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TOPIC : QUALITY STANDARDS AS PER ISO
ISO stands for International Organization for Standardization
ISO would have different acronyms in different languages (IOS in English, OIN in
French), so the founders decided to give it the short form ISO.
ISO is derived from the Greek isos, meaning equal.
They are a network of national standards bodies. These national standards bodies make
up the ISO membership and they represent ISO in their country.
ISO is an independent, non-governmental organization.
Through its members, it brings together experts to share knowledge and develop
voluntary, consensus-based, market relevant International Standards that support
innovation and provide solutions to global challenges.
They have a Central Secretariat in Geneva, Switzerland, that coordinates the system.
How did they come to existence ?
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 23rd February 1947 the new organization, ISO, officially began operations.
Since then, ISO has published 21542 International Standards and related documents,
covering almost every industry, from technology, to food safety, to agriculture and
healthcare.
Today they have members from 162 countries and 3914 technical bodies to take care of
standard development.
More than 135 people work full time for ISO’s Central Secretariat in Geneva, Switzerland.
ISO office in Geneva, Switzerland
ISO has 3 most popular standards:
 ISO 9001 Quality management
Makes sure your products and services meet customers needs with this
family of standards.
 ISO 14001 Environmental management
Improves your environmental performance with this family of standards.
 ISO/IEC 27001 Information security management
Ensure your organization's information is secure with this family of
standards.
EVOLUTION OF ISO 9000 STANDARDS
1987 version
The emphasis was placed on conformance with procedures rather than the overall
process of management.
1994 version
Emphasized on quality assurance via preventive actions, instead of just checking
final product, and continued to require evidence of compliance with documented
procedures.
2000 version
It replaced all three former standards of 1994 issue (ISO 9001, ISO 9002 and ISO
9003).
This version sought to make a radical change in thinking by introducing the concept
of process management (the monitoring and optimisation of a company's tasks and
activities, instead of just inspection of the final product).
ISO 9000 Requirements include:
• Approve documents before distribution;
• Provide correct version of documents at points of use;
• Use your records to prove that requirements have been met; and
• Develop a procedure to control your records.
2008 version
The 2008 version only introduced clarifications to the existing requirements of ISO
9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
There were no new requirements.
ISO 9001 was supplemented with adding a new standards to the family:
• ISO 9000:2005 "Quality management systems.”
ISO 2015 version
In 2012, the ISO TC 176 (responsible for ISO 9001 development) celebrated 25
years of implementing ISO 9001, and concluded that it is necessary to create a new
QMS model for the next 25 years.
The 2015 version is also less prescriptive than its predecessors and focuses on
performance. This was achieved by combining the process approach with risk-based
thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
The scope of the standard was not changed, however, the structure and core terms were
modified to allow the standard to integrate more easily with other international
management systems standards.
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 also means what the organization does to enhance customer
satisfaction, and achieve continual improvement of its performance.
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.
 Achieve continual improvement of its environmental performance.
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 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.
To be really efficient and effective, the organization can manage its way of doing things
by systemizing it. So that 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-
the-art model to follow.
Companies in such fields as aerospace, automobiles, defence, or health care devices have
been operating management systems for years.
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 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.
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 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 programme, or
 If it will motivate staff by setting a clear goal.
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 etc..
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 etc..
 Creates a more efficient, effective operation.
 Increases customer satisfaction and retention.
 Reduces audits.
 Enhances marketing.
 Improves employee motivation, awareness, and morale.
 Promotes international trade.
 Increases profit.
 Reduces waste and increases productivity.
 Common tool for standardization.
 Enables to meet the requirements of an internationally uniform quality system.
 Motivates the employees and develops pride in them for achieving excellence.
ADVANTAGES
QUALITY MANAGEMENT PRINCIPLES
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
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.
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.
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.
Process approach:
A desired result is achieved more efficiently when activities and related resources
are managed as a process.
System approach:
Systems approach is based on the generalization that everything is inter-related
and interdependent. A system is composed of related and dependent element which when
in interaction, forms a unitary whole.
Continual Improvement:
Improvement of the organization's overall performance should be a permanent
objective of the organization.
Evidence-based decision making:
Effective decisions are based on the analysis of data and information.
Relationship management:
An organization and its external providers (suppliers, contractors, service
providers) are interdependent and a mutually beneficial relationship enhances the ability
of both to create value.
Benefits of ISO 9001 and ISO 14001
Common language for dealing with customers and suppliers worldwide in B2B.
Increase efficiency and effectiveness.
Model for continual improvement.
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.
Sustainable business.
Qualify suppliers for global supply chains.
Technical support for regulations.
The ISO Survey
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 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.
?
?
Quality  standards  as  per  iso

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Quality standards as per iso

  • 1. TOPIC : QUALITY STANDARDS AS PER ISO
  • 2. ISO stands for International Organization for Standardization ISO would have different acronyms in different languages (IOS in English, OIN in French), so the founders decided to give it the short form ISO. ISO is derived from the Greek isos, meaning equal. They are a network of national standards bodies. These national standards bodies make up the ISO membership and they represent ISO in their country. ISO is an independent, non-governmental organization. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. They have a Central Secretariat in Geneva, Switzerland, that coordinates the system.
  • 3. How did they come to existence ? 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 23rd February 1947 the new organization, ISO, officially began operations. Since then, ISO has published 21542 International Standards and related documents, covering almost every industry, from technology, to food safety, to agriculture and healthcare. Today they have members from 162 countries and 3914 technical bodies to take care of standard development. More than 135 people work full time for ISO’s Central Secretariat in Geneva, Switzerland.
  • 4. ISO office in Geneva, Switzerland
  • 5. ISO has 3 most popular standards:  ISO 9001 Quality management Makes sure your products and services meet customers needs with this family of standards.  ISO 14001 Environmental management Improves your environmental performance with this family of standards.  ISO/IEC 27001 Information security management Ensure your organization's information is secure with this family of standards.
  • 6. EVOLUTION OF ISO 9000 STANDARDS 1987 version The emphasis was placed on conformance with procedures rather than the overall process of management. 1994 version Emphasized on quality assurance via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. 2000 version It replaced all three former standards of 1994 issue (ISO 9001, ISO 9002 and ISO 9003). This version sought to make a radical change in thinking by introducing the concept of process management (the monitoring and optimisation of a company's tasks and activities, instead of just inspection of the final product).
  • 7. ISO 9000 Requirements include: • Approve documents before distribution; • Provide correct version of documents at points of use; • Use your records to prove that requirements have been met; and • Develop a procedure to control your records. 2008 version The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. ISO 9001 was supplemented with adding a new standards to the family: • ISO 9000:2005 "Quality management systems.”
  • 8. ISO 2015 version In 2012, the ISO TC 176 (responsible for ISO 9001 development) celebrated 25 years of implementing ISO 9001, and concluded that it is necessary to create a new QMS model for the next 25 years. The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization. The scope of the standard was not changed, however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.
  • 9.
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  • 11. 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 also means what the organization does to enhance customer satisfaction, and achieve continual improvement of its performance. 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.  Achieve continual improvement of its environmental performance.
  • 12. 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 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.
  • 13. 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. To be really efficient and effective, the organization can manage its way of doing things by systemizing it. So that 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- the-art model to follow. Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years.
  • 14. 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 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.
  • 15. 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.
  • 16. 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.
  • 17. 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 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 programme, or  If it will motivate staff by setting a clear goal.
  • 18. 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 etc..
  • 19. 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 etc..
  • 20.  Creates a more efficient, effective operation.  Increases customer satisfaction and retention.  Reduces audits.  Enhances marketing.  Improves employee motivation, awareness, and morale.  Promotes international trade.  Increases profit.  Reduces waste and increases productivity.  Common tool for standardization.  Enables to meet the requirements of an internationally uniform quality system.  Motivates the employees and develops pride in them for achieving excellence. ADVANTAGES
  • 21. QUALITY MANAGEMENT PRINCIPLES 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationships
  • 22. 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. 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. 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. Process approach: A desired result is achieved more efficiently when activities and related resources are managed as a process.
  • 23. System approach: Systems approach is based on the generalization that everything is inter-related and interdependent. A system is composed of related and dependent element which when in interaction, forms a unitary whole. Continual Improvement: Improvement of the organization's overall performance should be a permanent objective of the organization. Evidence-based decision making: Effective decisions are based on the analysis of data and information. Relationship management: An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
  • 24. Benefits of ISO 9001 and ISO 14001 Common language for dealing with customers and suppliers worldwide in B2B. Increase efficiency and effectiveness. Model for continual improvement. 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. Sustainable business. Qualify suppliers for global supply chains. Technical support for regulations.
  • 26. 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.
  • 27.
  • 28. 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.
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  • 30. ? ?