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ISO 9001: 2008 Quality Management System
Awareness Program

- Prasad K N
ISO – An Organisation

International Organization
for Standardization
www.iso.org
ISO Story…

Who we are:
We are a network of national standards bodies.
These national standards bodies make up the
ISO membership and they represent ISO in their
country.
More details on our members can be found in
the full list of ISO members
ISO Story…

How we work:
ISO is an independent, non-governmental
organization made up of members from the
national standards bodies of 162 countries. We
have a Central Secretariat in Geneva,
Switzerland, that coordinates the system
ISO Story…
Our story:
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’. In February 1947 the new organisation,
ISO, officially began operations.
Since then,we have published over 19 500 International Standards covering
almost all aspects of technology and manufacturing.
Today we have members from 162 countries and 3 368 technical bodies to
take care of standard development. More than 150 people work full time for
ISO’s Central Secretariat in Geneva, Switzerland.
ISO Story…
Our name:

Because 'International Organization for
Standardization' would have different acronyms in
different languages (IOS in English, OIN in French for
Organisation internationale de normalisation), our
founders decided to give it the short form ISO. ISO is
derived from the Greek isos, meaning equal.
Whatever the country, whatever the language, the
short form of our name is always ISO
ISO Story…
Benefits of ISO International Standards:
ISO International Standards ensure that products
and services are safe, reliable and of good quality.
For business, they are strategic tools that reduce
costs by minimizing waste and errors and increasing
productivity. They help companies to access new
markets, level the playing field for developing
countries and facilitate free and fair global trade
More information

• ISO office in
Geneva, Switzerland
The ISO Survey
The ISO Survey (cont.)
 The worldwide total of certificates to ISO

9001:2001 at the end of 2007 was 951 486.
 This was increase of 6 % over 2006 when the total was
896 929 certificates.
 Certificates had been issued in 175 countries
compared to 170 the previous year.
The ISO Survey (cont.)
The ISO Survey (cont.)
 The worldwide total of ISO 14001 certificates at the

end of 2007 was 154 572.
 This was an increase of 21 % over 2006 when the total
was 128 211.
 Certificates had been issued in 148 countries
compared to 140 the year before.
International Organization
for Standardization

Overview of ISO 9001
And
ISO 14001
www.iso.org
Quality Management Principles
ISO Documentation
ISO 9001 and ISO 14001 in brief
 ISO 9001 and ISO 14001 are among ISO's most
well known standards ever.
 They are implemented by more than a million
organizations in some 175 countries.
 ISO 9001 helps organizations to implement

quality management.

 ISO 14001 helps organizations to implement
environmental management.
Quality management
 ISO 9001 is for quality management.
 Quality refers to all those features of a product (or

service) which are required by the customer.
 Quality management means what the
organization does to:
 ensure that its products or services satisfy the

customer's quality requirements and
 comply with any regulations applicable to those
products or services
Quality management (cont.)
 Quality management also means what the

organization does to:
 enhance customer satisfaction and
 achieve continual improvement of its performance
Environmental management
 ISO 14001 is for environmental management. This

means what the organization does to:
 minimize harmful effects on the environment
caused by its activities,
 to conform to applicable regulatory requirements,
and to
 achieve continual improvement of its environmental
performance.
Generic standards
ISO 9001 and ISO 14001 are generic standards.
Generic means that the same standards can be applied:
 to any organization, 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.
Generic standards (cont.)
Generic also signifies that
 no matter what the organization's scope of activity
 if it wants to establish a quality management
system, ISO 9001 gives the essential features
 or if it wants to establish an environmental
management system, ISO 14001 gives the essential
features.
Management systems
 Management system means what the
organization does to manage its processes, or

activities in order that
 its products or services meet the organization’s
objectives, such as
 satisfying the customer's quality requirements,
 complying to regulations, or
 meeting environmental objectives
Management systems
 To be really efficient and effective, the
organization can manage its way of doing things

by systemizing it.
 Nothing important is left out.
 Everyone is clear about who is responsible for
doing what, when, how, why and where.
 Management system standards provide the
organization with an international, state-of-theart model to follow.
Management systems (cont.)
 Large organizations, or ones with complicated

processes, could not function well without
management systems.
 Companies in such fields as
aerospace, automobiles, defence, or health care
devices have been operating management systems for
years.
 The ISO 9001 and ISO 14001 management system
standards now make these successful practices
available for all organizations.
Processes, not products
 Both ISO 9001 and ISO 14001 concern the way an






organization goes about its work.
They are not product standards.
They are not service standards.
They are process standards.
They can be used by product manufacturers and
service providers.
Processes, not products (cont.)
 Processes affect final products or services.
 ISO 9001 gives the requirements for what the

organization must do to manage processes affecting
quality of its products and services.
 ISO 14001 gives the requirements for what the
organization must do to manage processes affecting
the impact of its activities on the environment.
Certification and registration
 Certification is known in some countries as

registration.
 It means that an independent, external body has
audited an organization's management system and
verified that it conforms to the requirements specified
in the standard (ISO 9001 or ISO 14001).
 ISO does not carry out certification and does not
issue or approve certificates,
Accreditation
 Accreditation is like certification of the certification

body.
 It means the formal approval by a specialized body - an
accreditation body - that a certification body is
competent to carry out ISO 9001:2008 or ISO
14001:2004 certification in specified business sectors.
 Certificates issued by accredited certification bodies and known as accredited certificates - may be
perceived on the market as having increased
credibility.
 ISO does not carry out or approve accreditations.
Certification not a requirement
 Certification is not a requirement of ISO 9001 or

ISO 14001.
 The organization can implement and benefit from an
ISO 9001 or ISO 14001 system without having it
certified.
 The organization can implement them for the
internal benefits without spending money on a
certification programme.
Certification is a business decision
 Certification is a decision to be taken for business






reasons:
if it is a contractual, regulatory, or market requirement
If it meets customer preferences
it is part of a risk management program
if it will motivate staff by setting a clear goal
ISO does not certify
 ISO does not carry out ISO 9001 or ISO 14001

certification.
 ISO does not issue certificates.
 ISO does not accredit, approve or control the
certification bodies.
 ISO develops standards and guides to encourage
good practice in accreditation and certification.
The ISO 9000 family
 ISO 9001 is the standard that gives the requirements

for a quality management system.
 ISO 9001:2008 is the latest, improved version.
 It is the only standard in the ISO 9000 family that
can be used for certification.
 There are 16 other standards in the family that can
help an organization on specific aspects such as
performance improvement, auditing, training…
The ISO 14000 family
 ISO 14001 is the standard that gives the
requirements for an environmental

management system.
 ISO 14001:2004 is the latest, improved version.
 It is the only standard in the ISO 14000 family
that can be used for certification.
 The ISO 14000 family includes 21 other standards
that can help an organization specific aspects such
as auditing, environmental labelling, life cycle
analysis…
Benefits of ISO 9001 and ISO 14001
 International, expert consensus on state-of-the-art

practices for quality and environmental management.
 Common language for dealing with customers and
suppliers worldwide in B2B.
 Increase efficiency and effectiveness.
 Model for continual improvement.
Benefits of ISO 9001 and ISO 14001
(cont.)
 Model for satisfying customers and other stakeholders.
 Build quality into products and services from design

onwards.
 Address environmental concerns of customers and
public, and comply with government regulations.
 Integrate with global economy.
Benefits of ISO 9001 and ISO 14001
(cont.)
 Sustainable business
 Unifying base for industry sectors

 Qualify suppliers for global supply chains
 Technical support for regulations
Benefits of ISO 9001 and ISO 14001
(cont.)
 Transfer of good practice to developing countries
 Tools for new economic players

 Regional integration
 Facilitate rise of services
Resources
Golden Advice

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ISO 9001 & 14001 Awareness

  • 1. ISO 9001: 2008 Quality Management System Awareness Program - Prasad K N
  • 2. ISO – An Organisation International Organization for Standardization www.iso.org
  • 3. ISO Story… Who we are: We are a network of national standards bodies. These national standards bodies make up the ISO membership and they represent ISO in their country. More details on our members can be found in the full list of ISO members
  • 4. ISO Story… How we work: ISO is an independent, non-governmental organization made up of members from the national standards bodies of 162 countries. We have a Central Secretariat in Geneva, Switzerland, that coordinates the system
  • 5. ISO Story… Our story: 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’. In February 1947 the new organisation, ISO, officially began operations. Since then,we have published over 19 500 International Standards covering almost all aspects of technology and manufacturing. Today we have members from 162 countries and 3 368 technical bodies to take care of standard development. More than 150 people work full time for ISO’s Central Secretariat in Geneva, Switzerland.
  • 6. ISO Story… Our name: Because 'International Organization for Standardization' would have different acronyms in different languages (IOS in English, OIN in French for Organisation internationale de normalisation), our founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal. Whatever the country, whatever the language, the short form of our name is always ISO
  • 7. ISO Story… Benefits of ISO International Standards: ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors and increasing productivity. They help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade
  • 8. More information • ISO office in Geneva, Switzerland
  • 10. The ISO Survey (cont.)  The worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 951 486.  This was increase of 6 % over 2006 when the total was 896 929 certificates.  Certificates had been issued in 175 countries compared to 170 the previous year.
  • 11. The ISO Survey (cont.)
  • 12. The ISO Survey (cont.)  The worldwide total of ISO 14001 certificates at the end of 2007 was 154 572.  This was an increase of 21 % over 2006 when the total was 128 211.  Certificates had been issued in 148 countries compared to 140 the year before.
  • 13. International Organization for Standardization Overview of ISO 9001 And ISO 14001 www.iso.org
  • 16. ISO 9001 and ISO 14001 in brief  ISO 9001 and ISO 14001 are among ISO's most well known standards ever.  They are implemented by more than a million organizations in some 175 countries.  ISO 9001 helps organizations to implement quality management.  ISO 14001 helps organizations to implement environmental management.
  • 17. Quality management  ISO 9001 is for quality management.  Quality refers to all those features of a product (or service) which are required by the customer.  Quality management means what the organization does to:  ensure that its products or services satisfy the customer's quality requirements and  comply with any regulations applicable to those products or services
  • 18. Quality management (cont.)  Quality management also means what the organization does to:  enhance customer satisfaction and  achieve continual improvement of its performance
  • 19. Environmental management  ISO 14001 is for environmental management. This means what the organization does to:  minimize harmful effects on the environment caused by its activities,  to conform to applicable regulatory requirements, and to  achieve continual improvement of its environmental performance.
  • 20. Generic standards ISO 9001 and ISO 14001 are generic standards. Generic means that the same standards can be applied:  to any organization, 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.
  • 21. Generic standards (cont.) Generic also signifies that  no matter what the organization's scope of activity  if it wants to establish a quality management system, ISO 9001 gives the essential features  or if it wants to establish an environmental management system, ISO 14001 gives the essential features.
  • 22. Management systems  Management system means what the organization does to manage its processes, or activities in order that  its products or services meet the organization’s objectives, such as  satisfying the customer's quality requirements,  complying to regulations, or  meeting environmental objectives
  • 23. Management systems  To be really efficient and effective, the organization can manage its way of doing things by systemizing it.  Nothing important is left out.  Everyone is clear about who is responsible for doing what, when, how, why and where.  Management system standards provide the organization with an international, state-of-theart model to follow.
  • 24. Management systems (cont.)  Large organizations, or ones with complicated processes, could not function well without management systems.  Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years.  The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations.
  • 25. Processes, not products  Both ISO 9001 and ISO 14001 concern the way an     organization goes about its work. They are not product standards. They are not service standards. They are process standards. They can be used by product manufacturers and service providers.
  • 26. Processes, not products (cont.)  Processes affect final products or services.  ISO 9001 gives the requirements for what the organization must do to manage processes affecting quality of its products and services.  ISO 14001 gives the requirements for what the organization must do to manage processes affecting the impact of its activities on the environment.
  • 27. Certification and registration  Certification is known in some countries as registration.  It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001).  ISO does not carry out certification and does not issue or approve certificates,
  • 28. Accreditation  Accreditation is like certification of the certification body.  It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors.  Certificates issued by accredited certification bodies and known as accredited certificates - may be perceived on the market as having increased credibility.  ISO does not carry out or approve accreditations.
  • 29. Certification not a requirement  Certification is not a requirement of ISO 9001 or ISO 14001.  The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified.  The organization can implement them for the internal benefits without spending money on a certification programme.
  • 30. Certification is a business decision  Certification is a decision to be taken for business     reasons: if it is a contractual, regulatory, or market requirement If it meets customer preferences it is part of a risk management program if it will motivate staff by setting a clear goal
  • 31. ISO does not certify  ISO does not carry out ISO 9001 or ISO 14001 certification.  ISO does not issue certificates.  ISO does not accredit, approve or control the certification bodies.  ISO develops standards and guides to encourage good practice in accreditation and certification.
  • 32. The ISO 9000 family  ISO 9001 is the standard that gives the requirements for a quality management system.  ISO 9001:2008 is the latest, improved version.  It is the only standard in the ISO 9000 family that can be used for certification.  There are 16 other standards in the family that can help an organization on specific aspects such as performance improvement, auditing, training…
  • 33. The ISO 14000 family  ISO 14001 is the standard that gives the requirements for an environmental management system.  ISO 14001:2004 is the latest, improved version.  It is the only standard in the ISO 14000 family that can be used for certification.  The ISO 14000 family includes 21 other standards that can help an organization specific aspects such as auditing, environmental labelling, life cycle analysis…
  • 34. Benefits of ISO 9001 and ISO 14001  International, expert consensus on state-of-the-art practices for quality and environmental management.  Common language for dealing with customers and suppliers worldwide in B2B.  Increase efficiency and effectiveness.  Model for continual improvement.
  • 35. Benefits of ISO 9001 and ISO 14001 (cont.)  Model for satisfying customers and other stakeholders.  Build quality into products and services from design onwards.  Address environmental concerns of customers and public, and comply with government regulations.  Integrate with global economy.
  • 36. Benefits of ISO 9001 and ISO 14001 (cont.)  Sustainable business  Unifying base for industry sectors  Qualify suppliers for global supply chains  Technical support for regulations
  • 37. Benefits of ISO 9001 and ISO 14001 (cont.)  Transfer of good practice to developing countries  Tools for new economic players  Regional integration  Facilitate rise of services