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Related ArticlesISO 9001:2015
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ISO 9001 Misconceptions
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ISO 9000 PublicationsISO9000:2K Handbook
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ISO 9000

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 2000 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.

How do I get help?

We provide a number of resources that can help you meet ISO 9001 requirements. Just follow the links in the navigation panel on the left to find out more.  If you have a more specific query please contact us now


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