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ISO 9000 Overview 110

Quality Training

Class Information

Tooling U classes are offered at the beginner, intermediate, and advanced levels. The typical class consists of 12 to 25 lessons and typically requires at least two hours of instruction time.

Class Name:	ISO 9000 Overview 110
Description:	This class identifies and describes the key components of the ISO 9000:2000 standard.
Prerequisites:	none
Difficulty:	Beginner
Number of Lessons:	20

Class Outline

Objectives
What Is ISO 9000?
The Importance of the Customer
ISO 9000 Background
Advantages of ISO Registration
Types of ISO 9000 Companies
ISO 9000:2000 Contents
ISO 9001:2000 Components
Quality Management System
The Importance of Documentation
Management Responsibility
Resource Management
Product/Service Realization
The Importance of Processes
Measurement, Analysis, and Improvement
ISO Registration Steps
The Audit Process
ISO 9000:1994 vs. 9000:2000
Continual Improvement
Summary

Class Objectives

Define ISO 9000:2000.
Explain the relationship of the customer to quality.
Describe the role of the International Organization for Standardization.
State some advantages of ISO 9000 registration.
Identify industries suitable for ISO 9000 registration.
List the documents contained in ISO 9000:2000.
List the main clauses contained in ISO 9001:2000.
Define the Quality Management System.
Identify the hierarchy of documentation.
Explain the role of management in a quality system.
Define resource management in a quality system.
Define product realization for a quality system.
Explain the relationship of process design to product realization.
Define process analysis and improvement for a quality system.
Describe the steps required to obtain ISO 9000 registration.
Describe the auditing process.
Distinguish between ISO 9000:1994 and ISO 9000:2000.
Define continual improvement.

Class Vocabulary
continual improvement		The belief that an organization must constantly measure the effectiveness of its processes and strive to meet more difficult objectives to satisfy customers.
customer		An organization or individual that receives a product or service from the company. The key goal of ISO 9000 registration is customer satisfaction.
external auditor		An individual outside of the organization that objectively assesses the effectiveness of the organization's quality system. External auditors are required to register with ISO 9000.
input		The state of activities and resources before a process is carried out.
internal auditor		An individual within the organization that audits his or her own company to determine the effectiveness of its quality system. Internal auditors are required by ISO 9000.
International Organization for Standardization		An organization based in Switzerland that develops and publishes standards for its international membership base.
ISO 9000:1994		An older version of the ISO 9000 standard. Organizations were required to transition to the 2000 version of the standard by Dec. 15, 2003.
ISO 9000:2000		The most recent ISO standard that lists requirements for the creation and implementation of an effective Quality Management System. ISO 9000:2000 also refers to the section of the standard containing introductory material.
ISO 9001:2000		The section of the ISO 9000 standard containing the list of requirements. ISO 9001:2000 is the auditable section of the standard.
ISO 9004:2000		The section of the ISO 9000 standard containing guidance and additional recommendations. ISO 9004:2000 is a supplemental section that is not included in the audit.
management review		A periodic review of the Quality Management System performed by upper management to analyze its effectiveness.
output		Activities and resources resulting from a process.
processes		A set of activities that uses resources to transform inputs into outputs. Essentially, a process describes the way things get done.
product		According to ISO, the result of a process. A product is essentially something a company makes or provides for a customer. There are four general categories for products: hardware, software, services, and processed materials.
Quality Management System		The objectives and processes of a company designed to focus the company toward quality and customer satisfaction. The QMS consists of written documents that address the ISO 9000 standard.
quality policy manual		The document containing the overall objectives and direction of the organization. Upper management is responsible for drafting the policy manual.
resource		A supply, product, structure, or skill that is necessary for the operation of the quality system.
services		A type of product that does not have physical substance. A hair cut, a medical exam, and carpet cleaning are all services.
standard operating procedure		A document describing the processes of an organization. It contains a moderate amount of detail.
supplier		An organization that provides a product to another organization. Products are often passed in a chain, from the supplier to the organization to the customer.
surveillance audit		A periodic audit performed by an external auditor to ensure that an organization still meets ISO 9000 requirements. Surveillance audits are required by ISO 9000.
work instruction		A document describing specific activities and tasks within the organization. It contains the greatest amount of detail.