The Thermo Fisher Scientific 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 supersedes 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 Thermo Fisher Scientific organization.

In 2009 Thermo Fisher Scientific announced a global initiative for a single ISO Quality registrar. Our new Quality Management System registrar is QMI-SAI. The Rochester facility is currently registered and the Denmark facility is in the process of completing its registration.

Thermo Scientific Nalgene and Nunc 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.

You may download a PDF rendition of our ISO Certificate for our Rochester, NY location (PDF, 664K), also covering activities conducted at our Fairport, NY facilities.

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 are audited by an independent third party once 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 are certain of it.