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QualityManagementSystem.com
   International Organization for Standardization
   Guidelines on how to document the
    processes in specific industries
   The goal:
    ◦ Consistency
    ◦ Set of complete, easy to follow instructions




                                  QualityManagementSystem.com
   ISO standards are really a Quality
    Management System
   With specific rules on documentation and
    record-keeping
   Is not a replacement for
    Total Quality Management
    (TQM)




                            QualityManagementSystem.com
   They can co-exist
   ISO focuses on consistency and record-
    keeping
   TQM focuses on employee involvement &
    product improvement




                           QualityManagementSystem.com
   ISO is methodical and rigorous
   Break production process down into key steps
   Each process is then analyzed




                            QualityManagementSystem.com
   Measure each process to meet quality
    standard
   Document the process to Standard Operating
    Procedure
   Performs audits




                           QualityManagementSystem.com
   Review 21 elements for each key process
   Detailed plan for applied elements




                            QualityManagementSystem.com
   Employee training
   Written standard operating procedures
   Management buy in
                  buy-in
   Tool calibrations and records
   Internal & external auditing
    I      l           l di i
   Document control
   Input material quality verification
   Plans for handling non-conforming product



                           QualityManagementSystem.com
   Ensure the production follow the procedure
   Ensure the product is consistent
   Assures consistency, not quality
            consistency




                            QualityManagementSystem.com
QualityManagementSystem.com
   ISO is a rigorous method of ensuring QMS
   ISO certification proves quality control
   Important for other businesses and
    customers




                            QualityManagementSystem.com
QualityManagementSystem.com

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A simple guide to understanding iso standards

  • 2. International Organization for Standardization  Guidelines on how to document the processes in specific industries  The goal: ◦ Consistency ◦ Set of complete, easy to follow instructions QualityManagementSystem.com
  • 3. ISO standards are really a Quality Management System  With specific rules on documentation and record-keeping  Is not a replacement for Total Quality Management (TQM) QualityManagementSystem.com
  • 4. They can co-exist  ISO focuses on consistency and record- keeping  TQM focuses on employee involvement & product improvement QualityManagementSystem.com
  • 5. ISO is methodical and rigorous  Break production process down into key steps  Each process is then analyzed QualityManagementSystem.com
  • 6. Measure each process to meet quality standard  Document the process to Standard Operating Procedure  Performs audits QualityManagementSystem.com
  • 7. Review 21 elements for each key process  Detailed plan for applied elements QualityManagementSystem.com
  • 8. Employee training  Written standard operating procedures  Management buy in buy-in  Tool calibrations and records  Internal & external auditing I l l di i  Document control  Input material quality verification  Plans for handling non-conforming product QualityManagementSystem.com
  • 9. Ensure the production follow the procedure  Ensure the product is consistent  Assures consistency, not quality consistency QualityManagementSystem.com
  • 11. ISO is a rigorous method of ensuring QMS  ISO certification proves quality control  Important for other businesses and customers QualityManagementSystem.com