| ISO 9001 - Quality Management Systems
Requirements The ISO 9001:2000
standard is the actual things a quality management system needs to
have in it. This is the "standard" and as such, it has the
requirements that must be fulfilled to get your
certification/registration.
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The 1987 and 1994 editions of ISO 9001 were focused on standardizing
processes primarily through extensive documentation. Although the
intent was to provide customer satisfaction and improvement those
terms never actually appeared in the standard.
The 1994 edition, the ISO 9001 edition before the 2000 revision,
had one clause with 20 sub-clauses. Each of the sub-clauses
focused on a specific type of operation in companies. For example,
there was a clause (4.3) titled "Contract Review" that focused on
customer order review.
Another one was a clause titled "Process Control" (4.9). However, it
focused on production processes, not all processes. Each was
considered a separate entity and was treated that way when
documenting and implementing, as well as being audited.
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The 2000 edition was completely reformatted and re-focused. This
edition contains only five clauses. They are based of the
processes most companies have. The new formatting is geared toward
the interaction of the processes in companies. All processes in
companies rely on each other for their input and output.
The Process Approach
ISO 9001:2000 requires companies to identify the processes in their
organization as well as the interaction of these processes in order
to enhance customer satisfaction through continual improvement.
The process approach starts with customer requirements as the
initial input and customer satisfaction and continual improvement as
the output. The phrases "customer satisfaction" and "continual
improvement" actually appear in this standard and requirements have
been set for measuring and monitoring activities based on objective
measurements.
The clauses are: (follow links for more information)
4 - Quality management system
5 - Management responsibility
6 - Resource management
7 - Product realization
8 - Measurement, analysis and improvement
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Another of the significant changes from
previous editions is there is only one standard opposed to three.
The 2000 revision of ISO 9001 includes everything from product
design or development to servicing the product after the sale.
Speaking of design and development, under the previous edition of
the standard companies could simply choose not to include specific
operations or processes in the scope of their quality management
system and certification.
For example, if they didn’t want to include product design
engineering, sometimes referred to as "wild cards" because of the
lack of standardization between engineers, they chose certification
to ISO 9002, which didn’t include design control. This is no longer
possible.
You can only exclude a process by justifying that it doesn’t affect
customer or regulatory requirements. That's tough to prove when you
design and/or develop the product or service what customers buy.
This initially resulted in many companies not transitioning from the
1994 edition to the 2000 standard and therefore eventually losing
their certification.
Online
ISO 9000 Introduction Course
Auditor Training:
Classroom
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Auditor Training
Courseware
What
is a Quality Management System?
What is ISO 9000?
What is ISO 9004?
What is ISO 19011?
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