1. ISO 9001:2000 The 5 Phase Plan to Implementation www.tnaqconsutling.com Sterling, VA 703-801-3673 rterry@tnaqconsulting.com Terry & Associates Quality Consulting, LLC

2. What is ISO 9001:2000? ISO 9001:2000 is an international standard for implementing a quality management system

3. ISO 9001:2000 sets out how a company can establish an effective quality management system to meet its stakeholders’ needs Why Use ISO 9001:2000?

4. ISO 9000:2000 - Fundamentals and Vocabulary Provides an introduction to Quality Management Systems (QMS) and vocabulary ISO 9001:2000 - Requirements Specifies requirements for a QMS where capability to provide product that meets customer and regulatory requirements needs to be demonstrated ISO 9004:2000 - Guidelines for Performance Improvement Provides guidance on using an established QMS to further enhance customer satisfaction and product/service quality IS0 9000:2000 Series of Standards

5. 1. Customer focus 2. Leadership 3. Involvement of people 4. Process approach 5. System approach to management 6. Continual improvement 7. Factual approach to decision making 8. Mutually beneficial supplier relationship Eight Quality Management Principles

6. CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM Measurement, analysis and improvement Product InputOutput Management responsibility Resource management Clause 5 Clause 6 Clause 8 Clause 7 Customers Requirements Product realization Customers Satisfaction Value adding activities Information flow Introduction to ISO 9000:2000

7. 1. Scope 1.1General 1.2 Application 2. Normative reference 3. Terms and definition e.g., Supplier Organization Customer ISO 9001:2000 Requirements

8. Possibility to reduce scope No 9002 or 9003 Can reduce the scope of requirements related to “product realization” May not exclude any requirement that affects ability to provide product and/or service that meets customer and regulatory requirements Permissible Exclusions

9. To meet the requirements you must:  Document  Implement  Maintain  Continually improve effectiveness 4 Quality Management System

10. 4.1 General requirements Processes, interaction, improvement 4.2 Documentation requirements General Quality manual Control of document Control of records

11. 5 Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning Objectives Management system

12. 5.5 Responsibility, authority and communication Top management emphasis Management representative  Includes promotion of customer requirements throughout the organization Internal communication 5.6 Management review Lists of inputs and outputs Recommendation for improvement Action items expected Records 5 Management Responsibility

13. 6 Resource Management 6.1 Provision of resources to improve processes and enhance customer satisfaction 6.2Human resource Determine competence Provide training or other action Evaluate effectiveness of action 6.3 Infrastructure Buildings, workspace, utilities Process equipment Support services 6.4 Work environment Manage conditions of environment to achieve product requirement conformance

14. 7 Product Realization 7.1 Plan and develop the processes Include product objectives, relevant processes and resource, appropriate test and validation 7.2 Customer related processes Customer requirement - stated and implied Statutory and regulatory Product requirements and changes Organization ability Communication with customers 7.3 Design and development Planning, inputs, outputs, systematic reviews, verification and validation, control of changes

15. 7 Product Realization 7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product 7.5 Production and service provision Controlled conditions including product characteristics, work instructions, suitable equipment, measuring devices, and system Release, delivery and post delivery activities Validation of processes when no other method Identification and traceability of product and it’s status Care of customer property Preservation of product  Includes constituent parts

16. 7 Product Realization 7.6 Control of monitoring and measuring devices Calibrated where necessary Adjusted and readjusted Identifies status Safeguarded from invalid adjustment Protected from damage or deterioration

17. 8 Measurement, Analysis, and Improvement 8.1 General Plan and implement Measurement and monitoring processes  To demonstrate product conformity, system conformity and continually improve the QMS 8.2 Monitoring and measurement Customer satisfaction  Perception of fulfillment Internal planned audit, etc.  Auditors independent of their own work Processes  Demonstrate achievement of planned results Product  Monitor and measure characteristics  Conformity with acceptance criteria  Waivers / concessions

18. 8 Measurement, Analysis, and Improvement 8.3 Control of nonconforming product Elimination, concession, preclude intended use 8.4 Analysis of data Customer satisfaction Product and process requirements and trends Suppliers 8.5Improvement Continually improve effectiveness of the system Corrective action Preventive action

19. Next Steps Phase I:Assess the present situation Phase II:Plan the implementation / transition Phase III:Implement plan Phase IV:Assess and review Phase V:Consolidate and improve Phase VI:External assessment

20. Next Steps Phase I: Assess the Present Situation

21. Next Steps Phase II: Plan the Implementation/Transition

22. Next Steps Phase III: Implement the Plan

23. Next Steps Phase IV: Assess and Review

24. Next Steps Phase V: Consolidate and Improve

25. Next Steps Phase VI: External Assessment

26. Summary ISO 9001:2000 is much more project driven Top management have greater accountability The organization is required to measure business performance against objectives If implemented correctly, it will help the organization to:  Be more competitive  Improve cycle times  Reduce costs  Improve morale

27. Terry & Associates Quality Consulting, LLC Terry & Assoc. provides a full range of consulting, and in-house training in international standards, regulatory requirements, and process improvement techniques which maximizes performance and profitability for your company. Contact us or visit our website for ways in which we can help support your organization’s ISO 9001:2000 implementation or transition or other business process improvement activities.

28. Terry & Associates Quality Consulting, LLC Sterling, VA 703-801-3673 rterry@tnaqconsulting.com Website: http://www.tnaqconsulting.com http://www.tnaqconsulting.com