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Quality Management Systems and Standards ISO 9000

Quality Management Systems and Standards ISO 9000. What is ISO. International Organization for Standardization Develops voluntary standards to help promote international trade Network of national standards bodies

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Quality Management Systems and Standards ISO 9000

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  1. Quality Management Systems and StandardsISO 9000

  2. What is ISO • International Organization for Standardization • Develops voluntary standards to help promote international trade • Network of national standards bodies • Has published over 19,500 international standards covering technology and manufacturing

  3. What is ISO 9000? • Family of standards relating to quality management systems

  4. The ISO 9000 Family • ISO 9000: 2005 – Basic concepts and language • ISO 9001: 2008 – Requirements of a quality management system • ISO 9004: 2009 – How to make quality management systems more efficient and effective

  5. ISO 9000: 2005 • Covers concepts and language • Helps make sure everyone is using the same terms to mean the same thing.

  6. ISO 9000: 2005 Example Quality management system • Management system to direct and control an organization with regard to quality • Management System – system to establish policy and objectives and to achieve those objectives • System – set of interrelated or interacting elements • Organization – group of people and facilities with an arrangement of responsibilities, authorities, and relationships • Quality – Degree to which a set of inherent characteristics fulfils requirements

  7. ISO 9001: 2008 • Requirements for a quality management system • 8 clauses • Scope • Normative references • Terms and definitions • Quality management system • Management responsibility • Resource management • Product realization • Measurement, analysis and improvement

  8. The Eight Principles of ISO 9000 • Customer focus • Leadership • Involvement of people • Process approach • System approach to management • Continual improvement • Factual approach to decision making • Mutually beneficial supplier relationships

  9. Operating Principle

  10. ISO 9004: 2009 • Provides guidance for the continual improvement of the quality management system

  11. Documentation of a Quality Management System • Quality policy • Quality manual • Quality objectives • Quality procedures

  12. ISO 9001 Certification/Registration • ISO does not offer certifications • Organizations can hire an outside company to audit them to certify that they are meeting ISO 9001 • These organizations must meet ISO 19011:2011

  13. Why become ISO 9001 certified? • Increase quality of the product • Shows customers that the organization has high quality • Increase profits through increased sales and decreased waste • Makes organization accountable • Some organizations require their suppliers to be ISO 9001 certified

  14. Becoming ISO 9001 Certified • Develop a quality manual • Document procedures • Secure top management’s commitment • Ensure customer requirements are determined and met • Hire an accredited certification company • Conduct internal audits • Submit to external audits

  15. Certification Statistics

  16. Certification Statistics

  17. ISO 9001 vs. TQM • Not interchangeable • ISO 9000 may be redundant in an organization with TQM • ISO 9000 can be a stepping stone to TQM

  18. Questions?

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