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In our ISO 9000 consulting room
we answer some basic questions and provide links to further resources as well as
more articles from the panel on the left:
What
is ISO 9000?
What is
the purpose of ISO 9001?
What type of
organizations use ISO 9000
Why
do customers require compliance with ISO 9001?
How does the 2000 version differ from the 1994 version?
How do we get the most out of these standards?
Where can I find more information about the requirements?
How can we convert our system into a process based QMS?
We don't have any formal QMS so what should we do?
What is ISO 9000? ..top
ISO
9000:2000
explains the concepts, the principles and defines the terms
used in the family of international quality management system
standards.
Apart from being a standard in its own right, ISO 9000 is a family
of international standards that define quality management system
requirements. There are three standards in the family: ISO 9000,
ISO 9001 and ISO 9004.
What is the purpose of
ISO 9001? ..top
ISO
9001:2000 specifies quality
management systems requirements. Its purpose is to provide an
equitable basis for assessing the capability
of organizations to meet customer and applicable regulatory
requirements – it is not a design specification for a quality
management system. Also ISO 9001 is applied -it is not implemented
simply because it contains assessment criteria and not design
criteria. It is for this reason that systems designed around ISO
9001:1994 were not effective.
What type of
organizations use ISO 9000? ..top
In general the type of
organizations that use ISO 9000 of which there are over 500,000
worldwide, tend to be those that have customers that will only
trade with suppliers that have ISO 9001 certification. If your
customer don't require ISO 9001 certification, you don't need to
use ISO 9000 but you might find the standards useful in providing
a set of principles and a framework on which to build a robust
quality management strategy. Many successful organizations are not
ISO 9001 certified and have no wish to go down the certification
road.
Why
do customers require compliance with
ISO 9001? ..top
ISO 9001 applies when
invoked in a invitation to tender or a contract and this is
normally the case where a customer needs confidence that its
suppliers have the capability to meet specific requirements. Where
a customer can verify that its requirements have been met on
receipt of a product or service, there is no need to impose ISO
9001 on these suppliers. However, many organizations impose ISO
9001 on their suppliers regardless of it being a necessity.
How does the 2008 version of ISO 9000 differ from the 2008
version? ..top
There are no new
requirements in ISO 9001:2008. The changes are cosmetic see
in depth analysis
How do we get the most out of these
standards? ..top
By far the best way to use
these standards is to firstly read them all starting with ISO
9000. Unless you have a clear understanding of the concepts and
principles, the other standards won't make much sense. The read
ISO 9004 to get an idea of the kind of areas your management
system needs to cover. Then put them down and design you
management system around your business using the concepts in ISO
9000. When you have designed your business processes, consult ISO
9001 to identify any aspects you have overlooked. DON'T design
your system around ISO 9001. It was not intended to be used in
this way and its primary use is in assessing management systems
just like a test specification is used to test a product. You
wouldn't design your product around the test spec would you? To
get help in designing you management system use our contact form
and we will steer you towards a practical solution commensurate with your
needs.
Where can I find more information about the requirements?
..top
We have several sources of
information. There are links to several articles in the
panel on the left. There is our
Glossary that defines lots of
terms used in this field, another is our Fact
Sheets that cover a range of topics but by far the best is the
ISO 9000 Quality
System Handbook that covers all 250 of the requirements as
well as concepts, principles, flow charts etc.
How can we convert our system to a process based QMS?
..top
If you have a traditional ISO 9000 based management system
that is described through a Quality Manual and a set of 20 or so
procedures you won't have a process based management
system. Your best solution is to read our book
Converting a QMS using the process approach,
then notify us of your top 5 concerns using our contact form
and we will steer you towards a practical solution commensurate with your
needs.
We don't have any formal QMS so what should we do?
..top
It depends on how your
organization is managed. There are 250 requirements in ISO 9001 so
your best solution is
to consult some of our books such as:
Finding the right place to start
A guide to process management
ISO
9000 Quality System Handbook
Send us questions using
our contact form and we will try to help.
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