ISO 9000 and Its Relation to System Validation

An important prerequisite to having confidence in a computer system is the construc­ tion of good quality assurance and quality control programs during the development of the product. The ISO 9000/EN 29000 is a very useful standard for developing a quality system for the development, supply, and maintenance of software. This pa­ per discusses the different subjects of the ISO 9000/EN29000 standard and indicates the documents where guidance for the application of the standard to software can be found. The end of the paper deals with the importance of certification of the com­ pany's quality system by a third party. Certification adds to the credibility of a sup­ plier and can be considered evidence of good practice.