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diagnostic imaging management services

FONAR and ISO 13485 Registration

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from over 90 countries. The purpose of ISO is to promote the development of standardization and related world activities to facilitate the international exchange of goods and services, and to develop cooperation in intellectual, scientific and economic activity.

FONAR is registered to ISO 13485 demonstrating that we have a quality management system meeting the stringent requirements of an international consensus on what constitutes good manufacturing practices, and that our organization delivers medical devices and related services meeting both our customers’ quality requirements and the applicable regulatory requirements.

Everyone at FONAR including production, manufacturing, R&D, customer service, shipping, receiving, marketing and sales is involved in the ISO registration process. It is not just a manufacturing system, but a company-wide way of doing business.

FONAR utilizes Intertek Testing Services (ITS), the world's largest industrial testing and certification company, as our accredited registrar. This means that an independent auditor has checked that the processes influencing quality conform to the standard’s requirements.

ISO registration guides companies in building quality into their products and services, and also helps to avoid costly after–the–fact inspections, warranties and rework. As a customer of FONAR you can be confident that you will benefit from services designed to meet your needs and ensure your satisfaction, that the products we manufacture have quality planned and documented into every step in the process and that our team of trained employees will perform consistently with the goal of improving all operations and meeting our commitments to you to do what we say we will do.