Post on 02-Apr-2018
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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
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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
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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
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