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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
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
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
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
Requirements
 Scope
 Normative References
 Terms and Definitions
 Quality Management System (QMS)
 Management Responsibilities
 Resource Management
 Product or Service Realization
 Measurement, Analysis and Improvement
1st Three Requirements
 Scope
 Normative Reference
 Terms and Definitions
INFORMATION ONLY
Requirements
Activity
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
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
5 – Management Responsibility
 Commitment
 Customer Focus
 Quality Policy
 Planning – Quality Objectives and QMS
 Define Responsibilities, Authorities and
Communication
 Review
6 – Resource Management
 Provision of Resources
 Human Resources
 Infrastructure
 Work Environment
7 – Product Realization
 Plan
 Customer Related
 Design and Develop
 Purchasing
 Production and Service Provision
 Control of Monitoring and Measuring
Devices
8 – Measure, Analyze and Improve
 Monitor and Measure
 Control of Nonconforming Product
 Analysis of Data
 Improvement
Documentation
Activity
Form 4 Groups of 3
Documentation
POLICY
PROCEDURE
WORK INSTRUCTIONS
RECORDS OR PROOF
OR PRACTICES
BREAK!
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
Implementation
Activity
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
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
Audit Activity
Form 2 Groups
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
Registration
 Select a Registrar
Qualifications and experience
Certificate recognition
Registration process
Time and cost constraints
Auditor qualifications
Registration Process
 Application for Registration
 Document Review
 Pre-Assessment
 Assessment
 Registration
 Follow-up Surveillance
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
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

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vdocuments.net_chapter-10-quality-management-systems.ppt

  • 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
  • 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
  • 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
  • 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
  • 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