ISO 9000 SERIES

Vijay Kumar Tirukkachi

CONTENTS
DEFINITION
WHAT IS ISO NEED OBJECTIVE HISTORY WHO CREATES STANDARDS PRINCIPLE ADVANTAGES & DISAVANTAGES

STRUCTURE OF SERIES
ELEMENTS OF ISO9000 CERTIFICATION PROCEDURE VARIOUS LOGOS CONCLUSION REFERENCES

 ISO 9000 is a series of standards , development

and published by the ISO that define,establish and maintain an effective quality assurance system for manufacturing and service industries.

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.

NEED
By implementing an organization can benefit many industries such as banking,
health care, manufacturing etc.,

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

value

To compete in domestic markets To improve quality system

OBJECTIVE
1. To promote development of standardization to facilitate international exchange of goods and services. 2. To promote cooperation in intellectual, scientific, technological, and economic activity

HISTORY
1946 London - delegates from 25 countries to facilitate the international coordination
and 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 developed
ISO revised and issued BS5750 in 1987 as ISO 9000 series Revised in 1994 and 2000 ISO9001:2000 is valid till next year.

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

PRINCIPLE
PLAN, DO, CHECK & ACT

ISO 9000

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

 A greater degree of internal control.

Greater productivity and cost reduction Evidence of compliance

Recognition of standard achieved

Greater productivity and cost reduction

DISADVANTAGES
Assessment and certification are costly Need to change and accept new working practices may strain
management

Unless carefully planned it become non-cost effective and

burdensome

Iso9001 only complements and supplements product quality

standards

STRUCTURE OF SERIES

STANDARD

CONTENT

APPLICATION

ISO 9000

Provides definition and concepts. Explains how to select other standards for a given business Quality assurance in design, development, production, installation and servicing Quality assurance in production and installation

All industries including software development

ISO 9001

Engineering and construction firms, manufacturers that design, develop, install and service products Companies in the chemical process industries that are not involved in product design or after sales service Small shops, divisions within a firm, equipment distributors that inspect and test supplied products All industries

ISO 9002

ISO 9003

Quality assurance in test and inspection

ISO 9004

Quality management and quality system elements

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

 Scope: The specified requirements are generic and applicable to all organizations,
regardless of their type and size.

Normative Reference:
Terms and vocabulary Supplier, Organization, Customer.

Quality management system

QUALITY Quality is the totality of characteristics of an entity that bear on its ability
to satisfy stated and implied needs
Customer satisfaction, whole organization involvement

Quality Service

DOCUMENTATION
I. II. III. IV.
General
Quality manual Control of documents

Control of records

DOCUMENTATION PYRAMID

Management responsibility
Management commitment
Customer focus

Quality policy : vision , mission , commitment

Planning

Responsibility, Authority and Communication

1. Responsibility and authority 2. Management representative 3. Internal communication
MANAGEMENT REVIEW 1. Review input 2. Review output

Resource management
Provision of resources Human resources Infrastructure Work environment

TRAINING

Measurement,analysis,improvement
It is done

To demonstrate conformity of product To ensure conformity of QMS

AUDITING
External audit:
auditing by an external certification body

Internal audit:
by internal staff trained for this process

IMPROVEMENT

Corrective action Preventive action Continual improvement

THE CONTINUOUS IMPROVEMENT MECHANISM

UNSATISFACTORY OUTCOME
WORK IMPROVEMENT TEAM CAUSE INVESTIGATION CORRECTIVE ACTION PREVENTIVE ACTION REVIEW

Educate

Steps to ISO Registration

Application Internal audit Process diagram Documentation Internal audit Certifier Issue of certificate

Award of the ISO 9000 certificate

 FROM INTERNET
ISO 9000 Selection and use (2001), available from http://www.iso.org/iso/en/isoonline.frontpage Explains what the ISO 9000 standards are and how they are used; and provides guidelines on how implement a quality
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

VARIOUS LOGOS OF ISO9001

Various logos used in pindustries

PS 9000 is an application of the standard for
Pharmaceutical Packaging Materials.

High GMP conditions are maintained

 High quality standards

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

REFERENCE
http://www.iso.org/iso/en/isoonline.frontpage Quality Assurance and Quality Management in
Pharmaceutical Industry by anjaneyulu,marayya

www.pharmaworld.com