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 1. Basics of ISO 2. Benefits 3. Requirements 4. Documentation Procedures 5. How to Implement ISO 6. How to do an Internal Audit 7. 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. 1 st Three Requirements Scope Normative Reference Terms and Definitions INFORMATION ONLY

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 1. Basics of ISO 2. Benefits 3. Requirements 4. Documentation Procedures 5. How to Implement ISO 6. How to do an Internal Audit 7. How to Register

27. Resources