WHY DOES THE STANDARD SEEM SO VAGUE?

The standard is intentionally vague so it can accommodate just about any business operation. It has been devised so that you can meet its basic requirements by operating your business your way. ISO 9000 defines basic principles for a sound business operation, and you must interpret it according to your business. You are the expert, and only you can define how you must operate. ISO 9000 requires that you operate in the manner that you say you do (say what you do and do what you say) while meeting certain basic requirements.

WHAT ARE THE DIFFERENCES BETWEEN ISO 9001, ISO 9002, AND ISO 9003?

ISO 9001 is the most comprehensive in scope, confirming process conformance from the initial development of a product through production, test, installation, and servicing. ISO 9002 covers only the procurement, production, installation, and servicing portion of your business. Both standards require the same degree of conformance to their respective scope of activities.

ISO 9003, unlike the previous two, addresses only final inspection and testing and has a significantly lower conformance requirement. This standard is somewhat controversial and many feel that it generally undermines the entire standard especially when a company uses it solely to claim certification.

  ISO 9001 ISO 9002 ISO 9003
4.1 Management Responsibility x x *
4.2 Quality System x x *
4.3 Contract Review x x x
4.4 Design Control x o o
4.5 Document and Data Control x x x
4.6 Purchasing x x o
4.7 Control of Customer Supplied Product x x x
4.8 Product Identification and Traceability x x *
4.9 Process Control x x o
4.10 Inspection and Testing x x *
4.11 Control of Inspection, Measuring, and Test Equipment x x x
4.12 Inspection and Test Status x x x
4.13 Control of Nonconforming Product x x *
4.14 Corrective and Preventive Action x x *
4.15 Handling, Storage, Packaging, Preservation, and Delivery x x x
4.16 Control of Quality Records x x *
4.17 Internal Quality Audits x x *
4.18 Training x x *
4.19 Servising x x o
4.20 Statistical Techniques x x *

x = strict requirement
* = less strict requirement
o = not required

SHOULD WE USE ISO 9001 OR ISO 9002?

The two standards are nearly identical. Choose ISO 9001 if your organization carries out the innovative design of products or services, otherwise, choose ISO 9002. The only difference in the standards' requirements is in section 4.4 "Design Control." This section is required in ISO 9001 and is "not applicable" in ISO 9002. Any description or interpretation of ISO 9001 pertains equally to ISO 9002, ignoring section 4.4.

Here are more details:

Title:
ISO 9001 is named " Quality System - Model for quality assurance in design / development, production, installation and servicing."
ISO 9002 is named " Quality System - Model for quality assurance in production, installation and servicing."

Scope:
ISO 9001 applies in situations when:
a) design is required and the product requirements are stated principally in performance terms, or they need to be established, and
b) confidence in product conformance can be attained by adequate demonstration of a supplier's capabilities in design, development, production, installation and servicing.
ISO 9002 applies in situations when:
a) the specified requirements for product are stated in terms of an established design or specification, and
b) confidence in product conformance can be attained by adequate demonstration of a supplier's capabilities in production, installation and servicing.

DOES ISO 9001 APPLY TO SERVICES INDUSTRIES?

Yes! ISO 9001 applies as much to services industries as it does to manufacturing industries. Although the language of the standard uses the word "product" it defines product (in section 3.1 Note 2) to "include service, hardware, processed materials, software or a combination thereof." The standard also states (in the introduction) that the requirements "are generic and independent of any specific industries or economic sector."

In practice, the manufacturing industries have gotten an earlier start on registration than the services industries. Regardless of what industry segment you are in, deciding whether or not to seek compliance depends on what your customers expect of your organization.

HOW CAN I OBTAIN COPIES OF AN ISO STANDARD?

Greece (ELOT)

Address:
Hellenic Organization for Standarization (ΕΛΟΤ)
313, Acharnon Street
GR-111 45 Athens

Telephone:+ 30 1 228 00 01
Telefax:+ 30 1 228 30 34
Telex:21 96 21 elot gr
Telegram:elotyp-athens
Internet:[email protected]

WHAT PUBLICATIONS DOES INTERNATIONAL ORGANIZATION FOR STANDARIZATION PROVIDE FREE OF CHARGE?

The following publications, available directly from the International Organization for Standardization, may interest you:

ISO brochure: Compatible technology worldwide
An easy-to-read introduction to ISO and the world of international standardization. Answers the most common questions asked by newcomers to the field, press and public.
1994, 20 p., ISBN 92-67-10205-2

List of ISO members
Addresses, telephone and telefax numbers, telex and telegram codes.
Biannual, 8 p., bilingual.

List of technical committees
Numbers and titles of technical committees.
Biannual, 8 p., bilingual

ISONET Leaflet
Leaflet on the ISO Information Network, the worldwide network of national standards information centres.

ISO 9000 Forum Library
A list of publications on quality management, quality assurance standards, and related issues relevant to ISO 9000.
Biannual, 8 p., bilingual.

Publicizing your ISO 9000 registration
A booklet which provides guidelines and examples for companies who wish to promote their ISO 9000 registration.
1993, 20 p., bilingual, ISBN 92-67-01077-8

Table of worldwide equivalence of ISO 9000 series of standards
A poster listing countries which have adopted the ISO 9000 series and giving their national designation of the standards.
1994, A3, bilingual.

Implementing ISO 9000
This poster-type brochure clarifies for businesses how to obtain the maximum benefits from their investment in implementing the ISO 9000 International Standards on quality management and quality assurance.
1994, a folded poster

Vision 2000
A strategy for International Standards' implementation in the quality arena during the 1990s
1992, 16 p.

Conformity assessment -- An introduction
This document is intended as a concise introduction to conformity assessment. Its primary application is for businesses which seek to demonstrate that their product category (hardware, software, processed materials or services) is in conformance with a nominated standard.
1994, 8 p.

At last. A business club that really means business
A leaflet that presents the ISO 9000 Forum in 200 words.
1993.

WHAT IS THE ISO 9000 FORUM?

ISO has established a forum to serve the needs of ISO 9000 users by: providing information (including a newsletter); facilitating international discussions on new developments and issues affecting the application of the ISO 9000 standards; promoting the exchange of experience in such areas as training, promotion and operation of relevant schemes; harmonizing practices in the application and interpretation of the ISO 9000 standards; providing advice to ISO TC 176 or the relevant ISO decision making body.