The rapid changes in the environment for clinical research require major efforts to reduce cost and time without jeopardizing compliance to applicable regulations. The international standard on quality management, ISO 9004, offers relevant tools to fulfill these requirements. An important step toward implementation of a quality system is awareness of the products, which are generated in the clinical research process; an overview of these products is presented. Ideas on the organizational structure of the quality function are included as well.
EC Note for Guidance: Good Clinical Practice on Medicinal Products in the European Community. III/3976/88-EN, Final-11 July 1990.
2.
DIN ISO 9001.Quality systems-Model for quality assurance in design/development, production, installation and servicing. (German-English-French edition). Berlin: Beuth Verlag; 1990.
3.
DIN ISO 9004.Quality management and quality system elements —Guidelines. (German-English-French edition). Berlin: Beuth Verlag; 1990.
4.
ISO/DIS 9004–2:1990.Quality management and quality system elements — Part 2: Guidelines for services. (German-English edition). Berlin: Beuth Verlag; 1990.
5.
AuterhoffGQualitätssicherung in der pharmazeutischen Industrie. Ein Vergleich arzneimittelrechtlicher Regelwerke mit der DIN-ISO-Normenreihe 9000 bis 9004. Pharm Ind. 1991;53:798–803.
6.
DIN ISO 8402 (Draft).Quality management and quality assurance; vocabulary. (German-English edition.) Berlin: Beuth Verlag; 1992.
