Comments on the new requirements of ISO 9001:

After extensive research and international participation, and after going through several different drafts issued during two years, ISO 9001 third edition, which is the final version of ISO 9001:2000, was published on December 15, 2000. ISO 9001:2000 replaces the versions ISO 9001:1994 and ISO 9002:1994 and ISO 9003:1994 which are now included in only one standard, ISO 9001:2000.
The scope of ISO 9001:2000 is extended and includes: applicable regulatory requirements, customer satisfaction, continual improvement and permissible exclusions.

Permissible exclusions of not applicable requirements depend on the organizations products or services, customer requirements and/or business activities. These exclusions however are limited to the requirements contained in clause 7 - Product Realization.

Compared to ISO 9001/9002:1994 the structure of ISO 9001:2000 was changed completely, including the name Quality System was changed to Quality Management System. The requirements seem to be more general and provide improved flexibility. ISO 9001:2000 is aimed equally at manufacturing as well as service organizations, with a strong focus on customer satisfaction.

Good news for those organizations with an implemented ISO 9000:1994 quality system dealing already with customer satisfaction, analysis of data and continual improvement: if any, only minor changes should be required to operational procedures. The bulk of changes are in the structure of the documentation, namely the manual and quality system procedures.

In addition to changing the description of Quality System to Quality Management System, ISO 9000:2000 replaces the terms and definitions of supplier and subcontractor used in ISO 9000:1994:

ISO 9000:1994 ISO 9000:2000
subcontractor > supplier
supplier > organization

Most organizations had already made these changes anyway in their documentation.

The new four primary standards of ISO 9000 are

ISO 9000:Quality management systems – Fundamentals and vocabulary

ISO 9001:Quality management systems - Requirements

ISO 9004:Quality management systems – Guidance for Performance Improvement

ISO 19011:Guidelines on Quality and Environmental Auditing

Note: For the new revised standard ISO 9001:2000 the Terms and Definitions are included in ISO 9000:2000. Definitions and vocabulary used in ISO 9000:1994 have been defined in ISO 8402:1994.
New Requirements

In addition to the new name Quality Management Systems - Requirements, the new revision of the standard ISO 9001:2000 has a completely new structure.

1-Scope,
2-Normative Reference and
3-Terms and Definitions, there are five main clauses:
4-Quality Management System
5-Management Responsibility
6-Resource Management
7-Product Realization
8-Measurement, Analysis and Improvement

Since the standard was completely rewritten, in some cases it is difficult to precisely determine what are new requirements, considering that certain activities for the compliance with the standard are implied and/or are/were a logical consequence of a documented requirement in both versions, ISO 9000:1994 and ISO 9000:2000.


Resource : rcg-iso9000.com

 

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