ISO 13485 Certified
Nalge Nunc International Management commitment to our customers
The Nalge Nunc International (NNI) Rochester, New York and Roskilde, Denmark
manufacturing facilities extended their Quality System to be in compliance to ISO 13485
in May 2003 and May 2004, respectively. This upgrade supercedes the ISO 9001 system that was in place
since May 1995. This new quality management system assures that our products are designed, manufactured
and distributed with the full commitment of the NNI organization. Our
registrar for Quality Management System certification has remained the British Standards
Institute. NALGENE® and NUNC™ Brand Products have long been recognized for their quality,
reliability and consistency. Our ISO 13485 certification is further proof of our commitment
to manufacturing quality products for our customers.
GMP Registered
Your added assurance
In March 1998, our Rochester, New York location was registered as a GMP (Good
Manufacturing Practices) facility for Class 1 devices (design exempt) with the Food and
Drug Administration. Selected NALGENE® and NUNC™ products comply with 21 CFR Parts 820 Quality
System Regulation. Adhering to GMP regulations for selected products is further proof of
our commitment to bring you consistent NALGENE® and NUNC™ quality.
To make sure we maintain our standards, we’re audited by an independent third party twice a year. Our loyalty to the highest standards is proof of our commitment to bring you the best quality.
All of our products come with a warranty: We will repair or replace most products at no charge. (For specific warranty details, see the technical information that accompanies your products.)
You can depend on our quality, we’re certain of it.
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