
Review homework
• Chapter 8, 9

Final Exam
requirments

ISO 9000

Baldridge

Six sigma

Assignment
• Problem 14-4
•...
ISO 9000

Present Homework
• Chapter 11 - 15

ISO 9000

Final Exam
Presentations

Submit Final Exams

Complete Critiq...
ISO 9000
ISO 9000ISO 9000
What You Need To Know
ISO 9000
Why is ISO 9000 so important?
What do you need to know about
ISO 9000?
What are the ISO 9000 Series Standards?
Wh...
ISO 9000
What are ISO 9000What are ISO 9000
Standards?Standards?

ISO 9000 Standards
• Define the required elements of an...
ISO 9000
Who created the standards?Who created the standards?

International Organization for
Standardization - Geneva

...
ISO 9000
How did ISO get started?How did ISO get started?

1906 - International Electro-technical Commission

1926 - Int...
ISO 9000
ISO OrganizationISO Organization
General
Assembly
Council
Technical
Management Board
Technical
Advisory
Groups
Te...
ISO 9000
What has ISOWhat has ISO
Accomplished?Accomplished?

ISO film speed code

Standard format for telephone and ban...
ISO 9000
ISO 9000:2000 Consists of 3ISO 9000:2000 Consists of 3
AreasAreas

ISO 9000:2000 Quality Management Systems:
fun...
ISO 9000
ISO 9000 Family ofISO 9000 Family of
StandardsStandards

ISO 8402 - QA and Quality management vocabulary

ISO 9...
ISO 9000
What are the elements ofWhat are the elements of
the standards?the standards?

Management
responsibility

Resou...
ISO 9000
Element Standard:Element Standard:
Management ResponsibilityManagement Responsibility

Management must have a wr...
ISO 9000
Element Standard:Element Standard:
Process ControlProcess Control

The company must identify all processes that
...
ISO 9000
Why is ISO 9000 important?Why is ISO 9000 important?

European Union directive
• ISO 9000 certification required...
ISO 9000
Why adopt ISO 9000?Why adopt ISO 9000?

To comply with customers who require
ISO 9000

To sell in the European ...
ISO 9000
Third party registrationThird party registration
Accreditors
(RAB in US)
Registrars
Supplier Companies
ASQC
ISO 9000
Ten Steps to ISOTen Steps to ISO
RegistrationRegistration
2. Select the appropriate standard
1. Set the registrat...
ISO 9000
Six Essential Elements of aSix Essential Elements of a
Successful Registration EffortSuccessful Registration Effo...
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Iso 90000

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Iso 90000

  1. 1.  Review homework • Chapter 8, 9  Final Exam requirments  ISO 9000  Baldridge  Six sigma  Assignment • Problem 14-4 • Read Ch 10, 11, 12 Week 13 AgendaAgenda
  2. 2. ISO 9000  Present Homework • Chapter 11 - 15  ISO 9000  Final Exam Presentations  Submit Final Exams  Complete Critiques  Assignment • Apply TQM principles to your work and your life Week 16 AgendaAgenda
  3. 3. ISO 9000 ISO 9000ISO 9000 What You Need To Know
  4. 4. ISO 9000 Why is ISO 9000 so important? What do you need to know about ISO 9000? What are the ISO 9000 Series Standards? What are the elements of the Standards? What is quality system registration? Ten steps to ISO 9000 registration AGENDA ELEMENTS ISO 9000ISO 9000
  5. 5. ISO 9000 What are ISO 9000What are ISO 9000 Standards?Standards?  ISO 9000 Standards • Define the required elements of an effective quality management system • Can be applied to any company • Adopted by the United States as the ANSI/ASQC Q90 series.  Revised 2000 – wider applicability
  6. 6. ISO 9000 Who created the standards?Who created the standards?  International Organization for Standardization - Geneva  ISO tech committee - TC 176 started in 1979  Standards created in 1987 • To eliminate country to country differences • To eliminate terminology confusion • To increase quality awareness
  7. 7. ISO 9000 How did ISO get started?How did ISO get started?  1906 - International Electro-technical Commission  1926 - International Federation of the National Standardizing Associations (ISA)  1946 London - delegates from 25 countries decided to create a new international organization "the object of which would be to facilitate the international coordination and unification of industrial standards  1947 - ISO began to officially function  1951 - The first ISO standard was published • "Standard reference temperature for industrial length measurement".
  8. 8. ISO 9000 ISO OrganizationISO Organization General Assembly Council Technical Management Board Technical Advisory Groups Technical Committees Policy Development Committees Technical Committees Technical Committees Technical Committees
  9. 9. ISO 9000 What has ISOWhat has ISO Accomplished?Accomplished?  ISO film speed code  Standard format for telephone and banking cards  ISO 9000 which provides a framework for quality management and quality assurance  ISO 14000 series provides a similar framework for environmental management  Internationally standardized freight containers  Standardized paper sizes.  Automobile control symbols  ISO international codes for country names, currencies and languages
  10. 10. ISO 9000 ISO 9000:2000 Consists of 3ISO 9000:2000 Consists of 3 AreasAreas  ISO 9000:2000 Quality Management Systems: fundamentals and vocabulary  ISO 9001:2000 Quality Management Systems – Requirements (required for certification) Management responsibility Resource management Product/service realization Measurement, analysis, improvement  ISO 9004-2000 Quality Management Systems – Guidelines for performance improvement
  11. 11. ISO 9000 ISO 9000 Family ofISO 9000 Family of StandardsStandards  ISO 8402 - QA and Quality management vocabulary  ISO 9000-2 - Generic guidelines for applying ISO 9001, ISO 9002, and ISO 9003  ISO 9000-3 - Guidelines for applying ISO 9001 to the development, supply, and maintenance of software  ISO 9000-4 Application for dependability management  ISO 9004-2 Guidelines for services  ISO 9004-3 Guidelines for processed material  ISO 9004-4 Guidelines for quality improvement  ISO 9004-5 Guidelines for quality plans  ISO 9004-6 Guidelines for configuration management
  12. 12. ISO 9000 What are the elements ofWhat are the elements of the standards?the standards?  Management responsibility  Resource management  Quality System  Contract Review  Design Control  Document Control  Purchasing  Purchaser-Supplied Product  Product Identification and Traceability  Process Control  Inspection and Testing  Inspection, Measuring and Test Equipment  Inspection and Test Status  Control of Non- conforming product  Corrective Action  Quality Records  Internal Quality Audit  Training  Servicing  Statistical Techniques
  13. 13. ISO 9000 Element Standard:Element Standard: Management ResponsibilityManagement Responsibility  Management must have a written policy statement of their commitment to quality. This policy must be communicated to and understood by all employees.  Management must clearly define quality- related organizational responsibilities and interrelationships.  A management representative must be assigned to oversee the implementation and continuous improvement of the quality system.  Senior management must continually review the system.
  14. 14. ISO 9000 Element Standard:Element Standard: Process ControlProcess Control  The company must identify all processes that directly affect the quality of the product or service and ensure that these processes are carried out under controlled conditions, including: • Formal approval of process design and equipment. • Documented work instructions. • Development of quality plans describing how the process is to be monitored. • A suitable working environment. • Documented quality criteria.
  15. 15. ISO 9000 Why is ISO 9000 important?Why is ISO 9000 important?  European Union directive • ISO 9000 certification required by suppliers of “Regulated Products” • health, safety, and the environment • EC has strict corporate liability legislation protecting consumers  Globalization impact
  16. 16. ISO 9000 Why adopt ISO 9000?Why adopt ISO 9000?  To comply with customers who require ISO 9000  To sell in the European Union market  To compete in domestic markets  To improve the quality system  To minimize repetitive auditing by similar and different customers  To improve subcontractors’ performance
  17. 17. ISO 9000 Third party registrationThird party registration Accreditors (RAB in US) Registrars Supplier Companies ASQC
  18. 18. ISO 9000 Ten Steps to ISOTen Steps to ISO RegistrationRegistration 2. Select the appropriate standard 1. Set the registration objective 3. Develop and implement the quality system 4. Select a third-party registrar and apply 5. Perform self-analysis audit 6. Submit quality manual for approval 7. Pre-assessment by registrar 8. Take corrective actions 9. Final assessment by registrar 10. Registration!
  19. 19. ISO 9000 Six Essential Elements of aSix Essential Elements of a Successful Registration EffortSuccessful Registration Effort Senior Management Commitment to the EffortSenior Management Commitment to the Effort Appropriate ISO 9000 TrainingAppropriate ISO 9000 Training An Effective Management Review ProcessAn Effective Management Review Process Documentation of the Quality SystemDocumentation of the Quality System An Effective Internal Auditing SystemAn Effective Internal Auditing System An Effective Corrective Action ProcessAn Effective Corrective Action Process

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