C101: DEMO OF ISO: 9001-2008 AWARENESS TRAINING PRESENTATION KIT
Iso awareness training
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ISO 9001:2008 ISO 9001:2008
QUALITY MANAGEMENT SYSTEM QUALITY MANAGEMENT SYSTEM
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BACKGROUNDBACKGROUND
• The International Organization for Standardization (ISO) is a worldwide organization that develops many different kinds of Standards.
• ISO was formed in February 23, 1947 February 23, 1947 in GenevaGeneva.
• First Family of Quality Standard was released in 1987.
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WHAT IS ISO?WHAT IS ISO?
• The official title for the International Organization for Standardization
• It is derived from the Greek isos, meaning “equal”, which is the root of the prefix “iso”.
• ISO is the specialized international agency for standards making.
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WHAT IS WHAT IS ISO 9000?ISO 9000?
• Primarily concerned with Quality Management.
• Achieve Customer Satisfaction and continual improvement.
• ISO 9001:2008 is the actual specification for QMS. It can be used irrespective of size or type of organization.
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ISO 9000 SERIESISO 9000 SERIES
• ISO is the internationally accepted minimum requirements for quality management systems.
• It provides for 3rd party registration of the organization’s QMS.
• It has become a condition requirement for doing business with many organizations around the world.
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WHAT IS ISO 9001: 2008WHAT IS ISO 9001: 2008
Applicable to all types & sizes of Organizations with possible permissible omissions of certain requirements
ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing
requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004.
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WHY PURSUE ISO 9001?WHY PURSUE ISO 9001?
• To comply with internationally accepted quality standards
• To meet customer requirements
• To increase customer satisfaction
• To keep up with the competition
• To improve quality management system
• To reduce process variation and rework cost
• To increase personal satisfaction
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Top 10 countries for ISO 9001 certificates - 2010
Rank Country No. of certificates
1 China 297,037
2 Italy 138,892
3 Russian Federation 62,265
4 Spain 59,854
5 Japan 59,287
6 Germany 50,583
7 United Kingdom 44,849
8 India 39,250
9 USA 25,101
10 Korea, Republic of 24,778
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• 75% Reduction in customer claims• 95% improvement in delivery time• Reduced defects from 3% to 0.5%• 65% reduction in product cycle time• 85% increase in on-time delivery• International acceptance and recognition• Facilitated trade in international markets• Promoting of safety, reliability and
quality
CASE STUDIES SHOWEDCASE STUDIES SHOWEDISO Registration resulted in:
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NEW ISO 9001:2008
QMSQMSResource
Management
Measurement, Analysis &
Improvements
Product Realization
Management
Responsibility
Continual Improvements cycle
General Requirements
General Requirements
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ISO 9001:2008 STRUCTUREISO 9001:2008 STRUCTURE
• Four major sections
–Management Responsibility
–Resource Management
–Product Realisation
–Measurement, Analysis and Improvement
• Divided into 21 elements
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ISO 9001:2008 STRUCTURE IISO 9001:2008 STRUCTURE I
Management Responsibility
1. Management commitment
2. Customer focus
3. Quality policy
4. Planning
5. Administration
6. Management review
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ISO 9001:2008 STRUCTURE IIISO 9001:2008 STRUCTURE II
Resource Management
7. Provision of resources
8. Human resources
9. Facilities
10.Work environment
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ISO 9001:2008 STRUCTURE IIIISO 9001:2008 STRUCTURE III
Product Realisation
11. Planning of realisation processes
12. Customer-related processes
13. Design and/or development
14. Purchasing
15. Production and service operations
16. Control of measuring and monitoring Equipments
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ISO 9001:2008 STRUCTURE IVISO 9001:2008 STRUCTURE IV
Measurement, Analysis and Improvement
17.Planning
18.Measurement and monitoring
19.Control of nonconformity
20.Analysis of data
21.Improvement
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KEY QMS PRINCIPLESKEY QMS PRINCIPLES
Create an ISO( QMS ) document like Manual, procedures and processes that affect quality.
Ensure that all processes adhere to those written procedures.
Documented evidence that the quality standard is being implemented effectively.
Periodic internal and external audits to ensure continued suitability, compliance, and effectiveness of the QMS.
Define what shouldbe done?
Do what you say?
Show what you have done?
Verify system effectiveness
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ISO 9001:2008 PROCESS MODELISO 9001:2008 PROCESS MODELC
US
TO
ME
R’S
CU
ST
OM
ER
QMS
5.ManagementResponsibility
7. ProductRealization
6. ResourceManagement
8. MeasurementAnalysis and Improvements
Requirements
Satisfaction
Continual Improvement ofthe Quality Management System
ConsumptionProduct
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8 PRINCIPLES 8 PRINCIPLES
Based on Eight
Quality
Management
Principles
Leadership
Process
approach
Involvemen
t of people
System
approach to
ManagementContinual
improvement
Factual
approach to
decision
making
Mutual
beneficial
supplier
relationship
Customer
focus
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PROCESS APPROACHPROCESS APPROACH
Definition:- Process is a set of interrelated or interacting activities which transforms Inputs into Outputs.
Ensure Continual
Improvement
Identify the
Processes
Do it for all “Value Adding Processes”
Establish Measuring Criteria
Identify the Interactions
to other Processes
Identify the Inputs & Outputs
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PROCESS APPROACH PROCESS APPROACH CONTINUAL IMPROVEMENTS OF ALL PROCESSES
PDCA CYCLEPDCA CYCLE
Processes in terms
of Added Value
DODO
Continual Improvements
of Processes Based on
Objective Measurements
ACTIONACTION
Measure Results of Process
Performance and Effectiveness
(Objective Measurements)
CHECKCHECK
Understanding &
Meeting the Requirements
PLANPLAN
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PDCAPDCA STANDS FOR STANDS FOR
PP PLAN
DD DO
CC CHECK
AA ACT/ ACTION
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E.g. - PURCHASING PROCESSE.g. - PURCHASING PROCESS
Performance Measurements
Delivery status – On-time, On spec, NCP etc
Supplier evaluation
Outputs Receipt of
Materials on right conditions
Right Quality, Right Quantity
Right Time
Purchasing Procedure
Interactions toStorageInspection and TestingManufacturingFinance
Inputs Required item /
quantity / date Applicable specs Supplier source Suppliers
capability to meet our requirements
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Provision of Resources
Human Resources
Infrastructure
Work Environment
6.
Resource Management
General Requirements
Documentation Requirements
Planning
Customer Related Processes
Design & DevelopmentPurchasing
Production & Service Provision
Management Commitment
Customer Focus
Quality Policy
Planning
Responsibility, Authority & Communication
Management Reviews
5.
Management Responsibility
8. Measurement Analysis &
Improvements
STRUCTURE OF THE STANDARDSTRUCTURE OF THE STANDARD4.
Quality Management System Requirements
7.
Product Realization
General
Monitoring & Measurements
Control of NCP’s
Analysis of Data
Improvements
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CRITERIA FOR CRITERIA FOR MEASUREMENTSMEASUREMENTS
Internal AuditsEffectiveness & Efficiency of ProcessesOpportunities for ImprovementsUse of Data / InformationEffective & Efficient Use of ResourcesAdequacy, Accuracy and Performance of MeasurementsRelationships with customers/ suppliers/ other interested parties
Financial MeasurementsPrevention costNon conforming / failure costLifecycle cost
Self Self AssessmentAssessment
Satisfaction Surveys for customers and other interested parties
Feedback on productsCustomer & market requirements
System System PerformancePerformance
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CRITERIA FOR MEASUREMENTCRITERIA FOR MEASUREMENT
Inspection and testing of incoming, in process and final productsProduct verificationProduct validation
Process Capability / Process validationReaction timeCycle time / throughput (Capacity)Utilization of new technologyWaste reductionCost reductionProducts
Processes
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CHALLENGES IN CHALLENGES IN IMPLEMENTING STANDARDIMPLEMENTING STANDARD
Communication
Management Support
Other employee Support
ISO 9001ISO 9001
Encouragement
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5 M’s OF ISO 5 M’s OF ISO
• Men
• Material
• Machinery
• Measurement
• Methods
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LEVELS OF DOCUMENTATIONLEVELS OF DOCUMENTATION
04/10/23 29
QualityManual
Level 1
Level 2
Level 3
Level 4
Methods & Procedures
Job Instructions, Forms & Templates
RecordsDocuments Verifying that Requirements Have Been Met
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BENEFITSBENEFITS
• Increased employee morale as they are asked to take control of their processes (empowerment).
• Reduction in conflicts.
• Improved communications.
• Performance evaluation (Continual Improvement).
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ISO STANDS FORISO STANDS FOR
INTERNATIONAL ORGANIZATION INTERNATIONAL ORGANIZATION FOR STANDARDIZATIONFOR STANDARDIZATION
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WHAT ARE THE WHAT ARE THE INSTRUMENTS FOR INSTRUMENTS FOR
CALIBRATION?CALIBRATION?
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CONFORMITY CONFORMITY
The fulfillment of a requirement.
NONCONFORMITYNONCONFORMITY
The preferred term (ISO 19011, ISO 9001) for the non-fulfillment of requirements (also known as deficiency,
discrepancy, finding, infraction, non-compliance).
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CALIBRATIONCALIBRATIONAll the operations for the purpose of determining the values of the errors of a measuring instrument (and if necessary, to determine other metrological properties).
COMPLIANCECOMPLIANCEAn indication or judgment that the product or service meets the requirements of the relevant specification or regulation; also the state of meeting the requirements.
IMPLIED NEEDS- IMPLIED NEEDS- without saying it directly, understood
STATED NEEDS- STATED NEEDS- declared requirements
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A SMALL TRUTH TO MAKE A SMALL TRUTH TO MAKE LIFE 100% LIFE 100%
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THEN WHAT MAKES 100% ?THEN WHAT MAKES 100% ?
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HARD WORK HARD WORK H+A+R+D+W+O+R+K
8+1+18+4+23+15+18+11 = 98%
KNOWLEDGEKNOWLEDGEK+N+O+W+L+E+D+G+E
11+14+15+23+12+5+4+7+5 = 96%
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LOVELOVEL+O+V+E
12+15+22+5 = 54%
LUCKLUCKL+U+C+K
12+21+3+11 = 47%
( don't most of us think this is the most important ??? )
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THEN WHAT MAKES 100% ?THEN WHAT MAKES 100% ?IS IT MONEY? ... NO ! ! !
M+O+N+E+Y
13+15+14+5+25 = 72%
LEADERSHIPLEADERSHIP ? ... NO ! ! !
L+E+A+D+E+R+S+H+I+P
12+5+1+4+5+18+19+9+16 = 89%
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Every problem has a solution, only if we perhaps change our attitude.
To go to the top,
to that 100%,
what we really need to go further... a bit more...
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ATTITUDEATTITUDE
A+T+T+I+T+U+D+E 1+20+20+9+20+21+4+5 = 100%
and Work that makes OUR It is OUR ATTITUDE towards Life; Life 100% ! ! !
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Change Your Attitude …
And You Change Your Life ! ! !
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INSTRUCTIONS FOR INSTRUCTIONS FOR LIFE/WORKLIFE/WORK
Take in to account that great love, great achievement involves great risk.
When you loose don't loose the lesson
Follow the three “ R”s: Respect for self,
Respect for others and,
Responsibility for all your actions
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INTERNATIONAL SURVEY INTERNATIONAL SURVEY SHOWS HOW YOU CAN GAIN SHOWS HOW YOU CAN GAIN MAXIMUM BENEFIT FROM MAXIMUM BENEFIT FROM
ISO ISO
• IMPROVED PLANNING & CONTROL 90%
• IMPROVED CUSTOMER SERVICE 95%
• IMPROVED PRODUCTIVITY 90%
• INCREASED ABILITY TO TENDER 9% FOR CONTRACTS
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INTEGRITY OF SYSTEM MAINTAINED 80 %
BY OBJECTIVE APPROVAL GAINING A MARKETING ADVANTAGE 84 %
INCREASE IN MARKET SHARE 75 %
REDUCTION IN CUSTOMER AUDITS 90 %
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REDUCTION IN COST 90 %
INCREASE IN EXPORTS 40 %
( THIS SURVEY IS BASED ON FEED BACK RECEIVED FROM ISO 9000 ( QMS ) CERTIFIED COMPANIES ON ABOVE POINTS)
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ADVANTAGES OF ISOADVANTAGES OF ISO
Marketing Tool
Sets benchmark
Acts as a set of discipline
Basis for TQM
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• Serves Export/domestic Customer’s requirement
• Helps to revisit system
• Helps document practices
• Helps in manpower training.
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• Brings clarity in roles and responsibilities
• Reduces frustration
• Helps tide over problems arising out of manpower training
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EXPECTED EXPECTED BENEFITS OF ISOBENEFITS OF ISO
Inspires confidence in the company’s potential
It helps the company achieve consistent levels of quality.
The overall image of the company in the market is likely to improve
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Market share can go up with the resultant improved market credibility.
Company’s own management has greater confidence in its own internal system.
The systematic approach to problem solving results in elimination of chronic problems by taking care of the root causes.
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Exports of the organization can be increased as ISO 9000 System standards are Globally accepted in over 150 countries
ISO 9000 implementation puts a company on the road to TQM
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