What's ISO 9000?

ISO 9000 is an international family of generic quality standards, originally published by ISO (International Organization for Standardization) in 1987 and updated in 1994 and again in 2000. It has currently been adopted by over 100 nations. It has been adopted by the European Union and by the U.S. as ANSI/ASQC Q9000, has been accepted by the U.S. Department of Defense and NASA, and has been incorporated into FDA and NATO standards. It is also the foundation for many industry-specific standards such as QS-9000 for the automotive industry. This international standard specifies elements necessary for the foundation of a quality management system, but does not specify how the requirements are to be implemented. It does not replace product safety or regulatory standards or requirements.

What are the significant changes in ISO 9001:2000?

The ISO 9001:2000 changes include: focus on a process approach, including a process model; more consistent terminology; enhanced compatibility with ISO 14000; continual improvement of the quality management system; and significant emphasis on achieving customer satisfaction by meeting customer requirements.

How do I get started implementing ISO 9001?

Successful companies start an ISO 9001 implementation process with management commitment. A typical schedule for implementation ranges from 12 to 15 months. For information on our complete 14-step process, cclick here

What are the benefits of ISO 9001 registration?

ISO 9001 helps meet customer requirements, enhances your company's image, reduces multiple audits, and provides a basis for quality improvement. If you export to Europe,, registration will help you comply with European Union directives.

What's the role of the registrar?

A registrar is an impartial independent auditing body, who evaluates your company against a given quality standard, for example, ISO 9001. Registrars are the only accredited body capable of providing a company with ISO 9001 registration. A list of registrars is available from ASQ by calling 1-800-248-1946.

What's the difference between a lead and an internal auditor?

Lead auditors and auditors are trained to audit both suppliers and facilities outside their own organizations (also known as second- and third-party audits) as well as elements within their own organization. Internal auditors are trained to audit their company's internal systems only (first-party audits).

How does ISO 9000 compare with the FDA's Medical Device Quality System Regulation?

FDA's Medical Device Quality System Regulation includes elements from ISO 9000 as well as other international standards. The Medical Device Quality System Regulation is mandatory as stated by the FDA, while ISO 9001 is a voluntary quality management system.

How does ISO 9000 compare with QS-9000, AS 9100, and TL 9000?

All of the elements of ISO 9001 are contained in QS-9000, AS 9100, and TL 9000; however, QS-9000 also contains additional elements specific to the automotive industry, AS 9100 has specific aerospace requirements, and TL 9000 is customized for the telecommunications industry. Also, QS-9000 is built around ISO 9001:1994, and there are no plans to update it, since eventually it will be replaced by ISO/TS 16949, which incorporates several European automotive standards.

What's the difference between CQA (certified quality auditor) and registered lead auditor status?

If you have completed CQA training and passed ASQ's CQA exam, you will be certified by the ASQ as a quality auditor. To be a registered lead auditor, you must first take a five-day approved training program, pass the necessary exam, and then apply to the RAB or IRCA for certification as a registered lead auditor. NOTE: To attain registration as a lead auditor, you must pass the written final exam, earn a passing grade in the course's continuous assessments, and meet prescribed professional requirements, which include conducting a number of actual audits. To become an auditor for an automotive registrar, additional training is required.

What's the difference between ISO 9000 and business process improvement?

The difference is that business process improvement deals with the overall business systems of an organization, and can include an ISO 9001 quality management system. Business process improvement or Six Sigma is a natural next step after ISO 9001 implementation.

What is Six Sigma?

Six Sigma is a quality philosophy that uses customer-focused goals and measurements to drive continuous improvement at all levels in any enterprise. The goal is processes that are so robust that defects are measured at levels of only a few parts per million. Six Sigma implementation requires top management leadership, since the concept must be embraced throughout the organization.

We survey customers regularly and they're happy; what can Six Sigma do for us?

If your customers are "happy," but not checking the "top box" on those surveys, Six Sigma can help by raising their perceptions of you. Remember-they may be happy now, but customers are also fickle. They will jump to anyone that promises (and delivers) better value in the marketplace. It has been estimated that customers who rate you as "good" are six times more likely to change suppliers as those who rate you as "excellent."

Is Six Sigma "zero defects"?

Six Sigma considers a small, but finite, number of defects. The number is so small that it is perceived as "virtual perfection." The fact that it is not zero (albeit small) allows people to "buy into" Six Sigma intellectually. Most people have a problem with "zero" because they are human and cannot believe in "zero." They will, however, be willing to strive for only three parts per million because it is a finite number. They're then willing to try for it, which is really all you need to get started.

Will Six Sigma improve the bottom line?

When you look at all the "re" words in our vocabulary (rework, retest, reedit, redo, reprocess, recheck, rewrite, etc.), you get a feel for the amount of waste in our operations. Six Sigma focuses on reducing that waste, and the results fall to the bottom line. Most organizations run costs-of-poor-quality at anywhere from 10 to 25% of their sales figures. Imagine those numbers dropping to the bottom line-what a loud sound!

We're a service organization; how does Six Sigma apply to us?

Whether you're service or manufacturing, you do your work in "processes." These processes are what Six Sigma strives to improve. Whether a process generates a lot of wasted effort in a service transaction or scrap material in manufacturing, it makes little difference to an unhappy customer. Service processes probably have more potential to improve than manufacturing, since industrial engineers have rarely concentrated on service processes, but have looked at manufacturing since the days of Frederick Taylor.

Why do we need Six Sigma if we already have a quality system in place?

Six Sigma is a set of continual improvement tools that move quality forward and reduce costs. If your organization is not improving, it is probably falling behind.

How do we handle measuring what we have now versus what we should measure?

You may already be measuring the right things. If the measurements are from the customer's view, you're already there. If you're not, then the Six Sigma measurements are what you should have been measuring. Discard those that drive you away from the customer.

Is Six Sigma like SPC (statistical process control)?

Six Sigma is a philosophy of belief in perfection and customer delight. SPC is one of the tools used to support the Six Sigma philosophy. All the classical quality tools that you've learned, like Pareto charts, fishbone diagrams, control charts, or statistics in general support Six Sigma.

What does "defects per unit (DPU)" mean? What is a "unit"?

First of all, a unit is a measure of the work you do-it can be a report, a gadget, a contract, a phone call, or anything else that describes the product you produce (yes, even in a service organization there are "products"). "Defects per unit" only describes what "percentage" of your units will have defects that pass on to the "customer" (who may be the person performing the next step in the process). A base of one million is generally used instead of one hundred, as you do in percentages, because the numbers are usually small. Hence, in Six Sigma we commonly speak of defects per million opportunities (DPMO).

What examples exist of real savings and benefits from other companies that have used Six Sigma?

There are many stories of savings and improvements in Motorola, Citibank, General Electric, AlliedSignal, Texas Instruments, and others that are almost legendary. If you look at some of their annual reports, you will see success stories of all kinds attributed to Six Sigma. The key is to have the commitment and understanding to realize that there is something here that can work in your enterprise, if it's properly supported and implemented.

I understand Six Sigma. What are some of the advanced tools that I can consider?

There are many other customer-focused tools that enhance Six Sigma. Quality function deployment (QFD), Taguchi methods, etc., are just a few. All of the traditional and new tools that work in your operation can be used and understood.

I've heard and read about "Black Belts." What does this term mean?

The term "Black Belt" was coined at Motorola to designate an expert in the application of Six Sigma tools, much as the traditional definition of a "Black Belt" describes an expert in the martial arts. However, "Black Belts" aren't the only ones that can use Six Sigma tools because most of them are not that complicated. We also train "Green Belts," who have the skills to assist as members of project teams. 

How long does it take to implement Six Sigma?

It took the originators of Six Sigma, Motorola, anywhere from 5 to 10 years to really apply the concept. The purpose of Six Sigma training, education, senior management commitment, and these FAQs is to do it faster, with fewer mistakes and false starts.

How much will it cost to implement Six Sigma?

A good training program, in useful tools, at the proper time is an "investment" rather than a cost. The initial outlay is in the form of training in Six Sigma basics and dedicating trained personnel, full-time, to eliminating non-value-added costs. In reality, the training and deployment focus people on doing a better job of what they should be doing anyway.

Who should be trained to use Six Sigma tools?

This answer is simple-just about everyone at all levels. When the entire organization is committed to and understands the Six Sigma philosophy, the greatest gains can be made. However, most organizations start the process with the senior executive staff and then begin to identify and train team leaders.

What do "processes" mean and why are they important in implementing Six Sigma?

A process is the way we work. It's the methodology used to deliver the goods and services we provide. By focusing on "processes" we see ways to improve and provide more and better products and services at lower cost, and keep our customer happy.

How many people are required for Six Sigma implementation?

You can start with any number, however, the real strength of the Six Sigma philosophy comes when everyone in the operation is applying this training-management and workers. The common language, the common goals, and the common methods all help reinforce the effectiveness of the concept. /span>