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2-15-05: I apologize, but this page has not
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Frequently Asked Questions
About ISO 9000
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ISO 9001:2000 Certification
CSC can help your company upgrade
your current quality system to the new ISO 9001:2000 revisions.
For more information please contact
us.
Why Should we become ISO 9001 Certified?
ISO 9001 is recognized as the quality management standard by more
than 130 countries worldwide (more than are in the United Nations!).
The US Department of Economic Development has forecast that by
2006 there will be 1,000,000 organizations registered to ISO 9001
word-wide. In the USA,
today there are approximately 50,000. But what are the reasons you
should be implementing the standard?
Organization - The first step to improving a process is to
gain complete control over it. When you have control, you have a
baseline from which to work. Effective use of ISO 9001 achieves
this control by understanding exactly what is supposed to happen
and knowing if it works. An additional
advantage of the ISO 9000 process is that it provides specific
targets for employees to meet. These targets motivate employees to
achieve, therefore maximizing their productivity.
Ease of Training - The importance of properly defined
training cannot be overstated. Using the documented procedures
laid down by the standard, new employees can grasp the
requirements of each task from the beginning. In this regard,
training is made easier and can be focused toward more specific
roles.
New Markets - With the technological advances made in the
last two decades, the business world has truly become a global
marketplace. The potential to increase your market by exporting is
massive. ISO 9000 certification is your passport to international
markets.
Competitive Advantage - As an internationally recognized
symbol of consistent and dependable quality, ISO 9000 provides a
substantial competitive advantage. It stands to reason that
registered firms would receive preferential consideration. Large
corporations and Government departments have already begun to
specify ISO 9000 as a prerequisite to contract bidding. Look at
your industry. Are your competitors already certified or working
toward ISO 9000?
Legal Liability - With product liability becoming an
increasingly important consideration, demonstrating "Good
Practice" is advisable. ISO 9000 provides:
external evidence of control over all processes, traceability of
product, complete records of production and efficient mechanisms
for product recall. In addition, if your company has ISO 9001 its
design process for new products will also be fully documented.
Cost -The most important factor in considering ISO 9000 is
this: companies who have implemented ISO 9000
standards have shown savings averaging from 10-15% per annum.
These savings result from better work practices, more efficient
time management and the reduction of direct quality costs such as
remakes. There will also be hidden cost savings such as the time
and energy currently invested in external audits conducted by
customers and suppliers. In addition, by determining these
customers and suppliers' individual specifications, you will
impress upon them the importance of their needs to your company.
A recent ISO 9000
press release from the International Organization for
Standardization provides the following information:
* At the end of 1998, more than 270,000 ISO 9000 certificates were
issued; an increase of 48,500 over 1997.
* 143 countries had ISO 9000 certificates issued, up from 128 at
the end of 1997.
* The USA and Italy showed the highest growth rate in 1998, with
6,406 and 5,961 certificates issued respectively.
* Europe accounted for 83% of certificates issued for ISO 9000.
* The Far East, which accounted for 2% of all certificates in
1997, is now at 14%.
Key Benefits of ISO
9000 Certification
Many experts believe that the driving factor to become
"Quality Certified" is market pressure. Very simply,
organizations that can demonstrate higher quality will out-perform
those that cannot, or will not.
The reason is obvious: quality, in products, services, practices,
and procedures is a competitive asset; and a variety of private
and public sector facilities are actively developing formal
quality programs.
Organizations that
become Quality Certified are able to:
Improve
business efficiency
Ensure
quality and repeatability of results
Ensure
timely, accurate, accessible information
Develop
"best practices" and eliminate costly surprises
Save
administrative costs
Facilitate
the organization's ability to obtain contracts
Enter new
markets that may have been previously closed
Enhance
credibility for procurements requiring teaming
Enhance
credentials for professional publications and research
Facilitate
patent filings
Why should we choose
CSC as our partner?
CSC has developed a proven
implementation method that will document your system, train key
personnel to manage it and prepare you for your registration
assessment. Whether your company is large or small, manufacturing
or providing a service, we can help you implement an ISO 9001
based Quality Management System. Many of CSC's customers are small
companies (2-30 employees) where resources are limited but who
need an ISO 9001 registration. Our contribution involves our
experience as specialists trained in the ISO 9000 philosophy, and
our background in business management. We also possess experience
in guiding other firms through the same process.
To take the time to train your staff for this level of specialist
knowledge would be counter-productive for most. As with attorneys
and accountants, it is often advisable to trust the experts to get
you through the process. Could you do the same thing yourself?
Perhaps, but at what cost ultimately? Your staff is hired to
operate and manage your business enterprise, not to learn how to
prepare for a registrar’s audit.
CSC offers
comprehensive services that will help you achieve your Quality
goals. We can:
Help you select a Registrar that has experience in your industry
Conduct an
initial company review
Help you
establish policies and objectives
Identify
documentation requirements
Prepare
documentation
Manage
implementation schedules, training and follow-up actions
Conduct
training on Internal Auditing, SPC, Gage R&Rs, FMEAs, etc.
Identify and
implement electronic tools to better manage these systems
Conduct
internal audits
Complete
corrective actions
Conduct
vendor and supplier audits
Help you
maintain your quality program
As part of our
normal approach we complete a full assessment prior to the
registration audit. All members of our team are trained Lead
Auditors, so assessments are carried out in the same way, and to
the same standard, as the Registrar.
For more information
on ISO 9000 certification programs please
contact
us.
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Internal Auditor Training
Interested in Training your Internal Auditors?
Internal Auditing is one of the elements assessed in the Quality System
audit. The better your audit team the better your system. CSC has
developed an internal auditing course for companies going through
registration, as well as for registered companies who want to expand their
audit team.
We customize each program to fit your
needs. If you have an existing documented system, we can integrate your
own procedures and audit forms into the program so that the training will
be conducted on processes and procedures familiar to those being trained.
Courses for new auditors are generally
2-3 days, depending on the complexity of your business and are
provided at a location of the customer's choice.
Auditor improvement courses can be
provided in as little as 1/2 day, minimizing the impact on your
operations.
Each participant receives a comprehensive
internal auditor training package that includes detailed
interpretations of the ISO 9001 standard as well as auditing
tips for each ISO requirement and standard audit forms.
Finally, what makes our course so
effective is that we can include an optional supervised internal audit on the final day
of the course so that the participants get some immediate hands-on
training.
For more information on Internal Auditor
Training please contact
us.
Additional Training Courses
Interested in Training?
CSC offers several different quality management training programs
specifically directed to ISO 9001, TS 16949, QS 9000, ISO/IEC 17025, and ISO
9000-3 / TickIT certification. We provide quality system awareness training for
organizations thinking about developing an approved quality management
system. We also provide staff and management-level training for firms that
have already begun the process to become certified.
We also possess many attributes above and
beyond the implementation of Quality Management Systems. Here are some
examples of programs we can provide:
Electronic Document and Forms Management
Statistical Process
Control
Measurement System
Analysis/Gage R&R
Failure Modes and
Effects Analysis
Cost of Quality
Measurement
Other programs have been customized to
the clients' requirements. If you have a quality management related problem and are
not sure how to handle it, we will give you an honest answer.
For more information on these training
programs please contact us.
Frequently Asked Questions
ISO 9000
What is ISO?
The International Organization for Standardization (ISO) is the
international agency for standardization. At present, it comprises the
national standards bodies of 91 countries. The American National Standards
Institute (ANSI) is the member body representing the United States. ISO is
made up of approximately 180 Technical Committees. Each Technical
Committee is responsible for one of many areas of specialization ranging
from asbestos to zinc. The purpose of ISO is to promote the development of
standardization and related world activities to facilitate the
international exchange of goods and services, and to develop cooperation
in intellectual, scientific, technological, and economic activity. The
results of ISO technical work are published as international standards.
The standards discussed here are a result of this process.
What are the ISO 9000 series standards?
The ISO 9000 series is a set of 3 individual, but related documents on the
concepts of quality management systems. They
are generic, not specific to any particular products or organizations. They can be used by
manufacturing and service industries alike. These standards were developed
to effectively develop, implement and improve an organization's quality
management system. The ISO
9000 Series of standards do not themselves specify how you have to do
anything, just what you have to consider.
There are several benefits to implementing this series in your company.
For example, it will guide you to build quality into your product or
service and avoid costly, after-the-fact inspections, warranty costs, and
rework. In addition, you may also be able to reduce the number of audits
customers perform on your operation. Increasingly, customers are accepting
supplier quality system registration from an accredited third-party
assessment based on these standards.
How does the Series work?
ISO 9000 as a stand alone document provides definitions and terminology
for use with IS 9001. ISO 9001 is "The "Standard" which
organizations get certified / registered to. ISO 9001 was originally developed
for use in contractual situations such as those between a customer and a
supplier. ISO 9004 provides guidelines for improving the performance of
your quality management system to meet business needs and take
advantage of opportunities.
Are there U.S. standards that are the
same as the ISO 9000 Series?
Yes. The United States adopted verbatim the ISO 9000 series as the ANSI/ASQ
Q9000 series.
Who is using them?
Everyone!!! Organizations around the globe have built and continue to build their
quality management systems around these standards. Both large and small companies
with international businesses perceive the ISO 9000 series as a route to
open markets and improved competitiveness. You don't have to be a
multinational corporation or have business overseas to benefit from
implementing these standards in your company.
What about the Malcolm Baldridge National
Quality Award, the Deming Prize, etc.? Aren't these programs equivalent or
better "standards" than the IS0 9000 series?
The answer to this question is simple: you can't hope to meet the
expectations of any of these programs if you aren't already implementing
the ISO 9000 standards in your company. These standards
provide the foundation on which you can build your quality management and
quality assurance systems so you may ultimately achieve a high level of
success. Moreover, the ISO 9000 series is the only system accepted
internationally.
Are there any additional guidelines for
the ISO 9000 (ANSI/ASQ Q9000) series?
Yes. ISO 9004-2 was prepared as a guideline for service industries and ISO
9000-3 deals with software. In addition, there is the ISO 19011 standard on various aspects of auditing quality
management systems. There are
also documents on guidelines for implementing ISO 9001;
project management; process industries; configuration management; quality
plans; quality manuals; economics of quality; and continuous improvement.
Of course, there is the vocabulary document ISO 8402 (ANSI/ASQ A8402) that
defines the terminology contained in the ISO 9000 series.
Are the standards readily understood?
The standards were designed to be user-friendly. They are generic in
nature and follow a logical, easily understood format. However, each
company is unique and there may be wide differences in companies'
readiness to implement the standards.
How much will it cost and how long will
it take to implement these standards?
Unfortunately there is no set answer. Each company is different. The
answer really depends on how developed your present system is and the
implementation strategy you adopt.
I'm hearing a great
deal about being registered to ISO 9001. What does this mean?
Of all the questions about the ISO 9000 series, this is probably the one
that causes the most concern. Increasingly, European and other foreign
customers expect U.S. companies to have their quality systems registered
to ISO 9001. This generally involves having an accredited
independent third party conduct an on-site audit of your company's
operations against the requirements of the standard. Upon
successful completion of this audit, your company will receive a
registration certificate that identifies your quality management system as being in
compliance with ISO 9001. Your company will also be listed
in a register maintained by the accredited third-party registration
organization. You may publicize your registration and use the third-party
registrar's certification mark and the accreditation body's mark on your
advertising, letterheads, and other publicity materials (but not on your
products).
How long does it
take to get certified?
Certification times vary. Companies have been certified in as little as 3
months or in as many as 3 years. On average though, you can plan on 9 to
18 months from the time you decide to get certified until your
registration assessment, depending on the resources that you dedicate to
these efforts.
How hard is it to implement an ISO/QS
system?
How hard your implementation will be depends completely on what your
current system is like. If you have a fairly good system (you review most
of what you do; you control most of what you do; you document much of what
you do and you do what you document), then implementation will be fairly
easy. Unfortunately, most organizations don't review or control as well as
they should - hence the standards.
If my company is not registered as
complying with IS0 9001, does it mean that we
will not be able to sell our products globally?
ISO 9000 registration is not a legal requirement for access to foreign
markets, but it can be beneficial. In the European Union (EU) for many
regulated products, ISO 9000 registration is an alternative for product
certification, not an absolute requirement. In fact, as cited in most EU
legislation, quality system registration is neither mandatory--there are
other paths to product certification--nor is it a stand-alone procedure.
Manufacturer compliance with either EN 29002 or 29003 is usually combined
with product type testing at the design stage for full certification to EU
legal requirements. Manufacturers interested in the European markets need
to review relevant EU product safety directives available from the U.S.
Department of Commerce for specifics applicable to their product area.
Outside of regulated product areas, the importance of ISO 9000
registration as a competitive market tool varies from sector to sector.
For instance, in some sectors, European companies may require suppliers to
attest that they have an approved quality system in place as a condition
for purchase. This could be specified in any business contract. ISO 9000
registration may also serve as a means of differentiating
"classes" of suppliers, particularly in high-tech areas, where
high product reliability is crucial. In other words, if two suppliers are
competing for the same contract, the one with ISO 9000 registration may
have a competitive edge with some buyers. Sector and product areas where
purchasers are more likely to generate pressure for ISO 9000 registration
include aerospace, autos, electronic components, measuring and testing
instruments, and so on. ISO 9000 registration may also be a competitive
factor in product areas where safety or liability are concerns.
How long is a registration valid?
The accredited third-party registrar will perform periodic surveillance to
assure that your quality system is being maintained. Registrars are also
required to perform a full re-audit after a specified time (typically three or four
years). If you fail to maintain your quality system, the registrar will
suspend or cancel your registration.
Is being assessed to ANSI/ASQ Q9001,
the same as being assessed to ISO 9001?
Yes, but to eliminate debate, make sure that the third-party registrar
includes both the ISO number and date and the ANSI/ASQ number and date on
your registration certificate and in the registrar's published directory
of registered suppliers (for example, "ISO 9001-2000; ANSI/ASQ
Q9001-2000").
If I decide IS0 9001 registration is
strategically right for our business, how do I choose a competent
registrar?
There are many factors that will affect your choice of a registrar, such
as: what is their mutual recognition status, are they knowledgeable in my
industry as well as in auditing quality systems, how many similar firms
have they registered, what is re-audit schedule and does it complement our
business cycle, and, most important, are they accredited. Your selection
of an accredited registrar won't automatically guarantee access to all
global markets, but it is the best way to ensure that you have a competent
registrar whose methods of operation and qualifications have been
subjected to intense scrutiny, with the full weight of the ANSI due
process system behind it. It can give you assurance that the dollars you
invest in this decision are spent wisely. The
Registrar
Accreditation Board and the American
National Standards Institute work continuously on behalf of U.S.
industry so that registrars accredited in the United States will be
recognized internationally.
What is QS 9000?
QS-9000 is the shorthand name for "Quality System Requirements
QS-9000." It is the common supplier quality standard for Chrysler
Corporation, Ford Motor Company, and General Motors Corporation. QS-9000
is based on the 1994 edition of ISO 9001, but it contains additional
requirements that are particular to the automotive industry. These
additions are considered automotive "interpretations" by the ISO
community of accreditation bodies and registrars. QS-9000 applies to
suppliers of production materials, production and service parts, heat
treating, painting and plating and other finishing services. It does not,
therefore, apply to all suppliers of the Big Three. For more information
see the QS 9000 FAQs.
ISO 9000 Faces Complete Restructuring
Under 2000 Revisions
The ISO 9000 quality management systems (QMS) standards are set to take on
a completely different look under revisions slated for release in November
or December of 2000. The International Organization for Standardization
(ISO) requires all of its standards to be reviewed every five years to
determine whether they should be confirmed, revised or withdrawn. ISO
9000, first released in 1987, underwent limited revisions in 1994. A more
thorough revision was begun by ISO Technical Committee (TC) 176, Quality
Management and Quality Assurance, in 1996, with Subcommittee (SC) 2,
Quality Systems, developing revision drafts. The First Committee Draft
(CD1) of the ISO 9000: 2000 standards was released in July 1998, with the
Second Committee Draft (CD2) published in February 1999 and the Draft
International Standard (DIS) released in November 1999. These drafts
consist of four primary standards, replacing more than 20 standards and
documents.
The four primary standards are:
ISO 9000: Quality Management Systems - Fundamentals and Vocabulary,
replacing ISO 9000-1 and 8402
ISO 9001: Quality Management Systems - Requirements, replacing ISO
9001, 9002 and 9003
ISO 9004: Quality Management Systems - Guidelines for Performance
Improvement, replacing ISO 9004-1
ISO 19011: Guidelines on Auditing Quality and Environmental Management
Systems, replacing ISO 10011-1, 10011-2 and 10011-3, as well as the
ISO 14010, 14011 and 14012 environmental auditing standards
Other old ISO 9000 standards and
documents are being reviewed by ISO/TC 176 for incorporation into the new
standards, withdrawal or reissue as technical reports. The new standards,
particularly ISO 9001, are being designed to be more generic, to follow a
process-based structure, to be more compatible with the ISO 14000 series
of environmental management systems (EMS) standards, and allow for
integrated management systems. Under the 2000 revisions, ISO 9001 becomes
more generic through the new option of being tailored to omit requirements
that don't apply to an organization or limit the scope of application
under Section 1.2, Permissible Exclusions. This eliminates the need for
the less comprehensive ISO 9002 and 9003 standards. In addition, there are
no QMS documentation layout or structure requirements.
The new process-based structure, similar
to that used in ISO 14001, creates a completely different look for ISO
9001. The 20 elements have been replaced by five clauses containing 23
elements. The two standards are more compatible under this approach,
making it easier to integrate management systems and combine
documentation.
ISO 9004, Section 4.3 and ISO 9000,
Section 0.2. set forth eight quality management principles, which
have been identified to facilitate the achievement of quality objectives.
These principles are the basis of ISO 9001. They are:
Customer Focus
Leadership
Involvement of
People
Process Approach
System Approach
to Management
Continual
Improvement
Factual Approach
to Decision Making
Mutually
Beneficial Supplier Relationships
Major clauses of ISO 9001: 2000 are:
Quality Management System (2
elements), which briefly states general requirements, including such
documentation as procedures and work instructions. It sets the general
framework to establish a quality management system, which defines and
manages processes in order to produce a good product or service and
allow for continual improvement.
Management Responsibility (6 elements), under which management
defines policy, objectives, planning and quality management system
requirements, while providing for feedback through management review for
change authorization and initiation of improvement. It addresses
management's responsibility to establish a system that continually meets
customer needs and expectations, even in times of organizational change.
This responsibility includes quality objectives at each organizational
function and level.
Resource Management (4 elements), where necessary resources, such
as human resources and facilities, are determined and applied. Theses
resources, which include new elements covering facilities and work
environment, are required to implement and maintain the quality
management system.
Product Realization (6 elements), under which processes, such as
customer-related processes, design, purchasing, and production and
service operations, are established and implemented. These processes are
needed to manufacture product and/or deliver services from receipt to
delivery. Organizations must define and describe their unique business
processes, but are not obliged to use the standard's structure.
Measurement, Analysis and Improvement (5 elements), where results
are measured, analyzed and improved through internal audits,
nonconformity control and continual improvement. Organizations are
required to measure and monitor processes, and product and/or service
conformity. Collected data must be analyzed to initiate corrective and
preventive action for continual improvement.
2-15-05: I apologize, but this page has not
been updated for a while now. My main focus these days is "Free
Stuff" and "Links".
Please contact me directly
for more information on how I can assist you.
|