Fundamental knowledge on pharmaceutical product development and translation from laboratory to market. Quality management systems: Quality management & Certifications. ISO Quality Standards 1. Introduction to ISO 14000 2. Principle of ISO 14000 3. Features of ISO 14000 4. Advantages of ISO 14000 5. ISO 14000 Series 6. Process of ISO 14001 Certification 7. Environmental Management System (EMS) 8. Features of EMS

1. B.PHARM.VII-SEMESTER
BP702T.
INDUSTRIALPHARMACY-II(Theory)

2. QUALITYMANAGEMENTSYSTEMS
Dr. Ajay K. , Maharishi Arvind College of Pharmacy, Jaipur
ISO Quality Standards
ISO 14000

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LEARNINGOBJECTIVES
After completing this presentation, you will be able to understand:
ISO Quality Standards
1. Introduction to ISO 14000
2. Principle of ISO 14000
3. Features of ISO 14000
4. Advantages of ISO 14000
5. ISO 14000 Series
6. Process of ISO 14001 Certification
7. Environmental Management System (EMS)
8. Features of EMS
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ISO 14000

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ISO 14000
1. Introduction to ISO 14000

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ISO 14000
1. Introduction to ISO 14000

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ISO 14000
Related to
Environmental Management System
(EMS)
 ISO 14000 family provides practical tools to manage
the environmental responsibilities of companies and
organizations.
 It was initially published in 1996 and revised in 2004.
1. Introduction to ISO 14000

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 Considered as generic management system and
 is applicable for:
 Any organization (single-site to large MNCs, high risk to low risk
companies).
 The manufacturing industries (equipment manufacturers and
suppliers), process industries and service industries.
 All industries of local government, public and private sectors.
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ISO 14000
1. Introduction to ISO 14000

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 Basic features are:
 Minimum harmful effects on environment.
 Continuous improvement to achieve the desired
performances.
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ISO 14000
1. Introduction to ISO 14000

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Explained by
PDCA Model
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ISO 14000
2. Principle of ISO 14000

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ISO 14000
a. Plan: Designing of aim, objective and processes to achieve the desired result.
b. Do: Designed process should be performed step by step. The changes are
noted and data is stored to analyze the results.
c. Check: The evaluation of the data and results recorded in the previous steps.
d. Act: The evaluation of the data and results helps to improve the process. In
this step, the problems of the result are rectified for the continuous
improvement.
 For this purpose, Do and Check steps may be repeated several times for
the better outcome. The causes of the difference in the results are
identified and improved. This step is often named as ‘Adjust’.
2. Principle of ISO 14000

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ISO 14000
a. EMS (Environmental Management System).
b. Environmental related evaluations, investigations and
auditing.
c. The investigation of the process performances.
d. Environmental labels and declarations.
3. Features of ISO 14000

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ISO 14000
Better marketability.
Better utilization of resources.
Environmental responsibilities.
Better quality of finished goods and products.
Customers’ satisfaction.
Enhancement of the reputation and reliability of the
organization.
Improvement of the relationship among management,
employees, customers and investors.
Reduction in cost.
This certification can help an organization by:
4. Advantages of ISO 14000 By getting ISO certification, any organization can
maintain their conformation to the environmental regulations.

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ISO 14000
5. ISO 14000 Series

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ISO 14000
6. Process of ISO 14001 Certification Registration and Certification procedure of ISO 14001

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ISO 14000
7. Environmental Management System (EMS)
 Monitors
 Reviews
 Summarizes
 Evaluates
 Reports and
 Improves
the Environmental Performances
to achieve the environmental goal.
 to reduce the environmental impact and
 to increase the efficiency.
 Waste reduction is one of the important goals of EMS.

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ISO 14000
8. Features of EMS Improvement of environmental performances.
Controlling and managing of environmental policies, in systematic way, to maintain
the long-term effect of better products, service and customer satisfaction.
Process design to control the pollution and waste reduction.
Reducing the impact of environmental factors.
Training of the personnel about the process and control.
Assistance of planning, controlling and monitoring the environmental policies in
organization.
Continuous improvement to meet the desired goal and result.
Maintains the accountability between the management and employee personnel.

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19. B.PHARM. VII-SEMESTER BP 702 T. INDUSTRIAL PHARMACY-II (Theory)
DR. AJAY K. TIWARI, ASSOCIATE PROFESSOR
MAHARISHI ARVIND COLLEGE OF PHARMACY, JAIPUR (RAJ.)
AJAY81AJAY@GMAIL.COM WHATSAPP: 9782226444
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