A Brief Introduction to the ISO 9000:2000 Series Standards

Prepared by C. S. Tritt, Ph.D.

October 10, 2001

The ISO 9000:2000 series of standards consists of the following individual quality management system (QMS) standards:

ISO 9000 (QMS – Fundamentals and Vocabulary) describes the fundamentals and terminology of quality management systems.

ISO 9001 (QMS – Requirements) specifies requirements for a quality management system.

ISO 9004 (QMS – Guidelines for Performance Improvements) provides guidelines that consider the effectiveness and efficiency of quality management systems.

ISO 19011 provides guidance on auditing quality and environmental management systems.

Quality Management Principles from ISO 9000

a) Customer Focus

b) Leadership

c) Involvement of People

d) Process Approach to Activities

e) System Approach to Management

f) Continual Improvement

g) Factual (Objective) Approach to Decision Making

h) Mutually Beneficial Relationships

ISO 9000 Sections

1. Scope

2. Fundamentals of Quality Management Systems

3. Terms and Definitions

Throughout ISO 9001:2000 and ISO 9004:2000, wherever the term “product” occurs, it can also mean service.

ISO 9001 specifies the requirements for a quality management system that can be used for internal application by organizations, or for certification (formerly registration), or for contractual purposes. It focuses on the effectiveness of the quality management system in meeting customer requirements.

ISO 9001 Outline

1. Scope

1.1 General

1.2 Application

2. Normative Reference

3. Terms and Definitions

4. Quality Management System

4.1 General Requirements

4.2 Documentation Requirements

4.3 Management Responsibility

4.4 Management Commitment

4.5 Customer Focus

4.6 Quality Policy

4.7 Planning

4.8 Responsibility, Authority and Communication

4.9 Management Review

5. Resource Management

5.1 Provision of Resources

5.2 Human Resources

5.3 Infrastructure

5.4 Work Environment

6. Product Realization

6.1 Planning of Product Realization

6.2 Customer-Related Processes

6.3 Design and Development

6.4 Purchasing

6.5 Production and Service Prevision

6.6 Control of Monitoring and Measuring Devices

7. Measurement, Analysis and Improvement

7.1 General

7.2 Monitoring and Measurement

7.3 Control of Nonconforming Product

7.4 Analysis of Data

7.5 Improvement

Annexes (Appendices)

A. Correspondence between ISO 9001:2000 and ISO 14001:1996 (an environmental management standard)

B. Correspondence between ISO 9001:2000 and ISO 9001:1994

The ISO 9001:2000 Standard is 23 pages long (including the annexes).

Organizations may request exemption from Section 7 requirements that do not apply to their operations.

ISO 9004 gives guidance on a wider range of objectives for quality management systems than does ISO 9001. Its objectives include continual improvement of an organization’s overall performance, efficiency and effectiveness. ISO 9004 is recommended as a guide for organizations wishing to move beyond the basic requirements of ISO 9001. It is not intended for certification or contractual purposes.

ISO 9004 Outline

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Quality Management System

4.1 Managing Systems and Processes

4.2 Documentation

4.3 Use of Quality Management Principles

5. Management Responsibility

5.1 General Guidance

5.2 Needs and Expectations of Interested Parties

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, Authority and Communication

5.6 Management Review

6. Resource Management

6.1 General Guidance

6.2 People

6.3 Infrastructure

6.4 Work Environment

6.5 Information

6.6 Suppliers and Partnerships

6.7 Natural Resources

6.8 Financial Resources

7. Product Realization

7.1 General Guidance

7.2 Processes Related to Interested Parties

7.3 Design and Development

7.4 Purchasing

7.5 Production and Service Operations

7.6 Control of Measuring and Monitoring Devices

8. Measurement, Analysis and Improvement

8.1 General Guidance

8.2 Measuring and Monitoring

8.3 Control of Nonconformity

8.4 Analysis of Data

8.5 Improvement

Annexes

A. Guidelines for Self-Assessment

B. Process for Continual Improvement

The ISO 9004:2000 Standard is 57 pages long (including the annexes).