Huestis Medical - Remanufacturing Accreditations

Note

The "ISO" name, meaning equal
(as in isometric, isobar, etc.), was chosen by IOS founders for their belief that the development and use of standards would make all things equal.

Huestis Medical applies these exacting ISO 9000 standards to its manufacturing and remanufacturing processes to provide consistent, reliable, and world-class quality.

Remanufacturing — Accreditations

ISO9002 logo Huestis Medical has assembled a collection of achievements and accreditations to document our commitment to quality remanufacturing. Our objectives and procedures are fully documented with an impressive array of accomplishments including ISO 9001/9002 and EN46001 registration.

We also have an active membership in IAMERS (International Association of Medical Equipment Remarketers and Servicers) and hold various state and FDA registrations.

ISO 9000 Quality Registration

ISO 9000 Series Standards, developed by the International Organization for Standardization (IOS), fundamentally represent a company's ability to demonstrate that it has an appropriate quality management system for the products or services it offers, and that it has been audited to assure that these standards are being met.

ISO 9001 and 9002 Standards are the most comprehensive standards in the ISO system. ISO 9001 pertains to companies that have functions that perform design/development, production, installation and servicing, while ISO 9002 Standards govern production and installation. The "ISO" name, meaning equal (as in isometric, isobar, etc.), was chosen by IOS founders for their belief that the development and use of standards would make all things equal. Huestis Medical applies these exacting standards to its manufacturing and remanufacturing processes to provide consistent, reliable, and world-class quality.

IAMERS

Huestis Medical is an active member of IAMERS (International Association of Medical Equipment Remarketers and Servicers), a self-regulating organization whose members must agree in writing to a strict code of "ethics." The purpose of the association is to educate consumers on quality remanufactured equipment and to enforce high standards of ethical and professional practices among its members. This is done in cooperation with the US Food and Drug Administration, the Commerce Department, and the State Department.

Department of Health and Human Services

Huestis Medical (American Radiographics, Inc.) is registered with the Department of Health and Human Services, Public Health Service for the Food and Drug Administration, as a rebuilder/refurbisher of Radiology equipment. The registration number for the American Radiographics Division is 1221678. For the Pro-Tronics Division, the registration number is 1219183. Huestis Medical is also registered with the Commonwealth of Massachusetts as a remanufacturer of X-ray equipment.

Good Manufacturing Procedure

Huestis Medical observes Good Manufacturing Procedure as set forth by the FDA. All equipment is labeled and compliant with the FDA's latest regulations.

Military Standards

Performance and reliability drives Huestis manufacturing. Our quality assurance conforms to MIL-I-45208A, MIL-C-45662 and MIL-Q-9858A.

Comprehensive Users' Lists

Our customers are our best salespeople. Ask about our complete users' listings of Huestis Medical remanufactured systems.