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about ISO 9001:2000, 9004:2000, QMS

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Iso

  1. 1. ISO 9001 : 2000 ISO 9004 : 2000 Agustini West Coast University (ISO : International Organization for Standardization’s)
  2. 2. ISO 9001 and ISO 9004 in brief <ul><li>ISO 9001 and ISO 9004 are among ISO's most well known standards ever. </li></ul><ul><li>ISO 9001 helps organizations to implement quality management systems-requirements. </li></ul><ul><li>ISO 9004 helps organizations to implement quality management systems- guidelines for performance improvements . </li></ul>
  3. 3. Future ISO 9000 Family (Subject to Ballot) ISO 9000 Core Standards Brochures 9000 9001 9004 19011 10012 Withdraw or transfer to other TC 9000-3 9000-4 9004-2 9004-3 9004-4 10005 * Document status TR to be considered at next revision <ul><li>QMP </li></ul><ul><li>Sel & Use </li></ul><ul><li>Small Bus </li></ul><ul><li>Handbook </li></ul>Technical Specs Other ISO 9000 Standards Technical Reports 10006 * 10007 * 10013 10014 10015 * 10017 TS16949
  4. 4. EXPECTED QUALITY by the Customer PLANNED QUALITY by the Company PRODUCED QUALITY by the Company PERCEIVED QUALITY by the Customer Measurement of the Performance of the Company Me a sure ment of the Client’s satisfaction The ISO 9000:2000 requirements
  5. 5. <ul><li>“ A COHERENT PAIR ”: </li></ul><ul><ul><li>ISO 9001:2000 – Quality Management Systems: REQUIREMENTS (WHAT ?) </li></ul></ul><ul><ul><li>ISO 9001 oriented effectiveness and certification, </li></ul></ul><ul><ul><li>ISO 9004:2000 - Quality Management Systems: GUIDELINES FOR PERFORMANCE IMPROVEMENTS </li></ul></ul><ul><ul><li>(HOW ...?) </li></ul></ul><ul><li>ISO 9004 oriented effectiveness and efficiency </li></ul>Presentation of ISO 9000:2000
  6. 6. Relationship ISO 9001/ISO 9004 <ul><li>2 stand-alone standards, each being part of a “consistent pair” </li></ul><ul><li>Common structure based on “Process Approach” </li></ul><ul><li>Harmonized terminology </li></ul><ul><li>Based on 8 “Quality Management Principles” previously endorsed by ISO/TC176 </li></ul><ul><li>TC :Technical Committee </li></ul>
  7. 7. The eight Quality Management Principles (ISO 9000 Principles) : <ul><li>Customer Focus </li></ul><ul><li>Leadership </li></ul><ul><li>Involvement of People </li></ul><ul><li>Process Approach </li></ul><ul><li>Systems Approach to Management </li></ul><ul><li>Continual Improvement </li></ul><ul><li>Factual Approach to Decision Making </li></ul><ul><li>Mutually beneficial supplier relationship </li></ul>
  8. 8. Process-based structure <ul><ul><li>Management responsibility </li></ul></ul><ul><ul><ul><li>Policy, objectives, planning, system, review </li></ul></ul></ul><ul><ul><li>Resource management </li></ul></ul><ul><ul><ul><li>Human resources, information, facilities </li></ul></ul></ul><ul><ul><li>Product realization </li></ul></ul><ul><ul><ul><li>Customer, design, purchasing, production, calibration </li></ul></ul></ul><ul><ul><li>Measurement, analysis and improvement </li></ul></ul><ul><ul><ul><li>Audit, process/product control, improvement </li></ul></ul></ul>
  9. 9. Basic process model MANAGEMENT ACTIVITIES ENABLERS CUSTOMER INPUTS CUSTOMER SATISFACTION DESIRED OUTPUTS
  10. 10. The 9 criteria of the EFQM Model The percentages were established following a wide ranging survey to collect views We acknowledge here the key role of leadership, policy and strategy, the management of people and the management of partnerships and resources. EFQM : European Foundation for Quality Management Innovation and Learning Leadership 100 points (10%) Processes 140 points (14%) Key Performance Results 150 points (15%) People 90 points (9%) Policy and Strategy 80 points (8%) Partnerships & Resources 90 points (9%) People Results 90 points (9%) Customer Results 200 points (20%) Society Results 60 points (6%) Capacity 500 points (50%) Results 500 points (50%) Results Enablers
  11. 11. Process Model (ISO 9001:2000) Management responsibility Measurement , analysis , improvement Resource management QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT OF C u s t o m e r R e q u i r e m e n t s C u s t o m e r Product realization Input Output Product S a t i s f a c t i o n
  12. 12. Process Model (ISO 9004:2000) Management responsibility Measurement , analysis , improvement Resource management QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT OF R e q u i r e m e n t s Product realization Input Output Product S a t i s f a c t i o n I n t e r e s t e d P a r t i e s I n t e r e s t e d P a r t i e s
  13. 13. Development process for ISO 9001 and ISO 9004 <ul><li>User surveys </li></ul><ul><li>Specifications </li></ul><ul><li>Project approach </li></ul><ul><ul><ul><li>Review of comments received </li></ul></ul></ul><ul><ul><ul><li>Verification process </li></ul></ul></ul><ul><ul><ul><li>Validation pilot studies </li></ul></ul></ul><ul><li>Extensive use of electronic communications </li></ul>
  14. 14. <ul><li>“ To provide confidence, as a result of demonstration, in product conformance to established requirements” </li></ul>ISO 9001:2000 - Requirements
  15. 15. Understand the role of ISO 9001 standard: <ul><li>Product and/or service quality oriented </li></ul><ul><li>Confidence to own management </li></ul><ul><li>Confidence to customers </li></ul><ul><li>‘ Established requirements’ </li></ul><ul><li>Customer satisfaction </li></ul>
  16. 16. <ul><li>“ Benefits for all interested parties through sustained customer satisfaction” </li></ul>ISO 9004:2000 - Guidelines
  17. 17. ISO 9004:2000 <ul><li>ISO 9004 completely re-written </li></ul><ul><li>Revised terminology, harmonized with ISO 9001 </li></ul><ul><li>Annex on self-assessment added </li></ul><ul><li>Includes the requirements from ISO 9001 (in clearly delineated boxes). </li></ul><ul><li>More “user-friendly” </li></ul><ul><li>Benefits “For all interested parties” </li></ul>
  18. 18. Think Performance Improvement… Think ISO 9004!! <ul><li>Increase profits </li></ul><ul><ul><li>leadership and customer focus </li></ul></ul><ul><ul><li>clear objectives </li></ul></ul><ul><ul><li>increased efficiency </li></ul></ul><ul><ul><li>improved employee performance </li></ul></ul><ul><ul><li>employee and customer satisfaction </li></ul></ul><ul><ul><li>efficient use of resources </li></ul></ul>
  19. 19. Potential Benefits and Opportunities for Organizations
  20. 20. What the new standard means for your organisation <ul><li>Customer focus </li></ul><ul><ul><li>Need to stop and think: </li></ul></ul><ul><ul><ul><li>“ Who are my customers?” </li></ul></ul></ul><ul><ul><ul><li>“ What do they really want?” </li></ul></ul></ul><ul><ul><ul><li>“ What are my key processes to be sure they get what they want?” </li></ul></ul></ul><ul><ul><ul><li>“ Does that tie in with what I want??” </li></ul></ul></ul><ul><li>More emphasis on defining objectives </li></ul><ul><li>Providing leadership </li></ul>
  21. 21. Better integration of QMS <ul><li>Better integration of QMS into the Day-to-Day running of the Business </li></ul><ul><li>Need to define and understand key processes </li></ul><ul><ul><li>Inputs </li></ul></ul><ul><ul><li>Outputs </li></ul></ul><ul><ul><li>Measurements </li></ul></ul>
  22. 22. Quality Management Style <ul><li>Focus on the entire system </li></ul><ul><li>Customer is main concern </li></ul><ul><li>Communication at all levels </li></ul><ul><li>Continuous Improvement </li></ul><ul><li>Responsibility assigned </li></ul>
  23. 23. Why Implement a QMS? (ISO 9000) <ul><li>Ensure Customer Satisfaction </li></ul><ul><li>Improve Quality System </li></ul><ul><li>Enhance Control of Resources </li></ul><ul><li>Improve Suppliers Performance </li></ul>
  24. 24. Analysis of Data Organizational Objectives Customer requirements Statutory & regulatory requirements Defect rate and customer returns QMS controls Purchasing Examples of objectives set by the Organization
  25. 25. Analysis of Data Examples of results recorded by the Organization Organizational Results Customer satisfaction Statutory & regulatory compliance Quality system metrics Inspection and test Supplier performance Organizational Objectives Customer requirements Statutory & regulatory requirements Defect rate and customer returns QMS controls Purchasing
  26. 26. Effectiveness of the QMS Organizational Objectives Organizational Results The gap measures the lack of effectiveness of the quality management system. The narrower the gap, the more effective the QMS. Things are looking good! 0 0 100 100
  27. 27. Effectiveness of the QMS Organizational Objectives Organizational Results Management should get a wake up warning! The gap measures the lack of effectiveness of the quality management system. 0 0 100 100
  28. 28. Effectiveness of the QMS Organizational Objectives Organizational Results The Organization is in trouble! The gap measures the lack of effectiveness of the quality management system.
  29. 29. Improvement in the QMS Organizational Objectives Organizational Results Improvement can also be measured % 100 75 50 25 0 Improvement in the QMS
  30. 30. Improvement in the QMS Organizational Objectives Organizational Results Customer Focus Corrective Action Procurement Improvement Initiatives These actions may cause the organization to revise its objectives .
  31. 31. Management Review The improvement processes are also evaluated during management review meetings and appropriate action taken. Which may cause the organization to again revise its objectives. Organizational Objectives Organizational Results 0 0 100 100 Customer Focus Corrective Action Procurement Improvement Initiatives Management Review
  32. 32. Opportunities <ul><li>“ Use the QMS as a useful MANAGEMENT tool, not just “to show the auditor” </li></ul><ul><li>Better understanding of customer needs </li></ul><ul><li>Beyond “Compliance” towards “Excellence” </li></ul><ul><li>Beyond “Effectiveness” towards “Efficiency” </li></ul>
  33. 33. Conclusion: <ul><li>The eight Quality Management Principles are the foundation of a Quality Management System. </li></ul><ul><li>Stepping stone to performance improvement. </li></ul>
  34. 34. Stepping-Stone to Excellence <ul><li>Alignment ISO 9001 and ISO 9004 </li></ul><ul><li>ISO 9004 for self-assessment of maturity </li></ul><ul><li>Focus on improvement in performance </li></ul><ul><li>Compatibility with Quality Awards </li></ul>
  35. 35. Thank You

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