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ISO 9001:2000 Registered
To achieve ISO 9001:2000 certification by the International Organization
for Standardization — a worldwide governing body — a
company must demonstrate that it has an effective quality assurance
system that satisfies all the required applicable industry standards.
An external auditor, or registrar, conducts an onsite audit of
the company’s manufacturing processes to determine if it
is in compliance with that industry’s best practices.
Puritan is ISO 9001:2000 Registered, and all production comes under
the most stringent quality controls.
ISO 13485:2003 Medical Device Regulations
ISO 13485 is the ISO 9000 for medical device manufacturers. Embracing the FDA’s good manufacturing practices, this standard defines terms such as: medical device, active medical device, active implanted medical device, sterile medical device, and more.
This international standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
CE
Mark Certified
CE Mark certified signifies conformance to a unified set of product
regulations common to all countires in the European Union. Products
bearing the CE Mark indicate that the manufacturer has met or
exceeded all standards established by the EU’s governing
body in its safety regulations.
FDA Registered
Puritan brand products are manufactured under FDA requirements
for medical devices. Our Quality Systems conform to the Food and
Drug Administration’s Good Manufacturing Practices (GMPs).
Our quality control procedures include the following: verification
and documentation of raw materials and machine settings; visual
examinations of finished goods for correct raw materials, labels,
packaging, dimensions, contamination and tip adhesion. Results
are recorded and records maintained for five years.
Our
Customers
Leading national medical distributors whose products you find
in hospitals, emergency, and treatment rooms across the country,
partner with us for their many private label products. We manufacture
proprietary applicators and provide specially packaged and promotional
products for the major diagnostic and pharmaceutical companies
in the U.S. and abroad.
Anthrax
Testing
U.S. diagnostic companies are working hard to meet the challenge
presented by the pressing need to wage a war against bio-terrorism.
Puritan Medical Products Company works closely with this industry
in the development of swabs for the rapid tests being designed
for the detection of pathogens such as anthrax.
Environmental
Partnerships
Puritan and its suppliers support responsible forestry practices
and are signatories to certification programs such as The Sustainable
Forestry Initiative and the Chain of Custody program. We value
our country’s environmental heritage and are committed to
doing our part to assure that our forests, lakes, and streams
are here for America to enjoy for generations to come.
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