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 ISO 9000 series?

ANSWER

The term ISO 9000 unfortunately has two different meanings:
it refers to a single standard (ISO 9000) and it refers to a set
of three standards (ISO 9000, ISO 9001, and ISO 9004). All three
make up the ISO 9000 series and are referred to as quality
management system standards.

ISO 9000 discusses definitions and terminology and is used
to clarify the concepts used by the ISO 9001 and ISO 9004
standards. ISO 9001 contains requirements and is often used
for certification purposes while ISO 9004 presents a set of
guidelines and is used to develop quality management
systems that go beyond ISO 9001.

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 the following
standards: ISO 9000, ISO 9001, and ISO 9004. In the narrow sense, the
term ISO 9000 refers only to the ISO 9000 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 standard).

QUESTION

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

ANSWER

When an organization claims that it is ISO 9001 certified or
registered, it means that an independent registrar has audited
its quality management system (QMS) and certified that it meets
the ISO 9001 requirements. It means that a registrar has given a
written assurance that ISO's quality management system
standard has been met.

However, when companies say that they are ISO 9001 compliant,
they usually mean that they have met ISO's QMS requirements but
have not been formally certified by an independent registrar. In effect,
they are self-certified. This is perfectly acceptable to ISO and to 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 it's certified or compliant,
it's not saying that its products and services meet the ISO 9001
requirements. The ISO 9001 standards are process standards, not
product standards.

NOTE: ISO published the ISO 9001 2008 standard on November 15, 2008.
This means that most ISO 9001 books, ebooks, web pages, and articles
published before November 15, 2008 are out-of-date and technically
obsolete. They should, therefore, be ignored.

QUESTION	What's the difference between being certified and being accredited?
ANSWER	Registrars audit and certify organizations who wish to become ISO 9001 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 9001 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 management
system is a network of processes. Your quality manual is supposed
to document your 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 management
system (QMS) is a web of real processes.

A quality management system is a set of interrelated or interacting
elements that organizations use to direct and control how quality
policies are implemented and quality objectives are achieved.

A process-based QMS uses a process approach to manage
and control how its quality policy is implemented and quality
objectives are achieved. A process-based QMS is a network
of many interrelated and interconnected processes (elements).

Each process uses resources to transform inputs into outputs.
Since the output of one process becomes the input of another
process, processes interact and are interrelated by means of
such input-output relationships. These process interactions
create a single process-based QMS.

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
a complete QMS. 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 QMS that exists in the real world.
Your quality management 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 management system. As we have seen, this is wrong.

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

ISO wants you to establish a quality management system that complies
with the ISO 9001 2008 standard and to document that system using a
quality manual. That's your basic 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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First published on October 24, 2001. Updated on December 2, 2011.

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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 specific 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.