Differences between FDIS and DIS versions of ISO 9001:2000

Numerous changes were introduced in the ISO/FDIS 9001:2000 standard. A sampling of the differences are listed below.

Added a NOTE that the Plan-Do-Check-Act (PDCA) methodology can be applied to all processes. Also added Risk Management to the list of management system requirements not included in ISO 9001.

Changed title of clause 1.2 from “Permissible Exclusions” to “Application”. Also clarified that wherever the term “product” occurs, it can also mean “service”

Quality Management System
Moved quality manual, control of documents, and control of quality records into this section from Management Responsibility.

Added that “outsourced” processes affecting product conformity must be identified and controlled.

Management Responsibility
Added that the management review must assess opportunities for improvement.

Expanded review outputs to include “decisions” (not just actions).

Resource Management
Expanded the infrastructure requirement to cover examples such as buildings, utilities, transport, and communication.

Product Realization
Added a NOTE that the design and development requirements of 7.3 can be applied to development of product realization processes.

Also added a NOTE that the review of each customer order may be impractical in some situations (like Internet sales). In those cases, the product information in catalogs and ads could be reviewed.

Expanded that design and development information must be provided for purchasing (in addition to production and service).

Revised throughout the standard to have “monitoring” come before “measurement” whenever the two terms are used together.

Measurement, Analysis, and Improvement
Changed from customer “satisfaction and/or dissatisfaction” to customer “perception” of whether requirements are met or not.

Switched from use of auditor “independence” to auditor “impartiality and objectivity”.

Added different ways to deal with nonconforming product:

(a) take action to eliminate detected nonconformity,
(b) authorize use, release, or acceptance under concession,
(c) take action to preclude its original intended use or application.

A complete list of the changes from the DIS to FDIS level of ISO 9001:2000 can be viewed at DIS to FDIS Changes.