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QMS & ISO 9001:2000

Quality – Policy, Procedures, Management System & Process

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QMS & ISO 9001:2000

  1. 1. QMS & ISO 9001 Quality – Policy, Procedures, Management System & Process Anand Subramaniam
  2. 2. <ul><li>“In a completely rational society, the best of us would be teachers and the rest of us would have to settle for something less” </li></ul><ul><ul><li>- Lee Iacocca </li></ul></ul>
  3. 3. Highlights <ul><li>Quality Management System (QMS) </li></ul><ul><li>QMS - Process </li></ul><ul><li>QMS & ISO 9001 </li></ul>
  4. 4. Quality Management System (QMS)
  5. 5. Quality Policy <ul><li>Driven by Senior Management </li></ul><ul><li>Quality Mission - overall quality direction </li></ul><ul><li>Consistent with the firm’s overall policy </li></ul><ul><li>Encompasses firm’s goals and practices </li></ul><ul><li>Starting point for a Quality Management System. </li></ul>
  6. 6. Quality Procedures <ul><li>Steps to accomplish quality policies and fulfill customer’s requirements. </li></ul><ul><li>Quality procedures and policies, need to be: </li></ul><ul><ul><li>defined </li></ul></ul><ul><ul><li>documented </li></ul></ul><ul><ul><li>communicated </li></ul></ul><ul><li>Quality procedures should be: </li></ul><ul><ul><li>attainable </li></ul></ul><ul><ul><li>up-to-date with revisions and releases </li></ul></ul>
  7. 7. Quality Management Systems (QMS) <ul><li>Based on ISO 9000 standards (family) </li></ul><ul><li>Policies / procedures defined and documented </li></ul><ul><li>Structure, roles & responsibilities defined and established </li></ul><ul><li>Customer specification met on delivered products and / or services </li></ul>
  8. 8. Why QMS? <ul><li>Continuous process improvement </li></ul><ul><li>Evaluation and analysis of customer requirements </li></ul><ul><li>Defined processes to achieve products and / or services acceptable to the customer </li></ul><ul><li>Forms the basis for an enhanced quality culture in any organisation </li></ul>
  9. 9. QMS - Documentation <ul><li>Records </li></ul><ul><li>Quality plans </li></ul><ul><li>Specifications </li></ul><ul><li>Quality manual </li></ul><ul><li>Procedures, work instructions, drawings </li></ul>
  10. 10. Quality Manual <ul><li>Firm’s documented Quality Policy and Quality Management System </li></ul><ul><li>Authoritative collection of procedures describing how to perform the quality tasks. </li></ul><ul><li>ISO 9001:2000, chapter 2, “A Practical Quality Manual Explained” serves as a guideline for compiling this document. </li></ul>
  11. 11. QMS – Evaluation & Audits <ul><li>QMS continuously improved via Audits </li></ul><ul><li>Audits as stipulated in ISO 19011 </li></ul><ul><li>Three types of audits: </li></ul><ul><ul><li>First-party </li></ul></ul><ul><ul><ul><li>Organisation itself </li></ul></ul></ul><ul><ul><li>Second-party </li></ul></ul><ul><ul><ul><li>Customer </li></ul></ul></ul><ul><ul><li>Third-party </li></ul></ul><ul><ul><ul><li>External independent group </li></ul></ul></ul>
  12. 12. QMS - Process
  13. 13. QMS Process Establish Quality Policy & Procedures Define Customer Needs Determine Process Provide Resources Determine and apply methods to measure processes Prevent defects and eliminate their causes Continuous process improve-ments
  14. 14. QMS & ISO 9001
  15. 15. QMS – Why use ISO 9001? <ul><li>For continuous improvement of QMS </li></ul><ul><ul><li>Identify current process problems </li></ul></ul><ul><ul><li>Establish improvement objectives </li></ul></ul><ul><ul><li>Search for solutions </li></ul></ul><ul><ul><li>Evaluate solutions </li></ul></ul><ul><ul><li>Implement solutions using improvement tools </li></ul></ul><ul><ul><li>Measure, verify, and evaluate results </li></ul></ul><ul><ul><li>Solution implementation </li></ul></ul>
  16. 16. Identify current process problems <ul><li>Non existing process </li></ul><ul><ul><li>Disjointed activities, performed in a non-sequencial manner </li></ul></ul><ul><li>Ineffective process </li></ul><ul><ul><li>Does not meet customer requirements </li></ul></ul><ul><li>Inefficient process </li></ul><ul><ul><li>Requirements are met, but process is wasteful </li></ul></ul><ul><li>Complex process </li></ul><ul><ul><li>Results depend on too many factors </li></ul></ul>
  17. 17. Establish Objectives & Evaluate Solution <ul><li>Improvement Objectives </li></ul><ul><ul><li>Based on customer requirements and metrics </li></ul></ul><ul><li>Search and Evaluate Solutions </li></ul><ul><ul><li>DFSS - Design for Six Sigma </li></ul></ul><ul><ul><li>DMADV - Design, Measure, Analyse, Design, Validate </li></ul></ul><ul><ul><li>IDOV – Identify, Design, Optimise, Verify </li></ul></ul><ul><ul><li>DMAIC - Define, Measure, Analyse, Improve, Control </li></ul></ul><ul><ul><li>JIT - Just in time </li></ul></ul>
  18. 18. Implement Solution <ul><li>Improvement Tools </li></ul><ul><ul><li>FMEA - Failure mode and effect analysis </li></ul></ul><ul><ul><li>VAA - Value added analysis </li></ul></ul><ul><ul><li>SPC - Statistical process control </li></ul></ul><ul><ul><li>QFD - Quality function deployment </li></ul></ul>
  19. 19. Measure & Verify Implemented Solution <ul><li>Measure, Verify & Evaluate Results </li></ul><ul><ul><li>Compare with Improvement Objectives </li></ul></ul><ul><li>Solution Implementation </li></ul><ul><ul><li>Projects </li></ul></ul><ul><ul><li>Workouts </li></ul></ul><ul><ul><li>Process management teams </li></ul></ul><ul><ul><li>Kaizen events </li></ul></ul>
  20. 20. <ul><li>“Anyone who thinks customers aren’t important should try doing without them for a week.” </li></ul><ul><ul><li>Source - unknown </li></ul></ul>
  21. 21. <ul><li>Good Luck </li></ul><ul><li>http://www.linkedin.com/in/anandsubramaniam </li></ul>

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