Troemner Quality and Safety Certifications

ISO

ISO 9001ISO 9001 Certifications: In 1993, Troemner was one of the first companies in the Philadelphia area to achieve ISO 9001 accreditation. Troemner has a thoroughly documented quality system that ensures our customers receive the products and services they request. Troemner’s ISO 9001 quality system has been audited regularly by internal, external, and customer auditors, to ensure our continued compliance with this standard. Troemner has also been accredited since 1995 to meet the requirements of ISO/IEC 17025 “General Requirements for the Competence of Testing and Calibration Laboratories” (formerly ISO Guide 25). In 2013, Troemner’s quality system achieved ISO 13485 accreditation for the design and manufacture of Class I medical devices.


ISO 13485In 2013, Troemner, LLC announced the achievement of ISO 13485: 2003 Certification for their quality management system by NQA (National Quality Assurance, USA) one of the largest and most respected ISO registrars in the world. The company has taken the next step and is now officially registered with the FDA in the United States. Both the ISO 13485:2003 standard and the FDA 21 CFR Part 820 regulation are internationally recognized and require a thoroughly documented quality management system which focuses on the customer, management, internal procedures and processes. By meeting the requirements of these standards, Troemner ensures they have the ability to design and manufacture medical devices that consistently meet customer and regulatory requirements.


UL

ULProducts with this symbol are listed by Underwriters Laboratories, Inc. and have been evaluated by UL and meet their applicable standards. UL has developed more than 800 Standards for Safety. Our Standards for Safety are essential to helping ensure public safety and confidence, reduce costs, improve quality, and market products and services. Millions of products and their components are tested to UL’s rigorous safety standards with the result that consumers live in a safer environment than they would have otherwise.


CUL Listed

CULUL’s Certification Organization accreditation for Canada encompasses all UL global testing facilities, services, product categories and programs.



CSA

CSACanadian Standards Association - Products with this symbol assures you that the product meets certain safety standards and/or performance criteria set by the Canadian Standards Association. Troemner, LLC complies as listed for the following safety standards as listed in each piece of equipment we sell.


TUV

TUVTÜV SÜD is a globally recognized testing, inspection, and certification organization offering the highest quality services for a wide range of industries worldwide. A product with this symbol assures you that the product meets certain internationally recognized safety standards and/or performance criteria set by the International Electrotechnical Commission (IEC).


CE Mark

CEThe CE mark (officially CE marking) is a mandatory safety mark on many products placed on the single market in the European Economic Area. The CE mark is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. To permit the use of a CE mark on a product, proof that the item meets the relevant requirements must be documented. Sometimes this is achieved using an external test house which evaluates the product and its documentation. Often it is achieved by a company-internal self-certification process. In any case the responsible organization (manufacturer, representative, importer) has to issue an EC-Declaration of Conformity (EC-DoC) indicating his identity (location, etc.), the list of European Directives he declares compliance with, a list of standards the product complies with, and a legally binding signature on behalf of the organization.


Safety Standards

Troemner, LLC complies with the following safety standards as listed in each piece of equipment we sell.


IEC

IEC 61010-0

Safety requirements for electrical equipment for measurement control and laboratory use.


IEC 61010-2-010

Particular requirements for laboratory equipment for the heating of materials.


IEC 61010-2-051

Particular requirements for laboratory equipment for mixing and stirring.


Declaration of RoHS Conformity


With reference to the Directive 2011/65/EU on the restriction of use of certain hazardous substances in electrical equipment (RoHS), recast of the previous 2002/95/EC Directive, the Company Troemner, LLC, based in 201 Wolf Drive, Thorofare, NJ, USA, declares that 230V Laboratory Products satisfy the requirements of the RoHS Directive beginning July 22, 2014.


Based on what above stated, Troemner, LLC actively maintains the necessary action to ensure Supply chain’s continuity. In particular: the update of the needed information concerning the evolution of the RoHS Directive, the search for alternative Suppliers in order to ensure the continuity of supply, research and development of alternative substances and processed to ensure Customer continuity, quality and performance of its products.

View our Declaration of RoHS Conformity