ISO 9000 - Questions and Answers


QUESTION	What does the term "ISO" stand for?
ANSWER	The term ISO stands for the International Organization for Standardization. You would reasonably assume that it ought to be IOS, but it isn't. Apparently, the term ISO was chosen (instead of IOS), because iso in Greek means equal, and ISO wanted to convey the idea of equality - the idea that they develop standards to place organizations on an equal footing.

QUESTION

What standards make up the new ISO 9000 2000 series?

ANSWER

So far, ISO has developed three new standards in the ISO 9000 series: ISO 9000:2000, ISO 9001:2000, and ISO 9004:2000.

ISO 9001:2000 contains ISO's new quality management system requirements. This is the standard you need to use if you wish to become certified (registered).

ISO 9000:2000 and ISO 9004:2000 contain ISO's new quality management system guidelines. Refer to these standards if you wish to learn more about ISO's approach to quality management. ISO 9000:2000 presents definitions and discusses terminology, while ISO 9004:2000 is a set of guidelines for improving performance. Use ISO 9004:2000 if you wish to develop a quality management system that goes beyond the basic ISO 9001:2000 requirements, or if you wish to continually improve the performance of your quality management system. While these two guideline standards will certainly help you, they are not intended to be used for certification purposes.

ISO is also working on a fourth new standard: ISO 19011. ISO 19011 will replace the old ISO 10011 quality auditing standards. The final version of this new standard is expected in the year 2002 or 2003.

In summary, the new ISO 9000 series of standards will ultimately consist of four primary standards: ISO 9000, ISO 9001, ISO 9004, and ISO 19011.


QUESTION	What's the difference between ISO 9000 and ISO 9001?
ANSWER	The term ISO 9000 has two meanings: a broad one and a narrow one. In the broad sense, the term ISO 9000 includes at least the following standards: ISO 9000:2000, ISO 9001:2000, ISO 9004:2000, and ISO 19001 (an audit standard not yet available). In the narrow sense, the term ISO 9000 refers only to the ISO 9000:2000 standard (which talks about definitions and vocabulary). But, in most cases, the term ISO 9000 is used in the broad sense. So the term ISO 9000 has two meanings (a broad one and a narrow one), while the term ISO 9001 has only one very specific meaning (it refers to the ISO 9001:2000 standard, or an older version of this standard). Unfortunately, ISO has created this fundamental ambiguity. Who knows why? We don't. We don't like it, but we're stuck with it, along with everyone else.

QUESTION

What's the difference between being certified and being compliant?

ANSWER

When a company claims that they are ISO 9000 certified or registered, they mean that an independent registrar has audited their quality system and certified that it meets the ISO 9001:2000 requirements (or the old ISO 9001:1994, 9002:1994, or 9003:1994 requirements). It means that a registrar has given a written assurance that ISO's quality management system standard has been met.

However, when a company says that they are ISO 9000 compliant, they usually mean that they have met ISO's quality system requirements but have NOT been formally certified by an independent registrar. In effect, they are self-certified. This is perfectly acceptable for many companies, especially small ones. Of course, an official Certificate does tend to carry more weight in the market place.

Please note that when a company says they're certified or compliant, they're NOT saying that their products and services meet the ISO 9000 requirements. The ISO 9000 standards are process standards, not product standards.


QUESTION	What's the difference between being certified and being accredited?
ANSWER	Registrars audit and certify organizations who wish to become ISO 9000 registered or certified. Accreditation Bodies, on the other hand, evaluate and accredit registrars. In effect, accreditation bodies audit the auditors. Accreditation bodies certify that registrars are competent and authorized to issue ISO 9000 certificates in specified business sectors.

QUESTION

What's the difference between a Quality Manual and a Quality System?

ANSWER

A quality manual is just a document, while a quality system is a network of processes. Your quality manual is supposed to document your quality system; it's not supposed to BE your system. Your manual is NOT your system. They're two different things. Your quality manual is all about paperwork, while your quality system is a web of REAL processes.

A quality system is a network of interrelated processes. A process is made up of people, work, activities, tasks, records, documents, forms, resources, rules, regulations, reports, materials, supplies, tools, equipment, and so on - all the things that are needed to transform inputs into outputs. In general, a quality system includes all the things that are used to regulate, control, and improve the quality of your products and services.

Obviously, a quality system is not a manual; nor is it a computer program. This is an important point. It's important because many consultants sell quality manuals and computer programs that claim to provide an instant solution: usually all you have to do is edit the manual or install the computer program and, bingo, you've got yourself a complete quality system. This is false and misleading!

A manual is just a document and a computer program is just an information system, it's not a real quality system that exists in the real world. Your quality system does not sit on your shelf, nor does it live inside your computer!

All of this needs to be clarified because some people think that once they've written their quality manual or purchased a computer program to manage ISO documents, they're finished. This is because they believe that their quality manual or their computer program IS their quality system. As we have seen, this is wrong.

Of course, there's nothing wrong with writing a manual or using computers to help you manage or document your quality system. Just don't confuse a paper system with real system!

NOTE:
The terms quality system and quality management system mean the same thing. Remember, ISO wants you to develop a quality management system that meets the ISO 9001:2000 standard. That's your mission.


QUESTION	What should our procedures and work instructions look like?
ANSWER	Procedures and work instructions can take any suitable form as long as the result is effective. ISO does not specify what form these documents should take. Procedures can take the form of a narrative, a flow chart, a process map, or any other suitable form. As long as the procedure is effective, it really doesn't matter what it looks like. Work instructions can also take any suitable form. However, one of the best ways to document a work instruction is to use a form. Forms are particularly useful because they become records once they're filled in.


QUESTION	What's the difference between corrective and preventive action?
ANSWER	Corrective actions are steps that are taken to remove the causes of existing nonconformities, while preventive actions are steps that are taken to remove the causes of potential nonconformities. Corrective actions address actual problems, ones that have already occurred, while preventive actions address potential problems, ones that haven't yet occurred. In general, the corrective action process is a problem solving process, while the preventive action process is a risk analysis process.


QUESTION	What's the difference between design verification & design validation?
ANSWER	Design verification is a process whose purpose is to examine design outputs and to use objective evidence to confirm that outputs meet design input requirements. Your purpose here is to see whether your design outputs meet your organization's design goals. Design validation is a process whose purpose is to examine products and to use objective evidence to confirm that these products meet customer needs and expectations. Your purpose here is to see whether your product does what your customer or user wants it to do under real-world conditions.

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BACK TO FAQ	*Answers to "WHAT" Questions about ISO 9000*


QUESTION	What's the difference between a procedure and a work instruction?
ANSWER	*A procedure* describes how a process is performed, while a work instruction describes how a task is performed. Work instructions tend to be more detailed than procedures.**


QUESTION	What's the difference between a work instruction and a record?
ANSWER	Work instructions describe how tasks should be done, while records document how tasks were actually done. Work instructions are used before the task is performed, while records are used after the task has been performed. Work instructions come before the fact, while records come after the fact.