The International Association of Medical Equipment Remarketers (IAMERS) announced on Monday that the association will raise the bar on professionalism by developing educational opportunities to help members obtain International Standards Organization (ISO) certification.

IAMERS, established in 1993, has its membership based in companies that sell and service pre-owned diagnostic imaging equipment. Their mission is to promote and sustain professionalism and ethics among members. Many of these members do currently hold ISO certification, but the association wants to increase certification to encompass every member. "IAMERS is the only trade association that specializes in pre-owned sales and services in diagnostic imaging equipment. We've always held our members to a high level of professional ethics and knowledge and this is another way we can display that requirement," said IAMERS President Diana Upton.

The certification is offered through the International Organization for Standardization, the world's largest developer and publisher of international standards. "ISO is a known way to establish a level of professionalism that end users can have confidence in. It's the gold standard."

Part of the rationale behind this push is due to the current economic climate. With tightened budgets, hospitals and health care facilities are increasingly turning to the pre-owned and refurbished market to meet their equipment needs. With an elevated interest in pre-owned equipment, there comes an increase of companies offering sales and services. "Now, more than ever, the health care industry needs to have confidence in the professionals that work in the pre-owned diagnostic imaging equipment market," Upton said.

As Upton indicated, even prior to the current ISO push, and since its inception, IAMERS has been working with the FDA and other governmental agencies with the goal of educating and continually increasing the level of professionalism among membership. Members of the association abide by a strict code of ethics, with the IAMERS Ethics Committee responsible for enforcement. Still, the ISO certification will be another feather in the cap.

For IAMERS, the two ISOs relevant to members are ISO 13485 and ISO 9001. The choice between one or the other will be dependent on what the member specializes in. Additional ISOs are being explored for possible future accreditation.

ISO 13485 details requirements for the design and manufacture of medical devices while ISO 9001 is part of the ISO family of standards for quality management, which include checking output for defects and taking appropriate and corrective action.

As the certifying organization, the International Organization for Standardization is a non-government organization with a network of national standard institutes for 159 countries with a Central Secretariat in Geneva, Switzerland. For the United States, American National Standards Institute (ANSI), founded in 1918, has accredited 220 standards developers responsible for nearly 10,000 American National Standards (ANS).

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