The U.S. started very late in the adoption of the ISO 9000 series when compared to other countries. The rapid development of ISO in Europe has been driven by their desire to have a unified market for manufacturers and to reduce the differing national product certification programs that made selling products in multiple national markets a costly undertaking. Once many of the larger U.S. companies realized the benefits of having an international quality standard with third-party audit and registration requirements, they started rapidly over the last two to three years to impose the requirements on their own U.S. suppliers. 9001 registered provides the customer a much stronger level of assurance that the products they receive are of high quality. It means that the product meets or exceeds and conforms to the regulatory, safety and customer design requirements that have been specified for the product.
Most companies claim their products are high quality.
An independent audit organization reviews the company's quality management system every six months to a year. The ISO registrar is responsible under strict international and U.S. agreements to verify that the registered company is meeting its commitment to quality and safety. In addition, the ISO standards require registered companies to have an internal audit program that tells internal company management whether its quality system is effective and working satisfactorily. An ISO 9001 company must document its product's designs and have them formally reviewed and approved as meeting applicable regulatory, safety and customer requirements. Compliance to those designs is not only verified by the required internal audit program but also by the independent registrar.