The document summarizes the key changes between ISO 9000:2000 and earlier versions. ISO 9000:2000 takes a process approach and focuses on continual improvement. It addresses eight quality management principles and requires identifying processes, determining requirements, implementing actions, and continual improvement. The main requirements include developing a quality manual, procedures, records, management responsibility, resource management, product realization, measurement and improvement.

1. ISO 9000:2000

2. ISO 9000:1994 Specified Quality System Requirements Twenty Quality System Elements 1. Management Responsibility 2. Quality System 3. Contract Review 4. Design Control 5. Document & Data Control 6. Purchasing 7. Control Of Customer Supplied Product 8. Product Identification & Traceability 9. Process Control 10. Inspection & Testing 11. Control Of Inspection, Measuring, & Test Equipment 12. Inspection And Test Status 13. Control Of Nonconforming Product 14. Corrective And Preventive Action 15. Handling, Storage, Packaging, Preservation, & Delivery 16. Control Of Quality Records 17. Internal Quality Audits 18. Training 19. Servicing 20. Statistical Techniques ISO 9001 - All 20 Elements; ISO 9002 - No Design Control; ISO 9003 - No Design Control, Purchasing, Process Control Or Servicing

5. THE PROCESS MODEL IS THE BASIS FOR THE STANDARD Continual Improvement Of The Quality Management System Management Responsibility Resource Management Product Realization Measurement Analysis, Improvement Customer Customer Satisfaction Requirements Product Value Added Activities Information Flow

6. QUALITY MANAGEMENT SYSTEM

8. DOCUMENTATION REQUIREMENTS (Paragraph 4.2) Quality Policy & Objectives Quality Manual Documented Procedures Essential Documents Quality Records

9. THE QUALITY MANUAL Scope Justification For Exclusions Documented Procedures Or Reference Describe Interactions

12. MANAGEMENT RESPONSIBILITY

13. MANAGEMENT RESPONSIBILITY Paragraph 5.1 - Management Commitment Evidence Of Commitment Communication Establish Quality Policy Establish Quality Objectives Management Reviews Available Resources

20. RESOURCE MANAGEMENT

21. PROVISION OF RESOURCES (Paragraph 6.1) The Organization Must Determine & Provide Resources Needed: To Implement & Maintain The QMS To Continually Improve Effectiveness To Address Customer Satisfaction

25. Determine & Manage Conditions Achieve Conformity To Requirements RESOURCE MANAGEMENT Paragraph 6.4 - Work Environment

26. PRODUCT REALIZATION

33. DESIGN AND DEVELOPMENT Paragraph 7.3.3 - Design & Development Outputs Enables Verification Against Inputs Approved Prior To Release Meet Input Requirements Provide Appropriate Information Product Acceptance Criteria Essential Product Characteristics

35. DESIGN AND DEVELOPMENT Paragraph 7.3.5 - Design & Development Verification Output Meets Input Requirements Record Results And Follow-up Actions

36. DESIGN AND DEVELOPMENT Paragraph 7.3.6 - Design & Development Validation Confirm Product Is Capable If Practical - Prior To Delivery Or Implementation Record Results And Necessary Actions

37. DESIGN AND DEVELOPMENT Paragraph 7.3.7 Control of Design & Development Changes Changes Identified & Records Maintained Must Be Reviewed, Verified & Validated As Appropriate Approved Prior To Implementation Include Evaluation Of Effect Record Results Of Review & Necessary Actions

45. PRODUCTION & SERVICE PROVISION Paragraph 7.5.4 Preservation Of Product Preserve Conformity Identification, Handling, Packaging Storage & Protection Preservation - Product Components

47. MEASUREMENT, ANALYSIS AND IMPROVEMENT

49. MONITORING AND MEASUREMENT Paragraph 8.2.1 Customer Satisfaction Monitor Customer Perceptions Measurement of These Perceptions - Effectiveness Of QMS Methods of Obtaining & Using Must Be Determined

51. MONITORING AND MEASUREMENT Paragraph 8.2.3 Monitoring & Measurement of Processes Apply Suitable Methods For Monitoring & Measurement Of QMS Process Confirm Ability Of Processes - Planned Results Results Not Achieved - Corrective Action Must Be Taken

52. MONITORING AND MEASUREMENT Paragraph 8.2.4 Monitoring & Measurement of Product Monitor & Measure Characteristics Of Product Taken At Appropriate Stages Evidence Of Conformity Records - Authority Responsible For Release No Product Release & Service Until All Activities Completed

58. THE PROCESS CENTERED ENTERPRISE (or the end of the organization chart) Tight Job Definition and Narrow Focus Close Supervision Ignorance of the Big Picture Incongruent Goals Information Attenuation Lack of Ownership, Accountability, Responsibility Alienation, Boredom, Discontent Life in the Functional Organization:

59. THE PROCESS CENTERED ENTERPRISE Everyone Knows the Organization’s Processes Everyone Knows where he or she fits in Everyone Knows who’s responsible for the Processes Everyone Knows what the Customers Need Everyone Knows the Real Enemy Everyone is Measured on Processes Everyone's Head is Turned 90 Degrees Recognizing a Process Centered Organization:

60. THE PROCESS CENTERED ENTERPRISE The Process Payoff: Order Cycle - Standard Order Cycle - Premium Order Cycle - Custom Production Cycle Submittal Cycle Inventory Turns Sales 30-40 days 10-13 days 40-50 days 8-15 days 3-5 weeks 8 $108M 10 days 1-5 days 23 days <3 days 5 minutes 20 $159M Functional Process

61. THE PROCESS CENTERED ENTERPRISE Identify Processes Document and Standardize Processes Rewrite Job Descriptions Realign Measurement and Reward Systems Redefine Management/Leadership Roles Reorganize Around Processes Reshape Language, Culture, and Customs How Do We Get There?

63. THE PROCESS CENTERED ENTERPRISE Introducing the Process Owner: “ A process owner is someone who spends their time thinking about work and processes. My job is linking tasks into one body of work and then looking at the complete process and making sure that it all works together” Charles Dunagan Process Owner Customer Order and Inquiry Fulfillment Shell Chemical Co,