TQM

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

8. Requirements
Activity

9. The Other 5 Requirements
5 - MANAGEMENT
4 - QMS COUNTINUAL
7 - PRODUCT
6 - RESOURCE
8 - MEASUREMENT,
ANALYSIS
INPUT OUTPUT
CUSTOMER
RESPONSIBILITY
IMPROVEMENT
REALIZATION
MANAGEMENT AND IMPROVEMENT
REQUIREMENTS PRODUCT
SATISFACTION
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
POLICY
PROCEDURE
WORK INSTRUCTIONS
RECORDS OR PROOF
OR PRACTICES

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
ISO Homepage
http://www.iso.org/iso/home.htm
ISO 9001 Auditing Practices Group:
Non Conformity handout
www.iso.org/tc176/iso9001auditingpracticesgroup
Common Sense Consulting:
Process Assessment and Audit Worksheet
http://www.schnauber.com/free-stuff.html
National Food Service Management Institute:
United States Department of Agriculture
http://sop.nfsmi.org/HACCPBasedSOPs.php