Quality management as worldwide business philosophy of organizations has entered into a new phase. With the adoption and appearance on the scene of standard series ISO 9000:2000 based on quality management principles, the managers have received a new model for quality improvement of products and services in their organizations. On the other hand sharp market competition is demanding good quality and highly innovative products. These two facts are mutually connected and integrated by quality management system standards even more. Business standardization process, however, is expanding through the control of the protection of the living environment, safety and health protection of the employees, good business practices in manufacturing, laboratory, etc. The series of ISO 9000:2000 standards has four standards, and ISO 9001 standard is a key element of the new QMS series. This is the only model for the design, application, assessment and QMS certification. As the most important standard in the new series it is justifiably the subject of attention of interest groups (present and future holders of certificates, accreditation and certification agencies, assessors and consultants). Basic instructions are described here for establishing of QMS project in an organization, starting the analysis with the applied ISO 9001:1994 model representing quality system (QS) from the aspect of: (i) general model, (ii) defined requirements, (iii) documentation model, and (iv) the way of the realization of the QMS project.