Information Documents are Available for ISO 9001:2000

You now have free electronic access to supplementary materials for ISO 9001:2000. Due to the dynamic nature of this information, these documents are subject to updating on a continuous basis. Descriptions and links to the documents are provided below:

Frequently Asked Questions (FAQ’s):
This is a comprehensive database of frequently asked questions and answers, designed to provide a concise and informative mechanism to assist users in understanding all aspects of the Year 2000 revisions. The questions address product introduction and transition issues. They are updated on a regular basis as a result of feedback and additional questions from users.

Brochure on Quality Management Principles:
These eight Quality Management Principles are the foundation for the revision of the ISO 9000 standards. A draft brochure that details the Quality Management Principles is available by linking to this address.

Transition Planning Guidance:
This document has been developed to assist user groups in understanding the issues that need to be considered during the transition from the 1994 editions of ISO 9001, ISO 9002, and ISO 9003 to ISO 9001:2000. Included in the Transition Planning Guidance are the following topics:

  • Explanation of the Transition Period
  • Transition Guidelines for User Groups
  • Authenticity of Information Regarding ISO 9001:2000
  • ISO 9001:1994 / ISO 9001:2000 Comparison of Requirements

Product Introduction Package:
A Product Introduction Package has been developed to assist users in applying ISO 9001:2000. It consists of a number of modules, each of which is a guidance document on a specific topic:

  • Guidance on ISO 9001:2000 clause 1.2 “Application”
  • Guidance on the Documentation Requirements of ISO 9001:2000
  • Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000

Further modules for the Product Introduction Package may be developed following analysis of feedback from users. Currently under development is a module giving Guidance on the use of the “Process Approach”. Brief descriptions of the current modules are given below:

Guidance on ISO 9001:2000 Clause 1.2 “Application”
One objective of the Year 2000 revisions is to simplify the structure and reduce the number of standards within the family. This has been achieved by replacing ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994 with a single quality management system standard for requirements, ISO 9001:2000.

ISO 9001:2000 is intended to be generic, and applicable to all organizations, regardless of type, size, and product category. It is recognized, however, that not all these requirements will necessarily be relevant to all organizations. Under certain circumstances, an organization may be able to justify excluding some specific ISO 9001:2000 requirements from its quality management system. ISO 9001:2000 makes allowance for such organizations, through clause 1.2, Application.

This guidance document has been developed to provide users with information regarding the intent of clause 1.2 (Application) of ISO 9001:2000, including some typical examples of its use in practical situations.

Guidance on the Documentation Requirements of ISO 9001:2000
Two of the most important objectives in the revision of the ISO 9000 series of standards have been:

1) to develop a simplified format that will address small, as well as, medium and large organizations, and 
2) for the required documentation to be more relevant to the desired results of the organization’s process activities.

The purpose of this additional guidance is to explain the intent of the new standard with specific regard to documentation.

Guidance on the Terminology Used In ISO 9001:2000 and ISO 9004:2000
To assist in the readability and translation of the new standards, great care has been taken to use the correct English words and terms to describe the concepts and requirements. The objective was to use simple and technically accurate terms, and to the greatest extent possible, rely on common dictionary definitions. As with most technical subjects, there are some terms that have a very specific meaning different from their commonly used dictionary definitions. This module lists key words and terms, and either references, or gives, the definitions for them.