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 registered?
ANSWER None. There is no difference. In some countries organization's
say they're certified, and in others they say they're registered.
It's the same thing.

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'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 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 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.

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.
Answers to "HOW" Questions about ISO 9000

QUESTION How many countries use ISO 9000?
ANSWER See: The ISO Survery of Certifictions.

QUESTION How many ISO 9000 certificates have been issued?
ANSWER See: The ISO Survery of Certifictions.

QUESTIO
N
How much does it cost to become ISO 9001 Certified?
ANSWER This is one of our most popular questions. Unfortunately, there is
no simple answer. How much it costs depends on a lot of factors. It
depends on how long you take to develop your quality management
system, how many people are involved, whether you hire outside
consultants or not, and how much your registrar charges.
So instead of trying to give you a simple answer, we'll show you
how to construct your own answer. One approach is to start with a
Gap Analysis. A Gap Analysis will tell you what steps you need to take
to upgrade or develop your quality management system (QMS). Once
you know what needs to be done, you can figure out how long the
work should take, who should do it, and how much it should cost.
With this kind of information, you can plan your system development
project and prepare a budget using the following kinds of cost
categories:
Internal costs
Gap Analysis
Project planning
System development
System documentation
System implementation
Training and awareness
Internal quality audit
System modifications
External costs
Services
Consultants
Professional fees
Gap Analysis
Project planning
System development
System documentation
System implementation
Training and awareness
Internal audit services
System modifications
Travel and living expenses
Registrars
Professional fees
Application fee
Registration fee
Initial assessment
Certification audit
Surveillance audits
Reassessments
Travel and living expenses
Products
Publications
Software
For detailed cost estimates, including daily fees, please
talk to ISO 9000 consultants and registrars in your area.

QUESTION How long will it take to become ISO 9001 Certified?
ANSWER In order to determine how long it will take to become ISO 9001
certified or registered, you have to figure out how long it will take
to develop or upgrade your quality management system (QMS). One
way of figuring this out is to start with a Gap Analysis. A Gap Analysis
will tell you what steps you need to take to upgrade or develop your
QMS. Once you know what needs to be done, you can figure out
how long the work should take.
In general, it can take from three months to three years to develop
a complete QMS. How long it will actually take will depend on a lot
of factors, including how many people work on the project, how
knowledgeable they are, and how large your organization is.
Once you've developed your QMS, your registrar may want you to
wait another three or more months before the certification (registration)
audit is done. This is because you need to be able to prove that your
quality system is actually working, and because it takes at least three
months to develop an adequate record of performance. You may wish
to use our ISO 9001 Compliance Audit to make sure that your quality
management is compliant before you ask your registrar to carry
out an external audit of your system.

QUESTION How much time do we have to upgrade to ISO 9001:2008?
ANSWER ISO published the new ISO 9001 2008 standard on November 15, 2008.
According to ISO and I AF, you had two years to upgrade to the new
standard. Therefore, the new deadline was November 15, 2010.
Your old ISO 9001 2000 certificate was obsolete on that date.
This also means that most ISO 9001 books, ebooks, web pages, and
articles published before November 15, 2008 are out-of-date, technically
obsolete, and probably inaccurate. They should, therefore, be ignored.

QUESTION How can I get in touch with ISO Headquarters?
ANSWER To talk to ISO in Switzerland, please use ISO's Contact Page.

QUESTION How do I choose an ISO 9001 Registrar?
ANSWER When choosing a registrar, we suggest that you:
Make sure that the registrar's ISO 9001 certificates
are recognized and respected in your industry.
Make sure that your customers will be
impressed with the registrar's certificate.
Find out whether your registrar has been formally
certified by a recognized accreditation body.
Find out whether your registrar has been authorized
to issue ISO 9001 certificates in your specific industry.
Find out how many certificates the
registrar has issued in your industry.
Clarify how the registrar performs external audits.
Clarify how initial assessments are performed.
Clarify how certification audits are performed.
Clarify how surveillance audits are performed.
Find out how the registrar handles problems.
Find out how nonconformities are handled.
Find out how the registrar handles complaints.
Find out the conditions that would cause the
registrar to revoke an organization's certificate.
Ensure that the registrar's auditors are suitable.
Ensure that auditors have been properly trained.
Ensure that auditors are certified or registered.
Ensure that auditors know your industry.
Confirm that suitable auditors are assigned to audits.
Confirm that suitable auditors will be available.
Confirm that suitable auditors will be available
in your area or region when you need them.
Verify that audit assignments will be formally
discussed with you before audits are scheduled.
Verify that you will have a chance to review the
auditors' credentials before audits are scheduled.
Confirm how much the registrar will charge.
Confirm how much it will cost to apply for
registration and to maintain your registration.
Confirm how much it will cost for the initial assessment,
for the certification audit, and for future surveillance
audits and reassessments.
Confirm how much it will cost for travel expenses.
Ask the registrar for a list of client references.
Ask referees to evaluate registrar's performance.
Ask referees how problems were handled.

QUESTION How can I become an ISO 9001 auditor?
ANSWER If you wish to become an ISO 9001 auditor, probably the best place
to start is by contacting your country's ISO Member Body. Your ISO
Member Body will either be able to provide training or tell you who
to contact. ISO Registrars will also be able to provide training or tell
you who can provide training in your area. For more information,
please see our ISO Trainers page.

QUESTION How should I format my ISO 9001 documents?
ANSWER ISO does not specify a document format. How you format your
ISO 9001 documents is entirely up to you. However, ISO does expect
you to control your ISO 9001 documents. For more information about
how to control your documents, please see the next question (below).

QUESTION How should I control my ISO 9001 documents?
ANSWER Your organization must develop and document a procedure to
control its QMS documents. Your procedure must ensure that you:
Approve documents before you distribute them.
Provide the correct version of documents at points of use.
Review and re-approve documents whenever you update them.
Specify the current revision status of your documents.
Identify changes that are made to documents.
Preserve the usability of your quality documents.
Preserve the identity of your documents.
Preserve the readability of your documents.
Monitor documents that come from external sources.
Identify documents that come from the outside.
Control the distribution of these external documents.
Prevent the accidental use of obsolete documents.
Identify obsolete documents that have been retained.
"What procedures are required?"
The standard requires six specific procedures, a quality manual,
a quality policy and quality objectives. It also requires
documentation needed to plan, operate and control your
processes. For an effective system, most organizations will
need more than the six specified procedures.
More on this topic...
What is included in "work environment" and what do we need to do to
manage it?
You must provide the physical resources needed to fulfill
customer requirements. How does your work environment
affect product quality? Think about temperature, cleanliness,
humidity, layout of equipment, vibration, static, light, noise and
any other factors that impact the product or the ability of
employees to produce conforming product.
Some work environment issues will overlap with preservation of
product. For example, temperature controls or ESD procedures.
These can be covered in another procedure, as long as they are
taken care of.
More on this topic...
What is a quality plan?
A quality plan is a "document specifying the quality
management system elements and the resources to be applied
in a specific case". The "case" may be a product, project,
process or even a specific contract.
The quality plan can consist of production paperwork, a formal
plan, a table of requirements, or other form of document that
specifies what needs to be done for operation, control,
monitoring and measuring of the process, project or product.
Incoming inspection: do we have to inspect everything?
This is a common question from organizations starting ISO
9001 programs, so here is the good news: there is no
requirement that you have to inspect everything. The
requirement is that you determine how you will know that you
have good parts, raw materials and services that go into
making your product.
More on this topic...
Do I need to include all of my suppliers under my purchasing procedure?
Even things like cleaning supplies?
You are able to evaluate if purchases have an affect on quality
of the product or service. Decide for each item purchased how
important they are to the product or service, and determine
what control you will need. Items that directly influence quality
will need to come from suppliers that have been evaluated to
determine that they can meet the quality requirements. Others
may be purchased based on price or delivery concerns.
Do we need to control our forms?
One of our frequently answered questions has to do with the
control of Forms. Why do forms have to be controlled, and how
in the world can we control them all? Well, forms are designed
to make sure that you collect the data that is required. Forms
often are also acting as work instructions, indicating steps and
order of steps for a process, telling what data to collect and
specifying the acceptable limits for that data. If a change is
made, it is important to get that change out to everyone using
the form. More on this topic...
Implementation Questions
I want to lead my company to ISO 9001 Registration, where do I start?
Start by getting a general idea of what the standard means,
and how it will affect your organization. Learn about ISO 9001.
I have been looking at your products, what customer feedback have you
received?
Glad you asked! We are very proud of the customer feedback
from our customers.
"We had our pre-audit on Wednesday and did very well on it. I
want to thank you for all the help in getting us to the point
where we are now. We went it alone like you had said we could
and we are very happy with the results. When we started this I
was worried it would be too much to handle because of all the
documentation involved. Your ISO 9001-2008 doc's were a
godsend. By doing it without a consultant, I believe you get a
lot better understanding of the quality system."

"Thanks for a great product that has exactly met our needs.
The documents are well laid-out, easy to alter and easy to
understand for general staff requirements. Your product has
significantly reduced the time and effort required to implement
ISO 9001. Everyone struggles when trying to write a manual or
procedures. I would prefer to spend my organization's quality
time and money on the continual improvement concepts of our
ISO-9001 system, as opposed to belaboring the semantics of a
Quality Manual". Pat, Enerflex More feedback...
Technical Questions
If our company does a corrective action, and it prevents the problem from
recurring, is this considered preventive action?
No, your corrective action is taken to prevent reoccurrence of
the problem; it is part of the corrective action process. In order
to be considered preventive action you must be preventing a
problem from occurring in the first place. One good place to
determine preventive action is during management review,
when you review data from the QMS. You can look at that data
to see what problems might occur in the future, and take action
to prevent them from occurring. You might also find
opportunities for preventive action by reviewing corrective
actions to see if the information shows you other problems that
might occur, and take action to prevent them.
How can we identify requirements not stated by the customer, but
necessary?
This requirement is found in Customer Related Processes;
these are "implicit" requirements. What do you know about
your product that the customer does not need to specify, or
may not even know themselves? You know the intended use of
your product, and are the expert on the product. If a customer
in a luggage shop requests "Carry on Luggage", they may not
know what the acceptable size is to be able to carry on the
bag. But the company that sells their bag as "Carry on
Luggage" should know what the restrictions are, and meet
those restrictions even though the customer did not know the
size they needed.
How can supplier performance be measured?
The most common aspects of performance that are measured
are quality, service and price. What can you put goals and
numbers to that will tell you how the supplier is performing in
each of these areas? Decide what the most critical aspects are
to you, is it an item that you can get from a number of
different suppliers? Is price, or on-time delivery the deciding
factor? Or is it an item or material that can vary in quality and
will affect the quality of your product? In this case, the supplier
with the most consistent quality may be the best source,
regardless of the price. Measure what is most important about
what is being supplied.
What are the "Eight Quality Management Principles", and how do they
relate to what is required by ISO 9001:2008?
ISO 9001:2008 is based on these principals. While they are not
part of the requirements of the standard, a good QMS will be
built around these principals. You should be familiar with the
principals, and consider how you can use them in building your
system. Can you incorporate them into your Quality Policy,
Quality Goals, and Quality Management System Review?
How is 7.5.1 "Control of production and service provision" different from
7.1 "Planning of product realization"?
In 7.5.1 the requirements focus on the processes that actually
create your hardware or your service that is delivered to your
customers. You are required to follow the plan that you created
based on requirements in 7.1
A written procedure for this section will be useful in defining
how you are meeting these requirements. By clearly
documenting the way that you are satisfying the requirements
of 7.5.1 you will ensure that the requirement are understood
and followed consistently.
Most organizations will also need documentation in the form of
work instructions to control these processes. Your planning in
7.1 will determine where these are needed; to meet the
requirements of 7.5.1 these must be in place, available to
employees performing the process. Instructions can take many
different forms: written steps, pictures, drawings, prints,
travelers or flow charts are some of the methods used. Specify
in your procedure what documents are necessary for the
control of your processes.
The procedure should also state how you ensure that suitable
equipment is used, and how release, delivery and post-delivery
activities are controlled.


Pre- Course Questionnaire
For
ISO 9001 QMS Lead Auditor
The purpose of this questionnaire is to help determine your knowledge of the ISO 9000
Series of quality management system standards. This Questionnaire should be completed
prior to attending the course and handed over to the course tutor during the registration
period on day one.
1. Identify the three main standards that form the ISO 9000:2008 series.
____________________________________________________________________
____________________________________________________________________
2. Briefly explain the purpose of each standard.
____________________________________________________________________
____________________________________________________________
________3. Identify the title of the five main sections within ISO 9001:2008
____________________________________________________________________
____________________________________________________________
______________________________________________________
4. Is continual improvement a mandatory requirement of ISO 9001:2008?
____________________________________________________________________
____________________________________________________________________

5. Define what is meant by the term Scope of a Quality Management System.
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
6. What do you understand by PDCA?

____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________
________7. Does the standard require measurement of customer satisfaction?
____________________________________________________________________
____________________________________________________________
____________________________________________________
8. Can registration to ISO 9004 be given by a third party registration body?
____________________________________________________________________
____________________________________________________________
______________________________________________________
9. Does the standard require an ISO 9001 registered organisation to only use ISO 9001
registered suppliers?
____________________________________________________________________
____________________________________________________________
________10. What is the purpose of ISO 19011?
____________________________________________________________________
____________________________________________________________________
11. What is difference between corrective and preventive action?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
___________________________________________________________________
12. Give your understanding of the term Quality Policy.
____________________________________________________________________
____________________________________________________________
________13. Within the standard, which clauses require a documented procedure to be
maintained?
____________________________________________________________________
____________________________________________________________________

14. Within the standard, identify six clauses, which require documented records to be
kept, and what clause determines this.
____________________________________________________________________
____________________________________________________________________
15. What records need to be maintained in connection with suppliers?
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________
________16. Which Clause within the standard requires measurable objectives to be
established?
____________________________________________________________________
____________________________________________________________
______________________________________________________

17. Identify two acceptable methods of measuring customer satisfaction.
____________________________________________________________________
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