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THE ISO 9000 1994
QUALITY STANDARD
ISO 9000
What are ISO 9000 Standards?
Generic standards that provide guidance for:
Implementation of effective quality systems
Assurance for products and services
Improvement of existing quality systems
International Organization for Standardization
(IOS), Geneva, Switzerland, 1987
Related Standards: BSI, ANSI, AQAP (NATO)
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What is the Role of the
ISO 9000 Standards?
These standards set the basic rules for quality
systems - from concept to implementation -
whatever the product or service
When implemented they provide a set of rules
for manufacturing a product or delivering a
service
Ensure that a provider has the capability to
produce the required goods or services using
procedures and processes that are repeatable
and reliable.
ISO 9000 Standards
Standards based on 8 quality
management principles
Customer focused organization
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationship
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ISO 9000 Series
ISO 9001
A comprehensive standard for quality
systems
Assessment of ability to meet customer
and regulatory requirements
Addresses customer satisfaction
This is the ISO standard for which third-
party certification can be obtained
ISO 9000 Quality Manuals
Level I
Quality
Policy Manual
Level II
Quality Procedures Manual
Level III
Quality Records and Forms
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Cultural Shift from ISO to TQM
•Leadership
•People
•Results
Plan Do
Act Check
Quality Cultural
Tools
ISO Gap TQM
ISO 9000 2000 CHANGES
The standard is now divided into:
Clause 4.0 - Quality Management
System Requirements
Clause 5.0 - Management Responsibility
Clause 6.0 - Resource Management
Clause 7.0 - Product Realization
Clause 8.0 - Measurement, analysis and
improvement
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Structure of the ISO 9000 – 2000 Standard
4 Quality 5 Management 6 Resource 7 Product 8
Management Responsibility Management Realization Measurement
System Analysis &
Requirements Improvements
Management
General Commitment Provision of Planning General
Requirements Resources
Customer Focus Customer
Documentation Human Monitoring &
Related Measurements
Requirements Resources Processes
Quality Policy
Infrastructure Control of NCP’s
Design &
Development
Planning
Analysis of Data
Work
Environment Purchasing
Responsibility,
Improvements
Authority &
Communication Production &
Service
Provision
Management
Reviews
New ISO 9000:2000
Management
Responsibility
General Measurement, General
Resource
Analysis &
Requirements Management QMS Improvements
Requirements
Product
Realization
Continual Improvements cycle
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ISO 9001:2000 – Process Model
Continual Improvement of
the Quality Management System
[Link]
Responsibility
CUSTOMER’S
CUSTOMER
ISO 9000:2000 Quality
Satisfaction
6. Resource 8. Measurement
Analysis and
Management Improvements
Management System
7. Product
Requirements Product Consumption
Realization
Role of Management
Establish Quality System
Philosophy and Procedures
Commit Resources
Time
People
Money
Proactive involvement
Implement and maintain quality systems
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Role of Employee
Establish work instructions
Write work instructions
Follow work instructions
Record results
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In other words….
Say what you do!
Do what you say!
Prove it!
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