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Premium member Presentation Transcript : ISO 9001 Auditing Practices Group Guidance on: Aligning the QMS with the achievement of organizational and business successBusiness, Quality and Excellence Models and Tools: © ISO & IAF 2009 – All rights reserved 2 Business, Quality and Excellence Models and Tools There are many links between business, quality and excellence and many models and tools from which an organization can choose. The following are some examples: The Balanced Scorecard Business Excellence models ISO 9001:2008 Quality Management Systems Six Sigma Deming and Juran modelsBalanced Scorecard: © ISO & IAF 2009 – All rights reserved 3 Balanced Scorecard A system that translates an organization’s mission and strategy into a comprehensive set of performance measures that provides the framework for a strategic measurement and management system. Kaplan and NortonThe Balanced Scorecard Model: © ISO & IAF 2009 – All rights reserved 4 The Balanced Scorecard ModelBusiness Excellence Models: © ISO & IAF 2009 – All rights reserved 5 Business Excellence Models Many types of business excellence models exist throughout the world: Deming Award EFQM Model and Award National Business Excellence Models and Awards Malcolm Baldrige AwardTypical National Excellence Model: © ISO & IAF 2009 – All rights reserved 6 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 ManagementISO 9001:2008: © ISO & IAF 2009 – All rights reserved 7 ISO 9001:2008 Quality Management SystemsThe ISO Model: © ISO & IAF 2009 – All rights reserved 8 The ISO Model Continual Improvement of the Quality Management System Resource Management Measurement, Analysis, Improvement CUSTOMER Requirements Management Responsibility Product Realization CUSTOMER Satisfaction Product Inputs OutputsComparison: © ISO & IAF 2009 – All rights reserved 9 Comparison Balanced Scorecard ISO 9001:2008 Vision and Strategy Quality Policy Quality objectives Customer Customer focus Customer related processes Customer satisfaction Internal Business Processes QMS General requirements Product Realization Organization’s Business Results Not specifically addressed in the standard.Comparison: © ISO & IAF 2009 – All rights reserved 10 Comparison Excellence Model ISO 9001:2008 Policy and Strategy Quality Policy Quality objectives Customer & Market Focus Customer Satisfaction Customer focus Customer related processes Customer satisfaction People Management Human Resources Business Processes QMS General requirements Product Realization Organization’s business results Not specifically addressed in the standard.ISO 9001:2008: © ISO & IAF 2009 – All rights reserved 11 ISO 9001:2008 ISO 9001:2008 specifies requirements for a quality management system where an organization: Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and 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 statutory and regulatory requirements.The Sydney Model: © ISO & IAF 2009 – All rights reserved 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 that effectiveness and improvement can 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 objectives and more importantly their related corporate organizational, business and/or financial objectives.Improvement and Effectiveness: © ISO & IAF 2009 – All rights reserved 13 Improvement and Effectiveness There are many examples and requirements in ISO 9001:2008 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.Effectiveness: © ISO & IAF 2009 – All rights reserved 14 Effectiveness Extent to which planned activities are realized and planned results achieved. ISO 9000:2005 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: 2008 0.3Improvement and Effectiveness: © ISO & IAF 2009 – All rights reserved 15 Improvement and Effectiveness Top Management shall ensure that the quality policy includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system. ISO 9001: 2008 5.3 The organization shall continually improve the effectiveness of 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: 2008 8.5.1The Concept of the Sydney Model: © ISO & IAF 2009 – All rights reserved 16 The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. ISO 9001: 2008 8.4 The Concept of the Sydney Model And to ensure that the organization’s quality and/or business objectives have been met!The Sydney Model: © ISO & IAF 2009 – All rights reserved 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.Analysis of Data: © ISO & IAF 2009 – All rights reserved 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 OrganizationAnalysis of Data: © ISO & IAF 2009 – All rights reserved 19 Examples of results recorded by the Organization Analysis of Data 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 PurchasingEffectiveness of the QMS: © ISO & IAF 2009 – All rights reserved 20 Effectiveness of the QMS Organizational Objectives Organizational Results 0 0 100 100 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!Effectiveness of the QMS: © ISO & IAF 2009 – All rights reserved 21 Effectiveness of the QMS Organizational Objectives Organizational Results 0 0 100 100 Management should get a wake up warning! The gap measures the lack of effectiveness of the quality management system.Effectiveness of the QMS: © ISO & IAF 2009 – All rights reserved 22 Effectiveness of the QMS Organizational Objectives Organizational Results 0 0 100 100 The Organization is in trouble! The gap measures the lack of effectiveness of the quality management system.Improvement in the QMS: © ISO & IAF 2009 – All rights reserved 23 Improvement in the QMS Organizational Objectives Organizational Results % 100 75 50 25 0 Improvement can also be measured Improvement in the QMSImprovement in the QMS: © ISO & IAF 2009 – All rights reserved 24 Improvement in the QMS Organizational Objectives Organizational Results Customer Focus Corrective Action Procurement Improvement Initiatives These actions may cause the organization to revise its objectives. What actions are taken when gaps are identified? In this example, the organization identified three key areas for improvement.Management Review: © ISO & IAF 2009 – All rights reserved 25 Management Review Organizational Objectives Organizational Results 0 0 100 100 Customer Focus Corrective Action Procurement Improvement Initiatives 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.The Effectiveness of the Organization: © ISO & IAF 2009 – All rights reserved 26 The Effectiveness of the Organization After analyzing the data and reaching a conclusion on the effectiveness of the QMS , the same process is then used to determine if the quality management system has had an effect on the Organization’s business and/or financial results .Effectiveness of the Organization: © ISO & IAF 2009 – All rights reserved 27 Effectiveness of the Organization QMS Results Organizational Business Results 0 0 100 100 The gap now measures the lack of business effectiveness of the organization. The narrower the gap, the more effective the organization.Business Improvement in the Organization: © ISO & IAF 2009 – All rights reserved 28 Business Improvement in the Organization Organizational Objectives Organizational Results % 100 75 50 25 0 And again, the improvements in the organization can be measured and managed. Improvement in the organizationAnalysis of Data: © ISO & IAF 2009 – All rights reserved 29 Analysis of Data Organizational Objectives Organizational Results 0 0 100 100 Improvement Initiatives Management Review QMS Results Business Results The Sydney Model is cyclical and can be used as often as required by an Organization. Continual ImprovementConclusion: © ISO & IAF 2009 – All rights reserved 30 Conclusion The effectiveness of the quality management system in meeting both quality and/or business objectives is likely to be the key attribute that ensures the on-going support and resource allocation to maintain the ISO 9001:2008 quality management system within the corporate environment. The overall result of using the Sydney model is an enhanced pro-active approach to meet QMS objectives and more importantly their related corporate business and/or financial objectives.PowerPoint Presentation: © ISO & IAF 2009 – All rights reserved 31 For further information on the ISO 9001 Auditing Practices Group, please refer to the paper: Introduction to the ISO 9001 Auditing Practices Group Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsigroup.com . The other ISO 9001 Auditing Practices Group papers and presentations may be downloaded from the web sites: www.iaf.nu www.iso.org/tc176/ISO9001AuditingPracticesGroup Disclaimer This paper has not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176, or the International Accreditation Forum (IAF). The information contained within it is available for educational and communication purposes. The ISO 9001 Auditing Practices Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information. You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
iso aSGuest125655 Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 22 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: February 02, 2012 This Presentation is Public Favorites: 0 Presentation Description No description available. Comments Posting comment... Premium member Presentation Transcript : ISO 9001 Auditing Practices Group Guidance on: Aligning the QMS with the achievement of organizational and business successBusiness, Quality and Excellence Models and Tools: © ISO & IAF 2009 – All rights reserved 2 Business, Quality and Excellence Models and Tools There are many links between business, quality and excellence and many models and tools from which an organization can choose. The following are some examples: The Balanced Scorecard Business Excellence models ISO 9001:2008 Quality Management Systems Six Sigma Deming and Juran modelsBalanced Scorecard: © ISO & IAF 2009 – All rights reserved 3 Balanced Scorecard A system that translates an organization’s mission and strategy into a comprehensive set of performance measures that provides the framework for a strategic measurement and management system. Kaplan and NortonThe Balanced Scorecard Model: © ISO & IAF 2009 – All rights reserved 4 The Balanced Scorecard ModelBusiness Excellence Models: © ISO & IAF 2009 – All rights reserved 5 Business Excellence Models Many types of business excellence models exist throughout the world: Deming Award EFQM Model and Award National Business Excellence Models and Awards Malcolm Baldrige AwardTypical National Excellence Model: © ISO & IAF 2009 – All rights reserved 6 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 ManagementISO 9001:2008: © ISO & IAF 2009 – All rights reserved 7 ISO 9001:2008 Quality Management SystemsThe ISO Model: © ISO & IAF 2009 – All rights reserved 8 The ISO Model Continual Improvement of the Quality Management System Resource Management Measurement, Analysis, Improvement CUSTOMER Requirements Management Responsibility Product Realization CUSTOMER Satisfaction Product Inputs OutputsComparison: © ISO & IAF 2009 – All rights reserved 9 Comparison Balanced Scorecard ISO 9001:2008 Vision and Strategy Quality Policy Quality objectives Customer Customer focus Customer related processes Customer satisfaction Internal Business Processes QMS General requirements Product Realization Organization’s Business Results Not specifically addressed in the standard.Comparison: © ISO & IAF 2009 – All rights reserved 10 Comparison Excellence Model ISO 9001:2008 Policy and Strategy Quality Policy Quality objectives Customer & Market Focus Customer Satisfaction Customer focus Customer related processes Customer satisfaction People Management Human Resources Business Processes QMS General requirements Product Realization Organization’s business results Not specifically addressed in the standard.ISO 9001:2008: © ISO & IAF 2009 – All rights reserved 11 ISO 9001:2008 ISO 9001:2008 specifies requirements for a quality management system where an organization: Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and 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 statutory and regulatory requirements.The Sydney Model: © ISO & IAF 2009 – All rights reserved 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 that effectiveness and improvement can 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 objectives and more importantly their related corporate organizational, business and/or financial objectives.Improvement and Effectiveness: © ISO & IAF 2009 – All rights reserved 13 Improvement and Effectiveness There are many examples and requirements in ISO 9001:2008 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.Effectiveness: © ISO & IAF 2009 – All rights reserved 14 Effectiveness Extent to which planned activities are realized and planned results achieved. ISO 9000:2005 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: 2008 0.3Improvement and Effectiveness: © ISO & IAF 2009 – All rights reserved 15 Improvement and Effectiveness Top Management shall ensure that the quality policy includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system. ISO 9001: 2008 5.3 The organization shall continually improve the effectiveness of 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: 2008 8.5.1The Concept of the Sydney Model: © ISO & IAF 2009 – All rights reserved 16 The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. ISO 9001: 2008 8.4 The Concept of the Sydney Model And to ensure that the organization’s quality and/or business objectives have been met!The Sydney Model: © ISO & IAF 2009 – All rights reserved 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.Analysis of Data: © ISO & IAF 2009 – All rights reserved 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 OrganizationAnalysis of Data: © ISO & IAF 2009 – All rights reserved 19 Examples of results recorded by the Organization Analysis of Data 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 PurchasingEffectiveness of the QMS: © ISO & IAF 2009 – All rights reserved 20 Effectiveness of the QMS Organizational Objectives Organizational Results 0 0 100 100 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!Effectiveness of the QMS: © ISO & IAF 2009 – All rights reserved 21 Effectiveness of the QMS Organizational Objectives Organizational Results 0 0 100 100 Management should get a wake up warning! The gap measures the lack of effectiveness of the quality management system.Effectiveness of the QMS: © ISO & IAF 2009 – All rights reserved 22 Effectiveness of the QMS Organizational Objectives Organizational Results 0 0 100 100 The Organization is in trouble! The gap measures the lack of effectiveness of the quality management system.Improvement in the QMS: © ISO & IAF 2009 – All rights reserved 23 Improvement in the QMS Organizational Objectives Organizational Results % 100 75 50 25 0 Improvement can also be measured Improvement in the QMSImprovement in the QMS: © ISO & IAF 2009 – All rights reserved 24 Improvement in the QMS Organizational Objectives Organizational Results Customer Focus Corrective Action Procurement Improvement Initiatives These actions may cause the organization to revise its objectives. What actions are taken when gaps are identified? In this example, the organization identified three key areas for improvement.Management Review: © ISO & IAF 2009 – All rights reserved 25 Management Review Organizational Objectives Organizational Results 0 0 100 100 Customer Focus Corrective Action Procurement Improvement Initiatives 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.The Effectiveness of the Organization: © ISO & IAF 2009 – All rights reserved 26 The Effectiveness of the Organization After analyzing the data and reaching a conclusion on the effectiveness of the QMS , the same process is then used to determine if the quality management system has had an effect on the Organization’s business and/or financial results .Effectiveness of the Organization: © ISO & IAF 2009 – All rights reserved 27 Effectiveness of the Organization QMS Results Organizational Business Results 0 0 100 100 The gap now measures the lack of business effectiveness of the organization. The narrower the gap, the more effective the organization.Business Improvement in the Organization: © ISO & IAF 2009 – All rights reserved 28 Business Improvement in the Organization Organizational Objectives Organizational Results % 100 75 50 25 0 And again, the improvements in the organization can be measured and managed. Improvement in the organizationAnalysis of Data: © ISO & IAF 2009 – All rights reserved 29 Analysis of Data Organizational Objectives Organizational Results 0 0 100 100 Improvement Initiatives Management Review QMS Results Business Results The Sydney Model is cyclical and can be used as often as required by an Organization. Continual ImprovementConclusion: © ISO & IAF 2009 – All rights reserved 30 Conclusion The effectiveness of the quality management system in meeting both quality and/or business objectives is likely to be the key attribute that ensures the on-going support and resource allocation to maintain the ISO 9001:2008 quality management system within the corporate environment. The overall result of using the Sydney model is an enhanced pro-active approach to meet QMS objectives and more importantly their related corporate business and/or financial objectives.PowerPoint Presentation: © ISO & IAF 2009 – All rights reserved 31 For further information on the ISO 9001 Auditing Practices Group, please refer to the paper: Introduction to the ISO 9001 Auditing Practices Group Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsigroup.com . The other ISO 9001 Auditing Practices Group papers and presentations may be downloaded from the web sites: www.iaf.nu www.iso.org/tc176/ISO9001AuditingPracticesGroup Disclaimer This paper has not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176, or the International Accreditation Forum (IAF). The information contained within it is available for educational and communication purposes. The ISO 9001 Auditing Practices Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.