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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
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.
In addition to the new name Quality Management Systems - Requirements, the new
revision of the standard ISO 9001:2000 has a completely new structure.
2-Normative Reference and
3-Terms and Definitions, there are five main clauses:
4-Quality Management System
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.
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