The document discusses Omnex Consulting's services for implementing quality management systems that are compliant with standards like ISO 9001, ISO 14001, and QS 9000. It outlines their approach which includes conducting an analysis, establishing cross-functional teams, assisting with registration, documenting processes and controls, and driving continuous improvement. The benefits of Omnex's approach are that it provides an easy to implement and maintain system that maximizes value and supports analysis for continual improvement.

1. Quality Management System Implementation

2. Omnex Introduction Consulting and Client Site Training in Quality and Management Systems Development and Implementation: ISO 9001:2000 Quality Management systems ISO/QS 9000; ISO/TS 16949 (Automotive) ISO 14000 Environmental Management Systems QOS/BOS/Balanced Scorecard Product and Service Development and Introduction Business Process Re-Engineering Productivity & Performance Enhancement IT Systems/Business Process Integration

3. Omnex Introduction Capabilities Recognized Worldwide Experts in ISO 9000 & 14000, QS-9000 and QOS Effective Strategic Business Approach to Implementations Specialized Client Site Training Performance Improvement systems and methodologies International Resources with Multi-language and Global Service Delivery Capabilities Bias Toward Action

4. Omnex Approach

5. Omnex Approach Conduct Discovery Analysis and Develop Plan Establish Cross Functional Team & Objectives Assist in Selecting Registrar, Plan Registration Process Create an Operating System Define and Document Key Business Processes Define and Document Key Business Process Controls Establish Effective Data Management Initiate Effective Management Review Drive Continuous Improvement

6. Strategic Value of Omnex Approach Easy to Implement Easy to Understand and Use Easy to Maintain Maximize Value, Minimize Paperwork Supports Analysis for Continuous Improvement

7. Conduct Discovery Analysis Understand existing systems Understand existing processes and activities Understand functional organizational structure Map to system objectives Align with current system and ISO 9001:2000 Develop Implementation Plan

8. Need for Cross Functional Team, Objectives, Process Definition

9. Quality Management System Strategy

10. ISO 9001:2000 Defines a business using a Process Model Requirements organized in five categories Quality Management System Requirements Management Responsibility Resource Management Process Management Measurement, Analysis and Improvement Changes More business-based terminology and process model Definition of “Quality”: Requirements focus on “Customer Satisfaction,” not “conformance to specification” Formally mandates continuous improvement Expanded emphasis on management responsibility and resource assurance

11. ISO 9001:2000 Process Model Product realization Input Product/ Service (and/or service) Requirements Resource management Measurement, analysis, improvement Management responsibility Customer Customer Satisfaction QUALITY MANAGEMENT SYSTEM CONTINUAL IMPROVEMENT Output Quality Management System

12. New Requirements in ISO 9001:2000 Voice of the Customer-Expectations & Requirments Quantifiable Objectives Internal Communications Infrastructure Work Environment Customer Communications Measurement and Monitoring Customer Satisfaction Continual Improvement

13. ISO 9001:2000 Business Plan

14. Understand Primary Business Processes Product and Service Realization Marketing Sales Purchasing Design Production/Distribution Delivery Planning Quality Planning Analysis of Data Improvement Management Strategic Planning Resource Planning Performance Monitoring Measurement(Accounting) Documentation Analysis Maintain Records Human Resources Staffing Training

15. Utilize Flow Charts for Documentation

16. Define Key Business Process Controls Identify Performance Characteristics (Values) Conduct a Business Process Analysis (FMEA) Develop an Improvement Plan Implement a Control Plan Generate Data for Continuous Improvement

17. Employ Dynamic Process Control

18. Implementation Process

19. Organizing for ISO 9000 Implementation Management Team Develops Operating System in Management Responsibility Develops & Deploys Policy and Objectives Conducts Management Review Steering Committee Lead by Management Representative Cross functional Appoint by virtue of authority, position and expertise Champions for process teams Process Teams Cross functional Subject matter & process experts Develop all documentation

20. Implementation Structure Example

21. Implementation Steps Conduct Discovery Analysis Develop Implementation Plan Timing Roles and Responsibilities Status Assessment & Program Management Identify key indicators for improvement Form Steering Committee(s) Train and Orient Committee(s) Select & Orient Registrar

22. Implementation Steps Form Key Process Teams Train teams in methodologies for business processes Implement Approaches and methodologies Map and Document Key Processes Form Process Level Teams Map and Document Processes and Activities Develop Level III Documentation Implement Procedures, Work & Process Instructions

23. Implementation Steps Train Internal Audit Teams Establish Management Review Process Conduct Internal Audits concurrently with Implementation Process Establish Corrective & Preventive Action Conduct Pre-Audit Finishing Process Registration Audit

24. Effective Management Review Process Meet Regularly Maintain Discipline Drive System Implementation Process Focus on Strategically Critical Continuous Improvement Utilize Data Achieve and Maintain Shared Level of Understanding Support Effective Decision Making Take Action

25. Benefits of Omnex Approach Defined and Shared Responsibilities Documents Your Business Processes Easier to Implement and Maintain Drives Performance Improvement Focuses on Value Relevant and Sustainable

26. Typical Obstacles and Solutions Lack of Management Commitment No Defined Plan NVA Documentation/ Frequent Rewrites Lack of Understanding of Requirements Organization by Elements Address Early with Defined Objectives (Relevance) Plan Your Work, Work Your Plan Facilitate Documentation Training Organization by Key Processes & Activities

27. Need for Top Management Commitment If top management is not involved: There will be documents which do not reflect actual practices Managers will give only “lip service” to policy and its implementation—system will lack relevance ISO will be seen as a “paperwork monster” (generating enormous costs without benefit) that lessens value There will be a lack of clear, quantifiable improvement

28. Role of Omnex Consultants Provide Objective Voice Contribute Technical Expertise Maintain Focus and Discipline Expand the Vision of the Organization Provide Perspective from Other Successful Efforts Analyze and Identify Opportunities with Credibility Provide Disciplined Program Management Provide Dedicated Resources

29. Global Presence & Alliances Omnex, Inc. Training Development & Publishing Software Development AQuA ® BOSs ® AQSR, International International Offices Brazil Canada Germany (J-V) Mexico India Peoples Republic of China Taiwan Thailand Venezuela

30. Recent Domestic Clients Corrigan Moving Systems Defiance Engineering & Testing Delphi Automotive EASi-Meg Engineering Engineering Technology Ford Customer Service Division Ford Human Resources Service Center Ford Warranty Specialists General Motors Information Systems and Services Giffels Arch. & Engr. Hendrickson International Lucent Technologies Mobil Oil Petro Canada Siebe Automotive NA Teleflex Visteon