150 17 307 20 185
Share in percent 3,42 2,73 2,64 2,75 2,65 3,79 3,88 4,47 5,04 4.94
No. of countries 7 8 16 24 27 37 40 48 49 52
Countries Jan. Sept. June March Dec. Dec. Dec. Dec. Dec. Dec
Americas 1993 1993 1994 1995 1995 1996 1997 1998 1999 2000
Argentina 3 9 23 37 86 302 397 807 1 388 2 056
Antigua & Barbuda 1 1 1
Bahamas 1 1 1 2 2
Barbados 1 2 7 7 7 14
Bermuda 3 4 4 5
Bolivia 2 4 20
Brazil 19 113 384 548 923 1 198 2 068 3 712 6 257 6 719
Chile 9 11 21 29 34 61 135 235
Colombia 6 23 51 49 71 170 213 388 614
Costa Rica 1 2 2 2 7 12 33 79
Cuba 4 11 13 21 26
Dominica 1 1
Dominican Rep. 1 4 4 5 7 7 8
Ecuador 1 4 13 16 37 89
El Salvador 1 1 1 3 3 3 6 19
Grenada 1 1 1 2
Guatemala 1 1 3 3 8
Guyana 3 3 3 3 4
Honduras 2 3 4
Jamaica 2 12 10 12 12 20
Nicaragua 1 1 3
Panama 17 9 17 19 19
Papua New Guinea 1
Paraguay 1 3 6 9 30
Peru 6 7 8 13 46 74 141
Puerto Rico 2 4 12 25 23 31 36 37 37
Saint Lucia 4 4 4
Trinidad/Tobago 2 9 9 10
19 25 25
Uruguay 6 8 17 32
49 154 251
Venezuela 5 9 28 56 81 5 157 163 336 368
Central and South
Americas
27 140 475 733 1 220 1 713 2 989 5 221 8 972 10 805
Share in percent 0,10 0,30 0,68 0,77 0,96 1,05 1,34 1,92 2,61 2.64
No. of countries 3 6 9 12 15 19 23 28 29 30
Canada 292 530 870 1 290 1 397 3 955 5 852 7 585 10 556 11 435
Mexico 16 24 85 145 215 412 711 978 1 556 1 843
USA 893 2 059 3 960 5 954 8 762 12 613 18 581 24 987 33 054 35 018
North America* 1 201 2 613 4 915 7 389 10 374 16 980 25 144 33 550 45 166 48 296
Share in percent 4,32 5,61 6,99 7,77 8,15 10,44 11,25 12,34 13,14 11.82
No. of countries 3 3 3 3 3 3 3 3 3 3
*Data received from Quality Systems Update and WorldPreferred
Europe 1993 1993 1994 1995 1995 1996 1997 1998 1999 2000
Albania 1
Andorra 1 7
Armenia 4 4
Austria 101 200 434 667 1 133 1 824 2 627 3 245 3 421 3 826
Azerbaijan 1 1
Belarus 6 14 26 58
Belgium 180 464 870 1 226 1 716 1 871 3 042 3 176 3 495 3 760
Bosnia 2 10 34 33
Bulgaria 1 3 14 42 96 199 259
Croatia 2 8 22 38 96 121 336 302
Cyprus 1 5 5 7 11 42 62 184 289
Czech Rep. 18 47 101 180 366 746 1 443 1 500 3 855
Denmark 326 608 916 1 183 1 314 1 387 1 902 2 200 1 962 2 258
Estonia 1 1 1 4 1 26 77 175
Finland 185 324 496 646 772 951 1 445 1 450 2 105 2 200
France 1 049 1 586 3 359 4 278 5 536 8 079 11 920 14 194 16 028 17 170
Georgia 2 7
Germany 790 1 534 3 470 5 875 10 236 12 979 20 656 24 055 30 150 32 500
Greece 18 46 90 162 248 348 682 764 1 050 2 173
Hungary 3 23 58 125 309 423 1 341 1 660 3 282 4 672
Iceland 2 3 4 4 12 44 59 62 28 28
Ireland 100 893 1 132 1 410 1 617 2 056 2 534 2 854 3 100 3 330
Italy 188 864 2 008 3 146 4 814 7 321 12 134 18 095 21 069 30 367
Kazakhstan 1 2
Kyrgyzstan 2
Latvia 1 1 14 39 94
Liechtenstein 14 14 19 5 3 85 111 111
Lithuania 2 3 29 40 91 173
Luxembourg 4 10 21 40 48 46 89 106 113 136
Macedonia 1 3 8 21 46 49
Malta 1 3 7 12 28 45 49 56 176
Moldova 6 10 14 15
Monaco 1 1 2 5 5 10 20 20 20 26
Netherlands 716 1 502 2 718 4 198 5 284 7 986 10 380 10 570 10 620 11 036
Norway 91 172 400 679 890 1 109 1 273 1 503 1 509 1 600
Poland 1 1 16 41 130 260 669 768 1 012 2 075
Portugal 48 85 181 257 389 535 819 944 1 131 1 696
Romania 6 15 42 61 214 269 466 1 032
Russia 5 8 15 22 56 95 132 541 1 134
San Marino, Rep of 19 19 25 30
Slovakia 5 11 27 59 135 404 575 560 522
Slovenia 3 16 43 62 99 152 467 502 521 843
Spain 43 320 586 942 1 492 2 496 4 268 6 412 8 699 12 576
Sweden 229 365 618 871 1 095 1 931 2 789 3 489 3 786 4 358
Switzerland 410 569 945 1 520 2 065 3 701 4 653 6 426 7 124 8 660
Turkey 26 65 106 270 434 606 1 284 1 607 1 672 2 287
Ukraine 1 4 7 8 14 30 56 82 151
United Kingdom 18 577 28 096 36 825 44 110 52 595 53 099 56 696 58 963 63 700 63 725*
Uzbekistan 4
Yugoslavia 1 1 1 8 136 148 255 339

Europe 23 092 37 779 55 400 71 918 92 611 109 961 143 674 166 255 190 248 220 127
Share in percent 83,02 81,12 78,73 75,61 72,72 67,58 64,31 61,13 55,36 53.87
No. of countries 24 30 34 34 36 38 42 42 47 50
*Explanatory note for the UK figure : The increase in certificates issued in the United Kingdom is the lowest ever recorded
for that country a mere 25 which might suggest that the certification market in Britain has ground to a halt. In fact, one of
the leading British certification bodies appears to have got its sums wrong in 1999 obliging us to carry out a readjustment and
subtract 1 900 certificates from the year 2000 total. Without this drastic readjustment, the total for the United Kingdom for 2000
would have rather reflected a more gradual slowdown of certification activity in Britain. It needs to be recognized that the
United Kingdom is the most mature ISO 9000 certification market in the world, Britain having had a national quality
management system standard several years in advance of the ISO standard. In addition to the slowing down, the British
market appears to be undergoing a redistribution. Another leading certification body not only showed no overall growth, but
actually regressed by 461 certificates. However, ones loss appears to be anothers gain as two certification bodies
significantly increased their market share in 2000.

Far East 1993 1993 1994 1995 1995 1996 1997 1998 1999 2000
Brunei Darussalam 2 3 5 17 46 84 108 115 193
Cambodia 1 1 1
China 10 35 150 285 507 3 406 5 698 8 245 15 109 25 657
Hong Kong, China 69 161 336 551 739 1 312 1 637 1 940 2 150 2 570
Macau, China 9 18 30
Taipei Chinese 43 96 337 1 060 1 354 1 889 2 608 3 173 3 807 4 319
Fiji 1 1 4 8 8 8 8
Indonesia 1 8 22 55 125 340 1 273 1 442 1 525 1 860
Japan 165 434 1 060 1 827 3 762 7 247 6 487 8 613 14 564 21 329
Korea, Democratic
People's
330 495
Korea, Republic of 27 87 226 390 619 892 5 806 7 729 11 533 15 424
Malaysia 122 224 258 628 690 1 123 1 610 1 707 1 921 2 355
Mongolia 1 1 1 1
Myanmar 2 4 4 4 4
Nepal 1
Papua New Guinea 7 7 7 7
Philippines 4 13 79 102 155 629 668 723 1 027
Samoa 1 1
Singapore 243 523 662 1 003 1 180 1 808 2 909 3 000 3 140 3 900
Thailand 3 9 24 95 143 182 1 104 1 236 1 527 2 553
Vietnam 1 1 13 29 164 184

Far East 683 1 583 3 091 5 979 9 240 18 407 29 878 37 920 56 648 81 919
Share in percent 2,46 3,40 4,39 6,29 7,26 11,31 13,42 13,99 16,48 20.05
No. of countries 9 11 11 12 13 14 16 18 20 21

Australia 1 668 2 695 3 710 5 299 8 834 7 252 10 547 14 170 22 833 24 772
New-Zealand 194 489 918 1 180 1 692 2 226 2 399 2 581 2 469 2 527

Australia/New-
Zealand
1 862 3 184 4 628 6 479 10 526 9 478 12 946 16 751 25 302 27 299
Share in percent 6,69 6,84 6,58 6,81 8,27 5,83 5,79 6,16 7,36 6.68
No. of countries 2 2 2 2 2 2 2 2 2 2

World results Jan '93 Sept 93 June 94 March 95 Dec. 95 Dec. 96 Dec. 97 Dec. '98 Dec. '99 Dec. '00
World total 27 816 46 571 70 364 95 117 127 349 162 701 223 299 271 847 343 643 408 631
World growth 18 755 23 793 24 753 32 232 35 352 60 698 48 548 71 796 64 988
Number of
countries
48 60 75 88 96 113 126 141 150 158
Annex B: ISO 14000 Certifications
Worldwide: Growth from 1995 to end
of 2000
Countries Dec. Dec. Dec. Dec. Dec Dec
Africa/West Asia 1995 1996 1997 1998 1999 2000
Afghanistan 1 4
Bahrain 2 2
Egypt 1 7 13 35 78
India 1 2 28 40 111 257
Iran 2 8 12 12
Israel 4 6 25 25 60
Jordan 2 8 16
Kenya 2
Lebanon 1 4 5
Mauritius 1 1 2 3 4
Morocco 1 4
Namibia 1 4
Nigeria 1
Oman 1 1 1 2
Pakistan 1 2 2 2 4
Palestine 1
Qatar 1 1 1
Saudi Arabia 1 1 3 6
South Africa 21 30 82 126
Sri Lanka 2
Syrian Arab Republic 2 3
Tunisia 1 1 3
United Arab Emirates 1 4 9 36 48
Zambia 2 2 2
Zimbabwe 4 4

Africa/West Asia 1 10 73 138 337 651
Share in percent 0,39 0,67 1,65 1,75 2,39 2,84
No. of countries 1 6 10 15 21 25

Countries Dec Dec. Dec Dec Dec Dec
Americas 1995 1996 1997 1998 1999 2000
Argentina 1 5 28 37 84 114
Barbados 3 3 3 3 3
Bolivia 1
Brazil 2 6 63 88 165 330
Chile 1 5 11
Colombia 1 3 3 13 21
Costa Rica 1 7 20
Dominican Republic 1
Ecuador 1 1 1
Guatemala 1 1 2
Honduras 2
Paraguay 1
Puerto Rico 1 4 4
Peru 4 7 13
Saint Lucia 1 2
Trinidad & Tobago 1 1
Uruguay 1 3 10 22
Venezuela 1 7 7

Central and South
Americas
3 15 98 144 309 556
Share in percent 1,17 1,01 2,21 1,83 2,19 2,43

Canada 7 27 104 276 475
Mexico 2 11 39 63 159
USA 1 34 79 291 636 1 042

North America* 1 43 117 434 975 1 676
Share in percent 0,39 2,88 2,64 5,50 6,91 7,32
*Data received from Quality Systems Update and WorldPreferred
Countries Dec. Dec. Dec. Dec. Dec Dec
Europe 1995 1996 1997 1998 1999 2000
Andorra 2
Austria 11 56 80 132 156 203
Belgium 8 37 73 74 130
Croatia 2 3 8 8
Cyprus 3 4
Czech Republic 4 42 60 116
Denmark 21 96 270 314 430 580
Estonia 1 4 18
Finland 10 41 151 206 470 508
France 3 23 52 295 462 710
Germany 35 166 352 651 962 1 260
Greece 1 6 10 20 42
Hungary 3 12 28 121 164
Iceland 1 1 2 2
Ireland 3 8 82 96 115 163
Italy 27 103 123 243 521
Latvia 4
Liechtenstein 13 19 19
Lithuania 1 1 10
Luxembourg 1 6 6 6 9
Malta 2
Monaco 2 3
Netherlands 74 119 263 341 403 784
Norway 3 13 35 61 133 227
Poland 8 15 72 66
Portugal 1 7 15 28 47
Romania 1 1 5
Russian Federation 3
Slovakia 1 6 15 24 36
Slovenia 5 12 19 88
Spain 13 92 164 573 600
Sweden 2 25 194 304 851 1 370
Switzerland 18 170 360 543 690
Turkey 3 6 44 50 66 91
United Kingdom 61 322 644 921 1492 2 534
Yugoslavia 2 2

Europe 226 948 2 626 4 254 7 365 11 021
Share in percent 87,94 63,58 59,24 53,94 52,21 48,13
No. of countries 11 20 25 29 32 36
Countries Dec Dec. Dec. Dec. Dec. Dec
Far East 1995 1996 1997 1998 1999 2000
Brunei Darussalam 2
China 9 22 94 222 510
Hong Kong, China 7 46 56 51 105
Macau, China 1 1
Taipei Chinese 2 42 183 203 216 421
Indonesia 3 45 55 55 77
Japan 4 198 713 1 542 3 015 5 556
Korea, Democratic
People's Republic of

26
Korea, Republic of 19 57 174 263 309 544
Malaysia 7 36 86 117 174
Philippines 1 11 27 39 46
Singapore 37 65 78 87 100
Thailand 58 61 126 229 310
Vietnam 2 9 9

Far East 25 419 1 356 2 532 4 350 7 881
Share in percent 9,73 28,10 30,59 32,10 30,84 34,42
No. of countries 3 10 10 11 12 14

Australia 1 53 137 352 708 1 049
New-Zealand 3 26 33 62 63

Australia/New-Zealand 1 56 163 385 770 1 112
Share in percent 0,39 3,76 3,68 4,88 5,46 4,86

World results Dec '95 Dec '96 Dec '97 Dec '98 Dec '99 Dec '00
World total 257 1 491 4 433 7 887 14 106 22 897
World growth 1 234 2 942 3 454 6 219 8 791
Number of countries 19 45 55 72 84 98


Acknowledgements for the tenth cycle

The ISO Survey of ISO 9000 and ISO 14000 Certificates is a widely distributed publication and is
recognized as being the best source of information regarding the implementation of the ISO 9000 and
ISO 14000 family of standards. This success must first and foremost be credited to the many
dedicated contributors, who have generously offered their time and competence and made this survey
what it is today. We therefore wish to express our gratitude to all those who participated by providing
us with information on their own activities or activities in their region. Without their cooperation, this
publication would not have been possible.

The ISO Survey of ISO 9000 and ISO 14000 Certificates is published annually in English by the
International Organization for Standardization (ISO).

Enquiries on the ISO Survey of ISO 9000 and ISO 14000 Certificates awarded worldwide should
be addressed to: surveyqe@iso.ch

_________________________________________________________________________________

A companion publication:
The Directory of ISO 9000 and 14000 accreditation and certification bodies -
fifth edition

The ISO Directory was published by the ISO Central Secretariat last year, after a lapse of a few years.
The main sources of information for ISO 9000 and ISO 14000 certifications are the accreditation and
certification bodies. Although ISO 9000 and ISO 14000 certificates are not awarded by ISO itself, the
need was felt for ISO to play a role in the dissemination of information regarding these bodies. This
directory will contribute to meeting that need, giving information on the national programmes in
operation in countries worldwide.

The new edition of the ISO Directory of ISO 9000 and ISO 14000 accreditation and certification bodies
provides evidence of the continuing growth of the management system conformity assessment
industry. The directory has entries for 729 bodies in 94 countries offering management system
auditing and certification/registration services to the ISO 9000 (quality management) and/or ISO 14000
(environmental managements) standards. It also includes the contact details of 41 national
accreditation bodies.

Like other ISO publications, the Directory is available from any ISO member body and from the
ISO Central Secretariat, Case postal 56, 1211 Geneva 20, Switzerland. Tel: 749 03 37,
Fax: 749 09 47 and E-mail: sales@iso.ch. Price: CHF 44,00 (plus postage).

ISO 9000

Transition Planning Guidance
for ISO 9001:2000
Document: ISO/TC 176/SC 2/N474R
March 2001

CONTENTS
1.0 INTRODUCTION
2.0 EXPLANATION OF TRANSITION PERIOD
2.1 Pre-publication period Phase One
2.2 Co-existence period Phase Two
2.2.1 Duration of Phase 2
2.2.2 ISO/TC 176 IAF ISO/CASCO
2.3 Definitions of User Groups affected by the Transition Periods
2.3.1 Current Users
2.3.1.1 Users
2.3.1.2 Users of Industry Sector Schemes and Awards
Schemes
2.3.2 Transitional / Intermediate Users
2.3.3 New Users
3.0 TRANSITION GUIDELINES FOR USER GROUPS
3.1 Current Users
3.1.1 Organizations
3.1.2 Industry Sector Schemes and Quality Awards
3.1.3 National Standards Bodies
Page 1 of 31 Transition Planning Guidance
04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/2000rev4.html?printable=true
3.1.4 Accreditation Bodies
3.1.5 Certification/Registration Bodies
3.1.6 Training Bodies and Consultants
3.2 Transitional / Intermediate Users
3.3 New Users
4.0 AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2000
5.0 SUMMARISED COMPARISON OF KEY ENHANCEMENTS BETWEEN ISO
9001:1994 / ISO 9001:2000
5.1 Requirements correlation table
5.2 Applicability
5.3 Correspondence between ISO/FDIS 9001:2000 and ISO
9001:1994
5.4 Summarised analysis of key enhancements
1.0 INTRODUCTION
Several of the key standards within the 1994 version of the ISO 9000 family of
Quality Management and Quality Assurance standards have been revised to form
the core of the ISO 9000:2000 family of standards. These revisions will include:
The merging of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 into a
single ISO 9001:2000 standard.
The merging of ISO 8402 and part of the content of ISO 9000-1 into a new
ISO 9000:2000 standard.
The revision of ISO 9004-1 into a new ISO 9004:2000 standard.
The merger of ISO 10011 (Parts 1, 2 and 3) with ISO 14010, ISO 14011 and
ISO 14012 into a new guidelines standard for quality and environmental
management system auditing (to be numbered ISO 19011).
The other 20 or so documents within the 1994 edition of the ISO 9000 family of
standards are also being formally reviewed by ISO Technical Committee ISO/TC
176, to determine whether they should be revised, amended, or withdrawn from
the ISO 9000 family etc., in light of the above revisions.
Following extensive consultation with users of the 1994 edition of the ISO 9000
standards, a number of significant changes have been incorporated in the new
standards, particularly concerning their underlying concepts and structures.
In summary, these changes will require users to approach quality management
systems as a series of processes, and not merely follow, for example, the 20
element discrete quality management system structure given in ISO 9001:1994.
This process management approach is widely used in todays business world, and
has led to the development of a process-based structure for the new standards.
This new process-based structure is compatible with the Plan-Do-Check-Act
improvement cycle used in the ISO 14000 family of standards on environmental
management systems.
This Transition Planning Guidance has been developed to assist users in
understanding the issues that need to be considered during the transition from
using ISO 9001:1994, ISO 9002:1994, or ISO 9003:1994 to ISO 9001:2000.
In detailing the Transition Planning Guidance it has been found useful to provide
specific guidance to distinct User Groups, as follows:
Current Users
Transitional / Intermediate Users
New Users
2.0 EXPLANATION OF TRANSITION PERIOD
The Transition Period was two distinct phases:
a) Phase One
This relates to the period when ISO 9001:2000 is being developed, until the issue
of the approved International Standard. The following development stages were
included in Phase one and they have now been completed:
CD1 (completed):The First Committee Draft (released for comment)
CD2 (completed):The Second Committee Draft (released for comment /
ballot)
DIS (completed): Draft International Standard (released for comment /
ballot)
FDIS (started Sep 00): Final Draft International Standard (for ballot)
b) Phase Two
This is the period after ISO 9001:2000 has been published, and during which
accredited certification/registration to the 1994 editions of ISO 9001, ISO 9002, or
ISO 9003 continues to be available, in addition to accredited
certification/registration to ISO 9001:2000.
The above phases and their relationship with various user groups are illustrated in
the Transition Process Model (see Figure 1).
2.1 Pre-publication period - Phase One
This phase has a direct impact on user groups that have already implemented ISO
9001:1994, ISO 9002:1994, ISO 9003:1994 or ISO 9004:1994 regardless of
whether they have sought certification/registration (see annex A, items 1 and 3). It
is expected that the following user groups were affected during the phase, which
has been completed:
Individual organizations using ISO 9001/9002/9003 (including industry
associations)
Industry Sector Schemes and Award Schemes
National Standards Bodies (NSBs)
Accreditation Bodies(ABs)
Certification/Registration Bodies(CB/RBs)
Trainers and Consultants
2.2 Co-existence period - Phase Two
2.2.1 Duration of Phase 2
This phase concerns the co-existence of the availability of accredited certification to
the1994 editions of ISO 9001, ISO 9002, or ISO 9003 and to ISO 9001:2000. The
same user groups identified in 2.1 will be affected.
This phase will last from 15 December 2000 to 15 December 2003, during which
users will have to upgrade their quality management systems to meet the
requirements of ISO 9001:2000.
In acknowledgement of Certification/Registration Body interests and the contractual
issues relevant to certification/registration in various countries, it is highly
recommended that users contact their Certification/Registration Body, or relevant
Accreditation Body, for advice regarding the details or time frame for implementing
ISO 9001:2000. This is particularly important when their certificate is subject to
expiration based on a periodic audit.
2.2.2 ISO/TC 176 IAF ISO/CASCO
In September 1999 a joint meeting was held between the International
Accreditation Forum (IAF), ISO/TC176 and ISO/CASCO (ISO Committee for
conformity assessment), to establish common and consistent messages to ensure a
smooth transition to the new standards.
As a result of this meeting, a joint communiqu was issued detailing five specific
points concerning the transition to ISO 9001:2000. A copy of this communiqu is
given in Annex A. Further guidance regarding the Application (Clause 1.2 of ISO
9001:2000), and the implications for Scope Statements for certification purposes, is
available from web site http://www.bsi.org.uk/iso-tc176-sc2.
One of the five points specifies a maximum period of three years for the co-
existence of accredited certification to the 1994 and year 2000 editions of ISO 9001
(see Annex A, items 1 to 3). The IAF will co-ordinate enforcement of this policy by
the Accreditation Bodies.
ISO/CASCO has also been requested to determine how the current guidelines
(ISO/IEC Guide 61 and ISO/IEC Guide 62) that are followed by
Certification/Registration and Accreditation Bodies are affected by the new ISO
9001:2000. ISO/CASCO will liaise with ISO/TC176 and the IAF during revisions of
these Guides.
ISO 9001:1994 to ISO 9001:2000 Transition Model

Figure 1
2.3 Definition of User Groups affected by the Transition Periods
2.3.1 Current Users
2.3.1.1 Users of ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994
This user group category is defined as having completed the implementation of ISO
9001:1994, ISO 9002:1994 or ISO 9003:1994, regardless of whether or not they
are certified.
User groups that are in the process of implementing ISO 9001:1994, ISO
9002:1994 or ISO 9003:1994 are addressed as Transitional / Intermediate Users
(see 2.3.2).
2.3.1.2 Users of Industry Sector Schemes, based on ISO 9001:1994,ISO
9002:1994 or ISO 9003:1994 and Awards Schemes
This user group can be divided into two categories:
The first group is defined as those using quality management system programmes
based on ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 that include additional
quality management system requirements. These form a set of criteria that can
either be certified or accredited under the guidelines of a particular Industry Sector
Scheme (e.g. ISO/TS 16949 Quality systems Automotive suppliers Particular
requirements for the application of ISO 9001:1994).
The second group is defined as those using business excellence models
incorporating part of ISO 9001: 1994
This category of user may be certified or may have no intention to pursue third
party certification.
2.3.2 Transitional / Intermediate Users
This user category has been defined as those who are in the process of
implementing ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 and have not yet
reached full implementation of the standards' requirements.
This category also includes users of Industry Sector Schemes and Award Schemes.
It is recognized that this category may also include users who have started to
implement quality management systems based on a draft version of the ISO
9001:2000 standard.
This category of user may either be in the process of seeking
certification/registration, intending to pursue certification/registration in the near
future, or have no intention of becoming certified/registered.
2.3.3 New Users
A New User is defined as an organisation that is either:
a. Beginning to use ISO 9001:2000 for the first time;
b. Beginning to implement ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994
for the first time;
c. Is a potential user.
3.0 TRANSITION GUIDELINES FOR USER GROUPS
3.1 Current Users
3.1.1 Organizations using ISO 9001:1994, ISO 9002:1994 or ISO
9003:1994
Organisations certified to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 are
recommended to contact their specific Certification / Registration Body to discuss
the time frame for re-certification or upgrade of current certificates.
To facilitate a smooth transition from ISO 9001:1994, ISO 9002:1994 or ISO
9003:1994 to the ISO 9001:2000 revision (refer figure 2), the following key areas
have been identified as important to this user group:
Internal Auditor training (focusing on the changes between the current and
the new standards)
Management awareness (focusing on the benefits that can be added to
business as a result of the new approach in the new standard, the structure of
the new standard and the proactive top management role)
General staff awareness programs (to encourage total involvement and
understanding)
An understanding of process management
If all the requirements of ISO 9001:2000 cannot be applied in an
organisation, a clear understanding of the concept and criteria for the
justification of any "exclusions" will be necessary (see 6.2).
3.1.2 Industry Sector Schemes and Quality Awards
In general, Industry Sector Schemes are based on a relevant 1994 edition of an
ISO 9000 standard and are supplemented with additional requirements and/or a
higher level of compliance criteria.
In consideration of ISO 9001:2000s introduction of a process management
approach, it is recommended that these user groups commence a strategic plan to
assess the continuing suitability or need for supplemental requirements as soon as
possible.
The evaluation of supplemental requirements should be based on ISO 9001:2000.


KEY CONSIDERATIONS
Ref. Box 1
Use ISO 9001:2000
Scope of upgraded certificate, taking in account the application of the
Figure 2
While developing supplemental requirements to ISO 9001:2000, it is recommended
that the relevant user groups seek:
to ensure consistent interpretation of the ISO 9001:2000 requirements
to establish close relationships with the National Standards Bodies
standard (Clause 1.2)
Access to ISO Web Site
Access to SC2 Web Site
Ref. Box 2 (text is self explanatory)
Ref. Box 3
Continuing suitability of current 20 element system structure
Expert guidance with respect to Process Management approach
Determine applicability of ISO 9001:2000 to meet the specific operational
functions of the organisation
Ref. Box 4
Process Management orientation of the system
Ref. Box 5
Internal system review
Initial preliminary evaluation by Certification Body
Ref. Box 7
Training needs
Ref. Box 8
Management training/awareness of Process Management approach
Assistance in awareness may be sought from the Frequently Asked
Questions accessible on the ISO Web Site
Ref. Box 9
Enhancement of internal auditor process
Enhancement of internal training & qualifications
Ref. Box 11
Use of ISO 9004:2000 as a further information source for improvement of
quality performance
Expertise of persons involved in the redesign process
to establish close relationships with relevant Certification / Registration Bodies
or Accreditation Bodies
A consideration for Quality Award related Schemes, or similar programmes, is the
role of ISO 9004:2000 in providing guidance for performance improvement and in
assisting organizations to move toward TQM.
Although ISO 9004:2000 is a guidance, and not a requirements document, Quality
Award Schemes etc. may find it prudent to consider this document in their
processes, as ISO 9004:2000 includes an annex on organizational self-assessment.
3.1.3 National Standards Bodies (NSBs)
a) Information Focal Point
NSBs should be one of the primary information sources for organizations needing
assistance during the transition period.
It is recommended that NSBs establish a focal information point where assistance
can be obtained on problems that may be encountered during the initial application
of ISO 9001:2000 and related transition issues. These may include, for example,
questions relating to transition period timing, statutory issues, withdrawal of ISO
9001:1994, ISO 9002:1994 and ISO 9003:1994, interpretation, application, etc.
This will also provide a solid base for consistent communication with all interested
parties / user groups.
b) Information output to Users and Interested Parties
In an effort to provide a smooth transition for users and interested parties,
information regarding the ISO 9001:2000 revision of the standard should be
communicated in a timely manner.
It is recommended that NSBs synchronise their information programmes with the
information flows from ISO and ISO/TC 176 (www.bsi.org.uk/iso-tc176-sc2) and
reuse as much first hand information as considered relevant.
The information provided should also advise on the relationship and use of other
standards (or documents) in the new ISO 9000:2000 series, especially ISO
9004:2000 and ISO 9000:2000.
c) Translation Issues
If a requirement for translation of the new standards exists, the translation process
should be started immediately. This may be of particular importance, given the
significance of the changes that have been incorporated into ISO 9001:2000
compared with the previous content of ISO 9001:1994, ISO 9002:1994 and ISO
9003:1994.
(ISO/TC176 will soon be issuing a document "Translation tips" to provide guidance
on this subject.)
3.1.4 Accreditation Bodies
Accreditation Bodies should consider the need for reassessment of the accreditation
of individual Certification / Registration Bodies.
Auditor competence is expected to play a major role during the transition period.
Consideration should be given to the criteria that will be used to assess auditor
competency in performing audits that verify compliance to ISO 9001:2000.
The recent IAF, ISO/TC 176, ISO/CASCO communiqu has established a policy for
consistent accreditation assessment of the competency of Certification/Registration
Body personnel with respect to the new standards (see annex A, item 4), in an
effort to ensure that all accreditation bodies use uniform criteria.
3.1.5 Certification/Registration Bodies
The changes in the standards are expected to place a relatively heavy burden on
the Certification/ Registration Bodies. Not only will they have to plan to meet the
changes for their customer organizations, but they will have to plan to address the
changes within their own organizations. Many of the items of direct concern to the
Certification/ Registration Bodies during the transition period have been addressed
by the IAF, ISO/TC 176, ISO/CASCO agreement (see annex A).
The following are some of the aspects that should be considered by Certification/
Registration Bodies during the transition process:
Timing of assessment and certification activities based on ISO9001:2000
Arrangement of assessment schedules for existing customer organizations
Training of auditors
Protocols for encouraging users to implement ISO 9001:2000
Timely administration of upgraded certificates
The Certification/Registration Bodies will be one of the primary information sources
for organizations seeking assistance during the transition period.
It is important that the information they provide is well co-ordinated and consistent
with other Certification / Registration Bodies. To facilitate this process, it is
recommended that the Accreditation Bodies or NSBs participate in this co-ordination
task.
Most importantly, Certification / Registration Bodies will have the task of informing
their existing customer base of certified/registered organisations of the new
developments concerning ISO 9001:2000. This should be followed-up by regular
communication on the implementation of expected changes in the standard,
renewals of certification, individual transition arrangements etc., to avoid any
unnecessary confusion.
The competence of their auditors to assess to ISO 9001:2000 should be a major
item for consideration by Certification/Registration Bodies during the transition
period. It will be necessary to ensure that auditors receive appropriate training to
achieve the required levels of competence. It is recommended that Certification/
Registration Bodies start their auditor training programmes as soon as possible.
It is expected that a considerable number of current users will request upgrade
audits as soon as possible, to enable them to utilise their audit reports to facilitate
their own transition processes. Certification/Registration Bodies should therefore
schedule formal assessments to start against the revised ISO 9001:2000 standard.
However, following the IAF, ISO/TC 176, ISO/CASCO agreement, accredited
certificates may not be granted compliance with ISO 9001.2000 is ensured (see
annex A, items 1-3). (see annex A, items 13).
Note: Due to the process management approach of ISO 9001:2000,
current users who are considering "integrated" management systems
may wish to accelerate the implementation of such integrated systems.
This in turn will require Certification/ Registration Bodies to respond
accordingly and adopt an integrated audit approach.
3.1.6 Training Bodies and Consultants
Training Bodies and consultants have an important role to play in the transition
process and are paramount to the success of a smooth transition from ISO
9001:1994, ISO 9002:1994 and ISO 9003:1994 to ISO 9001:2000.
With respect to auditor training, consideration should be given to the currency of
existing auditor certification and the protocol to upgrade these auditors.
In the past, the 1994 revisions of these standards did not pose the same level of
transition complication, due to the low extent of changes that were introduced when
compared to the earlier 1987 editions. ISO 9001:2000 revision, provides a number
of significant changes that will require sound interpretation of its requirements.
All trainers and consultants should be aware that the issue of a process
management approach is the key to the application of ISO 9001:2000, and should
also be knowledgeable of the revised requirements.
It is recommended that training bodies start to meet the need for competent
auditors and other personnel, by preparing suitable courses based on ISO
9001:2000. The training should be divided into different user applications and be
based on factual interpretations and not opinions (see annex A, item 4).
3.2 Transitional / Intermediate Users
Transitional / Intermediate users are those who either have implemented, or are
currently in the process of implementing, ISO 9001:1994, ISO 9002:1994 or ISO
9003:1994.
Due to the change from the current 20 system element structure of the 1994 family
of ISO 9000 standards to that of a process management approach, it is strongly
recommended that this user group review their systems, or the development of
their systems, against the requirements of ISO 9001:2000.
Users with established systems should not just discard them, as parts will continue
to be required under ISO 9001:2000. However, some system documentation may
need to be revised or enhanced to meet the requirements of ISO 9001:2000.
Transitional / Intermediate users should consult with their Certification/Registration
Bodies or National Standards Bodies, in order to ensure that their information on
the transition of the standards is kept up-to-date.
3.3 New Users
Some new users may be currently considering the implementation of ISO
9001:1994, ISO 9002:1994 or ISO 9003:1994, it is recommended that they also
evaluate their quality system objectives with a view to implementing ISO
9001:2000.
Some portions of the 1994 editions of ISO 9001, ISO 9002 and ISO 9003 have
been consolidated into ISO 9001:2000.
Care should be taken when sourcing training or professional assistance during the
implementation of ISO 9001:2000, due to its new structure and process
management approach.
New users should commence implementation using ISO 9001:2000.
4.0 AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2000
It is of utmost importance to ensure the most uniform application of the
standard possible, given the inevitable variations caused by linguistic
differences.
The first contact for information regarding the requirements of ISO
9001:2000 should be limited to National Standards Bodies. It is
however, anticipated that organizations that have already established a
working relationship with Certification / Registration Bodies, may feel
more comfortable discussing ISO 9001:2000 requirements with them.
Other recommended sources of information are:
ISO maintains a Web Site www.iso.ch that carries general
information regarding the ISO 9001:2000 and ISO 9004:2000
revision program.
ISO/TC176 maintains a Web Site www.tc176.org which includes general
information on the structure and work programme of ISO/TC176
including links to related password-protected and public websites
The ISO/TC176/SC 2 Web Site (www.bsi.org.uk/iso-tc176-sc2) carries
detailed information on the ISO 9001/9004 revision program, updated
on a regular basis.
5.0 SUMMARISED COMPARISON OF KEY ENHANCEMENTS BETWEEN ISO
9001:1994 / ISO 9001:2000
A comparison between ISO 9001:1994 and ISO 9001:2000 related to key
enhancements is given in chapter 5.4 to assist the user in identifying the scope of
revisions to ISO 9001:2000. It is important to note that this comparison is not done
"word by word", it only contains a summary of salient issues relevant to ISO
9001:2000 in consideration of current ISO 9001:1994 requirements.
It is strongly recommended that the user obtain a copy of latest draft of ISO
9001:2000 from their respective ISO member body.
5.1 Requirements correlation table between ISO 9001:2000 and ISO
9001:1994
In the following table, the numbers in brackets show briefly how the quality system
requirements of ISO 9001:1994 fit into the new ISO 9001:2000, clauses 5 to 8.
It should be noted that although some clauses in ISO 9001:2000 have the same
title as in ISO 9001:1994, the contents may not be exactly the same and the
requirements may have been enhanced.
5 Management Responsibility
5.1 Management commitment (4.1/ 4.1.2.2/4.2.1)
5.2 Customer focus
5.3 Quality policy (4.1.1)
5.4 Planning (4.1.1/ 4.2.1/4.2.3)
5.5 Responsibility, authority and communication
(4.1.2/4.1.2.1/ 4.1.2.3/4.2.1/4.5/4.16)
6 Resource management
6.1 Provision of resources (4.1.2.2)
6.2 Human resources (4.1.2.1/4.18)
6.3 Infrastructure(4.9)
6.4 Work enviroment (4.9)
7 Product realization
7.1 Planning of product realization
(4.2.3/4.9/4.10/ 4.15/4.19)
7.2 Customer-related processes (4.3/4.7)
7.3 Design and development (4.4)
7.4 Purchasing (4.6)
7.5 Production & service provision (4.7/4.8/4.9/4.15/4.19)
8 Measurement, Analysis &
Improvement
8.1 General (4.10/4.20)
8.2 Monitoring and measurement
(4.10/4.17/4.20)
8.3 Control of nonconforming product (4.13)
8.4 Analysis of data (4.14/4.20)
8.5 Improvement (4.1.3/4.9/4.14)
5.2 Application of ISO 9001:2000
Previously, an organization was able to seek certification against either ISO
9001:1994, ISO 9002:1994 or ISO 9003:1994 dependent on the scope of their
business operations.
The publication of ISO 9001:2000 resulted in ISO 9001:1994, ISO 9002:1994 and
ISO 9003:1994 becoming obsolete after 15 December 2003. This will require that
organizations upgrade their existing certification if already certified, or that they
seek certification to ISO 9001:2000.
However, it is recognized that owing to:
a. the nature of an organization's product;
b. customer requirements;
c. applicable regulatory requirements;
not all the requirements of ISO 9001:2000 may be appropriate to every
organization.
Therefore ISO 9001:2000 will permit organizations to exclude compliance with
specific quality management system requirements that neither affect their ability,
nor absolve them from their responsibility, to provide product that meets customer
and applicable regulatory requirements, yet still allow those organizations to claim
conformity to the standard.
Exclusions will be restricted to clause 7 Product realization of ISO 9001:2000 and
will not apply to any other clauses of the standard. Details of justification for any
exclusions will have to be documented in the organisations Quality Manual.
It is recommended that users discuss any intention to exclude certain clauses of
ISO 9001:2000 with their selected Certification/Registration Body (see annex A,
item 5), and refer to the Guidance on this topic that is available from the
ISO/TC176/SC2 Website (see Section 4.0).
5.3 Correspondence between ISO 9001:1994 and ISO/FDIS 9001:2000
ISO 9001:1994 ISO/FDIS 9001:2000
1 Scope 1
2 Normative reference 2
3 Definitions 3
4 Quality system requirements [title only]

4.1 Management responsibility [title only]

4.1.1 Quality policy 5.1 + 5.3 + 5.4.1
4.1.2 Organization [title only]

4.1.2.1 Responsibility and authority 5.5.1
4.1.2.2 Resources 5.1 + 6.1 + 6.2.1 + 6.3
4.1.2.3 Management representative 5.5.2
4.1.3 Management review 5.6.1 + 5.6.2 + 5.6.3 + 8.5.1
4.2 Quality system [title only]

4.2.1 General 4.1 + 4.2.1 + 4.2.2 + 5.1 + 5.4.1
4.2.2 Quality system procedures 4.2.1
4.2.3 Quality planning 5.4.2 + 6.2.1 + 7.1
4.3 Contract review [title only]

4.3.1 General

4.3.2 Review 5.2 + 7.2.1 + 7.2.2 + 7.2.3
4.3.3 Amendment to a contract 7.2.2
4.3.4 Records 7.2.2
4.4 Design control [title only]

4.4.1 General

4.4.2 Design and development planning 7.3.1
4.4.3 Organizational and technical interfaces 7.3.1
4.4.4 Design input 7.2.1 + 7.3.2
4.4.5 Design output 7.3.3
4.4.6 Design review 7.3.1 + 7.3.4
4.4.7 Design verification 7.3.1 + 7.3.5
4.4.8 Design validation 7.3.1 + 7.3.6
4.4.9 Design changes 7.3.7
4.5 Document and data control [title only]

4.5.1 General 4.2.1 + 4.2.3
4.5.2 Document and data approval and issue 4.2.3
4.5.3 Document and data changes 4.2.3
4.6 Purchasing [title only]

4.6.1 General

4.6.2 Evaluation of subcontractors 7.4.1
4.6.3 Purchasing data 7.4.2
4.6.4 Verification of purchased product 7.4.3
ISO 9001:1994 ISO/FDIS 9001:2000
4.7 Control of customer-supplied product 7.5.4
4.8 Product identification and traceability 7.5.3
4.9 Process control 6.3 + 6.4 + 7.1 + 7.5.1 + 7.5.2 + 8.2.3
4.10 Inspection and testing [title only]

4.10.1 General 7.1 + 8.1
4.10.2 Receiving inspection and testing 7.4.3 + 8.2.4
4.10.3 In-process inspection and testing 7.4.3 + 7.5.1 + 8.2.4
4.10.4 Final inspection and testing 7.4.3 + 8.2.4
4.10.5 Inspection and test records 7.5.3 + 8.2.4
4.11 Control of inspection, measuring and test equipment
[title only]

4.11.1 General 7.6
4.11.2 Control procedure 7.6
4.12 Inspection and test status 7.5.3
4.13 Control of nonconforming product [title only]

4.13.1 General 8.3
4.13.2 Review and disposition of nonconforming product 8.3
4.14 Corrective and preventive action [title only]

4.14.1 General 8.5.2 + 8.5.3
4.14.2 Corrective action 8.4 + 8.5.2
4.14.3 Preventive action 8.4 + 8.5.3
4.15 Handling, storage, packaging, preservation &
delivery [title only]

4.15.1 General

4.15.2 Handling 7.5.5
4.15.3 Storage 7.5.5
4.15.4 Packaging 7.5.5
4.15.5 Preservation 7.5.5
4.15.6 Delivery 7.5.1 + 7.5.5
4.16 Control of quality records 4.2.4
4.17 Internal quality audits 8.2.2 + 8.2.3
4.18 Training 6.2.1 + 6.2.2
4.19 Servicing 7.1 + 7.5.1
4.20 Statistical techniques [title only]

4.20.1 Identification of need 8.1 + 8.2.3 + 8.2.4 + 8.4
4.20.2 Procedures

ISO/FDIS 9001:2000 ISO 9001:1994
1 Scope 1
1.1 General

1.2 Application

2 Normative references 2
3 Terms and definitions 3
4 Quality management system [title only]

4.1 General requirements 4.2.1
4.2 Documentation requirements [title only]

4.2.1 General 4.2.1 + 4.5.1
4.2.2 Quality manual 4.2.1
4.2.3 Control of documents 4.5.1 + 4.5.2 + 4.5.3
4.2.4 Control of quality records 4.16
5 Management responsibility [title only]

5.1 Management commitment 4.1 + 4.1.2.2 + 4.2.1
5.2 Customer focus 4.3.2
5.3 Quality policy 4.1.1
5.4 Planning [title only]

5.4.1 Quality objectives 4.1.1 + 4.2.1
5.4.2 Quality management system planning 4.2.3
5.5 Responsibility, authority and communication [title
only]

5.5.1 Responsibility and authority 4.1.2.1
5.5.2 Management representative 4.1.2.3
5.5.3 Internal communication

5.6 Management review [title only] 4.1.3
5.6.1 General 4.1.3
5.6.2 Review input 4.1.3
5.6.3 Review output 4.1.3
6 Resource management [title only]

6.1 Provision of resources 4.1.2.2
6.2 Human resources [title only]

6.2.1 General 4.1.2.2 + 4.2.3 + 4.18
6.2.2 Competence, awareness and training 4.18
6.3 Infrastructure 4.1.2.2 + 4.9
6.4 Work environment 4.9
7 Product realization [title only]

7.1 Planning of product realization 4.2.3 + 4.9 + 4.10.1
7.2 Customer-related processes [title only]

7.2.1 Determination of requirements related to the
product
4.3.2 + 4.4.4
7.2.2 Review of requirements related to the product 4.3.2 + 4.3.3 + 4.3.4
7.2.3 Customer communication 4.3.2
ISO/FDIS 9001:2000 ISO 9001:1994
7.3 Design and development [title only]

7.3.1 Design and development planning 4.4.2 + 4.4.3 + 4.4.6 + 4.4.7 + 4.4.8
7.3.2 Design and development inputs 4.4.4
7.3.3 Design and development outputs 4.4.5
7.3.4 Design and development review 4.4.6
7.3.5 Design and development verification 4.4.7
7.3.6 Design and development validation 4.4.8
7.3.7 Control of design and development changes 4.4.9
7.4 Purchasing [title only]

7.4.1 Purchasing process 4.6.2
7.4.2 Purchasing information 4.6.3
7.4.3 Verification of purchased product 4.6.4 + 4.10.2 + 4.10.3 + 4.10.4
7.5 Production and service provision [title only]

7.5.1 Control of production and service provision 4.9 + 4.10.3 + 4.15.6 + 4.19
7.5.2 Validation of processes for production and service
provision
4.9
7.5.3 Identification and traceability 4.8 + 4.10.5 + 4.12
7.5.4 Customer property 4.7
7.5.5 Preservation of product 4.15.2 + 4.15.3 + 4.15.4 +.4.15.5 + 4.15.6
7.6 Control of monitoring and measuring devices 4.11.1 + 4.11.2
8 Measurement, analysis and improvement <[title
only]

8.1 General 4.10 + 4.17 + 4.20.1
8.2 Monitoring and measurement [title only]

8.2.1 Customer satisfaction


5.4 Summarized analysis of key enhancements between ISO 9001:1994 /
ISO 9001:2000
SCOPE
ISO 9001:2000 - Clause 1.1 "General"
The Scope has been enhanced, including also the
requirements to address customer satisfaction through the
effective application of the system, including
processes for continual improvement and the assurance
of conformity
ISO 9001:1994 - Clause 1 corresponds
The requirements specified are aimed primarily at achieving
customer satisfaction by preventing nonconformity
ISO 9001:2000 - Clause 1.2 "Application"
This clause is new and is a general description of the
application of the standard.
Where any requirement(s) of this International Standard
cannot be applied due to the nature of the organization and
its product, this can be considered for exclusion
Where exclusions are made, claims of conformity to this
International Standard are not acceptable unless these
exclusions are limited to requirements within clause 7, and
such exclusions do not affect the organizations ability, or
responsibility, to provide product that fulfils customer and
applicable regulatory requirements.
There is no corresponding ISO 9001:1994 clause
TERMS AND DEFINITIONS
8.2.2 Internal audit 4.17
8.2.3 Monitoring and measurement of processes 4.9 + 4.17 + 4.20.1
8.2.4 Monitoring and measurement of product 4.10.2 + 4.10.3 + 4.10.4 + 4.10.5 + 4.20.1
8.3 Control of nonconforming product 4.13.1 + 4.13.2
8.4 Analysis of data 4.14.2 + 4.14.3 + 4.20
8.5 Improvement [title only]

8.5.1 Continual improvement 4.1.3
8.5.2 Corrective action 4.14.1 + 4.14.2
8.5.3 Preventive action 4.14.1 + 4.14.3
ISO 9001:2000 - Clause 3 "Terms and Definitions"
This clause states that the terms and definitions given in
ISO 9000:2000 Quality management systems
Fundamentals and vocabulary, apply to ISO
9001:2000.
The term organization replaces the term supplier, used
in ISO 9001:1994, and refers to the unit to which this
International Standard applies. Also, the term supplier"
now replaces the term subcontractor
Throughout the text of this International Standard,
wherever the term "product" occurs, it can also mean
"service"
ISO 9001:1994 - Clause 3 corresponds
The definitions that are given in ISO 8402 apply.
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
ISO 9001:2000 - Clause 4.1 "General Requirements"
Under this clause more emphasis has been added on the
need for continual improvement.
Clarification of the necessary steps to implement a quality
management system is given:
a) identify the processes needed for the quality
management system, and their application
throughout the organization
b) determine the sequence and interaction of
these processes,
c) determine criteria and methods needed to
ensure that both the operation and control of
these processes are effective
d) ensure the availability of resources and
information necessary to support the operation
and monitoring of these processes
e) measure, monitor and analyse these
processes, and
f) implement actions necessary to achieve
planned results and continual improvement of
these processes.
ISO 9001:1994 Clause 4.2.1 corresponds
ISO 9001:2000 - Clause 4.2.1 "General"
Under this clause, an indication is given about the quality
management system documentation required.
"The quality management system documentation shall
include:
a) documented statements of a quality policy
and quality objectives
b) quality manual
c) documented procedures required by this
International Standard
d) documents required by the organization to
ensure the effective planning, operation and
control of its processes
e) records required by this International
Standard"
This clause also requires an organization to ensure control
over any process that it chooses to outsource if the process
affects product confomity with requirements. Control of
such processes shall be identified within the quality
management system.
ISO 9001:1994 Clause 4.2.2 corresponds
ISO 9001:2000 - Clause 4.2.2 "Quality manual"
This clause has been enhanced to include the requirement
for an organization to specify and justify any exclusion in
the quality manual (refer to clause 1.2 of ISO 9001:2000).
The quality manual shall also have a description of the
sequence and interaction of the processes included in the
quality management system
ISO 9001:1994 - Clause 4.2.1 corresponds
MANAGEMENT RESPONSIBILITY
ISO 9001:2000 - Clause 5.1"Management commitment"
More emphasis is placed on Top management commitment.
Particular attention should be given to subclauses (a), (b),
(c) and (e). The latter refers to resources and has a direct
link to clause 6 "Resource Management".
a) communicating to the organization the
importance of meeting customer as well as
statutory and regulatory requirements;
b) establishing the quality policy;
c) ensuring that quality objectives are
established
d) ensuring the availability of resources
ISO 9001:1994 Clauses 4.1; 4.1.2.2 and 4.2.1 correspond
ISO 9001:2000 - Clause 5.2 "Customer focus"
This clause reinforces the involvement of top management
with customer requirements.
It states that Top management shall ensure that customer
requirements are determined and fulfilled with the aim of
enhancing customer satisfaction
ISO 9001:2000 - Clause 5.3 "Quality Policy"
This clause has been enhanced to ensure that Top
management establishes its policy for quality. Particular
attention should be given to subclause (b) which includes a
commitment to comply with requirements and
continually improve the effectiveness of the quality
management system, and subclause (c) which provides
a framework for establishing and reviewing quality
objectives;
ISO 9001:2000 - Clause 5.4.1 "Quality objectives"
Under this clause, the requirement for quality objectives,
at relevant functions and levels within the
organization has been enhanced.
It also states that the quality objectives shall be measurable
and consistent with the quality policy.
ISO 9001:1994 - Clause 4.1.1 and 4.2.1 correspond
ISO 9001:2000 - Clause 5.4.2 "Quality management system
planning"
This clause has been revised for clarity and to ensure that
managing change is included in planning.
Top management shall ensure that
a) the planning of the quality management system is
carried out in order to meet the requirements given in
4.1 as well as the quality objectives and
b) the integrity of the quality management system is
maintained when changes to the quality management
system are planned and implemented
ISO 9001:2000 - Clause 5.5.2 "Management Representative"
This clause now further clarifies that Top management shall
appoint a member of the management who, irrespective of
other responsibilities, shall have defined authority that
includes:
c) ensuring the promotion of awareness of
customer requirements throughout the
organization
ISO 9001:1994 - Clause 4.1.2.3 corresponds
ISO 9001:2000 - Clause 5.5.3 "Internal Communication"
This is a new clause that requires the Top management to
ensure that appropriate communication processes are
established within the organization and that communication
takes place regarding the effectiveness of the quality
management system
ISO 9001:2000 - Clause 5.6 "Management Review"
Further text has been included to address key input and
output requirements of a Management review.
Attention should be given to input related subclauses:
(b) customer feedback; (c) process performance and
product conformity; and (d) status of preventive and
corrective actions (f) planned changes that could
affect the quality management system.
And output related subclauses:
(a) improvement of the effectiveness of the quality
management system and its processes and (b)
improvement of product related to customer
requirements
RESOURCE MANAGEMENT
ISO 9001:2000 - Clause 6.1 "Provision of resources"
This clause further clarifies the requirement for an
organization to determine and provide the resources needed
to implement and maintain the quality management system
and continually improve its effectiveness, and to enhance
customer satisfaction.
ISO 9001:1994 - Clause 4.1.2.2 corresponds
ISO 9001:2000 - Clause 6.2.2 "Competence, awareness and
training"
The scope of this clause has been enhanced to include not
only training needs but competence and awareness. The
organization shall:
a) determine the necessary competence for
personnel performing work affecting product
quality,
b) provide training or take other actions to
satisfy these needs evaluate the effectiveness of
the actions taken
c) ensure that its personnel are aware of the
relevance and importance of their activities and
how they contribute to the achievement of the
quality objectives;
d) maintain appropriate records of education,
training, skills and experience.
ISO 9001:1994 - Clause 4.18 corresponds
ISO 9001:2000 - Clause 6.3 "Infrastructure"
The organization shall determine, provide and maintain the
infrastructure needed to achieve the conformity to product
requirements. Infrastructure includes, as applicable
a) building, workspace and associated utilities
b) process equipment, (both hardware and
software)
c) supporting services (such as transport and
communication)
Under this clause the primary requirement is to ensure
processes are carried out under controlled conditions.
ISO 9001:2000 - Clause 6.4 "Work Environment"
The organization shall determine and manage the work
environment needed to achieve conformity to product
requirements.
PRODUCT REALIZATION
Note: The title of Process Control as traditionally referred to
in ISO 9001:1994 has been replaced with the title "Product
Realization".
ISO 9001:2000 - Clause 7.1 "Planing of product realization"
Special attention shall be put on subclauses (a) to (d) that
further clarify requirements that shall be met to ensure
product realization processes are under control.
ISO 9001:1994 - Clause 4.2.3; 4.9; 4.10; 4.15 and 4.19
correspond
ISO 9001:2000 - Clause 7.2.1 "Determination of requirements
related to the product"
Under this clause, three new requirements have been added
in the process of determining customers needs. They are:
a) requirements not stated by the customer but
necessary for specified or intended use, where
known;
b) statutory and regulatory requirements
related to the product
c) any additional requirements determined by
the organization
ISO 9001:2000 - Clause 7.2.3 "Customer communication"
This clause is essentially a new requirement. The
organization is required to determine and implement
effective arrangements for communicating with customers.
In defining its communication requirements the organization
is required to meet a number of subclause requirements
from (a) to (c)
There is no corresponding SO 9001:1994 clause
ISO 9001:2000 - Clause 7.3.2 "Design and development
Inputs"
This clause has been enhanced to include clarification of the
design input requirements that are to be met. Particular
attention should be given to the following subclause:
a) functional and performance requirements
ISO 9001:2000 - Clause 7.3.4 "Design and development Review"
This clause has been enhanced to clarify that design and
development reviews must be systematic in ensuring
conformance with input requirements. If during the review
process a problem is identified, the organization shall
propose necessary actions.
In addition to recording reviews, the results of any
necessary actions SHALL be recorded.
ISO 9001:2000 - Clause 7.3.7 "Control of design and
development changes"
This clause now includes a requirement for the organization
to determine the effect of change on constituent parts and
product already delivered. The changes shall be reviewed,
verified and validated, as appropriate, and approved before
implementation.
ISO 9001:2000 - Clause 7.5.2 "Validation of processes for
production and service operation"
This clause now includes a requirement for the organization
to carry out process validation.
The organization shall establish arrangements for these
processes, including, as applicable:
a) defined criteria for review and approval of
the processes
b) approval of equipment and qualification of
personnel
c) use of specified methods and procedures
d) requirements for records
e) re-validation
MEASUREMENT, ANALYSIS AND IMPROVEMENT
ISO 9001:2000 - Clause 8.1 "General"
This clause requires that monitoring, measurement, analysis
and improvement processes needed to demonstrate
conformity of the product, ensure conformity of the quality
management system and continually improve the
effectiveness of the quality management system shall be
planned and implemented.
This shall include the determination of applicable methods,
including statistical techniques, and the extent of their use.
ISO 9001:1994 - Clause 4.10 and 4.20 correspond
ISO 9001:2000 - Clause 8.2.1 "Customer satisfaction"
This clause is new and emphasizes that the organization
shall monitor information relating to customer perception as
to whether the organisation has fulfilled customer
requirements.
ISO 9001:2000 - Clause 8.2.2 "Internal audit"
This clause has been enhanced by:
Selection of auditors and conduct of audits shall ensure
objectivity and impartiality of the audits process
ISO 9001:1994 Clause 4.17 corresponds
ISO 9001:2000 - Clause 8.2.3 " Monitoring and measuring of
processes"
This clause has been enhanced by:
These methods shall demonstrate the ability of the
processes to achieve planned results.
ISO 9001:1994 Clause 4.20 corresponds
ISO 9001:2000 - Clause 8.4 "Analysis of data"
In addition to the traditional statistical technique
requirement of the 1994 version, this clause focuses on the
Analysis of applicable data as one means of determining
where continual improvement of the quality management
system can be made.
The organization SHALL analyze this data to provide
information on:
a) customer satisfaction
b) conformance to product requirements
c) characteristics and trends of processes and
products, including opportunities for preventive
actions;
d) suppliers.
ISO 9001:1994 Clauses 4.14 and 4.20 correspond
ISO 9001:2000 - Clause 8.5.1 "Continual improvement"
The organization shall continually improve the effectiveness
of the quality management system through the use of the
quality policy, quality objectives, audit results, analysis of
data, corrective and preventive actions and management
review
ISO 9001:1994 - Clauses 4.1.3 and 4.9 correspond
ANNEX A
IAF ISO/TC 176 ISO/CASCO Joint Working Group
COMMUNIQUE
September 27, 1999
Results of the IAF ISO/TC 176 ISO/CASCO joint session on Transition
Planning for the Year 2000 ISO 9000 Standards
Background
Industry expects that the introduction of the new ISO 9000 Family of standards will
be a coordinated effort between the developers of the standards, certification /
registration bodies and accreditation bodies. An International Accreditation Forum
(IAF) ISO/TC 176 ISO/CASCO joint session was held on September 26, 1999 in
Vienna, Austria to establish common and consistent messages to ensure a smooth
transition to the new standards.
Scope of the work
To develop consistent implementation guidance for the new ISO 9000 standards for
such audiences as:
organizations already certified / registered to ISO 9001, ISO 9002 or ISO
9003 :1994
organizations presently not certified / registered to ISO 9001, ISO 9002 or
ISO 9003 :1994
certification / registration bodies
accreditation bodies
the general public
Agreements Reached
1. Accredited Certificates to the new ISO 9001 shall not be granted until
the publication of ISO 9001:2000 as an International Standard (IS)
For information - ISO 9001:2000 will replace the 1994 editions of ISO 9001, ISO
9002 and ISO 9003. A Draft International Standard (DIS) of ISO 9001 is due to be
released in November 1999.
Current plans are to circulate a Final Draft International Standard (FDIS) in the
third quarter of 2000 and to publish the new ISO 9001 as an International Standard
(IS) in the fourth quarter of 2000.
2. Certification/Registration body assessments to the latest draft of the
new standard may begin prior to publication of the ISO 9001:2000
International Standard (IS)
Certification / Registration Bodies may begin to assess conformity to the latest draft
of ISO 9001:2000 (ie, DIS or FDIS) prior to publication of the IS, so that
organizations may prepare and take any necessary actions. To minimize costs,
currently certified / registered organizations may consider taking advantage of the
opportunity for assessment to the latest draft of the new ISO 9001:2000 as part of
surveillance or reassessment audits for their existing certification / registration.
However, certificates should not be issued against any DIS or FDIS issues of the
standard. Accredited certificates shall only be issued against the International
Standard, and only after it has been published by ISO.
3. Certificates issued to the 1994 editions of ISO 9001, ISO 9002 or ISO
9003 shall have a maximum validity of 3 years from the date of publication
of ISO 9001:2000
Organizations certified / registered to the 1994 editions of ISO 9001, ISO 9002 and
ISO 9003 are encouraged to make the transition to ISO 9001:2000 as soon as
possible. It is recognized, however, that ISO 9001:2000 represents a fundamental
change of approach from the 1994 series (refer to latest revision of document
ISO/TC176/SC2 N439 "Transition Planning Guidance"). Certification /Registration
Bodies may assess organisations against the 1994 standards for up to three years
from the date of publication of ISO9001-2000. However, Certification / Registration
Bodies should encourage organizations to make the transition to ISO 9001:2000 in
time to ensure that certification / registration can be completed before their
certification / registration to the 1994 editions of ISO 9001, ISO 9002 and ISO 9003
expires.
4. ISO 9001:2000 will require auditors and other relevant
Certification/Registration Body personnel to demonstrate new
competencies
The publication of ISO 9001:2000 will require certification / registration bodies to
demonstrate that they have satisfactorily managed the transition period.
IAF member accreditation bodies will advise their accredited certification /
registration bodies (through an agreed standard letter) that accreditation
surveillance in the period following publication by ISO of ISO DIS 9001:2000 will
concentrate on how the certification / registration body is managing the change
within its certification / registration service. In particular, the surveillance will focus
on the competence of the certification / registration body auditors and other
relevant personnel with respect to the aspects of ISO DIS 9001:2000 that are
different from those necessary to provide certification / registration to ISO
9001/2/3:1994. The accreditation body will
assess the certification / registration body's program to ensure that its auditors and
other relevant personnel demonstrate knowledge and understanding of:
the eight Quality Management Principles on which the revised standards are
based (see Annex A);
the requirements of the latest draft of ISO 9001:2000 and;
the concepts and terminology of the latest draft of ISO 9000:2000.
The accreditation body will also assess the ability of the certification / registration
body support personnel to make the administrative changes required to be able to
offer certification / registration to the new standard. (Note that ISO 9004:1994
includes guidance on improvement of performance, and ISO 9004:2000 will also
include such guidance)
5. Certification / Registration Bodies will need to take particular care in
defining the scope of certificates issued to ISO 9001:2000, and the
permissible exclusions to the requirements of that standard.
Replacement of the 1994 editions of ISO 9001, ISO 9002 and ISO 9003 with a
single requirements standard (ISO 9001:2000) will necessitate the use of a very
clear and concise description of the activities of an organization that are included in
the certification / registration process. Attention should be given to the requirement
in the Draft Standard, which states that the organization may only exclude quality
management system requirements that neither affect the organization's ability, nor
absolve it from its responsibility, to provide product that meets customer
requirements and applicable regulatory requirements.
Session participants
The joint session was Chaired by Dr.Thomas Facklam, with Noel Matthews as
Secretary. Meeting representatives included:
Representing ISO/CASCO John Donaldson (Chairman ISO/CASCO), Yasukazu
Fukuda (Secretary CASCO);
Representing ISO/TC176 Kevin McKinley (Secretary ISO/TC176), Alister
Dalrymple (AFAQ), Nigel Croft (ISO/TC176);
Representing International Accreditation Forum, Inc. (IAF) Accreditors Roger
Brockway (UKAS), Masao Nagao (JAB), Xiao Jianhua (CNACR);
Representing IAF Certification / Registration Bodies Ian Day (IIOC), Tom Arnold
(IAAR), Tim Inman (ABCB);
Representing IAF Industry Dale Misczynski (ITIC), Peter Deichmann (ITIC),
Guenther Beer (BDI);
Representing International Auditor and Training Certification Association (IATCA) -
George Lofgren (ANSI-RAB), Scott Richter (RAB).
Published by the Joint Working Group October 1999
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