Analiza nivoa poslovne standardizacije u svetu i kod nas

The development and implementation of standardized management system (SMS) has allowed that today we are talking about business standardization, as the new model of good business practices applied worldwide. ISO 9000 was the forerunner, and today is the basis of business standardization. This can be said for ISO 9001: 2015, which was edited on September 15, and he will bring new models for other SMS. This paper provides a detailed analysis of the certification process in the world, Europe, the West Balkans and Serbia on various aspects, for seven standardized management systems for 2012/2013. year, and the first example of the application the new QMS model in Serbia.Razvoj i primena standardizovanih menadžment sistema (SMS) je omogućila da danas govorimo o poslovnoj standardizaciji, kao novom modelu dobre poslovne prakse, primenjene širom sveta. Serija ISO 9000 je bila preteča, a danas je osnova poslovne standardizacije. To se može reći i za ISO 9001:2015, koji je izašao 15. septembra, a on će doneti nove modele i za ostale SMS. Ovaj rad daje detaljnu analizu stanja sertfikacije u svetu, Evropi, Zapadnom Balkanu i Srbiji, po različitim osnovama, za sedam standardizovanih menadžment sistema za 2012/2013. godinu, kao i prvi primer primene novog QMS-a u Srbiji

Advanced multiresponse process optimisation: an intelligent and integrated approach

This book presents an intelligent, integrated, problem-independent method for multiresponse process optimization. In contrast to traditional approaches, the idea of this method is to provide a unique model for the optimization of various processes, without imposition of assumptions relating to the type of process, the type and number of process parameters and responses, or interdependences among them. The presented method for experimental design of processes with multiple correlated responses is composed of three modules: an expert system that selects the experimental plan based on the orthogonal arrays; the factor effects approach, which performs processing of experimental data based on Taguchi’s quality loss function and multivariate statistical methods; and process modeling and optimization based on artificial neural networks and metaheuristic optimization algorithms. The implementation is demonstrated using four case studies relating to high-tech industries and advanced, non-conventional processes

Impact analysis of the implemented quality management system on business performances in pharmaceutical-chemical industry in Serbia

International quality management standard (QMS) ISO 9001 became widely accepted as a framework for product and/or services quality improvement. There are recent research conducted in order to define relationships and effects between the applied QMS and financial and/or non-financial business parameters. The effects of the applied pharmaceutical quality system (PQS) on the business performances in Serbian pharmaceutical-chemical industry are analyzed in this paper using multivariate linear regression analysis. The empirical data were collected using a survey that was performed among experts from Serbian pharmaceutical-chemical industrial sector during 2010. An extensive questionnaire was used in the survey, grouping the questions in eight groups: Implementation of pharmaceutical quality system (AQ), Quality/strategy planning (QP), Human resource management (HR), Supply management (SM), Customer focus (CF), Process management (PM), Continuous improvement (CI), and Business results (BR). The primary goal of the research was to analyze the effects of the elements of first seven groups (AQ, QP, HR, SM, CF, PM, and CI) that present various aspects of the implementation of PQS, on the elements of business results (BR). Based on empirical data, regression relations were formed to present the effects of all considered elements of PQS implementation on the business performance parameters (BR). The positive effects of PQS implementation on the business performances such as the assessment of performance indicators, continual products and/or services quality improvement, and efficient problem solving, are confirmed in the presented research for the Serbian pharmaceutical-chemical industrial sector. The results of the presented research will create a room for the improvement of the existing models in application, and for attracting interested parties that aim to commence this business standardization process. Hence, implementation of PQS is not only the regulatory requirement or advertising movement, but very important issue for the development and improvement of business performances

An approach to TQM evaluation in pharma business

Purpose-The purpose of this paper is to explore the good practice (GxP) and standardised management system integration within total quality management (TQM) paradigm in pharmaceutical sector in Serbia. Also, the impact of all interested parties on quality management has been assessed. Design/methodology/approach-The cross-sectional study was performed, including different stakeholders within the pharmaceutical sector in Serbia: manufacturers, distributors, big pharma representative offices, as well as national regulatory authority. A survey instrument was developed, consisted of 16 questions, which were organised into four groups: questions in relation to implementation of ISO 9001, implementation of good distribution practice/good manufacturing practice, integration of management systems, and impact on TQM and business excellence. Total number of participants was 121. Findings-Standardised management systems (ISO 9001, ISO 14001, OHSAS 18001) support companies to improve business environment and management sustainability, but this survey indicated that it was ranked at the lower level then GxP, for pharmaceutical sector in Serbia. Although pharmaceutical companies has faced many challenges in recent years, the survey revealed high level of confidence in quality management systems, as well as the necessity of various management systems integration. Originality/value-The perception of TQM by the experts in pharmaceutical companies and regulatory authority is wider than the common TQM definition. From pharmaceutical point of view, TQM is a holistic approach to long-term success of organisation, oriented to all interested parties, with focus on a public health. Risk-based approach in new revision of both ISO and GxP will facilitate integration process towards TQM and business excellence