Compatitive study between quality management systems ,and briefly introduces environmental management system.

1. ISO 9001:2008
And 9001:2015
PRESENTED BY: MR. RAM SATISH GULUMKAR
1ST YEAR, MASTER OF PHARMACY
DEPARTMENT OF QUALITY ASSURANCE TECHNIQUES
BHARTI VIDYAPEETH’S COLLEGE OF PHARMACY,
NAVI MUMBAI.
PRESENTED TO: DR. VARSHA M. JADHAV

2. Contents
Here’s what you’ll find in this Presentation:
● What is management system
● Quality management principles
● Moving from ISO 9001:2008 to ISO 9001:2015
● ISO 9001:2015
● Debunking the myths
● Success stories
● ISO 14001:2015
● Conclusion
● References

3. A management system is a
way of defining an
organizations operations to
help it meet its objectives..
What is
management
System

4. “Implementing a quality management system will help you:
• Assess the overall context of your organization to
define who is affected by your work and what they
expect from you. This will enable you to clearly
state your objectives and identify new business
opportunities
• Put your customers first, making sure you
consistently meet their needs and enhance their
satisfaction. This can lead to repeat custom, new
clients and increased business for your organization.

5. • Work in a more efficient way as all your processes
will be aligned and understood by everyone in the
business or organization. This increases productivity
and efficiency, bringing internal costs down.
• Meet the necessary statutory and regulatory
requirements.
• Expand into new markets, as some sectors and
clients require ISO 9001 before doing business.
• Identify and address the risks associated with
your organization.

6. Quality Management Principles
0
1
Customer focus
02 Leadership
03
Engagement of
people
04
05
06
Process approach
Improvement
Evidence based
decision making
07
Relationship
management

7. Moving from
ISO 9001:2008
to ISO
9001:2015
to be more efficient
and improve customer
satisfaction.

8. Why has the
standard been
revised ?
● ISO standards are reviewed every five years
and revised if needed.
● This helps ensure they remain useful tools for
the marketplace.
● The challenges faced by business and
organizations today are very different from a
few decades ago and ISO 9001 has been
updated to take this new environment into
account.

9. What are the
major
differences ?
● The most noticeable change to the standard is
its new structure. ISO 9001:2015 now follows
the same overall structure as other ISO
management system standards (known as the
High-Level Structure), making it easier for
anyone using multiple management
systems.This helps ensure they remain useful
tools for the marketplace.
● Another major difference is the focus on risk-
based thinking.

10. What benefits does
the new version bring ?
ISO 9001:2015 :
● Puts greater emphasis on leadership engagement
● Helps address organizational risks and
opportunities in a structured manner
● Uses simplified language and a common structure
and terms, which are particularly helpful to
organizations using multiple management systems,
such as those for the environment, health & safety,
or business continuity
● Addresses supply chain management more
effectively
● Is more user-friendly for service and knowledge-
based organizations .

11. ISO 9001:2015
How is the standard structured ?
• Clause 0-3 – Introduction and scope of the standard
• Clause 4 – Context of the organization
• Clause 5 – Leadership
• Clause 6 – Planning
• Clause 7 – Support
• Clause 8 – Operation
• Clause 9 – Performance evaluation
• Clause 10 – Improvement

12. Debunking
the myths

13. Isn’t it an old document
designed for the way
businesses worked
in the 1990s ?
Does it mean lots of
extra paperwork ?
Three Quality Myths
Is it very
complicated ?
01 02 03

14. Success stories
Baltika
Breweries
Sénégalaise
Des Eaux
One step ahead
of customer needs
Optimizing
operations

15. Introduction
to ISO
14001:2015 ISO 14001 is an internationally agreed standard
that sets out the requirements for an
environmental management system. It helps
organizations improve their environmental
performance through more efficient use of
resources and reduction of waste, gaining a
competitive advantage and the trust of
stakeholders

16. First
The ISO 9001:2015 guidelines provide a
comprehensive framework for establishing,
implementing, and maintaining a quality
management system that can enhance
organizational performance and customer
satisfaction.
Conclusion
Second
The ISO 9001:2015 guidelines represent a
shift towards a more flexible and risk-based
approach to quality management, with a
greater emphasis on leadership, customer
focus, and continual improvement, compared
to the ISO 9001:2008 guidelines.
Third
The ISO 14001 guidelines provide a
framework for organizations to establish and
maintain an effective environmental
management system, reduce their
environmental impact, and improve
sustainability performance.

17. References
https://www.iso.org/iso-14001-environmental-
management.html
https://www.iso.org/standard/46486.html
https://www.iso.org/standard/62085.html
https://www.iso.org/publication/PUB100406.html

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