Chapter 10:
Quality Management
Systems
Jennifer Sadorus
Heather Heller
What’s ISO?
International Organization for
Standardization
 Provide international standards for
products and services

 Facilitates
services
worldwide exchange of goods and
What We Need to Know
1.
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3.
4.
5.
6.
7.
Basics of ISO
Benefits
Requirements
Documentation Procedures
How to Implement ISO
How to do an Internal Audit
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

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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
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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
INFORMATION ONLY
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Scope
Normative Reference
Terms and Definitions
Requirements
Activity
The Other 5 Requirements
5 - MANAGEMENT
RESPONSIBILITY
6 - RESOURCE
MANAGEMENT
4 - QMS COUNTINUAL
IMPROVEMENT
8 - MEASUREMENT,
ANALYSIS
AND IMPROVEMENT
CUSTOMER
SATISFACTION
INPUT
REQUIREMENTS
7 - PRODUCT
REALIZATION
OUTPUT
PRODUCT
MODEL OF A PROCESS-BASED QUALITY MANAGEMENT SYSTEM
4 – Quality Management System
(QMS)
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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
OR PRACTICES
RECORDS OR PROOF
BREAK!
Implementation
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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
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Auditor
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Techniques
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Trained in auditing principles and procedures
Objective, honest and impartial
Good communicator, listener and observer
Examination of documents
Observation of activities
Interviews
Procedure
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Pre-Audit Meeting
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
Audit
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Timetables, what is being audited, review requirements
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.
2.
3.
4.
5.
6.
7.
Basics of ISO
Benefits
Requirements
Documentation Procedures
How to Implement ISO
How to do an Internal Audit
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