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ISO 9000 SERIES

Vijay Kumar Tirukkachi

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CONTENTS

DEFINITION

WHAT IS ISO

NEED

OBJECTIVE

HISTORY

WHO CREATES STANDARDS

PRINCIPLE

ADVANTAGES & DISAVANTA

STRUCTURE OF SERIES

ELEMENTS OF ISO9000

CERTIFICATION PROCEDUR

VARIOUS LOGOS

CONCLUSION

REFERENCES

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ISO 9000 is aseries ofstandards , developm

and published by the ISO that define,establi

and maintain an effective quality assurance

system for manufacturing and service indust

http://en.wikipedia.org/wiki/Standardizationhttp://en.wikipedia.org/wiki/Standardization

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WHAT IS ISO

ISO is a name used for the International Organization for

Standardization.

ISO is not an acronym

It was formed in 1947 in geneva switzerland.

It is a federation of national standard bodies of 143 countries.

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NEED

By implementing an organization can benefit many industries such as ba

health care, manufacturing etc.,

The goal of this implementation is to achieve customer satisfaction at its

value

To compete in domestic markets

To improve quality system

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OBJECTIVE

1. To promote development ofstandardization to facilit

international exchange of goods and services.

2. To promotecooperationin intellectual, scientific,

technological, and economic activity

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HISTORY

1946 London - delegates from 25 countries to facilitate the international coordiand unification of industrial standards

1947 - ISO began to officially function

1951 - The first ISO standard was published

In 1979 to meet growing awareness of quality in industry BS5750 std were dev

ISO revised and issued BS5750 in 1987 as ISO 9000 series

Revised in 1994 and 2000

ISO9001:2000 is valid till next year.

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WHO CREATES STANDARDS

International Organization for Standardization - Geneva

ISO tech committee - started in 1979

Standards created in 1987

To eliminate country to country differences

To eliminate terminology confusion

To increase quality awareness

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PRINCIPLE

PLAN,

DO,

CHECK &

ACT

ISO 9000

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ADVANTAGES

For the customer:-

- Increase satisfaction and growth in confidence.

for the company:-

1)Well defined organization and responsibilities,i.e., minimize grey areas and possible

resources wastage.2)Establishment of proper communication channel

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A greater degree of internal control.

Greater productivity and cost reduction

Evidence of compliance

Recognition of standard achieved

Greater productivity and cost reduction

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DISADVANTAGES

Assessment and certification are costly

Need to change and accept new working practices may stmanagement

Unless carefully planned it become non-cost effective anburdensome

Iso9001 only complements and supplements product quastandards

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STRUCTURE OF SERIES

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STANDARD

CONTENT APPLICATION

ISO 9000 Provides definition and concepts.

Explains how to select other standards for a

given business

All industries including softwar

ISO 9001 Quality assurance in design, development,

production, installation and servicing

Engineering and construction fi

manufacturers that design, deve

service products

ISO 9002 Quality assurance in production and

installation

Companies in the chemical pro

that are not involved in product

sales service

ISO 9003 Quality assurance in test and inspection Small shops, divisions within a

equipment distributors that insp

supplied products

ISO 9004 Quality management and quality system

elements

All industries

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ISO 9001:2000 Requirements

1.Scope

2. Normative reference

3.Terms and definitions

4.Quality management system

5.Management responsibility 6.Resource management

7.Product realisation

8.Measurement, analysis and improvement

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Scope:

The specified requirements are generic and applicable to all organizationregardless of their type and size.

Normative Reference:

Terms and vocabulary

Supplier, Organization, Customer.

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Quality management system

QUALITY

Quality is the totality of characteristics of an entity that bear on its abto satisfy stated and implied needs

Customer satisfaction, whole organization involvement

Quality Service

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DOCUMENTATION

I. General

II. Quality manual

III. Control of documents

IV. Control of records

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DOCUMENTATION PYRAMID

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Management responsibility

Management commitment

Customer focus

Quality policy : vision , mission , commitment

Planning

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Responsibility, Authority and Communic

1. Responsibility and authority

2. Management representative

3. Internal communication

MANAGEMENT REVIEW

1. Review input

2. Review output

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Resource management

Provision of resources

Human resources

InfrastructureWork environment

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TRAINING

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Measurement,analysis,improveme

It is done

To demonstrate conformity of product

To ensure conformity of QMS

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AUDITING

External audit:

auditing by an external certification body

Internal audit:

by internal staff trained for this process

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IMPROVEMENT

Corrective action

Preventive action

Continual improvement

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THE CONTINUOUS IMPROVEMENT

MECHANISM

UNSATISFACTORY OUTCOME

WORK IMPROVEMENT TEAM

CAUSE INVESTIGATION

CORRECTIVE ACTION

PREVENTIVE ACTION

REVIEW

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Steps to ISO Registration

Educate

Application

Internal audit

Process diagram

Documentation

Internal audit

Certifier

Issue of certificate

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Award of theISO 9000certificate

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FROM INTERNET

ISO 9000Selection and use (2001), available from

http://www.iso.org/iso/en/isoonline.frontpageExplains what the ISO 9000

standards are and how they are used; and provides guidelines on how implement a

management system.Guidance on the Documentation Requirements of ISO 9001:2000,

(October 2000), Available on the Internet: http://www.bsi.org.uk/iso-tc176-Sc2

Publicizing your ISO 9000 or ISO 14000 certification,

Available on the Internet: http://www.iso.org/iso/en/isoonline

http://www.iso.org/iso/en/isoonlinehttp://www.iso.org/iso/en/isoonline

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VARIOUS LOGOS OF ISO9001

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Various logos used in pindustries

PS 9000 is an application of the standard for

Pharmaceutical Packaging Materials.

High GMP conditions are maintained

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High quality standards

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CONCLUSION

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 act as competitive barrier

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REFERENCE

http://www.iso.org/iso/en/isoonline.frontpage

Quality Assurance and Quality Management inPharmaceutical Industry by anjaneyulu,marayya

www.pharmaworld.com

http://www.iso.org/iso/en/isoonline.frontpagehttp://www.pharmaworld.com/http://www.pharmaworld.com/http://www.iso.org/iso/en/isoonline.frontpage

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