Comments on the new requirements
of ISO 9001, third edition
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. Following the 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. |
