THE ISO 9000

SERIES

Prepared by,

Nikhila.M.Nair

1st yr M-pharm

Dept.of pharmaceutics

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1.Introduction.

2.Principle

3.ISO 9000

4.Objectives

5.Advantages

6.Conclusion.

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Definition:

ISO 9000 is a series of standards ,

development & published by the ISO that define ,

establish & maintain an effective QA system for

manufacturing & service industries.

BACKGROUND: WHAT IS ISO?

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• ISO is a name used for the International standard

organization.

• Formed in 1947 in Geneva, Switzerland

• It is federation of national standards bodies of 143 countries.

• To increase quality awareness.

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OBJECTIVES

1.To facilitate International Trade of Goods & services.

2.To obtain competitiveness by obtaining required quality

in a cost effective way.

3. Promoting a TQC system.

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ADVANTAGES8

FOR THE CUSTOMER- Increase satisfaction & growth in confidence.

FOR THE COMPANY- Well defined organization & responsibilities,i.e., minimize possible resource wastage.

Establishment of proper communication channel.

PRINCIPLES OF ISO9

1. Customer focus

2. Leadership

3. Involvement of people

4. Process approach

5. System approach to management

6. Continual improvement

7. Factual approach to decision making

8. Mutually beneficial supplier relationship

PRINCIPLES OF NEW STANDARD10

Requirements of ISO 9001-200011

1.Scope

2.Normative reference

3.Terms & definitions

4. Quality management system

5.Management responsibility

6.Resource management

7.Product realization

8.Measurement, analysis & improvement.

It can be applied to any type of organization.

It help in maintaining an efficient quality system in an organization.

It creates confidence in customer on quality of product supplied.

It acts as competitive barrier.

REFERENCES

http://www.iso.org/iso/en/isoonloine.frontpa

ge

S.Bhaskar,Industrial Management, First

edition,2008 pg no-29.3-29.10

• T. Telsaing, Production Management,

first edition pg no- 977-995.

• www.pharmaworld.com.13

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