Evaluation of ISO 9001:2015 Quality Management System practices in small and medium enterprises

Organizations must be continually open to improvement in order to survive in a competitive environment. For this achievement, many organizations benefit from quality management approaches such as Total Quality Management (TQM), Six Sigma, Lean Production. The most common way to implement the TQM approach is to apply the requirements of the ISO 9001 Quality Management System. After 1987, when it was first published, the ISO 9001 standard was brought to the latest with the updates made in 2015. The ISO 9001: 2015 Quality Management System has been prepared in a structure that can be applied to all businesses regardless of its scale and way of working. In addition to large-scaled enterprises, the interest of small and medium-sized enterprises (SMEs) in this system continously increases due to the benefits it provides. The purpose of this study is to investigate how effectively the ISO 9001: 2015 Quality Management System is implemented in SMEs within the framework of the updates (e.g., risk based thinking) that came with its latest version and to reveal the weak areas and success factors for the implementation of the system. In the study, it was also aimed to explain why SMEs need a quality management system and to develop suggestions for improvements that can be made to increase the success of the implementation. In the study, ISO 9001: 2015 Quality Management System applications were examined in 22 SMEs operating commercially in Kayseri province, and their adaptation to the new concepts and issues in the standard, the nonconformities and the difficulties they encountered in practice were evaluated. In this context, different types of data obtained through structured and semi-structured questionnaires were transformed into findings by descriptive statistics and content analysis method. In this study, on the basis of new concepts and themes introduced with the ISO 9001: 2015 version, especially such new themes as "business planning and strategic direction", "process risk", " product and service risk ", "risk associated with the control of externally provided process, product and service" were examined in detail through PDCA cycle and identified the extent to which these themes were applied in SMEs with evidences. In terms of adaptation of SMEs to these changes, different practices were observed according to firm scale. As the size of SMEs increased, the reactions to the changes in the ISO9001 standard were welcomed and the effiency of the implementation increased. While the ISO9001 implementation practices predominantly create the perception of benefit in medium-sized enterprises, they are perceived as a waste of time and workload just for advertising purposes in small enterprises. It was observed that there were nonconformities in the implementation of the process approach in the quality management system, leadership and commitment, competence, awareness, internal audit and determining risks and opportunities. The challenges experienced by SMEs in applying and maintaining the standard were determined as follows: Different interpretation of the concepts in the ISO 9001 standard by individuals, too much documentation, lack of awareness for the importance of the standard, lack of motivation, and inadequacy of standard training. The study is thought to be a promising resource for other researchers and practitioners in terms of understanding and interpreting the ISO 9001 Quality Management System for SMEs. Keywords: SME, Quality Management System, ISO 9001: 2015 Standard, Risk Based Thinking, Content Analysis.