Back to School Quality 101_A Framework for QM
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The document discusses using a systems approach and ISO 9001 framework for quality management. It defines key terms like quality, quality management system, process, and system. ISO 9001 provides a framework for a quality management system with requirements in eight quality management principles: leadership, planning, support, operations, performance evaluation, improvement, and organizational context. Following a systems approach and using ISO 9001 helps organizations consistently meet customer needs and achieve business goals through an integrated network of processes.
Back to School Quality 101_A Framework for QM
- 1. Back to School Quality 101 ASQRS Quality Conference September 2016 1
- 2. A Framework for Quality Management: Using a system approach Lori Cohen Compass Quality Solutions ASQRS Quality Conference September 2016 2
- 3. Objective Provide an understanding of Quality Management Systems • System approach to Quality Management • ISO 9001as the framework ASQRS Quality Conference September 2016 3
- 4. Quality Definitions ASQRS Quality Conference September 2016 4 Quality: “Subjective term for which each person or sector has its own definition”……. Technical 1. Product or service characteristics that impact its ability to satisfy stated or implied needs 2. Defect-free product or service Juran – “fitness for use” Crosby - “conformance to requirements” Quality Management System (QMS): “A formalized system that documents the structure, responsibilities and procedures required to achieve effective quality management.”
- 5. ASQRS Quality Conference September 2016 5 Processes Resources Organization Structure Documents Quality Management System Coordinated activities to ensure Customer and Organization requirements are met
- 6. What is a process? ASQRS Quality Conference September 2016 6 A set of interrelated or interacting activities which transform inputs into outputs. ProcessInput Activities and tasks Product or Service Output Processes Resources Organization Structure Documents QMS Processes Materials Specification Resources
- 7. ASQRS Quality Conference September 2016 7 • All processes have inputs and outputs • Outputs often are inputs to next step Invoice customer Verify order (Inspect/test) Pack and ship order Customer receives order Purchase materials Produce orderCustomer places order Design Product/Service Process Processes Resources Organization Structure Documents QMS Processes Input Output Input A set of interrelated or interacting activities which transform inputs into outputs.
- 8. A collection of processes working together to achieve a common purpose…. • Processes and interaction managed as a network • Share resources • Consistently operate as a network What is a system? ASQRS Quality Conference September 2016 8 Resources Resources Goal
- 9. ASQRS Quality Conference September 2016 9 Engineering Human Resources Sales Purchasing Operations Design & Development Supplier Management Order Fulfillment Order Generation Customer Service Top Management Customer Satisfaction Organizational goals System approach Support Processes
- 10. The system approach • Focuses collective effort on achieving goals and objectives • Facilitates process improvement • Effectively utilizes resources • Enhances ability to consistently provide a quality product or service • Enhances overall performance of organization Benefits ASQRS Quality Conference September 2016 10
- 11. • Provide a practical model for Quality Management System (QMS) •Assist organizations in establishing and achieving sound quality practices •Provide methods for organizations to achieve and demonstrate quality performance to customers •Industry specific QMS standards •Aerospace •Automotive •Medical Quality System Standards ASQRS Quality Conference September 2016 11
- 12. ISO 9001:2015 Defines requirements for a Quality Management System Provides framework for • System approach • Business Management Quality System Standards ASQRS Quality Conference September 2016 12
- 13. ISO 9001:2015 5 Leadership 6 Planning 9 Evaluation 10 Improvement 8 Operation 7 Support ASQRS Quality Conference September 2016 13 Customer requirements Products and services 4 Context of organization QMS
- 14. ISO 9001:2015 ASQRS Quality Conference September 2016 14 4 Context of organization Defines organization • Mission/Vision • Issues affecting the results • Markets served • Relevant parties – customers, suppliers, employees – their needs and expectations • QMS Processes 5 Leadership 6 Planning 9 Evaluation 10 Improvement 8 Operation 7 Support
- 15. ISO 9001:2015 ASQRS Quality Conference September 2016 15 5 Leadership Defines Top Management’s responsibilities • Leadership - provide direction • Commitment - provide resources • Accountability - responsible for effectiveness/results 6 Planning Plans and actions to • Achieve goals and objectives • Address risk and opportunity 5 Leadership 6 Planning 9 Evaluation I0 Improvement 8 Operation 7 Support Processes for managing the organization
- 16. ISO 9001:2015 ASQRS Quality Conference September 2016 16 7 Support Resources needed for the maintenance and continual improvement • People – competent • Infrastructure/work environment • Monitoring /measurement tools/methods • Organizational knowledge • Documents • Communication 5 Leadership 6 Planning 9 Evaluation 10 Improvement 8 Operation - 7 Support Processes for managing resources
- 17. ISO 9001:2015 ASQRS Quality Conference September 2016 17 8 Operation Processes needed to provide product/service • Customer orders/contracts • Design and development • Purchasing • Production • Delivery • Control of nonconforming 5 Leadership 6 Planning 9 Evaluation 10 Improvement 8 Operation 7 Support Processes for planning, carrying out and controlling operations
- 18. ISO 9001:2015 ASQRS Quality Conference September 2016 18 9 Evaluation Monitor, measure and evaluate performance of QMS • Customer satisfaction • Internal Audits • Management review 10 Improvement Continually improve • Customer satisfaction • Products/services • QMS 5 Leadership 6 Planning 9 Evaluation 10 Improvement 8 Operation 7 Support Processes for monitoring effectiveness and improving QMS
- 19. ISO 9001:2015 5 Leadership 6 Planning 9 Evaluation 10 Improvement 8 Operation 7 Support ASQRS Quality Conference September 2016 19 Customer requirements Products and services 4 Context of organization Customer Satisfaction QMS results QMS
- 20. Summary A system approach to Quality Management is an effective way to meet customer expectations and achieve business goals ISO 9001provides the framework Thank you! ASQRS Quality Conference September 2016 20
- 21. ASQRS Quality Conference September 2016 21 Resources ASQ website http://asq.org/knowledge-center ISO website – ISO TC/176/SC2 Home page http://isotc.iso.org/livelink/livelink/open/tc176 SC2public