implementing iso 9000 in quality management system


Nov 9, 2013 (4 years and 8 months ago)



ISO 900

The methods and tools of quality management and quality assurance have evolved
over many decades to a remarkable degree of perfection

The first editions of the ISO 9000 standards (9000
to 9004) were completed in
1986 and published in the early part of 1987. Up to this point, one could have said
that the existence of the ISO 9000 standards was not a very un
sual kind of
international standardization event.


We did no
t have to wait very long, because it soon
became apparent tha
t the ISO
9000 standards would enjoy the most widespread recognition in industry, the most
rapid adoption by the international standards community, and the greatest sales of
any ISO standard in e


The ISO 9000 standards have been directly adopted, without change, as national
standards in at least 53 countries, including all of the EC and EFTA countries,
Japan and the US


Third party assessment and registration services exist for recogn
conformance to ISO 9000 standards i
n at least 32 countries.


The ISO 9000 standards have been cited as a basic building block for the
development and operation of the European Organization for Testing and
tification (EOTC).


Many nationally and
internationally recognized product certification systems (for
example the BSI
Kite mark

in the UK, and the JIS mark in Japan) have
incorporated the ISO 9000 standards as a first

phase requirement for approval to
use their mark in specific product certific
ation schemes.


Very many large industrial companies, particularly those with operations in many
countries, have initiated vigorous company programmes to implement the ISO
9000 standards at their operat
ions sites.


Numerous large governmental purchasers,

including the Ministers of Defence in
the UK and Singapore, and the Department of the Navy in the USA, have made
ISO 9000 registration (or its equivalent) a requirement for their large contract


Implementation of ISO 9000 affects the entire organization right from the start. If

pursued with total dedication, it results in 'cultural transition' to an atmosphere of

continuous improvement.

The process of implementing ISO 9000 depends on:


sophistication of your existing quality program,


The size of your organization, and


The complexity of your process.

The 14 essential steps, briefly described below, are to be followed through in order

implement ISO 9000 quality management system succe

Step 1: Top management commitment

Step 2: Establish implementation team

Step 3. Start ISO 9000 awareness programs

Step 4: Provide Training

Step 5. Conduct initial status survey

Step 6: Create a documented implementation plan

Step 7. Develop qualit
y management system documentation

Step 8: Document control

Step 9. Implementation

Step 10. Internal quality audit

Step 11. Management review

Step 12. Pre
assessment audit

Step 13. Certification and registration

Step 14: Continual Improvement


ISO 9001: 20
08 covers an extensive range of
requirements and seeks to
improve the quality of all of the organisation’s management activities, which
has the potential to result in some substantial overall organisational

ISO 9001:
2008 is one of the most nationally and internationally known
quality standards that affirms the independent approval of a management
system designed specifically to deliver high levels of customer satisfaction.

It has the potential to improve internal
and external accountability and
communication of management and production procedures.

ISO 9001 certification can help an organisation qualify for a tender or to
achieve preferred supplier status, typically for a Local Authority.

Potential limitations

Pursuing the standard has the potential to be expensive in terms of start
up and
running costs and has the potential be time consuming to implement.

There is less flexibility than other tools and it is much more difficult to use in
smaller parts of fo
r single issues.

Its origins are in the industrial sector and whilst the latest version, has been
made more user friendly for service organisations it may be less suitable for
socially enterprising organisations.

As a quality management standard, it was not designed to evaluate an
organisation’s broader impacts on society or the environment. ISO14001:2004,
however, provides a separate environmental management system standard.

he ISO 14000 Series

ISO has also deve
loped a family of environmental management standards called
ISO 14000. ISO 14001:2004 is the certification standard similar to ISO
9001:2000 in concept and structure. They both require organisations that
implement them to continually improve their performa
nce. Both standards
concern processes and not products directly. Both will share some similar
benefits and limitations due to these similarities.

ISO 14001:2004 (the latest version) is primarily concerned with ‘environmental
management’ or what the organis
ation does to minimise harmful effects on the
environment caused by its activities. The ISO 14000 family consists of standards
relating to Environmental Management Systems (EMS), which are tools to help
the organisation develop its environmental policy, ob
jectives and targets, and
classify them by when they apply to:

The organisational level (implementing EMS, conducting environmental
auditing and related investigations, and evaluating environmental

Products and services (using
environmental declarations and claims,
conducting life cycle assessment), addressing environmental aspects in
product standards, and understanding terms and definitions).

ISO 14001:2004 ensures that organisations are aware of environmental aspects
of thei
r work in order to minimise negative impacts and improve environmental
performance. ISO suggests that the standard can provide significant tangible
benefits, including:

Reduced raw material/resource use.

Reduced energy consumption.

Improved process


Reduced waste generation and disposal costs.

Utilisation of recoverable resources.

The standard can be implemented by a wide variety of organisations, whatever
their current level of environmental maturity. However, a commitment to
compliance with applicable environmental legislation and regulations is required,
along with a commitment to continuous improvement

Who can use ISO 9001: 2008?

The vast majority of ISO standards are highly specific to a particular product,
material, or p
rocess. However, ISO 9001 (quality) and ISO 14001 (environment)
are ‘generic management system standards’. ‘Generic’ means that the same
standard can be applied to any organisation, large or small, whatever its product
or service, in any sector of activity
, and whether it is a business enterprise, a
public administration, or a government department. ISO 9001 contains a generic
set of requirements for implementing a quality management system and ISO
14001 for an environmental management system.


Senior individuals in an organisation will need to be fully committed.

Proficiencies or skills
Training in understanding the standards may be
required. Actions taken to meet implementation to the requirements are left to the

itself. The organisation then needs to address the issues needed to
comply with the standards.

Staff time
Whilst this may vary depending on the size of the organisation and
the change that has to be implemented, estimates from organisations the

Evaluation Services and the Scottish Executive indicate that it can take
from between 6 and18 months to implement.

Courses, support, and information
The ISO website contains information on
all aspects of the ISO 9000 family as well as hardcopies, a Magic
al Demystifying
Tour of ISO 9000 and ISO 14000 and the ISO magazine, ISO Management
Systems, and other publications
ISO publications include the handbook, ISO
9001 for small busin