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ISO Insights for Innovators NCTC Tech & Toast November 11, 2010 Roy D’Ardenne, President Steve Anderson, Executive VP
Definition of “Quality” ,[object Object],[object Object],(c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T
Key Concepts from ISO 9000:2005 ,[object Object],[object Object],[object Object],[object Object],[object Object],(c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T
Continual improvement of the Quality Management  System (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T         Customers   Satisfaction         Customers   Requirements Management responsibility   Resource management Product realization Measurement, analysis, and improvement Product Input Output
Clause 4. Quality Management System (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Clause 5. Management Responsibility (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T ,[object Object],[object Object],[object Object],[object Object],[object Object]
Clause 6. Resource Management (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T ,[object Object],[object Object],[object Object],[object Object]
Clause 7. Product Realization (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T What is the clause about?  Defines the control of the processes necessary to produce the product or provide a service. Planning Customer related processes Design Purchasing Control, ID and Preserve Calibration
Clause 8. Measurement, Analysis and Improvement (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T What is the clause about?   System performance must be measured and monitored through: - internal audits - process measures - data analysis The information gathered is to be used for system improvement
Getting Management Buy-In ,[object Object],[object Object],[object Object],[object Object],[object Object],(c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T
Major Trends in ISO Standards Evolution  ,[object Object],[object Object],[object Object],[object Object],(c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T
Actual Case Study ,[object Object],[object Object],(c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T
ISO Case Study (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T (c) 2010 D'Ardenne Associates, Ltd.  ISO 9001:2008 Transition, Rev 0 What is the driving the Management Objective?   Internal : continuous improvement, strategic plan, company survival External : contracts, industry standards  Regulatory requirements :  OSHA, FDA, EPA, DOD, DHS
ISO Case Study (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T (c) 2010 D'Ardenne Associates, Ltd.  ISO 9001:2008 Transition, Rev 0 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO Case Study (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T (c) 2010 D'Ardenne Associates, Ltd.  ISO 9001:2008 Transition, Rev 0 What is the process & timing?   The process is usually driven by the resource requirements and budget. Timing can be very broad with a range from 90 days to 2 years depending on scope.
ISO Case Study (c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T (c) 2010 D'Ardenne Associates, Ltd.  ISO 9001:2008 Transition, Rev 0 ,[object Object],[object Object],[object Object],[object Object]
Where From Here ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],(c) 2010 D'Ardenne Associates, Ltd.  NCTC T&T
What are Your Questions ?
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ISO Insights For Innovators - NCTC Presentation 11-11-2010

  • 1. ISO Insights for Innovators NCTC Tech & Toast November 11, 2010 Roy D’Ardenne, President Steve Anderson, Executive VP
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  • 4. Continual improvement of the Quality Management System (c) 2010 D'Ardenne Associates, Ltd. NCTC T&T         Customers   Satisfaction         Customers   Requirements Management responsibility Resource management Product realization Measurement, analysis, and improvement Product Input Output
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  • 8. Clause 7. Product Realization (c) 2010 D'Ardenne Associates, Ltd. NCTC T&T What is the clause about? Defines the control of the processes necessary to produce the product or provide a service. Planning Customer related processes Design Purchasing Control, ID and Preserve Calibration
  • 9. Clause 8. Measurement, Analysis and Improvement (c) 2010 D'Ardenne Associates, Ltd. NCTC T&T What is the clause about? System performance must be measured and monitored through: - internal audits - process measures - data analysis The information gathered is to be used for system improvement
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  • 13. ISO Case Study (c) 2010 D'Ardenne Associates, Ltd. NCTC T&T (c) 2010 D'Ardenne Associates, Ltd. ISO 9001:2008 Transition, Rev 0 What is the driving the Management Objective? Internal : continuous improvement, strategic plan, company survival External : contracts, industry standards Regulatory requirements : OSHA, FDA, EPA, DOD, DHS
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  • 15. ISO Case Study (c) 2010 D'Ardenne Associates, Ltd. NCTC T&T (c) 2010 D'Ardenne Associates, Ltd. ISO 9001:2008 Transition, Rev 0 What is the process & timing? The process is usually driven by the resource requirements and budget. Timing can be very broad with a range from 90 days to 2 years depending on scope.
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  • 18. What are Your Questions ?
  • 19. Thank You for Attending

Editor's Notes

  1. D'Ardenne Associates, Ltd. copyright March 2009
  2. D'Ardenne Associates, Ltd. copyright March 2009
  3. D'Ardenne Associates, Ltd. copyright March 2009
  4. D'Ardenne Associates, Ltd. copyright March 2009
  5. D'Ardenne Associates, Ltd. copyright March 2009
  6. D'Ardenne Associates, Ltd. copyright March 2009
  7. D'Ardenne Associates, Ltd. copyright March 2009
  8. D'Ardenne Associates, Ltd. copyright March 2009
  9. D'Ardenne Associates, Ltd. copyright March 2009 D'Ardenne Associates, Ltd. copyright March 2009
  10. D'Ardenne Associates, Ltd. copyright March 2009 D'Ardenne Associates, Ltd. copyright March 2009
  11. D'Ardenne Associates, Ltd. copyright March 2009 D'Ardenne Associates, Ltd. copyright March 2009
  12. D'Ardenne Associates, Ltd. copyright March 2009 D'Ardenne Associates, Ltd. copyright March 2009
  13. D'Ardenne Associates, Ltd. copyright March 2009
  14. D'Ardenne Associates, Ltd. copyright March 2009