Contact Information: Xlear Media Contact: Kevin Wilson 513.898.1008
Xlear Achieves ISO 9001:2000 and ISO 13485:2003 Certifications
Certifications Validate Company's Commitment to Quality in All Aspects of Business
| Source: Xlear, Inc.
OREM, UT--(Marketwire - September 13, 2007) - Xlear, Inc., a leading manufacturer of xylitol
products, today announced that it has achieved ISO 9001:2000 and ISO
13485:2003 certification for quality management, which is the recognized
international standard for medical device regulations around the world. The
certification, awarded by the BSI Group, validates Xlear's focus on quality
and allows the company to market Xlear
Nasal Wash around the world as a medical device. In addition, Xlear can
now affix CE marking to Xlear Nasal Wash packaging, indicating that it
meets the essential health and safety requirements established by the
European Union.
The certification process, which was completed following extensive
preparation and a three-day audit in January 2007, evaluated every aspect
of Xlear's business, from manufacturing to supply chain, and logistics to
customer service. BSI also completed a follow-up assessment in July 2007.
The ISO 9001:2000 quality management system provides Xlear with a management framework that
will allow the company to continually monitor and quickly improve
performance in any area of its business. By meeting the standards, Xlear
has demonstrated that it has made efforts to streamline operations and
reduce waste, manage risk and ensure that the needs of customers are being
consistently considered and met.
"ISO certification is one of the crowning achievements in our
organization's history," said Bob Astleford, director of operations for Xlear, Inc. "This recognition provides us
with the quality seal of approval that we need to expand our manufacturing
capabilities, and build business opportunities worldwide. Carrying the CE
marking also demonstrates that our products are safe and effective
according to EU standards, and European consumers can now benefit from our
time-tested, doctor-recommended products. ISO certification provides us
with a competitive advantage in a variety of areas, enhances our brand, and
allows our employees to make even more of a positive impact on the
direction and success of our company."
The certification was awarded to Xlear
in its new 25,000 square foot Orem headquarters, which was completed in the
fall of 2006. The building includes an industrial cleanroom, water
purification system, and plumbing and sanitizing capabilities that allow
Xlear to meet ISO manufacturing standards for its own products, as well as
expand its contract manufacturing operations looking for an ISO-certified
manufacturing partner. The company's goal is to use its new building 24
hours a day, seven days a week.
"We now have the quality management system in place that makes Xlear a truly attractive manufacturing
partner to a variety of product companies," added Astleford. "The
certification is a compliment to all of our employees that have worked hard
to ensure that we think about our customers first in every aspect of our
business. As a result, all of our customers will know that we build quality
into all of our products, and will now carry a mark of quality that cannot
be challenged by anyone."
About Xlear, Inc.
Founded in 2000, Xlear, Inc. is recognized as one of the leading
manufacturers of xylitol products in the United States. Xlear, Inc. is
committed to providing consumers with the health benefits of xylitol by
manufacturing all-natural, health-enhancing products. Xlear, Inc. offers
Xlear Nasal Wash, an award-winning, patented saline and xylitol solution; a
complete line of dental health products under the Spry Dental Defense
System brand; XyloSweet, raw xylitol crystals used as a sugar substitute in
cooking, baking and general consumption; and Fine & Dandy Candy, a growing
line of healthy, xylitol-based candies. Xlear, Inc. is a private company
with headquarters in Orem, Utah.