Chapter 10:

Quality Management
Systems
Jennifer Sadorus
Heather Heller

Whats 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.
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

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

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)

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

Techniques

Trained in auditing principles and procedures

Objective, honest and impartial
Good communicator, listener and observer
Examination of documents
Observation of activities
Interviews

Procedure

Pre-Audit Meeting

Audit

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 suppliers quality system

3-Party System
Registrar

audits and certifies a suppliers

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