|
FONAR and ISO 9001 Certification:
What it Means to You
The FONAR Experience
FONAR earned ISO 9001 certification in April
1999 for the Design, Manufacture, Administration of Installation,
and Servicing of Magnetic Resonance Imaging Scanner Systems.
Fonar is using ITS (Intertek Services), the world's largest
industrial testing and certification company, as our accredited
registrar.
We learned as we were striving towards
ISO certification that it is all about an attitude and commitment
towards a complete quality system. By thinking in terms of
an organizational system as we each do our jobs, we behave
in ways that support others in the system. Everyone at FONAR
is part of the ISO certification experience -- marketing,
sales, research and development, customer service, shipping,
receiving. It is not just a manufacturing system, but a company-wide
way of doing business that puts the customer and his or her
needs at the center of all we do. ISO certification is not
a one-time event - it is just the first step in on-going continuous
quality improvement.
What is ISO?
ISO, the International Organization for
Standardization, is a worldwide federation of national standards
bodies from over 90 countries. 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 and
economic activity.
The American National Standards Institute
(ANSI) represents the United States in the International Organization
for Standardization. It is a private, non-profit membership
organization composed of private and public sector organizations,
and in fact was a founding member of ISO. ANSI does not develop
American National Standards but facilitates their development
by establishing consensus among qualified groups. ANSI also
has a role in governing the ISO.
What are Standards?
The ISO family of standards represents
an international consensus on good manufacturing practices
that ensures that the organization can deliver, time and time
again, the products or services that meet the client's quality
requirements.
When an organization has a management system
certified to an ISO 9000 standard, it means that an independent
auditor has checked that the processes influencing quality
conform to the relevant standards requirements. The objective
is to give an organization's management and its customer's
confidence that the organization is in control of the way
it does things.
International Standards were created to
facilitate trade, exchange and technology transfer through
enhanced reliability and effectiveness of the goods and services
we use.
While no organization must be ISO 9000
certified, it is fast becoming the standard for conducting
business in the international arena. In fact, ISO 9000 is
the only quality system accepted internationally. Many companies
in the European Community have already become ISO certified
and in some sectors, European companies require suppliers
to prove that they have a quality system in place as a condition
of purchase.
ISO 9000 certification is becoming widespread
in the United States as well. The big three auto manufacturers
have implemented quality management systems that conform to
ISO 9000 standards. Some U.S. government agencies, including
NASA, are implementing or considering implementing ISO 9000,
or are using the standards as guidelines within the agency.
For up-to-date information regarding agency participation,
check with the National Institute of Standards and Technology's
clearinghouse on federal ISO 9000 activities.
ISO 9000 series is a set of five individual,
but related, international standards on quality management
and quality assurance. They are generic and not specific to
any particular product or services.
ISO 9000 Quality Management and Quality
Assurance Standards - Guidelines for Selection and Use
ISO 9001 covers design, manufacturing,
installation and service (EN 46001 / ISO 13485 are specific
for Medical Devices)
ISO 9002 covers production, installation
and service
ISO 9003 covers final product inspection
and testing
ISO 9004 provides guidelines for internal
use by a producer developing its own quality system to meet
business needs.
What ISO is Not
It is important to point out that ISO 9000
certification does not indicate product quality for any product
or group of products. Rather ISO 9000 certifies that a company
has a Quality Management System in place and more importantly,
that it adheres to this system in conducting its business.
The standards in ISO are general enough that any manufacturing
organization can apply them.
Why Become ISO Certified?
ISO certification guides companies in building
quality into its products and services and helps to avoid
costly after-the-fact inspections, warranties and rework.
As a customer of FONAR, you can be confident that you will
benefit from:
For More Information
For those of you who like to browse the
Internet, here are a few on-line references:
|
