The document outlines the structure, objectives, and history of the International Organization for Standardization (ISO), which develops international standards to ensure quality, safety, and sustainability across various industries. It emphasizes the role of ISO in facilitating global trade and the certification processes for its standards such as ISO 9000, ISO 14000, and ISO 26000. The document also discusses the composition and functions of the ISO council and the benefits of ISO certification for organizations.

1. UNIVERSITY INSTITUTE OF PHARMA SCIENCES
Master of Pharmacy
Quality Management System.
Topic-International Organization for Standardization.
•Tariq Husain
•23MPH10001

2. INTRODUCTION TO ISO
• It is an independent, non-governmental, international organization that develops
and publishes a wide range of proprietary, industrial, and commercial standards.
• Founded in 1947, it comprises representatives from various national standards
organizations of over 175 countries among 195 countries.
• Its mission is to promote the development and implementation of international
standards that ensure quality, safety, efficiency, and sustainability in various
industries.
• ISO does not produce products or certify companies directly. Instead, it provides
the framework for standards that various certifying bodies then use.
• The ISO plays an important role in facilitating world trade by providing common
standards among different countries. These standards are intended to ensure that
products and services are safe, reliable, and of good quality.
• The ISO plays an important role in facilitating world trade by providing
common standards among different countries.
• ISO standards cover all fields, from healthcare to technology to
manufacturing to security to the environment

3. Structure and organisation.
• ISO is a voluntary organization whose members are recognized
authorities on standards, each one representing one country.
Members meet annually at a General Assembly to discuss the
strategic objectives of ISO. The organization is coordinated by a
central secretariat based in Geneva.
• A council with a rotating membership of 20 member bodies
provides guidance and governance, including setting the annual
budget of the central secretariat.
• The technical management board is responsible for more than
250 technical committees who develop the ISO standards.
• there is only one member per country.
• 6 permanent member of ISO.
• Members of ISO meet annually at a General Assembly to discuss
the strategic objectives of the organization

4. Objective of ISO
• Following are the objectives of ISO.
– Quality management: Improve the quality of products and services, enhance customer
satisfaction, and streamline business processes (e.g., ISO 9001).
– Environmental management: Minimize environmental impact, reduce waste, and promote
sustainability (e.g., ISO 14001).
– Information security: Protect sensitive information and mitigate cyber security risks (e.g., ISO
27001).
– Occupational health and safety: Create a safe and healthy work environment for employees
(e.g., ISO 45001).
• Overall, ISO standards aim to achieve consistency, quality, and safety across
different industries and regions, ultimately benefiting businesses, consumers, and
society as a whole.
• ISO develops and publishes standards for a vast range of products, materials, and
processes. Currently, the organization has over 24,362 standards, which are
included in the ISO Standards catalog, which is broken down into various segments,
such as healthcare technology, railway engineering, jewelry, clothing, metallurgy,
weapons, paint, civil engineering, agriculture, and aircraft.
• The ISO plays an important role in facilitating world trade by providing common
standards among different countries

5. History of ISO
• The organization that is known today as ISO began in 1926 as
the International Federation of the National Standardizing
Associations (ISA), which primarily focused on mechanical engineering.
The ISA was suspended in 1942 during World War II but, after the war, the
ISA was approached by the recently-formed United Nations Standards
Coordinating Committee (UNSCC) with a proposal to form a new global
standards body.
• In October 1946, ISA and UNSCC delegates from 25 countries met in
London and agreed to join forces to create the International Organization
for Standardization. The organization officially began operations on 23
February 1947.
• ISO Standards were originally known as ISO Recommendations (ISO/R),
e.g., "ISO 1" was issued in 1951 as "ISO/R 1
• 1951: The first ISO standard, ISO/R 1, was published, setting a standard
reference temperature for industrial length measurements..

6. .
1940s-
1950
1950s-
1980s
1920s-
1940s
1990s

7. Key takeaways:
• ISO was born from the need for international
collaboration and standardization after World
War II.
• It has grown steadily, expanding its scope and
impact on various industries and aspects of
global trade and commerce.
• With its commitment to quality, safety, and
sustainability, ISO continues to play a vital role
in shaping our world today.

8. ISO council
• The ISO Council is the governing body of the International Organization for
Standardization (ISO), a non-governmental organization that develops and
publishes international standards. It plays a crucial role in ensuring the
smooth functioning and strategic direction of ISO, and its decisions impact
the development and implementation of standards that affect various
industries and activities globally. Composition:
• The ISO Council comprises representatives from 20 elected member bodies
of ISO, each representing a different country.
• It includes six permanent members:
– France
– Germany
– India
– Italy
– Japan
– United Kingdom (UK)
– United States of America (USA)
• Other members are elected for a three-year term, ensuring diverse
representation.
• The council is chaired by a president elected from the council members.

9. Functions:
• Provides strategic guidance and direction to ISO.
• Oversees the development and implementation of the ISO multi-year
strategic plan.
• Approves the annual budget and financial planning.
• Represents ISO in its relations with other international organizations
and external stakeholders.
• Establishes policy frameworks for various areas like conformity
assessment, consumer interests, and intellectual property rights.
• Appoints the Secretary-General, the chief executive officer of ISO.
Key Activities:
• Reviews and approves new work items for standard development.
• Makes decisions on the publication and withdrawal of ISO standards.
• Monitors the performance of ISO and its technical committees.
• Approves the establishment and dissolution of technical committees.
• Addresses appeals and grievances related to ISO standards and
procedures

10. ISO Member

11. Various popular ISO
ISO 9001 ISO 14000 ISO 26000
ISO14001 ISO 22000 ISO 31000
ISO 27001 ISO 20000 ISO 450001
ISO 45001 ISO 14000 ISO 20121

12. ISO
ISO 9000 ISO14000 ISO26000
Quality management
system
environmental-
management policy
Social responsibilities

13. ISO 9000
• ISO 9000 is defined as a set of international standards on quality
management and quality assurance developed to help companies
effectively document the quality system elements needed to
maintain an efficient quality system. They are not specific to any
one industry and can be applied to organizations of any size.
• ISO 9000 can help a company satisfy its customers, meet regulatory
requirements, and achieve continual improvement. It should be
considered to be a first step or the base level of a quality system.
• ISO 9000:2015 - Fundamentals and vocabulary of quality
management systems
• ISO 9001:2015 - Requirements for quality management systems
(the most widely implemented)
• ISO 9004:2015 - Quality management - Quality of an organization -
Guidance to achieve sustained success
• ISO 19011:2011 - Guidelines on auditing management systems
• ISO 10015:2019 - Quality management - Guidelines for quality in
the public sector.

14. Parts of ISO 9000

15. Benefits of ISO 9001 Certification:
• Increased customer satisfaction
• Improved product and service quality
• Enhanced operational efficiency
• Reduced costs
• Competitive advantage
• Increased market access

16. Quality management system
principle.

17. Benefits of having ISO 9000
• Increased Customer Satisfaction
• Improved product and service quality
• Enhanced responsiveness to customer needs
• Reduced errors and rework
• Enhanced brand reputation

18. ISO 14000
• ISO 14000 is defined as a series of international environmental
management standards, guides, and technical reports. The
standards specify requirements for establishing an environmental-
management policy , determining environmental impacts of
products or services, planning environmental objectives,
implementing programs to meet objectives, and conducting
corrective action and management review.
• The primary objective of the ISO 14000 series of standards is to
promote effective environmental management systems in
organizations. The standards seek to provide cost-effective tools
that make use of best practices for organizing and applying
information about environmental management.
• The ISO 14000 family was developed in response to a recognized
industry need for standardization. With different organizational
approaches to environmental management, comparisons of
systems and collaboration had proved difficult.

19. Parts of ISO14000

20. Benefits of having ISO 14000
• Improved environmental compliance
• Pollution prevention
• New market opportunities
• Reduced health and safety risks
• Reduced health and safety risks

21. ISO 26000
• Absolutely ISO 26000 is a guidance standard, not a certifiable
standard, that provides recommendations for social responsibility
(SR) within organizations. It was released by the International
Organization for Standardization (ISO) in 2010.
• Scope: Covers a wide range of social responsibility issues, including:
– Human rights
– Labour practices
– The environment
– Fair operating practices
– Consumer issues
– Community involvement
– Governance
– Organizational impact.

22. Use of ISO 26000
• ISO 24000 provide the guidance to all types of
organizations related to
• Concepts, terms and definitions related to
social responsibility.
• To assist organizations in contributing to
sustainable development.
• It is intended to promote common
understanding in the field of social
responsibility.

23. Benefit of having ISO 26000
• Enhanced reputation and brand image.
• Improved stakeholder relationships.
• Increased employee engagement and
motivation.
• Reduced risk of negative publicity and legal
issues.
• Contribution to sustainable development.
• Improved access to finance and investment.

24. BENEFIT OF ISO
• ISO 9000 (Quality Management):Increased customer satisfaction
through improved product/service quality.
• Enhanced operational efficiency and reduced costs.
• Competitive advantage and access to new markets
• ISO 14000 (Environmental Management):Reduced environmental
impact and improved compliance with regulations.
• Enhanced resource efficiency and cost savings.
• Improved brand reputation and community relations
• Benefit of having ISO 26000.[Social responsibilities]
• Increased employee engagement and motivation.
• Reduced risk of negative publicity and legal issues.
• Contribution to sustainable development.
• Improved access to finance and investment.

25. Procedure for Certification.
Specific ISO
Evaluation
Requirements
Implementin
g changes
Perform
internal audit
Choose
certification
body
External audit
Maintining it

26. Procedure for ISO Certification
• 1. Identify the specific ISO standard that is applicable to your organization and its
industry.
• 2. Evaluate your current processes and practices against the requirements of the
ISO standard to identify areas that need improvement.
• 3. Create a detailed plan outlining the steps needed to meet the requirements of
the ISO standard. This may involve updating procedures, training employees, and
implementing new processes.
• 4. Make the necessary changes to your organization's processes and practices to
align with the ISO standard.
• 5.Perform internal audits to ensure that the implemented changes are effective
and meet the requirements of the ISO standard.
• 6. Choose an accredited certification body to conduct an external audit of your
organization's compliance with the ISO standard.
• 7. The certification body will conduct an on-site audit to verify that your
organization meets the requirements of the ISO standard.
• 8.if the organization passes the audit then it will receive the ISO certificaton.
• 9. To maintain your ISO certification, you will need to undergo regular surveillance
audits and recertification audits as required by the certification body.

27. Reference
• Wikipedia
• ISO.org
• Ansi.org
• google