Auditing ISO 9001:2000 Indianapolis Section of ASQ January 8, 2002

1. Auditing ISO 9001:2000Indianapolis Section of ASQJanuary 8, 2002 Baskar Kotte Quality Systems Enhancement, Inc., 1790 Woodstock Road Roswell, GA 30075 Toll Free : 1-866-577-4476 consult@enhancequality.com www.enhancequality.com

2. Summary • Auditing Focus • Eight QMS Principles • Purpose & Intent Of Year 2000 Standards • Terminology • ISO 9001: 2000 Requirements Sections • Deming Cycle • Process Approach • Process Model • System Approach • Continual Improvement • Customer Satisfaction • Differences Between ISO 9001: 1994 Vs ISO 9001: 2000 • Differences Table • Element Cross Reference • Auditing Tools and Techniques

3. Auditing Focus • Customer Satisfaction • ISO 9001: 1994 Vs ISO 9001: 2000 • Purpose & Intent • Auditing Tools and Techniques

4. The Eight Quality Management Principles Customer Focus Leadership Involvement of People Process Approach System Approach Continual Improvement Factual Approach to Decision Making Mutually Beneficial Supplier Relationships CLIPS CFM

5. Purpose and Intent of Year 2000 Standards Enhance Customer Satisfaction Consistently Meet the Customer Requirements All Organizations, Regardless of Type, Size or Product Provided Reduce Documentation Requirement

6. Terminology Changes in Terminology Customer = Customer Supplier = Organization Subcontractor = Supplier Nonconformance and Nonconformity Containment Action and Correction Correction and Corrective Action Corrective Action and Preventive Action Preventive Action and Corrective Action Impact Document and Record Continuous and Continual Improvement Process and System Approach Design and Development Efficient and Effective

7. ISO 9001:2000 Requirements sections 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement

8. Inputs Output Feedback Deming Cycle (PDCA Approach) Plan Act Do Customer Customer Check/ Study Requirements Satisfaction An Approach To Continual Improvement

9. Process Approach • Transformation of Inputs to Outputs • Output From One Process Forms the Input to the Next Process • Subset of a System

10. Process Model Continual improvement of the quality management system Customers Requirements Customers Satisfaction Management responsibility Resource management Measurement, Analysis and improvement Product Realization Product Input Output Value-adding activities Information flow

11. System Approach Consider Interrelated Processes as a System and Manage It Achieve Objectives / Targets Effectively

12. Continual Improvement Critical Focus For Improvement Stair-Step Improvement Incremental Trend line

13. Customer Satisfaction • Customer Requirement Compliance • Customer Feedback • Customer Dissatisfaction Gathering • Enhance Customer Satisfaction • Continual Improvement

14. Differences Between ISO 9001:1994 and ISO 9001:2000 Differences in scope Difference in Application Number of Clauses Direct Customer Focus Customer Complaints vs. Customer Satisfaction Number of Quality Records Number of Documented Procedures Concepts in Clause Reduction

15. Differences Table

16. Element Cross Reference • 4. 2, 5, 16 • 5. 1, 2, 3 • 6. 1, 2, 9,18 • 7. 2, 3, 4, 6, 7, 8, 9, 10, 11,12, 15, 19 • 8. 1, 9, 10, 13, 14, 17, 20

17. Auditing Tools and Techniques Time Management Process Based Audit Schedule Preparation of Audit Checklist Improved Interviewing Techniques for Objective Evidence Address Auditing “Your Own Work” vs. direct responsibility for the Activity Process Approach Effectiveness in the Absence of Documented Procedures Evidence of Management Commitment Gathering Objective Evidence