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Implementation of Quality Management Tools and Process-Based Management in Commercializing Organizations of Orthopaedic Devices in Colombia

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Knowledge Management in Organisations (KMO 2023)

Abstract

Quality Management Tools (QMT) are used for heading issues that affect the process performance in healthcare organizations (HCO) and improving key performance indicators related to stakeholders. QMT implementation in HCO is relevant to enhance the patient safety policy, risk mitigation, and prevent adverse event and cost increasing as in clinics and hospitals as in medical devices providers. The article aims to identify the quality management tools implemented in the logistics process in Colombian orthopaedic medical devices as initiative for strengthens the patient safety policy. A 15-questions electronic structured questionnaire was applied in 17 Colombian orthopaedic medical devices which was answered by its logistic coordinators as the process’ leaders. The results show that the three QMT most implemented are 5W + 1H, PDCA cycle and Six Sigma methodology. Furthermore, the HCO which have quality management indicators in reverse logistic processes perceive impacts as result of semester or annual internal audits. To conclude, orthopaedic medical devices organizations combine quality management systems with other methodologies and tools for enhancing the satisfaction of the stakeholders. Specifically, in the logistic process, organizations involve people and technology for getting better results focusing value-added assessment. Future works may be orientated to cover the whole logistic chain and integrate the impact evaluation with clinic and hospitals’ processes.

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References

  1. International Standardization Organization. ISO 9001:2015 Quality Management Systems. Requirements. Geneva

    Google Scholar 

  2. Kuyken, W.: The World Health Organization quality of life assessment (WHOQOL): position paper from the World Health Organization. Soc. Sci. Med. 41(10), 1403–1409 (1995)

    Article  Google Scholar 

  3. McCullough, K., et al.: An examination of primary health care nursing service evaluation using the Donabedian model: a systematic review. Res. Nurs. Health 46(1), 159–176 (2023)

    Article  Google Scholar 

  4. Rozo-Rojas, I., et al.: Identification of key factors in the implementation of quality management practices in Sterilization Centers. In: Proceedings of the LACCEI International Multi-conference for Engineering Education and Technology (2017). https://doi.org/10.18687/LACCEI2017.1.1.279

  5. Pinney, S.J., Page, A.E., Jevsevar, D.S., Bozic, K.J.: Current concept review: quality and process improvement in orthopedics. Orthop. Res. Rev. 8, 1–11 (2016)

    Google Scholar 

  6. Shukla, S., et al.: Implementation of adverse event reporting for medical devices India. Bull. World Health Organ. 98(3), 206–211 (2020)

    Article  Google Scholar 

  7. Bamford, D.R., Greatbanks, R.W.: The use of quality management tools and techniques: a study of application in everyday situations. Int. J. Qual. Reliab. Manag. 22(4), 376–392 (2005). https://doi.org/10.1108/02656710510591219

    Article  Google Scholar 

  8. Martelli, N., et al.: New European regulation for medical devices: what is changing? Cardiovasc. Intervent. Radiol. 42(9), 1272–1278 (2019). https://doi.org/10.1007/s00270-019-02247-0

    Article  Google Scholar 

  9. Dellifraine, J.L., Wang, Z., McCaughey, D., Langabeer, J.R., Erwin, C.O.: The use of six sigma in health care management: are we using it to its full potential? Qual. Manag. Health Care 22(3), 210–223 (2013)

    Article  Google Scholar 

  10. Chassin, M.R.: Is health care ready for Six Sigma quality? Milbank Q. 76(4), 565–591 (1998)

    Article  Google Scholar 

  11. Egbosimba, D.: Medical devices industry: the problem of clinical evaluation reports. Ann. Biol. Clin. (Paris). 77(5), 514–516 (2019)

    Google Scholar 

  12. Cunha Reis, A., et al.: Quality management tools applied to drug dispensing in hospital pharmacy: a scoping review. 19, 582–590 (2023)

    Google Scholar 

  13. George, J., Singh, A., Kumar, A.: A study of basic 7 quality control tools and techniques for continuous improvement. In: 2nd International Conference on Emerging Trends in Mechanical Engineering, Bhopal (2018)

    Google Scholar 

  14. Rozo-Rojas, I., Díaz-Piraquive, F.N., de Jesús Muriel-Perea, Y., Ordoñez-Díaz, M.S., Ospina-Prieto, L.A.: Risk management framework as technovigilance support at sterilization unit in the San Jose hospital (Colombia). In: Uden, L., Hadzima, B., Ting, I.-H. (eds.) KMO 2018. CCIS, vol. 877, pp. 437–451. Springer, Cham (2018). https://doi.org/10.1007/978-3-319-95204-8_37

    Chapter  Google Scholar 

  15. Rozo-Rojas, I., et al.: Identificación de las causas de variación en los procesos de esterilización de un hospital privado a través de la metodología Six SIGMA: Fases definir–medir. Conferencia Desarrollo e Innovación en Ingeniería, pp. 434–449 (2019)

    Google Scholar 

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Correspondence to Mayra Samara Ordoñez-Díaz .

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Ordoñez-Díaz, M.S., Rozo-Rojas, I. (2023). Implementation of Quality Management Tools and Process-Based Management in Commercializing Organizations of Orthopaedic Devices in Colombia. In: Uden, L., Ting, IH. (eds) Knowledge Management in Organisations. KMO 2023. Communications in Computer and Information Science, vol 1825. Springer, Cham. https://doi.org/10.1007/978-3-031-34045-1_32

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  • DOI: https://doi.org/10.1007/978-3-031-34045-1_32

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-031-34044-4

  • Online ISBN: 978-3-031-34045-1

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