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ISO 9000

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ISO 9000 update bu Bill Cook to ASQ Tampa (May 2010)

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ISO 9000

  1. 1. William E Cook Lead Auditor ISO 9001:2008, ISO/TS 16949, TL9000
  2. 2. <ul><li>ISO 9001:2008 </li></ul><ul><li>Over 1,000,000 certified companies worldwide </li></ul><ul><li>ISO 9001:2000 expires 11/13/2010 </li></ul><ul><li>Next revision in 2015 </li></ul><ul><li>Accreditation by ANAB in the US </li></ul>
  3. 3. <ul><li>Automotive </li></ul><ul><li>ISO/TS 16949:2009 </li></ul><ul><li>Incorporates ISO 9001:2008 with no changes in the TS specific requirements </li></ul><ul><li>Accreditation by IATF </li></ul><ul><li>Administered by five national Oversight Bureaus (IAOB in the US) </li></ul><ul><li>VDA 6.1, 6.2, 6.3 </li></ul>
  4. 4. <ul><li>Telecommunications </li></ul><ul><li>TL9000 release 5.0 (2009) </li></ul><ul><li>Incorporates ISO 9001:2008 with two new TL adders and several minor adder and note changes </li></ul><ul><li>Accredited by ANAB </li></ul><ul><li>Administered by the Quest Forum </li></ul><ul><li>TL 9000 Measurements Handbook release 4.0 </li></ul>
  5. 5. <ul><li>Aerospace </li></ul><ul><li>AS9100 manufacturers </li></ul><ul><li>AS9110 maintenance organizations </li></ul><ul><li>AS9120 retailers/distributors </li></ul>
  6. 6. <ul><li>Medical Device </li></ul><ul><li>ISO 13485 manufacturing </li></ul><ul><li>ISO 15378:2006 packaging </li></ul>
  7. 7. <ul><li>Food Safety & Hygiene </li></ul><ul><li>Hazard Analysis Critical Control Point (HACCP) </li></ul><ul><li>International Food Standard v.5 </li></ul><ul><li>BRC Global Standard Food Safety v.5 </li></ul><ul><li>ISO 22000 Food Safety </li></ul><ul><li>EN 15593 </li></ul>
  8. 8. <ul><li>Rail & Transportation </li></ul><ul><li>International Railway Industry Standard (IRIS) </li></ul><ul><li>Safety Quality Assessment System (SQAS) - for transportation companies hauling hazardous materials - not a certification </li></ul>
  9. 9. <ul><li>ISO 14001 </li></ul><ul><li>PEFC (Program for the Endorsement of Forest) </li></ul><ul><li>EEG 2009 Renewable Energy </li></ul><ul><li>EMAS (Eco-Management and Audit Scheme) </li></ul>
  10. 10. <ul><li>OHSAS 18001 </li></ul>
  11. 11. <ul><li>ISO 27001 </li></ul><ul><li>ISO 20000-1 </li></ul><ul><li>Data Privacy Audit </li></ul><ul><li>BS25999 Business Continuity Management </li></ul><ul><li>itSMF – BS15000 </li></ul><ul><li>SPICE (Software Process Improvement & Capability Determination) - ISO 15504 </li></ul>
  12. 12. <ul><li>DQS Benchmarking </li></ul><ul><li>Personnel Process Assessment (PPA) </li></ul><ul><li>IBEC – IQNet Business Excellence </li></ul>
  13. 13. <ul><li>4.1 General requirements “Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied … shall be defined within the quality management system.” </li></ul>
  14. 14. <ul><li>4.2.2 Quality manual </li></ul><ul><li>- scope of the QMS, including details and justification for any exclusions </li></ul><ul><li>- documented procedures, or reference to them </li></ul><ul><li>- description of the interaction between the processes of the QMS </li></ul>
  15. 16. <ul><li>5.3 Quality policy </li></ul><ul><li>- comply with requirements </li></ul><ul><li>- continually improve effectiveness of the QMS </li></ul><ul><li>- KISS </li></ul>
  16. 17. <ul><li>5.4.1 Quality objectives </li></ul><ul><li>- establish at relevant functions and levels within the organization </li></ul><ul><li>- measurable and consistent with the quality policy </li></ul>
  17. 18. <ul><li>5.6 Management Review </li></ul><ul><li>- Frequency? </li></ul><ul><li>- Cover the inputs and outputs required </li></ul>
  18. 19. <ul><li>6.2.2 Competence, training and awareness </li></ul><ul><li>- determine competence </li></ul><ul><li>- provide training, or take other action </li></ul><ul><li>- evaluate effectiveness </li></ul><ul><li>- awareness </li></ul><ul><li>- records </li></ul>
  19. 20. <ul><li>8.2.2 Internal audit </li></ul><ul><li>- Process oriented, not requirement based </li></ul><ul><li>- Value-added, not merely a compliance check </li></ul><ul><li>- Develop measures for all processes </li></ul>
  20. 21. <ul><li>8.5.1 Continual improvement </li></ul><ul><li>- Six Sigma </li></ul><ul><li>- Lean Manufacturing </li></ul><ul><li>- Kaizen </li></ul>
  21. 22. <ul><li>8.5.2 Corrective action </li></ul><ul><li>- Root cause analysis (5 Why, Cause and effect) </li></ul><ul><li>- Determine and implement action needed </li></ul><ul><li>- Review effectiveness </li></ul>
  22. 23. <ul><li>8.5.3 Preventive action </li></ul><ul><li>- Determine potential non-conformities and their causes </li></ul><ul><li>- Determine and implement action needed </li></ul><ul><li>- Review effectiveness </li></ul>

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