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ISO 9000
Quality Management Systems
Jay shah2
Before
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EXPECTED QUALITY
by the Customer
PLANNED QUALITY
by the Company
PRODUCED QUALITY
by the Company
PERCEIVEDQUALITY
by the Customer
Measurement of the Performance of the Company
Measurement of theClient’s satisfaction
TQM CONCEPT
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• Customer focus• Leadership• Empowerment• Process approach• Systemic approach• Continuous improvement• Decisions based on facts• Relationship with suppliers mutually
beneficiary
The 8 principles of TQM …
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Quality Control Quality Management
Past FutureDetect faults Prevent errorsLook for guilty persons Look for defaults in the processesAccuse Help, Moderate, FacilitatePunish MotivateMicro-management Systematic and systemic management
Transition towards TQM
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Deming’s wheel (P.D.C.A.)
PLAN DO
ACT CHECK
Continuous
Improvement
Continuous improvement
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Quality Improvement …
Up to what extent???
Confusion
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ISO 9000 – A WAY TO TQM !!!
Destination ……
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In The Early Days..
The quality movement can trace its roots back to middle Europe, where craftsmen began organizing into unions called guilds in the late 13th century.
This model was followed until the early 19th century when factories came to be and there was more emphasis on product inspection.
In the early 20th century manufacturers began to include quality processes in quality practices.
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The Beginning….
In 1946, delegates from 25 countries met in ““GENEVAGENEVA”(Switzerland) ”(Switzerland) and decided to create a new international organization, of which the object would be "to facilitate the international coordination and unification of industrial standards".
The new organization, ISO, officially began operations on 23 February 1947.
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I S OI S O International Standard Organization International Standard Organization
In Greek ISO means “In Greek ISO means “EQUALEQUAL” & is called as” & is called as
““International Organization of StandardInternational Organization of Standard””
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WHAT IS ISO 9000?
They provide a framework for quality system development in all types of industries including service organizations.
It is just purely a management system that will help to run business in a more organized and systematic manner which will lead organisation to a more consistent in quality of the service that it deliver to customers.
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1) 1) 14 Industrialized Countries from EUROPE,
2) The US (ANSI),
3) British Common Wealth.
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180 technical committees (TCs)620 active sub committees (SCs)
The actual standards preparation is done by ISO
Technical committees (ISO/TCs). TCs are assisted by member country Technical Action
Group (TAG).
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There are 158 National members out of the 195 total countries in the World :
ISO has three membership category, they are:
1) Member bodies
2) Correspondent Member
3) Subscribers Member
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██ ██ member bodiesmember bodies████ correspondent memberscorrespondent members████ subscriber memberssubscriber members██ ██ other places with an ISO 3166-1other places with an ISO 3166-1 code who aren't members of ISOcode who aren't members of ISO
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ISO 9000
Quality ManagementQuality System
Elements
Quality Assurance
Models
ISO 9001 ISO 9002 ISO 9003ISO 9004-1.-2,-3
ISO 9000 : SERIES OF STANDARDS
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ISO 9000-1 : Guidelines for selection and use ISO 9000-2 : Generic guideline for the application of
ISO 9001, ISO 9002, ISO 9003 ISO 9000-3 : Guideline for the application of ISO
9001 to development, supply, and maintenance of software
ISO 9000-4 : Guide to dependability program management
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ISO 9001 - Quality Assurance in design/ development,
production, installation and servicingISO 9002 - Quality Assurance in production and
installationISO 9003 - Quality Assurance in final inspection and
testISO 9004 - Quality management and quality system
elements
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List of Quality System Requirements
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Quality system Requirements Management Responsibility Quality System Contract Review Design Control Document and Data Control Purchasing Control of Customer Supplied Product Product identification and Traceability Process Control Inspection and Testing Control Inspection, Measuring, and Test Equipment Inspection and Test Status Control of Non Conforming Product Corrective and Preventive Action Handling, Storage, Packaging, Preservative, and Delivery Control of Quality Record Internal Quality Audits Training Servicing Statistical Techniques
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World wide equivalents of ISO 9000 StandardsCOUNTRY ISO 9000 Standard Nomenclature
Australia AS 3900
Brazil NB 9000
Canada Z 299
Denmark DS/ISO 9000
France NF EN 29000
Germany DIN ISO 9000
India IS 14000
Japan JIS Z 9900
Mexico NOM – CC 2
United State Q 9000
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IS:14000:1990 (ISO 9000:1994) IS:14001:1990 (ISO 9001:1994) IS:14002:1990 (ISO 9002:1994) IS:14003:1990 (ISO 9003:1994) IS:14004:1990 (ISO 9004:1994)
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ISO 9001 : 1994
ISO 9001 : 2000
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Principles of ISO 9000 Standard
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Based on eight quality
management
principles
Leadership
Process approach
Involvement of people
System approach to
ManagementContinual
improvement
Factual approach to
decision making
Mutual beneficial supplier
relationship
Customer focus
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A) Principle : 1 Customer focusA) Principle : 1 Customer focus
1) Organization depends 1) Organization depends
on their customers.on their customers.
2) Should understand the 2) Should understand the
customerscustomers need, need,
requirement, requirement,
expectation.expectation.
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Benefits :
1) Increased revenue & market share.
2) Improve customer satisfaction.
Application:
1) Research work.
2) Understanding the customers
needs, expectation, satisfaction..
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B) Principle : 2 LeadershipB) Principle : 2 Leadership
1) Leaders establish unity of purpose & direction of Organization.
2) Should create & maintained the internal environment.
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BenefitsBenefits : : 1) People will motivated towards Organization’s goals.
2) Activities are evaluated.
ApplicationApplication::
1) Clear vision of the Organization’s Future.
2) Setting challenging goals & targets.
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People at all levels are the essence of an Organization & their abilities are used for the Organization’s benefit.
C) Principle : 3 Involvement of peopleC) Principle : 3 Involvement of people
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BenefitsBenefits : :
1) Motivated, committed, Involved People within the Organization.) Motivated, committed, Involved People within the Organization.
2) Innovation & creativity. 2) Innovation & creativity.
Application:
1) People accepting the ownership of problems.
2) People freely sharing knowledge & experience.
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D) Principle:4 Process approachD) Principle:4 Process approach
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Benefits :
1) Lower cost & shorter cycle Times.
2) Improved, consistent, & predictable results.Application:
1) Systematically defining the activities.
2) Identifying the interfaces of key activities.
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Identification, understanding,
managing interrelated
process as a system
contributes to the
Organization’s effectiveness
& efficiency in achieving its
objectives.
E) Principle : 5 System approach to managementE) Principle : 5 System approach to management
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ApplicationApplication::
11) Structuring a system to achieve the Organization’s objectives.
2) Continually improving the system through measurement & evaluation.
Benefits :
1) Ability to focus the effort on the key processes.
2) Providing confidence to interested parties as consistency,
effectiveness & efficiency of the Organization.
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F) Principle :6 Continual improvementF) Principle :6 Continual improvement
Overall performance should be a permanent objective of the Organization .
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Benefits :
1) Increase the performance due to the improvement of the Organizational capabilities.
2) Flexibility to react quickly to the opportunities.
Application:
1) Providing training to the people for the continual Improvement.
2) Establishing the Goals for continual Improvement.
3) Recognizing & acknowledging improvement.
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G) Principle :7 Factual approach to decision makingG) Principle :7 Factual approach to decision making
Effective decisions are based on the analysis of data & information.
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BenefitsBenefits : :
1) Informed decisions. 1) Informed decisions.
2) Increased ability to demonstrate the effectiveness of the past decisions. 2) Increased ability to demonstrate the effectiveness of the past decisions.
3) Increased ability to review.3) Increased ability to review.
ApplicationApplication::
1) Analyzing data & information using valid method.1) Analyzing data & information using valid method.
2) Making decision & action based on analysis. 2) Making decision & action based on analysis.
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Mutually beneficial relationship between the Organization & supplier enhances the ability of both to create value.
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Benefits :
1) Optimizing of cost & resources.
2) Flexibility & speed will increase in the market.
Application:
1) Identifying & selecting key suppliers.
2) Clear & open communication.
3) Sharing information & future plans.
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Application
SurveillanceAudit
Documentation Review
Pre - Assessment
Registration Audit
Registration Decision
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DOCUMENTATION REQUIREMENTSDOCUMENTATION REQUIREMENTS
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Quality Management System DocumentationQuality Management System Documentation
Quality Manual Quality
System Procedures Work
InstructionsForms
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1) Quality Manual
Quality Policy Objectives Overview Responsibilities Requirements Policy/Responsibility
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2) Quality System Procedures
A set of procedures which detail how the requirements of the quality manual are to be implemented
Detailed procedures which define how the processes are to be performed and controlled
Specifying who is responsible for what
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3) Work Instructions
Detailed instructions for the performance of specific tasks
Such instructions may cover
-Materials
-Processes
-Verification
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4) Forms
Records that provide proof that specified activities were carried out
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Quality Management System
StandardISO 9000
Quality Manual
Quality System Procedures
Work Instructions
Forms
LEVEL 1
LEVEL 2
LEVEL 3
LEVEL 4
Policy Statement, Commitment, Organization, Responsibilities
Company Practices, Interfaces
Written Instructions to Control Tasks
Quality Records
Sales Design Purchasing Manufacturing Accounts Personnel After SalesAdvanced Industrial Pharmacy 51
ISO CertificateISO Certificate
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1) Continuous improvement
2) Marketing strategy
3) To meet Customer requirement
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11) Improved system documentation
2) Fewer customers audits
3) Improve customers relationship
4) Improved quality awareness
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Example Very Near To You !!!!!
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BAPUJI MBA COLLEGEBAPUJI MBA COLLEGE
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After Registration..
Life is not like this because….
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Naroola G. Conell RM. How to achieve ISO 9000 Registration
Economically and Effectively. New York 1996. Marcel Dekker, Inc.
Stamatis DH. Understanding ISO 9000 and implementing the
basics to quality. New York 1995. Marcel Dekker, Inc.
Rastogi PN.Total quality management theory & practice. AICTE Continuing Education Program .March 1989;Code No : 298.
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Krishnan NS. Total quality management 1.AICTE Continuing Education Program .December 1996 ; Code No
: 623.
Bali PL. Total quality management . AICTE Continuing Education Program .June 1997 ; Code No : 541.
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