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ISO 9001:2000 Implementation –  Increasing Value and Reducing Lead Time -  Removing Implementation Roadblocks Chad Kymal, CEO Omnex © Omnex  All rights reserved
Speaker Biography ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object]
About Omnex ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
About Omnex  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Omnex Systems EwQMS Suite of Integrated Modules
Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object]
ISO 9001:2000 Requirements and Deadlines
ISO 9001:2000 Process Model
ISO 9000 Series of Standards Terms and Definitions Guidance QMS Requirements ISO 9000:2000 ISO 9001:2000 ISO 9004:2000
ISO 9001:2000 Registration Process ,[object Object],[object Object],[object Object],[object Object],[object Object]
Steps to ISO 9001:2000 Implementation
ISO 9001:2000 Deadlines ,[object Object],[object Object],[object Object]
ISO 9001:2000 Roadblocks and Prevention
Roadblocks and Problems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Transitioning from ISO 9001:1994 - Key Differences
Transitioning from ISO 9001:1994 - Key Differences ,[object Object],[object Object],[object Object],[object Object],[object Object]
Transitioning from ISO 9001:1994 - Key Differences (cont’d) ,[object Object],[object Object],[object Object],[object Object]
Providing Value In ISO 9001:2000 Implementations
Getting Value from Your Implementation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Getting Value from Your Implementation (cont’d) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Creating the culture change and the savings quickly
ISO 9001:2000 Implementation Plan ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ISO 9001:2000 Implementation Plan ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Month 1 ,[object Object],[object Object],[object Object],[object Object]
Month 2 – Develop Documentation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Keep documentation to a minimum. Use software To implement and provide evidence of a process
Month 2 to 4 – Implement Software Modules 4.1, 4.2  building the process model, review of process metrics    and managing process variation.   4.2    document management.  5.1 - 5.4, 6.1  managing customer expectations, customer satisfaction,     continual improvement, and data analysis.   5.5 6.2, 6.4  human performance management functions, competency,     training management and satisfaction surveys     6.3    preventive and reactive maintenance.   7.1    project management.   7.1, 7.3    APQP, PPAP processes 7.4, 7.5    document management.  7.5  preventive and reactive maintenance. 7.4, 8.2.2  internal and external audit function with a focus on  process improvement.     7.6, 8.4  calibration and measurement systems analyses.   8.2.1  human performance management functions, competency,   training management and satisfaction surveys 8.2.3, 8.4, 8.5 managing customer expectations, customer satisfaction, continual improvement, and data analysis.   8.5.2, 8.5.3  document management.  Process Pro  Document Pro BOSS  HR Pro   TPM Pro  Project Planner  AQuA Pr Document Pro TPM Pro  Audit Pro  MSA Pro     HR Pro   BOSS Document Pro
Process Focus - Process Pro
The process flow shows the linkages between each step  within the process. You can then click to see the process flow definition.
 
Business Management System Control Plan – Example A
Customer Focus and Continual Improvement - BOSS
It all starts with the customer
Quality is what the customer says it is! Multiple customers and multiple expectations categories.
You can then align customer quality expectations with company driven process improvement activities.  EwQMS helps you measure key processes.
OFI’s can trigger improvement proposals so the team can  make adjustments to the process.
If  results indicate further analysis, team meetings  can be held to determine OFI’s.
Data for process measurables is kept within the EwQMS system for analysis and continuous improvement activities.
Excel data can also be imported using Data Exchanger, an EwQMS tool  giving you total flexibility in data collection.
You can then use the EwQMS report generator to report detailed information on a variety of process metrics.
EwQMS drill down functionality allows  management to quickly find the root cause  of process variation.
Again, EwQMS visual management tools allow  easy interpretation of metrics data.
Improvement proposals can be documented and tracked against  results.
Documentation – Document Pro
 
The Document Management Process  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Month 5 – Train Auditors and Conduct Audit ,[object Object],[object Object],[object Object]
Audit Pro
The Auditing Process   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
Conduct Registration Audit ,[object Object],[object Object],[object Object]

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Reducing timeincreasingvalue0503

  • 1. ISO 9001:2000 Implementation – Increasing Value and Reducing Lead Time - Removing Implementation Roadblocks Chad Kymal, CEO Omnex © Omnex All rights reserved
  • 2.
  • 3.
  • 4.
  • 5.
  • 6. Omnex Systems EwQMS Suite of Integrated Modules
  • 7.
  • 10. ISO 9000 Series of Standards Terms and Definitions Guidance QMS Requirements ISO 9000:2000 ISO 9001:2000 ISO 9004:2000
  • 11.
  • 12. Steps to ISO 9001:2000 Implementation
  • 13.
  • 14. ISO 9001:2000 Roadblocks and Prevention
  • 15.
  • 16. Transitioning from ISO 9001:1994 - Key Differences
  • 17.
  • 18.
  • 19. Providing Value In ISO 9001:2000 Implementations
  • 20.
  • 21.
  • 22. Creating the culture change and the savings quickly
  • 23.
  • 24.
  • 25.
  • 26.
  • 27. Month 2 to 4 – Implement Software Modules 4.1, 4.2 building the process model, review of process metrics and managing process variation. 4.2 document management. 5.1 - 5.4, 6.1 managing customer expectations, customer satisfaction, continual improvement, and data analysis. 5.5 6.2, 6.4 human performance management functions, competency, training management and satisfaction surveys 6.3 preventive and reactive maintenance. 7.1 project management. 7.1, 7.3 APQP, PPAP processes 7.4, 7.5 document management. 7.5 preventive and reactive maintenance. 7.4, 8.2.2 internal and external audit function with a focus on process improvement. 7.6, 8.4 calibration and measurement systems analyses. 8.2.1 human performance management functions, competency, training management and satisfaction surveys 8.2.3, 8.4, 8.5 managing customer expectations, customer satisfaction, continual improvement, and data analysis. 8.5.2, 8.5.3 document management. Process Pro Document Pro BOSS HR Pro TPM Pro Project Planner AQuA Pr Document Pro TPM Pro Audit Pro MSA Pro HR Pro BOSS Document Pro
  • 28. Process Focus - Process Pro
  • 29. The process flow shows the linkages between each step within the process. You can then click to see the process flow definition.
  • 30.  
  • 31. Business Management System Control Plan – Example A
  • 32. Customer Focus and Continual Improvement - BOSS
  • 33. It all starts with the customer
  • 34. Quality is what the customer says it is! Multiple customers and multiple expectations categories.
  • 35. You can then align customer quality expectations with company driven process improvement activities. EwQMS helps you measure key processes.
  • 36. OFI’s can trigger improvement proposals so the team can make adjustments to the process.
  • 37. If results indicate further analysis, team meetings can be held to determine OFI’s.
  • 38. Data for process measurables is kept within the EwQMS system for analysis and continuous improvement activities.
  • 39. Excel data can also be imported using Data Exchanger, an EwQMS tool giving you total flexibility in data collection.
  • 40. You can then use the EwQMS report generator to report detailed information on a variety of process metrics.
  • 41. EwQMS drill down functionality allows management to quickly find the root cause of process variation.
  • 42. Again, EwQMS visual management tools allow easy interpretation of metrics data.
  • 43. Improvement proposals can be documented and tracked against results.
  • 45.  
  • 46.
  • 47.
  • 49.
  • 50.  
  • 51.  
  • 52.