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Jim Owens: ISO 9000 Quality Management Systems

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Often we hear of a system or an organisation being “ISO 9000 compliant” or “ISO 9000 certified”, but what does this actually mean? And are we talking just about ISO 9000? And we hear people say that have implemented an ISO 9000 Quality Management System (QMS) – but is ISO 9000 a QMS?

ISO stands for International Standards Organisation, and it is a worldwide federation of accredited member bodies. These individual bodies are entitled to provide input to the international standards through technical committees. Suggested changes to the standards are then voted on by the bodies (at least 75% of member bodies must vote for a vote to be legitimate).
Eventually a standard becomes outdated and needs a complete overhaul; for example ISO9000:1994 was superseded by IS9000:2000

Do you have to obey the standards?

A standard is something that is “generally accepted”; just as the PMBOK is a strong recommendation of what good project managers should do – ISO 9000 is a recommendation for quality practices. But you don’t have to obey these standards if you don’t want to, there’s no legal penalty (but of course your project, project and organisation will suffer).
A “regulation” on the other hand must be obeyed, and it’s backed up by legal consequences if you don’t comply. For example in Australia only licensed electricians are permitted to install or modify mains electrical wiring, or to connect certain devices to it – that’s not a recommendation (a standard), it’s the law (a regulation).

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Has your organisation been certified by ISO?

“No!” There, that was simple – ISO is an international body that writes standards, including ISO 9001:2000, against which you can be certified, but ISO don’t certify anyone.
This is quite different from PMI (the authors of the PMBOK), because they certify PMP’s in project management.
To have an ISO 9000 compliant QMS, means that your QMS agrees in detail with ISO 9001.
Is ISO 9000 a Quality Management System (QMS)?

Before ISO 9000:2000 was released, the answer to this question was simply “no”, but many think the situation has now changed, and certainly the focus of the development of ISO 9000:2000 for some time, was that it could be considered a QMS – but did they succeed?
This is a controversial issue, so you have to consider this as my personal viewpoint – I believe that as ISO 9000 is an international standard, and just as the PMBOK is not a project management methodology, ISO 9000 is not a quality management system or a methodology in itself; rather it is a method of implementing and following an internally-produced quality system. For example, currently I am working for a large government department in Australia and one of my projects is to produce the Quality Plan, including the Quality Management System, and the Quality Manual. So I started by using ISO 9001 chapters 4 to 8 to define the Quality Manual. I’ve taken all the headings and subheadings from these chapters, and I’m “filling in the blanks” with applicable policies and procedures (some of which I am writing). So the totality of the details that I am slotting in will form the core of the QMS. If I write a QMS for another organisation then these details could be very different. – again I suggest that this is because ISO 9000 is a guide and not a system.
And lastly, from the ISO website “ISO 9001:2000 is an international standard that gives requirements for an organization’s Quality Management System (“QMS”)” This is, it “gives the requirement for” a QMS, it is not a QMS itself.

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Now meet the family.

ISO9000 is in fact a family of closely related standards that should be used together, currently they include:

— ISO 9000, this describes the fundamentals and terminology of a Quality Management System (QMS).

— ISO 9001 when people talk about being ISO 9000 certified, this is the standard that they are referring to. Note – this is the only standard that a QMS can be “certified” against. ISO 9001 specifies the detailed requirements for a QMS to demonstrate its ability to provide products and/or services that fulfil customer and regulatory requirements, and enhances customer satisfaction.

— ISO 9004 is the performance improvement standard, and it provides guidelines that consider both the effectiveness and efficiency of the QMS.

— ISO 19011 is a guide to auditing the QMS that you have produced.

And there is an up and coming draft standard – ISO 10005:2005 – that has been put out for comment, and this is a guide to writing quality plans, and will eventually replace ISO 100005:1995

ISO 9000 is very far-reaching; it covers just about everyone and every process in the organisation. The following is from the ISO website:

“The requirements cover a wide range of topics, including your supplier’s top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides.”

In fact there’s a very heavy emphasis on top-management support for the QMS, because if they’re not behind it, it will probably just end up as another book on the shelf gathering dust.

Why do we need a QMS?

A project (or a process) uses a set of specifications to produce a deliverable (product or service) for a customer. OK – that’s pretty basic, but our project, “Now with added QMS!” does it in style. The main difference is that a QMS can measure important metrics and make in-flight adjustments. Not only that, but it can also “learn” from mistakes (and successes), to continually improve the process. So that means that a good QMS can predict possible failures and pre-emptively take appropriate action, as seen in this old recall notice from the Ford motor company: “Why We Are Replacing 13 Million Firestone Tires? Ford Motor Company is replacing all Firestone Wilderness AT tires on any Ford Motor Company vehicle. This action is a precautionary measure. Our analysis of real-world data, information from the federal government and lab testing indicate that some of the Firestone Wilderness AT tires not covered by last year’s recall could, at some time in the future, experience increased failure rates.

— Ford Motor Company, 24 May 2001, The Boston Globe.”

That’s what ISO 9000 is all about – providing your customers with a quality service, and a quality service is what will keep them coming back to you and reccomending your services to others.

– Regards,
Jim Owens PMP

6 comments to Jim Owens: ISO 9000 Quality Management Systems

  • Ascent World is ISO Quality Certification Cosultant Company based in Mumbai – India, Dubai – UAE, Colombo – Srilanka and other parts of world. We are pioneer in ISO Certificates such as ISO 9001, ISO 14001, GMP and Product Certification as CE Marketing, ROHS. We are based in Mumbai , Dubai and Srilanka.

  • In general I agree with the statements in this article but I think one clarification is required. You state: “But you don’t have to obey these standards if you don’t want to”. This is true if you are not trying to get certified to the ISO standard or if you don’t have requirements (like customer requirements) to have a ISO 9001 compliant QMS. However, if you have requirements to be compliant or if you are trying to get a third party certification you are required to fulfill all of the requirements of the standard with very few exceptions and if there are exceptions they must be stated in your Quality Manual’s scope.

  • There are so many misconceptions about the ISO standard. I think because it is perceived as being quite a tough certification to achieve in terms of the work that is required, there is a focus by many on the loop holes which may allow you to achieve it in an easier way by not actually meeting the standard. Really this is not the correct way to go about things and it is important to remember the reason behind the certification is to provide a stamp of quality assurance.

  • So many Quality Professionals write Quality Manuals structured around the relevant standard. This makes perfect sense for the Professionals and the system auditors, but what about the company? I’m starting to think that Quality Professionals have been doing what is easy for them rather than what is best for the company. What are your thoughts?

  • Thank you for this article. ISO9001-2008 is the newest version of ISO9000. It is maybe change to new version soon.

  • Thanks for posting. ISO standards are really helpful to organisations.

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