Q: How many companies are certified to ISO
A: Per International
Organization for Standardization (ISO), by the end of 2004 there
were some 650,000 registered companies to this standard
Q: What are the benefits of ISO certification?
A: The benefits are numerous. Internally, your
company will use a management system that allows consistent
quality of products and services. Having an ISO certificate
helps your company to market its products and services to your
prospects as ISO certifications become a good credential
indicating that your company focuses on quality, customer
satisfaction and continual improvement. For more details on
benefits of ISO certification visit our
Download page and check our The Perfect Manual book.
Q: My company is planning to start
implementation of an ISO 9001 compliant system. Where can I find
basic information to start educating our staff?
A: There are literally countless resources on
the Internet on ISO and its standards. Searching for "ISO", you
most likely will end up with 100,000 plus results. You may start
from the ISO Website If you need a summary of benefits and do
not have much time for research, visit our
Download page and check our The
Perfect Manual book.
Q: What size of companies are your manuals and
procedures designed for?
A: Our materials are designed to address
requirements of particular standards; therefore our manuals and
documentation sets can be used by a company of virtually any
type and size. Feel free to check as an example our
ISO 9001: 2000
Q: How do I know if your quality and
environmental manuals and procedures will be suitable for my
A: Our ISO 9001, ISO
13485 and ISO 14001 manuals and procedures were designed to
address requirements of particular standards not industries. As
defined in element 1.2 Application of the ISO 9001:2000
Standard: "All requirements of this International Standard are
generic and are intended to be applicable to all organizations,
regardless of type, size and product provided" (ISO 9001).
Q: Does your company provide technical support
for your ISO 9001, ISO 13485 and ISO 14001 products that I
A: Our products do not require any technical
support. In fact, since the beginning of our operation in 1998
we did not receive a single inquiry for support. Our templates
are in Microsoft® Word and Excel formats and if you are
basically familiar with these programs, you are ready to go.
Please check samples of our documents on our
Q: Can I call you, if I have a question about
use of your manuals and documentation sets or management systems
A: Yes, you are welcome to call
us if you have such questions. We will be glad to assist you. If
you need help beyond a short conversation with your quality or
environmental management systems, we offer various consulting
Q: My company has been registered to ISO 9001
for a few years and now we plan to register to ISO 14001
standard. Do we need to establish separate ISO 14001 manual and
documentation for the new standard?
A: In our strong opinion, no! Our approach to
documentation of quality and environmental management systems is
optimization. If your company already have a Records Procedure
or Documentation Management Procedure, we can not justify
duplication of documentation - the processes are the same. Of
course you will need to develop and implement ISO 14001 specific
procedures, such as Environmental Aspects, Programs, Emergency
Preparedness, etc. This is the reason why we developed an
Integrated ISO 9001 / ISO 14001 Manual. Feel free to check our
Download page for a preview version
of ISO 9001 / ISO 14001 Integrated Manual
Q: We are a medical device manufacturing
company. ISO 13485:2003 excluded a number of requirements of ISO
9001, such a customer satisfaction. We feel that this is an
important element of building a loyal customer base. How can we
get around these differences and still comply with the standard?
A: A number of companies that we worked with in the
medical device industry have a similar opinion. We agree, while
compliance with regulatory requirements is the key element for a
company in a regulated environment, it may assist business to
know how satisfied their customers are. Based on our experience
in this area, we developed an Integrated ISO 9001 / ISO 13485
Quality Manual to allow a company to choose what set of
requirements fits its needs the best. Feel free to check our
Download page for a preview version
of ISO 13485 / ISO 9001 Integrated Manual
Q: Our company has a manufacturing facility in
Mexico. Many QMS documents were translated and now we have two
sets of manual and many procedures. When Spanish version is
changed, the English version often is forgotten. What can we do
to link bi-lingual documents to avoid this problem?
A: This is a typical
problem with multi-lingual documentation. The best solution we
found through years of working in this environment is to create
a single bi-lingual document formatted in two columns. With this
approach, it is easy to ensure that text in both languages will
be modified when needed.
Q: Can you guarantee our certification if we
purchase and use your manual and procedures?
A: The simple and straight-forward answer is
"No". This is simply because registrars are not looking just at
your manuals and procedures. They are looking at the
effectiveness of your quality or environmental management
system. Our manuals and procedures designed to save you time and
money on developing an effective quality or environmental
management system. Commitment of you management team to and
active involvement of all employees in your management system
will guarantee your certification!
Q: How long does it take to develop an ISO
9001 quality management system to be ready for a certification
A: Like anything else,
it depends on the effort, time and resource commitment of the
company. We have worked with companies that received
certificates in just 3-4 months, and we witnessed other
companies dragging the process for years. As a rule, most
registrars expect to see at least 2-3 months worth of records
demonstrating evidence of effectiveness of the system, so if
your management is totally committed and you have all the
resources you need, you may count on 3-4 months. Realistically,
average time would be around 6-9 months. Feel free to visit our
Consulting pages and contact us to discuss ways of optimizing
your pre-certification process.
Q: We are a small company. As a Quality
Manager I developed the entire system and am responsible for it.
How can we audit our quality system and comply with the
requirements of the standard?
A: There are two ways
you can audit your system in this situation. You may train an
employee, who is independent of activities audited or you may
consider external resources, such contract auditors. Feel free
to check our Auditing pages - we offer auditing and
pre-certification audit assistance to companies like yours.
Q: How do I know that your
company is a reputable business which I can trust?
A: Quality Works has
been in business since 1998. We served hundreds if not thousands
of customers around the World. We are a member of a local Better
Business Bureau chapter and BBB On-line Reliability Program.
Just click on the BBB On-line logo to check our BBB record.
Q: How do you deliver you documents, when
I order them?
A: All purchased
materials are e-mailed to clients after we receive purchase
confirmation from PayPal. Depending on our travel schedule, you
may receive your order within 30 minutes to 2-3 business days.
Call us today to discuss
your specific ISO management system needs!