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
INFORMATION ONLY

 Scope
 Normative Reference
 Terms and Definitions
Requirements
Activity
The Other 5 Requirements

5 - MANAGEMENT
RESPONSIBILITY

8 - MEASUREMENT,
6 - RESOURCE 4 - QMS COUNTINUAL ANALYSIS
MANAGEMENT IMPROVEMENT AND IMPROVEMENT

CUSTOMER
SATISFACTION

INPUT 7 - PRODUCT OUTPUT

REQUIREMENTS REALIZATION PRODUCT

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
OR PRACTICES

RECORDS OR PROOF
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