3. ISO 9000 provides guidelines for organizations to ensure quality requirements are met and quality improves continually. Certification under ISO 9001 involves meeting

1. Prepared By:- Ms. Mali Sunayana M.
Asst. Professor
Subject:- Pharmaceutical Quality Assurance
Sahyadri College Of Pharmacy, Methwade,
Sangola.
UNIT-I TOPIC-V
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2. Objectives
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Upon completion of this section, the student should be able to;
 Outline the development of ISO standards.
 Explain the aims and principles of ISO.
 Describe ISO 9000 and ISO 14000 families.
 List the elements of ISO 9000 certification.
 Explain the benefits of ISO certification

3. Introduction
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 Quality is a very important requirement for any product because it is one of
the biggest factors determining how successful it will be in achieving customer
satisfaction.
 Quality is often described as the extent to which a product or service meets the
existing standards or requirements.
 Quality has become the catchword across industries and professions and
quality management systems are being developed by the day to ensure better
business processes.
 One such quality management system is provided by the International
Organization for Standardization Which is abbreviated as ISO.

4. HISTORY OF ISO
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 Every country has its own standards for every industry. But in an increasingly
globalized business scenario, a need was felt for a common set of standards to
make it easier for businesses to sell their products anywhere in the world.
 Against this background, about 65 delegates from 25 countries met in London
in 1946 at the Institute of Civil Engineers.
 The agenda was to facilitate the unification of industrial standards at an
international level.
 The following year, in February 1947, the non-governmental organization
called International Organization for Standardization (ISO) was born and 67
technical committees were set up.

5. OVERVIEW OF ISO
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• From the 25 members who met to initiate this process, ISO has grown to a
huge network of more than 160 member countries who represent their nation's
standards organizations.
• The ISO headquarters is located in Geneva, Switzerland. The ISO is
considered the world's largest organization involved with developing voluntary
international standards.
• In this role, the ISO helps to facilitate global trade by creating common
standards across countries.
• Over the years since it began functioning, ISO has set more than 20, 000
standards in different areas right from manufacturing and agriculture to food
safety and healthcare

6. AIM OF ISO INTERNATIONAL STANDARDS
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• The purpose of the International Standards developed by ISO is to 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.
• Organizations often wish to certify their quality systems but the ISO does not
issue any such certificates. However, there are registered institutions and
accreditation bodies who are qualified to perform the certification on behalf of ISO.
•An organization that meets the requirements of certification is issued an ISO
certificate for the standards to which it conforms, and the certificate is valid for 3
years

7. Principles on which ISO Standards are based
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 Customer-focus
 Leadership
 Engagement of people
 Process Approach
 Continual improvement
 Evidence – based decision making
 Relationship management

8. ISO 9000 family
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 The ISO 9000 family is probably the best known of ISO standards. It is the set of
International Standards that lays down the framework for a quality management
system.
 The purpose of these is to guide organizations with the tools required to make
sure that their services or products meet quality requirements and drive the
process of continued quality improvement.
 These standards are universal and may be applied to organizations in any
industry and of any size.
 ISO 9000 standards were published first in 1987.
 Major revisions were made In 2000 and later in 2008.
 The most recent versions are the ones published In 2015.

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 Some of the important standards in this family include :
 ISO 9000:2015- basic concepts and vocabulary (definitions)
 ISO 9001: 2015- requirements .of a quality management system
ISO 9004: 2018 continuous improvement of quality management systems
 ISO 19011: 2011guidelines for internal and external audits of quality
management systems.
 While ISO 9000 is the standard that describes the quality management system,
it is ISO 9001 standard that describes what requirements must be met to achieve
that system in the organization.
 Thus, certification is given under ISO 9001 and not ISO 9000.

10. CRITERIA TO GET ISO 9001 CERTIFICATION
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 Organization must follow the guidelines laid down in the ISO 9001
standard.
 It must meet its own requirements.
 It must meet regulatory and statutory requirements.
 I 'must meet customer requirements.
 It must document its performance.

11. BENEFITS OF ISO 9001 CERTIFICATION
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There are several advantages of ISO 9000 certification and these impact all
aspects of an organization. The most important ones include:
1. Increased credibility from the ISO certification which increases the
organization's marketability.
2. The rigorous certification process exposes deficiencies in the organization and
when these are addressed, it leads to significant cost savings in terms of time and
money.
3. The certification helps to improve quality of products and processes resulting in
better/higher customer satisfaction.
4. Management control improves because of all the documentation and self-
assessment involved In the registration process.
5. Communication and interactions between the different departments in the
organization improve creating better team spirit.

12. IMPORTANT ELEMENTS OF ISO 9000
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1. Management Responsibility
2. Quality System
3. Contract Review
4. Design Control
5. Document and data control
6. Purchasing
7. Control of customer – supplied product
8. Product identification and traceability
9. Process control

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10. Inspection and testing
11. Control of inspection , measuring and test equipment
12. Inspection and test status
13. Control of non-conforming material
14. Corrective and preventive action
15. Handling, storage, packaging, preservation and delivery
16. Control of quality records
17. Internal Quality audits
18. Training , Servicing, Statistical techniques

14. ISO 14000
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 ISO 14000 family comprises the international standards, technical reports and
guides for environmental management by organizations.
They specify the requirements necessary to set up an environmental
management policy, plan and implement environmental objective determine the
impact of products or services on the environment and conducting corrective
actions and management review.
 By working towards ISO 14000 certification, organization can reduce the
negative impact of their processes on the environment (an, land or water).

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Some of the important standards in this family include:
• ISO 14004: 2016 - Environmental management systems - general guidelines.
implementation.
• ISO 14006: 2011 - Environmental management systems- guidelines to
incorporate ecodesign.
• ISO 14031: 2013 - Environmental Management - environmental
performance evaluation guidelines.
• ISO 14064: 2006 - Greenhouse gases standards.
•ISO 14020 2000 - Environmental Labels and Declarations - general
principles.

16. AIM OF ISO 14000
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• The ISO 14000 standards were developed as industries recognized the need for
standardization in the area of environmental management.
•
• They aim at ensuring organizations promote environmental management
systems that are effective.
•The first standard for environmental management system was the BS 7750 that
published in 1992.
• In 1996, ISO published the ISO 14000 family of standards, which was
subsequently revised in 2004 and the latest version available is of 2015.
•ISO 14001 is the standard to which organizations can get certified.

17. BENEFITS OF ISO 14000
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• ISO 14000 certification has several benefits for organizations, such as:
1. It helps meet legal obligations towards environmental protection.
2. Resources are used more efficiently.
3. Waste is reduced.
4. Environmental impacts get measured.
5. Customer and stakeholder trust increases.
6. Environmental obligations are managed the right way.
• ISO certifications are important for organizations because they provide
customers with evidence of the company's commitment to quality.
• The standards have a process-oriented approach and look at how processes
operate across departments and their interaction: they also help to focus on
the most critical of products and services and therefore, are an effective
check of the company's quality management systems.

18. REVIEW QUESTIONS
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1. Define ISO and discuss its aims and principles.
2. Explain the history of ISO standards development.
3. What are the important elements of ISO 9000 certification?
4. Discuss the benefits of ISO certification for a pharmaceutical company.
5. Explain the ISO 9000 family of standards.
6.What is the significance of the ISO 14000 family of standards?

19. REFERENCE
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1) A Text book of Pharmaceutical Quality Assurance by the
author Anusuya R.Kashi, Bindu Sukumaran, And Veena P.
Nirali Prakashan. Page No.5.1-5.5
2) www.google.com

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