iso 9000 series

1. A PRESENTATION ON IS0 9000
SERIES
PRESENTED BY –
MANDAKINI PORWAL
B.PHARM ,SEM-7TH ,4TH YEAR
(S.R.L.T INSTITUTE OF PHARMACEUTICAL SCIENCE
& TECHNOLOGY)

2. CONTENT-
• CONCEPT OF T.Q.M
• PRINCIPLE OF T.Q.M
• QUALITY ASSURANCE
• I.S.O
• I.S.O 9000 SERIES
• NEED FOR I.S.O
• IMPORTANCE OF ISO 9000 SERIES

3. WHAT IS ISO 9000?
GENEVA

4. TOTAL QUALITY MANAGEMENT
Total quality management (TQM) is a management
process aimed at bringing about excellence
through the continuous enhancement of quality
in an organisation. The basic philosophy of TQM
is “Doing the right thing right the first time, on
time, all the time, always striving for
improvement, and always satisfying the
customers”.

5. • Everyone is
involved in
Total
• Continuously
improving
service to
customers
Quality
• With data
and
profound
knowledge
Management

6. TQM IN PUBLIC SERVICE
• The purpose is to provide information and guidance to
the Head of Department in planning and activating the
process of improving quality in their departments.
• Create an environment that is conducive for the
inculcation of an excellent work culture.
TQM Concept
– Continues process in creating a culture of excellent
for the whole organisation and is customer-driven
– Aim to achieve total quality in all its operation
aspects.

7. PRINCIPLES OF TQM
Focus on
customer
Quality
Assurance
Measurement
of performance
Strategic
Planning
Training &
Recognition
Leadership &
commitment
by top
management
Teamwork

8. QUALITY ASSURANCE
• The objective can be achieved by adhering to
clearly laid quality standards for products, work
processes and input used
• Support in turn by quality inspection, tracing
sources of flaws and taking remedial action

9. TQM
( Employee involvementand
Product improvement)
ISO
(certification
shows that an
organizationis
following well-
established
industry
standards)
* ISOis the processthat typically shifts an organization's culture to allow
successful TQM implementation

10. In the context of
concerned with
ISO 9000,
the totality
quality is
of the
characteristics thatsatisfy needs.
Quality is defined as the degree to which a set of
inherent characteristics fulfill the requirements.

11. WHAT IS QUALITY ASSURANCE?
Quality assurance refers to “all those planned
and systematic actions that are necessary to
provide adequate confidence that a product or
service will satisfy given requirements for
quality”.

12. ISO9000 isaset of five guideline standards that
define the requirements for aneffective quality
managementsystem.Ofthefive,only three are
certification standards (ISO9001, 9002and
9003);both ISO9000 and 9004are guidelinesfor
theotherthree.

13. International Organization for Standardization
(ISO)
ISOisGreekroot meaningequal
These standards are guidelines on how to
document the processesin specificindustries. The
goal is consistency and a set of complete, easy to
followinstructions.
ISO guidelines is where the TQM process can
becomeabitoverwhelming.

14. ISO 9000
WHAT IS QUALITY???
The totality of features and characteristics of a
product or service that bears on its ability to
satisfy express or implied needs

15. STRUCTURE OF ISO 9000 SERIES
Types Standard Details
Guidelines
ISO 9000 Quality Management and Quality Assurance
Standards - Guidelines for Selection & Use
ISO 9004 Quality Management and Quality System Elements
- Guidelines
Quality
Assurance
Model
ISO 9001 Quality Systems - Model for Quality Assurance in
Design/Development, Production. Installation and
Servicing
ISO 9002 Quality Systems - Model for Quality Assurance in
Production and Installation
ISO 9003 Quality Systems - Model for Quality Assurance in
Final Inspection and Test

16. ISO standards are just a Quality Management
System (QMS) with specific guidelines on how to
document the processes. ISO is not, however, a
way togetaroundTotalQuality Management.
Since ISO is focused on consistency and record-
keeping, while TQM is focused on employee
involvement and product improvement, they go
hand in hand. Both are customer requirements
focused, but Total Quality Management is really
the drivingfactor.

17. NEED FOR ISO
•
•
Main factors are "Quality andStandardization"
around the world
Worldwide progress in tradeliberalization
– Interpenetration of sectors
– Worldwide communications systems
– Global standards needs for emergingtechnologies
– Developing countries
• I.S.O certification increase the confidence of
custemers.

19. IMPORTANCE OF ISO 9000 SERIES-
• ISO 9000 IS A QUALITY MANAGEMENT STANDARD
THAT PRESENT GUIDELINES INTENDED TO
INCREASE BUSINESS EFFICIENCY AND
CUSTOMER SATISFACTION
• THE GOAL OF ISO 9000 IS TO EMBED A QUALITY
MANAGEMENT SYSTEM WITHIN AN
ORGANISATION ,INCREASING PRODUCTIVITY
,REDUCING UNNECESSARY COSTS,& ENSURING
QUALITY OF PROCESSES & PRODUCT