Interview with a Manager

John Dobbs is director of regulatory affairs at Prism Devices, Inc., a medium-sized company involved in the manufacture and sale of medical devices. With the growing importance of overseas markets and the rapid globalization of the medical device industry, most U.S. manufacturers are faced with the task of developing and implementing a quality system that complies with both international and domestic requirements. It was Mr. Dobbs' task to accomplish this task and successfully obtain certification to the ISO 9001 and EN 46001 quality systems standards.

John graduated from Columbia University Graduate School of Business in 1976 and continued his education with advanced studies in law and regulatory affairs. He was hired by Prism to oversee the company's expansion into the European markets and ensure that the company would comply with all the requirement that the European Common market will have in force.

Although it is still more than a year away, the date of June 15, 1998, is approaching very rapidly for medical device manufacturers seeking to begin or continue selling in the European Union (EU). That is the day the EU's Medical Devices

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continuously looking for new ways of exceeding customer expectations, and to delivering products and services at a competitive price, then success is virtually guaranteed (Graham, 1995, pp. 79-80). The first step for any company preparing for its initial audit is to become familiar with the relevant standards and available resources. Since standards are revised over time, companies should be sure to obtain the most recent versions. Copies of the EU directives, relevant standards, and guidance documents are available from a number of organizations, including the American Society for Quality Control (ASQC), the Office of European Community Affairs, and the National Institute of Standards and Technology. The second step is to determine which standards apply to the firm and its products. For device manufacturers, the most widely used quality management and quality assurance standards used are those of the ISO 9000 family, compiled by the International Organization for Standardization (ISO). A virtual identical series of standards have been published as European norms under the designation EN 29000, and the requirements of the ISO standards are also reflected in the FDA's revised good manufacturing practices (GMP) regulation. To
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Approximate Pages = 7 (250 words per page)