This document provides an overview of ISO and ISO 9000 standards. It discusses: - The history and origins of ISO as an international organization for standardization. - An overview of the ISO 9000 family of quality management system standards, including the requirements of ISO 9001. - The key elements required by the ISO 9000 standards, such as management responsibility, resource management, and process control. - The importance of ISO 9000 certification for companies, including helping to comply with customers and regulations, improve quality, and increase profitability.

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2. Group Member
Khubaib Ur Rahman BSET-01113030
Usman Lateef BSET 01113109
Presented To
Sir Yasir Dawood
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3. Table Of contents
 ISO
History
Standards
Organization Block Diagram
 ISO 9000 Series
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Topic:

5. ISO HISTORY DEFINITIONS
 ISO is a network of the national standards institutes of 163
countries, on the basis of one member per country, with a
Central Secretariat in Geneva, Switzerland, that
coordinates the system.
 ISO is a non-governmental organization
 ISO (International Organization for Standardization) is
the world's largest developer and publisher
of International Standards.
 Member countries generate some 98 % of world gross
national income (GNI).
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6. How did ISO get started?
1906-International Electro-technical Commission
1926-International Federation of the National
Standardizing Associations (ISA)
1946 London - delegates from 25 countries decided to
create a new international organization "the object of
which would be to facilitate the international
coordination and unification of industrial standards
1947 - ISO began to officially function
1951 - The first ISO standard was published
 "Standard reference temperature for industrial length
measurement".
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7. African Regional Organization for Standardization (ARSO)
Arab Industrial Development and Mining Organization (AIDMO)
European Committee for Standardization (CEN)
Pan American Standards Commission (COPANT)
Euro Asian Council for Standardization, Metrology and Certification (EASC)
Pacific Area Standards Congress (PASC)
ASEAN Consultative Committee for Standards and Quality (ACCSQ)

8. World Health Organization (WHO), on health technologies
International Maritime Organization (IMO), on transport security
World Tourism Organization (UNWTO), on the quality of services related to
tourism.
World Economic Forum (WEF)
Consumers International (CI)
World Business Council for Sustainable Development (WBCSD), and
International Federation of Standards Users (IFAN)

9. ISO standards
 Make the development, manufacturing and supply of products
and services more efficient, safer & cleaner
 Facilitate trade between countries and make it fairer
 Provide governments with a technical base for health, safety
,Environmental legislation, and conformity assessment
 Share technological advances and good management practice
 Safeguard consumers, and users in general, of products and
services
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10.  Make life simpler by providing solutions to common problems
 ISO occupies a special position between the public & private sectors.
 And the broader needs of society, such as the needs of stakeholder
groups like consumers and users.
 ISO is able to act as a bridging organization in which a consensus can
be reached on solutions that meet both the requirements of business.
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ISO standards

11. Popular standards
• ISO 9000 Quality management
• ISO 14000 Environmental management
• ISO 3166 Country codes
• ISO 26000 Social responsibility
• ISO 50001 Energy management
• ISO 31000 Risk management
• ISO 22000 Food safety management
• ISO 27001 Information security management
• ISO 20121 Sustainable events
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12. ISO's structure

13. What has ISO Accomplished?
ISO film speed code
Standard format for telephone and banking cards
ISO 9000 which provides a framework for quality
management and quality assurance
ISO 14000 series provides a similar framework for
environmental management
Internationally standardized freight containers
Standardized paper sizes.
Automobile control symbols
ISO international codes for country names, currencies
and languages
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14. ISO 9000
What You Need To Know
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15. ISO 9000
What do you need to know about ISO
9000?
What are the ISO 9000 Series Standards?
What are the elements of the Standards?
Why is ISO 9000 so important?
What is quality system registration?
Ten steps to ISO 9000 registration
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16. Qualitymanagement
Quality management also means what the organization
does to
i. Enhance customer satisfaction, and
ii. Achieve continual improvement of its
performance.
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17. Management system
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
i. Satisfying the customer's quality requirements,
ii. Complying to regulations, or
iii. Meeting environmental objectives
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What is ISO 9000?
ISO 9000 is a standard in which to conduct business
It is a set of rules which should be followed in order to
meet the needs and understand the wants of customers
The standard is generic

19. What are ISO 9000 Standards?
ISO 9000 Standards
Define the required elements of an effective quality
management system
Can be applied to any company
Adopted by the United States as the ANSI/ASQC Q90
series.
Revised 2000 – wider applicability
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20. What is a Quality Management System?
Policies,
Processes
Procedures
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21. What is a Quality Management System?
Required for planning and executing
business processes
To meet customer requirements
Accredited to International Standards
by a Registrar
ISO 9001:2008 is an example
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23. ISO 9000 Family of Standards
ISO 8402 - QA and Quality management vocabulary
ISO 9000-2 - Generic guidelines for applying ISO
9001, ISO 9002, and ISO 9003
ISO 9000-3 - Guidelines for applying ISO 9001 to
the development, supply, and maintenance
of software
ISO 9000-4 Application for dependability
management
ISO 9004-2 Guidelines for services
ISO 9004-3 Guidelines for processed material
ISO 9004-4 Guidelines for quality improvement
ISO 9004-5 Guidelines for quality plans
ISO 9004-6 Guidelines for configuration
management
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24. What is The ISO 9000
Family?
 The family consists of
 ISO 9000 Quality Management Systems –
Fundamentals and vocabulary
 ISO 9001 Quality Management Systems –
Requirements
 ISO 9004 Quality Management Systems –
Guidelines for performance improvement
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What are the parts of ISO 9000?
ISO 9000 is composed of 5 different, but related
parts:
ISO 9000, 9001, 9002, 9003, and 9004
ISO 9000 and 9004 are guidelines, while ISO
9001, 9002, and 9003 are the categories in which
a company may apply for certification

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Part 1: ISO 9000
 ISO 9000: “Quality Management and
Quality Assurance Standards –
Guidelines for Selection and Use”
Written in order to determine which
category your organization should apply
for

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Part 2: ISO 9001
ISO 9001: “Quality Systems – Model for
Quality Assurance in Design/Development,
Production, Installation, and Servicing”
This is the category for companies which are
involved in manufacturing or the creation
and delivery of a service.

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Part 3: ISO 9002
ISO 9002: “Quality Systems – Model for Quality
Assurance in Production and Installation”
Companies who perform many functions, with
the exception of design and development, may
apply to this category

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Part 4: ISO 9003
ISO 9003: “Quality Systems – Model for Quality
Assurance in Final Inspection and Test”
This category is useful for outside of the
manufacturing sector, such as in distributors
ISO 9003 is being used less and may be dropped
in the future

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Part 5: ISO 9004
ISO 9004: “Quality Management
and Quality System Elements –
Guidelines”
Used in order to help interpret
the categories included in ISO
9000 certification

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ISO Implementation
Implementing ISO 9000 in an organization can be very
beneficial
The goal of this implementation is to achieve customer
satisfaction at its highest level

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How is ISO 9000 Being
Implemented Today?
ISO 9000 is being used in many organizations with
mixed results
If an organization implements ISO 9000 in order to
simply remain competitive and without mutually
beneficial goals in mind, it will most likely fail in
the long term

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How can ISO 9000 be used in
a business?
 ISO 9000 can benefit many industries, such
as: Banking
Health Care
Manufacturing, etc.
 ISO 9000 is generic, so it can be applied
virtually anywhere!
 Remember, ISO 9000 is just one part of an
entire system needed to create value for
customers

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FOOD
Today more than ever, food products regularly cross national
boundaries at every stage of the supply chain. ISO International
Standards create confidence in the products we eat or drink by
ensuring the world uses the same recipe when it comes to food
quality, safety and efficiency. Out of more than 19000 ISO
International Standards, some 1000 are specifically dedicated to food,
and deal with subjects as diverse as agricultural machinery, logistics,
transportation, manufacturing, labelling, packaging and storage.

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Energy efficiency and renewables
Reducing energy consumption and the dependency on
fossil fuels is a major challenge. Governments,
organizations and corporations around the world must
work together in order to move towards a more
sustainable future. ISO International Standards can
help solve the energy challenge by increasing energy
efficiency, and promoting the development of
renewable energy technologies

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Cars
ISO standards for the automotive industry cover all
aspects: safety, ergonomics, performance, test methods,
the environment, and the roll-out of innovative
technologies. Clearly, with more than a billion estimated
road vehicles in use worldwide

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The Impact of ISO 9000 Certification on
Sales
 ISO 9000 certification has been applied around the world and in all
sectors of industry.
 Nowadays for a company, receiving ISO 9000 certification is not only a
fashion or trend, but also a general requirement for running a good
business (Yann, 1998).
 The top 10 countries for ISO 9001 certificates as at 2009 are China ,
Italy, Japan, Spain, Russian Federation, Germany, U.K., India, U.S.A
and Korea.

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ISO 9000 in Spanish industry
 The impact of the ISO 9000 in Spain has been spectacular.
At present, there are more than 9,000 certified Spanish companies,
according to the latest report of the International Standardization
Organization (2000).
 In addition, the mean growth of ISO 9000 certification in Spain is
markedly higher than the European .
 It is also clear that certified companies show greater export capacity
than other companies, with a greater average percentage of turnover
devoted to major exports (Casadesu´ s and Heras, 1999).

39. ISO 9000:2000 Consists of 3
Areas
ISO 9000:2000 Quality Management Systems:
fundamentals and vocabulary
ISO 9001:2000 Quality Management Systems –
Requirements (required for certification)
Management responsibility
Resource management
Product/service realization
Measurement, analysis, improvement
ISO 9004-2000 Quality Management Systems –
Guidelines for performance improvement
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40. ISO 9000
 Quality Management Fundamentals
 Role of top management
 Checking the quality management system
 Role of statistical techniques
 Vocabulary
 Quality planning
 Customer satisfaction
 Continual improvement
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41. Who created the standards?
International Organization for
Standardization - Geneva
ISO tech committee - TC 176 started in
1979
Standards created in 1987
To eliminate country to country
differences
To eliminate terminology confusion
To increase quality awareness
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42. What are the elements of the
standards?
Management
responsibility
Resource management
Quality System
Contract Review
Design Control
Document Control
Purchasing
Purchaser-Supplied
Product
Product Identification and
Traceability
Process Control
Inspection and Testing
Inspection, Measuring and
Test Equipment
Inspection and Test Status
Control of Non-conforming
product
Corrective Action
Quality Records
Internal Quality Audit
Training
Servicing
Statistical Techniques
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43. Element Standard: Management
Responsibility
Management must have a written policy statement
of their commitment to quality. This policy must be
communicated to and understood by all
employees.
Management must clearly define quality-related
organizational responsibilities and
interrelationships.
A management representative must be assigned to
oversee the implementation and continuous
improvement of the quality system.
Senior management must continually review the
system.
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44. Element Standard: Process Control
The company must identify all processes that
directly affect the quality of the product or
service and ensure that these processes are
carried out under controlled conditions,
including:
Formal approval of process design and equipment.
Documented work instructions.
Development of quality plans describing how the
process is to be monitored.
A suitable working environment.
Documented quality criteria.
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45. Why is ISO 9000 important?
European Union directive
 ISO 9000 certification required by suppliers
of “Regulated Products”
health, safety, and the environment
EC has strict corporate liability legislation
protecting consumers
Globalization impact
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46. Why adopt ISO 9000?
To comply with customers who require ISO
9000
To sell in the European Union market
To compete in domestic markets
To improve the quality system
To minimize repetitive auditing by similar and
different customers
To improve subcontractors’ performance
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47. What the ISO 9000 Family is not
 A family of product standards
 A guarantee of product quality
 A method to rescue a troubled company
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48. Why Companies Implement ISO 9000
 Meet customer requirements
 Meet regulatory requirements
 Improve quality
 Increase profitability
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49. The Engineers Role in ISO
9000
 Engineers working in quality management may
be responsible for implementation of the entire
standard
 Project management task
 ISO 9001 Processes operated / managed by
technical personnel may include
 Design and development
 Planning of product realization
 Infrastructure
 Work environment
 Monitoring and measurement of product and
processes
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50. Processus, not Product
Both ISO 9001 concern the way an organization goes about
its work.
It is not product standards.
It is not service standards.
It’s process standards.
It can be used by Product manufacturers and service
providers.
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51. ISO 9001
 Organized by key business processes
 Quality management system
 Management
 Resources
 Product realization
 Measurement, analysis and improvement
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52. What are the benefits of ISO 9001 certification?
ISO 9001 certification is an ideal way for an organisation to
improve the way it operates and manages, irrespective of its
size or industry. Most organisations want ISO 9001
certification to qualify for a tender or to achieve preferred
supplier status: typically for public sector work. However,
there are many other benefits that can be added to these,
including:
 Improved internal working leading to less errors and re-work.
 Improved customer satisfaction and loyalty.
 Improved consistency with traceability.
 Improved morale and motivation.
 Preferential insurance premiums.
 Competitive advantage.
 Increased profitability.
 Enhanced status.
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53. Impact on Business Results
 ISO 9001 promotes
 Not entering into commitments that the
organization cannot meet
 Identification and management of resources
needed to meet organizational objectives
 Processes designed to meet organizational
objectives
 Reduction in waste
 Continual improvement of the quality
management system
 Satisfied customers
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54. Impact on Business Results
 ISO 9001 promotes
 Not entering into commitments that the
organization cannot meet
 Identification and management of resources
needed to meet organizational objectives
 Processes designed to meet organizational
objectives
 Reduction in waste
 Continual improvement of the quality
management system
 Satisfied customers
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ISO 9000 in Spanish industry
 The impact of the ISO 9000 in Spain has been
impressive.
At present, there are more than 9,000 certified
Spanish companies, according to the latest report of
the International Standardization Organization (2000).
 In addition, the mean growth of ISO 9000 certification
in Spain is markedly higher than the European .
 It is also clear that certified companies show greater
export capacity than other companies, with a greater
average percentage of turnover devoted to major
exports (Casadesu´ s and Heras, 1999).

56. The ISO:9000 Survey
The worldwide total of certificates to ISO 9001:2001 at the
end of 2007 was 9,51,486.
This was increase of 6 % over 2006 when the total was
8,96,929 certificates.
Certificates had been issued in 175 countries compared to 170
the previous year.

57. The ISO Survey
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58. Six Essential Elements of a
Successful Registration Effort
Senior Management Commitment to the Effort
Appropriate ISO 9000 Training
An Effective Management Review Process
Documentation of the Quality System
An Effective Internal Auditing System
An Effective Corrective Action Process
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59. Steps to ISO 9000 Certification
1. Hire Quality Management Consultant
2. Conduct Gap Analysis
3. Establish Quality Policy
4. Redefine Business Processes
=> 3 Core Processes
• Individual Benefits
• Institutional Benefits
• Health Promotions
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60. Steps to ISO 9000 Certification
5. Company Wide Quality Seminar
6. Prepare Quality Manual (electronic records)
Quality Policies
Quality Objectives
7. Establish Quality Metrics
8. Prepare Work Instructions
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61. Steps to ISO 9000 Certification
9. Quality Training for ALL
Audit Training (34 employees)
10. Appoint Lead Auditors
11. Conduct Pre-Assessment Audits (2)
12. Contract Registrar
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62. Steps to ISO 9000 Certification
13. Registration Audit
Audit Training (34 employees)
14. Conduct Internal Audits
2 per year
15. Surveillance Audits
2 per year
16. Re-Registration Audits
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63. How much does it cost?
•First Year – US$ 18,000
•Annual – US$ 5,000
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64. Ten Steps to ISO Registration
1. Set the registration objective
2. Select the appropriate standard
3. Develop and implement the quality system
4. Select a third-party registrar and apply
5. Perform self-analysis audit
6. Submit quality manual for approval
7. Pre-assessment by registrar
8. Take corrective actions
9. Final assessment by registrar
10. Registration!
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