CHAPTER 6

QUALITY MANAGEMENT SYSTEM (QMS)

International Organization for Standardization

(ISO)

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ISO – International Organization for Standardization

• Develop and publish International Standards.

• ISO creates documents that provide requirements,
specifications, guidelines or characteristics that can be used
consistently to ensure that materials, products, processes and
services are fit for their purpose.
• International Standards mean that consumers can have
confidence that their products are safe, reliable and of good
quality. ISO's standards on road safety, toy safety and secure
medical packaging are just a few of those that help make the
world a safer place.
• Regulators and governments count on ISO standards to help
develop better regulation, knowing they have a sound basis.
Thanks to the involvement of globally-established experts.

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 ISO – International Organization for
Standardization

• The ISO story began in 1946 when delegates from 25 countries

met at the Institute of Civil Engineers in London and decided to
create a new international organization ‘to facilitate the
international coordination and unification of industrial
standards’. On 23 February 1947 the new organization, ISO,
officially began operations.

• ISO is an independent, non-governmental international

organization with a membership of 164 national standards
bodies.

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 Founders of ISO, London 1946

FRIENDSHIP AMONG EQUALS

The ISO story began in 1946 when delegates from 25 countries met at
the Institute of Civil Engineers in London
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International Organization for Standardization
ISO Central Secretariat
Chemin de Blandonnet 8
CP 401 - 1214 Vernier, Geneva, Switzerland

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Central Secretariat premises in Geneva, Switzerland

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ISO (International Organization for Standardization) is the
international body responsible for developing and publishing the
ISO management system standards, including those that use
the High-Level Structure (HLS). The HLS was developed by
ISO to provide a common framework for management system
standards, which would make it easier for organizations to
integrate and align multiple management systems.

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ISO develops and maintains the management system standards,
while the HLS provides a standardized framework that is used
across multiple ISO management system standards. So, the
relationship between ISO and the HLS is that ISO uses the HLS
framework to ensure consistency and compatibility among its
management system standards.

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The HLS sets out a standardized structure, common text, and common
terms and definitions that apply across all management system
standards that use it. This means that ISO management system
standards that use the HLS, have a common structure and format,
making it easier for organizations to implement and maintain these
systems.

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What is ISO 9001 ?

ISO 9001 is the world’s most popular and most

commonly used standard for quality management
systems.

A standard is not a law, but an agreement or best

practice that an organization can apply voluntarily.
A standard reflects a good level of professionalism.

A quality management system is a tool with which

an organization can determine how it can meet the
requirements of its customers and the other
interested parties that are involved in its activities.

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WHY ISO 9001?

ISO 9001 sets out the criteria for a quality management system and
is the only standard in the family that can be certified to (although this
is not a requirement). It can be used by any organization, large or
small, regardless of its field of activity. In fact, there are over one million
companies and organizations in over 170 countries certified to ISO
9001.

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WHY ISO 9001?

This standard is based on a number of quality management

principles including a strong customer focus, the motivation
and implication of top management, the process approach and
continual improvement.

These principles are explained in more detail in ISO’s quality

management principles. Using ISO 9001 helps ensure that
customers get consistent, good-quality products and services,
which in turn brings many business benefits.

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There are (2) two benefits of ISO 9001:

1. ISO 9001 helps you increase customer satisfaction.

2. ISO 9001 is positive for your image: you show that you
comply with internationally recognized quality standards. This
is often a requirement for customers and suppliers to do
business with you.

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The most recent ISO 9001:2015 standard is constructed around (7)
Seven Quality Management Principles:

1. customer focus;
2. leadership;
3. engagement of people;
4. process approach;
5. improvement;
6. evidence-based decision making;
7. relationship management.

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To there are 10 steps to get started in implementing
ISO 9001:2015 and get certified.

1. Identify the reasons why you want to become ISO 9001 accredited.
because some of your customers demand it.

2. Purchase a copy of the standard

You will need to purchase a copy of the standard to determine the exact
requirements.

3. Strategy definition
The first step in the actual implementation is for top management to define
and write a formal document containing the Quality Policy and Objectives
as per the requirements of the ISO 9001:2015 standard.

4. Planning resources
Resources should be made available and realistic timelines set to ensure
that the QMS can be implemented within a reasonable time.

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5. Identify your processes
describe the interaction between the processes within you organization. A
simple process map specific to your company can be used for this.

6. Training needs
ISO 9001 requires that awareness, competence and training needs. This will
require internal or external training.

7. Develop documentation
ISO 9001:2015 requires controlled documentation of the Scope of the Quality
Management System, a Quality Policy, Quality Objectives and a Procedure for
the control of outsourced processes.

8. Implementing the QMS

Once the QMS has been developed, it should be implemented. As you
complete the development of certain sections, start training and implementing
it immediately, while development of the other sections continue.

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9. Pre-assessment audit

Although this is not a requirement of ISO 9001, a pre-assessment audit by

the certification body will enable you to identify any gaps between the
requirements of the standard and your existing processes. This audit can
be done at any stage and does not form part of the certification process.

10. Get certified

You need to identify and contact a nationally accredited certification body

to perform the actual certification. If possible, select a body that has
experience in your industry as they will be able to share the experience
they’ve had with similar companies.

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What are the ISO accrediting bodies for Malaysia?

The Department of Standards Malaysia (DSM) is mandated by the

Government of Malaysia to function as the National Standards Body
(NSB) as well as the National Accreditation Body (NAB) through the
Standards of Malaysia Act 1996 (Act 549).

DSM's vision is 'To lead the Nation to be an effective global player in

Standards & Accreditation in consonance with Malaysia's Vision 2020'.

Standards Malaysia
Department of Standards Malaysia
Ministry of International Trade and Industry
Level 4-7, Tower 2
Menara Cyber Axis
Jalan Impact, Cyber 6
63000 Cyberjaya Selangor
Malaysia
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THANK YOU FOR YOUR
ATTENTION

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