Pharmacy, Quality Assurance, Sem- VI, B pharm

1. ISO 9000 & ISO 14000 OVERVIEW
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2. ISO 9000 & ISO 14000 OVERVIEW
Quality management system 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.
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 standard 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 following year in February 1947, the non-governmental organization called International Organization for
standardization was born and 67 technical committees where set up
From the 25 members who made in initiate this process ISO has grown to a huge network of more than 160 member
countries who represents their National standards organizations.
The ISO headquarters is located in Geneva, Switzerland.
ISO has set more than 20,000 standards in different areas right from manufacturing and agriculture to food safety and
health care.
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3. ISO 9000 & ISO 14000 OVERVIEW
Aim of ISO
• The purpose of international standards developed by ISO is to ensure that products and
services are safe reliable and of good quality.
• For businesses, they are strategic tools that reduce cost 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.
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4. ISO 9000 & ISO 14000 OVERVIEW
Principles
of ISO
standards
Customer
focus
Leadership
Engagement
of people
Process
approach
Continual
Improvement
Evidence-
based
decision-
making
Relationship
management
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5. ISO 9000 FAMILY
ISO
9000
family:
ISO 9000 family of Standards deals with the quality management
system including the seven quality management principle upon
which the family of Standards is based.
The purpose of these is to guide organization with the tools required
to make sure that their services or products meets quality
requirement and drive the process of continuous quality
improvement.
ISO 9000 standards were published first in 1987 major revisions were
made in 2000 and later in 2008 the most recent version are the ones
published in 2015.
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6. ISO 9000 FAMILY
• ISO 9000: basic concept and vocabulary.
• ISO 9001: requirements of quality management system
• ISO 9002: production installation service
• ISO 90003: inspection and testing
• ISO 9004: continuous Improvement of quality management system
Some of the important standards in this family include
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7. ISO 9000 FAMILY
Benefits of ISO 9001
• Increase credibility which increases the organization's marketability.
• Significant cost saving in terms of time and money
• Better higher customer satisfaction
• Management control improves because of all the documentation and self-
assessment involved in the registration process
• Communication and interactions between the different department in the
organization improved.
• As organizations move to improve their quality the risk of product liability
begins to reduce.
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8. ISO 9000 FAMILY
Important
elements of
ISO 9000
• Management responsibilities
• Quality system
• Design control
• Purchasing
• Process control
• Inspection and testing
• Corrective and preventive action
• Training
• Servicing
• Control of quality record
• Internal quality audits.
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9. ISO 14000 FAMILY
ISO 14000 family:
• ISO 14000 family comprises the in international standards technical reports and guides for
Environmental Management by organizations.
• They specify the requirement necessary to set up an Environmental Management policy,
plan and Implement environmental objectives, determine the impact of product 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 process on the environment.
• In 1996, ISO published ISO14000 family of Standards which was subsequently revised in
2014 and the latest version available is of 2015.
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10. ISO 14000 FAMILY
• ISO 14000 for Environmental Management System- General guidelines on
implementation
• ISO 14006 Environmental Management System- guidelines to Corporate
eco-design
• ISO 14020 environmental label and declarations.
• ISO 14031 Environmental Management- environmental performance
evaluation guidelines
• ISO 14064 greenhouse gases standards
• ISO 14020 environmental label and declarations.
Some of the important standards in the family includes
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11. ISO 14000 FAMILY
Benefits of ISO 14000
• It helps meet legal obligations towards Environmental Protection.
• Resources are used more efficiently.
• Waste is reduced
• Environmental impacts get measured.
• Customer and stakeholder trust increases
• Positive impact on companies asset value
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12. ISO 14000 FAMILY
Elements
of ISO
14001:
Environmental
policy
Employee
involvement
Plan do
check act
model.
Continual
improvement
process
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