- 1. ISO 9001 Auditing Practices Group Aligning the QMS with the achievement of organizational and business success.
2. Business, Quality and Excellence Models and Tools There are many links between business, qualityand excellence and many models and tools from which an organization can choose. The following are some examples:
- Business Excellence models
- ISO 9001:2000 Quality Management Systems
3. Balanced Scorecard
- A system that translates an organizations mission and strategy into a comprehensive set of performance measures that provides the framework for a strategic measurement and management system.
4. The Balanced Scorecard Model 5. Business Excellence Models Many types of business excellence models exist throughout the world:
- National Business Excellence Models and Awards
6. ISO & IAF2004 All rights reserved June 2, 2009 Typical National Excellence Model SUPPLIER & PARTNERSHIP PERFORMANCE PEOPLE SATISFACTION CUSTOMER SATISFACTION IMPACT ON SOCIETY ENABLERS RESULTS LEADERSHIP PROCESSES ORGANIZATIONAL RESULTS Policy&Strategy Customer & Market Focus People Management Resource & Info Management 7. ISO 9001:2000 Quality Management Systems 8. The ISO Model Inputs Outputs Continual Improvement of the Quality Management System Resource Management Measurement, Analysis, Improvement CUSTOMER Requirements Management Responsibility Product Realization CUSTOMER Satisfaction Product 9. Comparison Not specifically addressed in the standard. Organizations Business Results QMS General requirements Product Realization Internal Business Processes Customer focus Customer related processes Customer satisfaction Customer Quality Policy Quality objectives Vision and Strategy ISO 9001:2000 Balanced Scorecard 10. Comparison QMS General requirements Product Realization Business Processes Not specifically addressed in the standard. Organizations business results Human Resources People Management Customer focus Customer related processes Customer satisfaction Customer & Market Focus Customer Satisfaction Quality Policy Quality objectives Policy and Strategy ISO 9001:2000 Excellence Model 11. ISO 9001:2000 ISO 9001:2000 specifies requirements for a quality management system where an organization:
- Needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements, and
- Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
12. The Sydney Model The concept of this model was developed by the ISO/TC176/IAF ISO 9001 Auditing Practice Group during their meeting in Sydney, Australia during 2003. The model illustrates thateffectivenessandimprovementcan be represented as a cyclical process that uses the components of the QMS to analyze data and then direct changes and initiatives that ensure continual improvement. The overall result is an enhanced pro-active approach to meet QMS objectivesand more importantly their related corporate organizational, business and/or financial objectives. 13. Improvement and Effectiveness There are many examples and requirements in ISO 9001:2000 that require the organization to address the effectiveness of its quality management system. Further requirements specify the need for continual improvements to the quality management system not just sporadic quality campaigns. 14. Effectiveness Extent to which planned activities are realized and planned results achieved. ISO 9000:2000 3.2.14 ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes.It focuses on the effectiveness of the quality management system in meeting customer requirements. ISO 9001: 20000.3 15. Improvement and Effectiveness Top Management shall ensure that the quality policy includes a commitment to comply with requirements andcontinually improve the effectivenessof the quality management system. ISO 9001: 20005.3 The organization shallcontinually improvetheeffectivenessof the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.ISO 9001: 20008.5 16. The Concept of the Sydney Model The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and toevaluatewhere continual improvement of the effectiveness of the quality management system can be made.ISO 9001: 20008.4 And to ensure that the organizations quality and/or business objectives have been met! 17. The Sydney Model In the following example, an organization has identified several quality objectives and has collected data on the results of these objectives.Using a gap analysis technique, the results are compared to the objectives and the degree of effectiveness of the QMS is established for a given time period. The same data also allows the organization to measure improvement and to take any necessary action based on the information and results. 18. Analysis of Data Organizational Objectives Customer requirements Statutory & regulatory requirements Defect rate and customer returns QMS controls Purchasing Examples of objectives set by the Organization 19. Analysis of Data Examples of results recorded by the Organization Organizational Results Customer satisfaction Statutory & regulatory compliance Quality system metrics Inspection and test Supplier performance Organizational Objectives Customer requirements Statutory & regulatory requirements Defect rate and customer returns QMS controls Purchasing 20. Effectiveness of the QMS Organizational Objectives Organizational Results The gap measures the lack of effectiveness of the quality management system. The narrower the gap, the more effective the QMS. Things are looking good! 0 0 100 100 21. Effectiveness of the QMS Organizational Objectives Organizational Results Management should get a wake up warning! The gap measures the lack of effectiveness of the quality management system. 0 0 100 100 22. Effectiveness of the QMS Organizational Objectives Organizational Results The Organization is in trouble! The gap measures the lack of effectiveness of the quality management system. 0 0 100 100 23. Improvement in the QMS Organizational Objectives Organizational Results Improvement can also be measured % 1007550250 Improvement in the QMS 24. Improvement in the QMS Organizational Objectives Organizational Results Customer Focus Corrective Action Procurement Improvement Initiatives What actions are taken when gaps are identified? In this example, the organization identified three key areas for improvement. These actions may cause the organization to revise its objectives. 25. Management Review The improvement processes are also evaluated during management review meetings and appropriate action taken. Which may cause the organization to again revise its objectives. Organizational Objectives Organizational Results 0 0 100 100 Customer Focus Corrective Action Procurement Improvement Initiatives Management Review 26. ISO 9004:2000 & The consistent pair ISO 9001 and ISO 9004 form a consistent pair of standards on quality management. ISO 9001 aims to give quality assurance of product and to enhance customer satisfaction, while ISO 9004 uses a broader perspective of quality management to give guidance for performance improvement. ISO 9001 ISO 9004 27. ISO 9004:2000 & The consistent pair Top management should therefore define methods for measurement of the organization's performance in order to determine whether planned objectives have been achieved.
- measurement of process performance throughout theorganization,
- external measurement, such as benchmarking andthird-party evaluation,
28. ISO 9004:2000
- assessment of the perceptions of customers and otherinterested parties of performance of products provided,
- measurement of other success factors identified bymanagement.
- assessment of the satisfaction of customers, people in theorganization and other interested parties,
29. The Effectiveness of the Organization After analyzing the data and reaching a conclusion on the effectiveness of theQMS , the same process is then used to determine if the quality management system has had an effect on the Organizationsbusiness and/or financial results . 30. Effectiveness of the Organization QMS Results Organizational Business Results The gap now measures the lack of business effectiveness of the organization. The narrower the gap, the more effective the organization. 0 0 100 100 31. Business Improvement in the Organization Organizational Objectives Organizational Results And again, the improvements in the organization can be measured and managed. % 1007550250 Improvement in the organization 32. Analysis of Data Improvement Initiatives Management Review The Sydney Model is cyclical and can be used as often as required by an Organization. Continual Improvement Organizational Obj