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Clinical Chemistry 42: 1561-1565, 1996;
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Clinical Chemistry, Vol 42, 1561-1565, Copyright © 1996 by American Association for Clinical Chemistry

ISO 9001 benefits and pitfalls: the path to successful certification

MS Krause Jr
E.I. DuPont de Nemours--Medical Products, Newark, DE 19714-6101, USA. krausems@gg.dadeint.com

The lifeblood of a business is developing and commercializing new products with minimum cost and time and maximum quality. Implementation of a quality management system is often used to achieve these goals, and the ISO 9001 standard for a business quality system is rapidly becoming the model of choice. The existence of an ISO-compliant system is a key to meeting the forthcoming regulatory requirements in the European Union and the US Food and Drug Administrations's proposed good management practices. DuPont has demonstrated leadership in the achievement of ISO registration. I describe the path to these successful registrations along with key lessons from the experience. Elements of success are management commitment, adequate resources, education, communication, total organizational involvement, and auditing of system performance. For the system to flourish and provide benefits to the users, sufficient time must be allocated for the organization to change.




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Copyright © 1996 by the American Association for Clinical Chemistry.