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Chapter 10: Quality Management Systems

Chapter 10: Quality Management Systems. Jennifer Sadorus Heather Heller. What’s ISO?. International Organization for Standardization Provide international standards for products and services Facilitates worldwide exchange of goods and services. What We Need to Know. Basics of ISO Benefits

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Chapter 10: Quality Management Systems

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  1. Chapter 10:Quality Management Systems Jennifer Sadorus Heather Heller

  2. What’s ISO? • International Organization for Standardization • Provide international standards for products and services • Facilitates worldwide exchange of goods and services

  3. What We Need to Know • Basics of ISO • Benefits • Requirements • Documentation Procedures • How to Implement ISO • How to do an Internal Audit • How to Register

  4. Getting to Know ISO • Found in 1946 – Geneva, Switzerland • 90 Member Countries • ANSI – USA Representative • ISO Technical Committee (TC) 176 • Developed the International Standards for Quality in 1987 • ISO 9000, 9001 & 9004

  5. Benefits of ISO Registration • Global competitiveness • Maintain or increase market shares • Secondary benefits for the supplier • Decrease in scrap, rework and nonconformities at final inspection • Increase in product reliability • Improved time to market, on-time delivery and throughput • Decrease in the cost of poor quality measured but external forces

  6. Requirements • Scope • Normative References • Terms and Definitions • Quality Management System (QMS) • Management Responsibilities • Resource Management • Product or Service Realization • Measurement, Analysis and Improvement

  7. Scope Normative Reference Terms and Definitions INFORMATION ONLY 1st Three Requirements

  8. Requirements Activity

  9. The Other 5 Requirements MODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM

  10. 4 – Quality Management System (QMS) • Identify the process • Determine the process sequence • Set methods for effective operation and control of process • Ensure availability of resources and information for the process • Monitor, measure and analyze the process • Continually improve the process • Document • Quality policies, manuals, procedures… • Set controls for documents and maintain records of conformance

  11. 5 – Management Responsibility • Commitment • Customer Focus • Quality Policy • Planning – Quality Objectives and QMS • Define Responsibilities, Authorities and Communication • Review

  12. 6 – Resource Management • Provision of Resources • Human Resources • Infrastructure • Work Environment

  13. 7 – Product Realization • Plan • Customer Related • Design and Develop • Purchasing • Production and Service Provision • Control of Monitoring and Measuring Devices

  14. 8 – Measure, Analyze and Improve • Monitor and Measure • Control of Nonconforming Product • Analysis of Data • Improvement

  15. Documentation Activity Form 4 Groups of 3

  16. Documentation

  17. BREAK!

  18. Implementation • Top Management Commitment • Appoint the Management Representative • Awareness • Appoint an Implementation Team • Training • Time Schedule • Select Element Owners • Review the Present System • Write the Documentation • Install the New System • Internal Audit • Management Review • Pre-Assessment • Registration

  19. Implementation Activity

  20. Internal Audits • Objectives • Does actual performance conform to documented QMS? • Initiate corrective action to deficiencies • Follow up on noncompliance items from previous audits • Provide continued improvement through feedback • Encourage possible improvements by thinking about the system

  21. How To Do An Internal Audit • Auditor • Trained in auditing principles and procedures • Objective, honest and impartial • Good communicator, listener and observer • Techniques • Examination of documents • Observation of activities • Interviews • Procedure • Pre-Audit Meeting • Timetables, what is being audited, review requirements • Audit • Determine how well the system has been implemented and maintained • Closing Meeting • Present a summary including nonconformities, corrective action and decide on follow-up

  22. Audit Activity Form 2 Groups

  23. Two Ways to be ISO Certified • 2-Party System • Customer audits the supplier’s quality system • 3-Party System • Registrar audits and certifies a supplier’s quality system

  24. Registration • Select a Registrar • Qualifications and experience • Certificate recognition • Registration process • Time and cost constraints • Auditor qualifications

  25. Registration Process • Application for Registration • Document Review • Pre-Assessment • Assessment • Registration • Follow-up Surveillance

  26. What We Now Know • Basics of ISO • Benefits • Requirements • Documentation Procedures • How to Implement ISO • How to do an Internal Audit • How to Register

  27. Resources

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