1. QUALITY INSTITUTE OF AMERICA, Inc.
PROFESSIONAL SERVICES IN
ISO 9000 and QS 9000
QUALITY MANAGEMENT
TRAINING
CONSULTING
AUDITING
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2. ISO 9000- 2008: Executive Briefing
AGENDA:
Why ISO 9000?
Value of Quality
Need for Quality Management System (QMS)
Historical evolution
Requirements of ISO 9k-2k
Documenting and Implementing a QMS
Using professional assistance
Copyright: Quality Institute of America

3. Copyright: Quality Institute of America
OFFICES
PARTNERING OFFICE
TETRAHEDRON, INC.
1414 KEY HIGHWAY
SUITE c
BALTIMORE, MD 21230
(USA)
CM, INC.
2800 JOHN STREET
SUITE 19
MARKHAM, ONTARIO
(CANADA)
BRANCH OFFICE
18A, ROAD 18
BANANI, DHAKA
(BANGLADESH)
CORPORATE OFFICE
8951 Ruthby St.
SUITE 12
HOUSTON, TX 77061
Copyright: Quality Institute of America

4. GROWTH OF ISO9000 IN NORTH AMERICA
Copyright: Quality Institute of America(SOURCE :McGraw Hill)

5. SAVINGS TO COSTS RATIOS
Copyright: Quality Institute of America(SOURCE: McGraw Hill)

6. SYSTEM GOODNESS & SAVINGS-TO-COSTS RATIO
Copyright: Quality Institute of America (SOURCE: McGraw Hill)

7. WHAT IS ISO 9000? THE STORY OF SMITHY-- THE VILLAGE BLACKSMITH
E- MAIL US FOR THE STORY. SEE HOW SUPERIOR BUSINESSES WORLD WIDE HAVE USED THE PRINNCIPLES OF ISO 9000 THROUGHOUT HISTORY.
Copyright: Quality Institute of America

8. CONTINUAL IMPROVEMENTOF THE
QUALITY MANAGEMENT SYSTEM
Customers
(and other
Interested
Parties)
Customers
(and other
Interested
Parties)
Management
Responsibility
Measurement,
analysis,
improvement
Satisfaction
Resource
Management
Requirements
Product
Realization
OUTPUT
INPUT
Product
Value-adding activities
Model of the process approach
Information flow
Copyright: Quality Institute of America

9. Copyright: Quality Institute of America
EXPLODE THE MYTH!
SAY WHAT YOU DO
DO WHAT YOU SAY
This catchy slogan can cause a lot of headaches. us, we will tell how not to fall into traps that this very popular slogan can spring on you.
Copyright: Quality Institute of America

10. Copyright: Quality Institute of America
ESSENCE OF AN ISO 9000 SYSTEM
The PDCA cycle is a trial and learning event that emphasizes learning by sequentially testing changes on a small scale.
This is the essence of ISO 9001:2008.
Act
Plan
Check Do
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11. Copyright: Quality Institute of America
PDCA Cycle
Improvement
Act
Plan
Check Do
Possible Changes
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12. Copyright: Quality Institute of America
HOW TO ACHIEVE QUALITY
CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS.
TODAY'S APPROACH--- BUILD IT IN THE PROCESS(ES) THAT CREATE PRODUCT AND SERVICES---DEFECT PREVENTION AND CONTINUOUS PROCESS IMPROVEMENT: “VARIABILITY REDUCTION” CLASSICAL APPROACH---- INSPECT IT IN, BY REMOVING DEFECTS.
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13. Copyright: Quality Institute of America
Theoretical framework relating quality and performance
Quality
Conformance to
requirements
Meets customer
expectations
Exceeds
customer
expectations
Superiority to
competitors
Avoids
customer
dissatisfaction
Reduced
rework/repair
Reputation
Reduced
returns,
complaints,
warranty
Increased
productivity
Customer
satisfaction
Reduced
costs
Increased
market
Premium
prices
Increased
profit
Copyright: Quality Institute of America

14. Copyright: Quality Institute of America
The Cost of Poor Quality (COPQ) “Iceberg”
Traditional Quality Costs
Inspection
(Easily Identified)
4-8%
Scrap
Warranty
Rework
Rejects
(tangible)
Engineering change orders
Lost sales
Additional Costs of Poor Quality
25-35%
(Difficult or impossible to measure)
Long cycle times
Late delivery
(intangible)
More Setups
Lost Customer Loyalty
Lost Opportunity
Expediting costs
Excess inventory
Copyright: Quality Institute of America

15. Copyright: Quality Institute of America
EVOLUTION OF ISO 9000
INDUSTRIAL REVOLUTION--VOLUME PRODUCTION-- NEED FOR CONFORMITY--SORT GOOD FROM BAD
WORLD WAR-- NEED FOR INTERCHANGEABILITY-- INSPECTION INADEQUATE
MIL-I MIL-Q-9858
Copyright: Quality Institute of America

16. Copyright: Quality Institute of America
EVOLUTION OF ISO 9000
ADOPTED BY NATO AS AQAP-1 (1968)
UK DEFENSE STANDARDS ( )
UK BS EVAL OF QA SYST
UK BS
TC 176: ISO--1983
ISO , UPDATED 1994
ISO 9000, December 2000
Copyright: Quality Institute of America

17. THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ANSI: American National Standards Institute.
Approximately 90 members in good standing.
USA
ANSI
Bangladesh
BSTI
PSI
Pakistan
BSI UK
Canada
CSA
Copyright: Quality Institute of America

18. ISO STANDARDS GENERATION PROCESS
Working Group Draft (WD) sent to
Relevant Subcommittee
Elevated to Committee Draft
Sent for Balloting to member countries: approved as is, Disapproved (Reasons required), Approved with comments.
Typically, series of improving versions are balloted until CD is accepted.
Copyright: Quality Institute of America

19. ISO STANDARDS GENERATION PROCESS
Draft International Standard
once subcommittee satisfied w/ CD
elevated to DIS status.
sent to all national standards bodies
more improvements may be necessary if positive ballots do not exceed 67% or negative ballots exceed 25%.
Release as an international standard
usually accepted as a national standard and published as such. (example: Q9001)
Copyright: Quality Institute of America

20. ISO 9000: DEFINITIONS QUALITY
DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILLS REQUIREMENTS
FITNESS FOR PURPOSE
MEET REQUIREMENTS
DELIGHTING CUSTOMERS
RIGHT FIRST TIME ALL THE TIME
Copyright: Quality Institute of America

21. ISO 9000: DEFINITIONS QUALITY MANAGEMENT
COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY
STRATEGIC PLANNING
POLICY /MISSION DEFINITION
EXECUTION OF POLICY
IMPLEMENTATION
Copyright: Quality Institute of America

22. ISO 9000: DEFINITIONS QUALITY SYSTEM
MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN ORGANIZATION WITH REGARD TO QUALITY
WHAT
WHO
HOW
WHERE
WHEN
Copyright: Quality Institute of America

23. ISO 9000: AN OVERVIEW THE 1994 STANDARDS
ISO 9001: “Quality Systems- Model for QA in Design, Development, Production, Installation, and Servicing”
ISO 9002: “ --Model for QA in Production, Installation, and Servicing”
ISO 9003: “--in Final Inspection and Test”

24. Copyright: Quality Institute of America
ISO 9001: DEFINITIONS
PRODUCT: Result of activities or processes-- may include service, hardware, software, processed materials or a combination thereof-- intended product offering only, not to unintended by-products.
TENDER: Offer made by a supplier in response to an invitation to satisfy a contract award to provide a product.
CONTRACT: Agreed requirements between a supplier and customer transmitted by any means.
Copyright: Quality Institute of America

25. Copyright: Quality Institute of America
ISO MAJOR CHANGES
Family of standards:
ISO 9000: Normative reference, provides fundamentals and terminology.
ISO 9001: Requirements, provides ability to demonstrate capability for quality.
ISO 9004: Guidelines for system, continual improvement- ‘consistent pair’
ISO 19011: Guidance on quality and environmental audits
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26. Copyright: Quality Institute of America
ISO MAJOR CHANGES
Eliminated 9002, 9003.
Only 9001 with permissible exclusions in clause 7.
Eight clauses (No- not lesser total requirements)
Essentially five groups of requirements:
Quality System
Management Responsibility
Resources
Product Realization
Measurement, analysis, improvement
Copyright: Quality Institute of America

27. Copyright: Quality Institute of America
ISO 9000: 2000
1994 Changes: No big deal, Registered companies had one year.
2000 Changes: Big deal. Got 3 years. Should take time to do it right, do all the right things.
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28. Copyright: Quality Institute of America
EIGHT MANAGEMENT
PRINCIPLES
Principle 1- Customer-Focused Organization
Principle 2- Leadership
Principle 3- Involvement of People
Principle 4- Process Approach
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29. EIGHT MANAGEMENT PRINCIPLES (contd.)
Principle 5- System Approach to Management
Principle 6- Continual Improvement
Principle 7- Factual approach to decision making
Principle 8- Mutually beneficial supplier relationships
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30. Copyright: Quality Institute of America
FOUR MAIN GROUPS
1. Management Responsibility.
2. Resource Management.
3. Management of Process.
4. Measurement, Analysis and Improvement.
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31. Copyright: Quality Institute of America
HIERARCHY OF DOCUMENTS
POLICY
PROCEDURES
INSTRUCTIONS
RECORDS/ FORMS
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32. Copyright: Quality Institute of America
POLICY
WHAT THE COMPANY WANTS EMPLOYEES TO DO
TOP LEVEL : COMPANY WANTS EVERYONE TO FOLLOW ISO 9001
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33. Copyright: Quality Institute of America
PROCEDURES
HOW DOES THE COMPANY WANT TO ACHIEVE ITS POLICY TO FULFILL THE VARIOUS REQUIREMENTS OF ISO PROCEDURES ARE MANDATORY.
A WRITTEN STATEMENT OF RESPONSIBILITIES AND THE ORGANIZED SEQUENCE OF ACTIONS WHICH COLLECTIVELY FULFILL A PARTICULAR FUNCTION, AND FULFILL THE REQUIREMENTS OF A PARTICULAR CLAUSE OF ISO 9001.
SEVERAL PROCEDURES MAY BE NECESSARY TO COMPLY WITH A PARTICULAR CLAUSE OF THE STANDARD.
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34. Copyright: Quality Institute of America
WORK INSTRUCTION
A WRITTEN STATEMENT OF HOW AN ACTIVITY IS TO BE PERFORMED (USUALLY) BY A PERSON
AN INSTRUCTION SUPPORTS A PROCEDURE: SEVERAL INSTRUCTIONS MAY BE NECESSARY TO SUPPORT A PROCEDURE
AN INSTRUCTION IS NECESSARY WHERE THE ABSENCE OF THE INSTRUCTION WOULD ADVERSELY AFFECT THE OBJECTIVE OF THE PROCEDURE THAT THE INSTRUCTION SUPPORTS
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35. Copyright: Quality Institute of America
ISO 9000: IMPLEMENTATION
ORGANIZATIONAL CHECKPOINTS:
Executive Steering Committee
Executive Champion
Project Team
Project Leader
Task Teams
Consultants
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36. Copyright: Quality Institute of America
ISO 9000: IMPLEMENTATION
IMPLEMENTATION CHECKPOINTS:
Design Structure of System
Design Document Control System
Identify Procedures and Instructions
Create Procedures and Instructions
Implement Procedures and Instructions
Training in Internal Audits
Copyright: Quality Institute of America

37. Copyright: Quality Institute of America
ISO 9000: IMPLEMENTATION
IMPLEMENTATION CHECKPOINTS
Use Internal Audits in detecting system inadequacies
Take Corrective Actions
Select Registrar
Pre- assessment (optional, by registrar-- somewhat discouraged by RAB)
Registration Audit
Celebrate
Surveillance (by Registrar)
Triennial Recertification
Copyright: Quality Institute of America