Insertion of Risk Management in Quality Management Systems with the Advent of ISO 9001:2015: Descriptive and Content Analyzes

  • Gabriel Henrique Silva RampiniEmail author
  • Fernando Tobal Berssaneti
  • Ana Maria Saut
Conference paper
Part of the Springer Proceedings in Mathematics & Statistics book series (PROMS, volume 281)


Quality management studies over time grow in importance both in the academic and the enterprise world. What was previously treated in isolation, these days are essential to the survival of an organization. Thus, the parts that make up the quality processes of the institutions must be studied in a continuous way aiming at optimizing the whole process. In this context, risk management, which despite having a range of guidelines and frameworks, is little applied in the context of quality management, and does not play a relevant role in the implementation of processes. However, the latest version of ISO 9001:2015 presents requirements focused on risk management. Therefore, the present article aims to outline a profile on the insertion of risk management into the scientific productions focused on the study of the ISO 9001:2015 Quality Management standard. In order to reach the objective, a descriptive and a content analysis was carried out, with samples of documents belonging to the Web of Science Core Collection and the Scopus database, from 2015 to 2018. After the analyzes, it was possible to identify the consistent evolution of the publications, diversity of journals interested in the subject, interdisciplinarity between quality management and risk management and finally the relevance of the risk-based thinking, the influence of ISO 31000:2009 and the integrated management system.


Risk-based thinking ISO 31000:2009 Integrated management system 


  1. 1.
    Samson, D., Terziovski, M.: The relationship between total quality management practices and operational performance. J. Oper. Manag. 17, 393–409 (1999). Scholar
  2. 2.
    Sousa, R., Voss, C.A.: Quality management re-visited: a reflective review and agenda for future research. J. Oper. Manag. 20, 91–109 (2002). Scholar
  3. 3.
    Maguad, B.: The modern quality movement: origins, development and trends. Total. Qual. Manag. Bus. Excel. 17, 179–203 (2006). Scholar
  4. 4.
    Dror, S.: The balanced scorecard versus quality award models as strategic frameworks. Total. Qual. Manag. & Bus. Excel. 19, 583–593 (2008). Scholar
  5. 5.
    Carvalho, M.M. de, Paladini, E.P., Bouer, G., Ferreira, J.J. do A., Miguel, P.A.C., Samohyl, R.W., et al.: Gestão da qualidade: teoria e casos, 10th edn. Elsevier, Rio de Janeiro (2005)Google Scholar
  6. 6.
    International Organization for Standardization: n.d. Accessed 15 Jan 2018
  7. 7.
    Fonseca, L.M.: From quality gurus and TQM To ISO 9001:2015: a review of several quality paths. Int. J. Qual. Res. 9, 167–180 (2015)Google Scholar
  8. 8.
    Cagnin, F., de Oliveira, M.C., Simon, A.T.: Requisitos de gestão de riscos da ISO 9001:2015 – uma avaliação do nível de inserção de fornecedores do setor automativo. XXIII Simpósio de Engenharia de Produção, Bauru (2016)Google Scholar
  9. 9.
    Silva, M.M., Fonseca, L.M., Sousa, S.D.: The impact of ISO 9001:2015 on ISO 22000 and food safety management systems (FSMS). Quality—Access to Success 17, 81–85 (2016)Google Scholar
  10. 10.
    Franceschini, F., Galetto, M., Mastrogiacomo, L.: ISO 9001 certification and failure risk: any relationship? Total. Qual. Manag. Bus. Excel., 1–15 (2016).
  11. 11.
    ISO 9000:2015 Quality Management Systems—Fundamentals and Vocabulary, 4th edn. International Organization of Standardization, Genebra (2015)Google Scholar
  12. 12.
    Juran, J.M., Gryna, F.M.: Controle da qualidade—Handbook. Makron Books (1988)Google Scholar
  13. 13.
    Gabriele, P.D., Treinta, F.T., Filho, J.R. de F., de Souza, M.C., Tschaffon, P.B., Brantes, S.R.: Sustentabilidade E Vantagem Competitiva Estratégica: Um Estudo Exploratório E Bibliométrico. Revista Produção Online 12, 729–755 (2012)Google Scholar
  14. 14.
    Pereira, J.A., Graciano, D.A., Verri, R.A.: O processo de preparação para a implantação de um sistema de gestão da qualidade: estudo das dificuldades na ótica do pessoal do setor de gestão da qualidade. GEPROS Gestão Da Produção, Operações E Sistemas 4, 61–81 (2016)CrossRefGoogle Scholar
  15. 15.
    Giesen, E.: Quality management for robust and reliable research. Int. J. Metrol. Qual. Eng. 6 (2015).
  16. 16.
    ISO 9001:2015 Quality Management Systems—Requirements, 5th edn. International Organization of Standardization, Genebra (2015)Google Scholar
  17. 17.
    Souza, A.M., Schmidt, A.S., Turcato, C.R. da S.: O aprendizado em organizações certificadas pela NBR ISO 9001:2000. Revista Produção Online 11, 289–318 (2011)Google Scholar
  18. 18.
    Heras-Saizarbitoria, I., Boiral, O.: ISO 9001 and ISO 14001: towards a research agenda on management system standards. Int. J. Manag. Rev. 15, 47–65 (2013). Scholar
  19. 19.
    Zacharias, O.J.: ISO 9001:2008 – Uma ferramenta de gestão empresarial. Quality Gestão Empresarial (2009)Google Scholar
  20. 20.
    ISO 31000:2018 Risk management—Guidelines, 2nd edn. International Organization of Standardization, Genebra (2018)Google Scholar
  21. 21.
    A Guide to the Project Management Body of Knowledge (PMBOK ® guide). Project Management Institute (2013).
  22. 22.
    Oliva, F.L.: A maturity model for enterprise risk management. Int. J. Prod. Econ. 173, 66–79 (2016). Scholar
  23. 23.
    Rosa, G.M., Toledo, J.C. de.: Gestão de riscos e a norma ISO 31000: importância e impasses rumo a um um consenso. V Congresso Brasileiro De Engenharia De Produção (2015)Google Scholar
  24. 24.
    Lalonde, C., Boiral, O.: Managing risks through ISO 31000: a critical analysis. Risk Manag. 14, 272–300 (2012). Scholar
  25. 25.
    Chiarini, A.: Risk-based thinking according to ISO 9001:2015 standard and the risk sources European manufacturing SMEs intend to manage. TQM J. 29, 310–323 (2017). Scholar
  26. 26.
    Eiras, F.C.S., Tomomitsu, H.T.A., Linhares, I.M.P., Carvalho, M.M. de.: Evolução das pesquisas de gestão de projetos: um estudo bibliométrico do International Journal of Project Management. GEPROS: Gestão Da Produção, Operações E Sistemas 1, 211–234 (2017)Google Scholar
  27. 27.
    Tranfield, D., Denyer, D., Smart, P.: Towards a methodology for developing evidence-informed management knowledge by means of systematic review. Br. J. Manag. 14, 207–222 (2003). Scholar
  28. 28.
    Guthrie, J., Petty, R., Yongvanich, K., Ricceri, F.: Using content analysis as a research method to inquire into intellectual capital reporting. J. Intellect. Cap. 5, 282–293 (2004). Scholar
  29. 29.
    Bacivarov, I.C., Bacivarov, A., Gherghina, C.: A new approach in the development of quality management systems for (micro)electronics. In: Proceedings of SPIE—The International Society for Optical Engineering, vol. 10010 (2016).
  30. 30.
    Rybski, C., Jochem, R., Homma, L.: Empirical study on status of preparation for ISO 9001:2015. Total. Qual. Manag. Bus. Excel. 28, 1076–1089 (2017). Scholar
  31. 31.
    Parra-López, C., Hinojosa-Rodríguez, A., Carmona-Torres, C., Sayadi, S.: ISO 9001 implementation and associated manufacturing and marketing practices in the olive oil industry in southern Spain. Food Control 62, 23–31 (2016). Scholar
  32. 32.
    Rodriguez, D.R., Leyva Proenza, L., Tellez Carralero, A., Marrero Tamayo, A., Segura, F.: Design of the quality management system by ISO 9001:2015. Case study. Dilemas Contemporaneos-Educacion Politica Y Valores 44 (2017)Google Scholar
  33. 33.
    Rodriguez, D.R., Leyva Proenza, L., Tellez Carralero, A., Marrero Tamayo, A., Segura Ramirez, F.R.: Partial implementation of the quality management system by ISO 9001:2015. Case study. Dilemas Contemporaneos-Educacion Politica Y Valores, 4 (2017)Google Scholar
  34. 34.
    Wong, S.: Risk-based thinking for chemical testing. Accred. Qual. Assur. 22, 103–108 (2017)CrossRefGoogle Scholar
  35. 35.
    Sari, Y., Wibisono, E., Wahyudi, R.D., Lio, Y.: From ISO 9001:2008 to ISO 9001:2015: significant changes and their impacts to aspiring organizations. In: IOP Conference Series: Materials Science and Engineering, vol. 273 (2017).
  36. 36.
    Palacios Guillem, M., Gisbert Soler, V., Perez-Bernabeu, E.: Quality management systems: lean manufacturing, Kaizen, risk management (UNE—ISO 31000) and ISO 9001. 3C TECNOLOGIA 4, 175–188 (2015)Google Scholar
  37. 37.
    Benetti, K.: Challenges of corporate risk management after global financial crisis. In: 10th International Days of Statistics and Economics, pp. 154–162. Praga (2016)Google Scholar
  38. 38.
    Barafort, B., Mesquida, A.-L., Mas, A.: Integrating risk management in IT settings from ISO standards and management systems perspectives. Comput. Stand. Interfaces 54, 176–185 (2017). Scholar
  39. 39.
    Samani, M.A., Ismail, N., Leman, Z., Zulkifli, N.B.: Development of a conceptual model for risk-based quality management system. Total. Qual. Manag. Bus. Excel., 1–16 (2017)Google Scholar
  40. 40.
    Nagel-Piciorus, C., Nagel-Piciorus, L., Sârbu, R.: Milestones in implementation of an integrated management system in the health sector case study radiologische netzwerk rheinland. Amfiteatru Economic 18, 432–455 (2016)Google Scholar
  41. 41.
    Muzaimi, H., Chew, B., Hamid, S.R.R.B.A.: Integrated management system: the integration of ISO 9001, ISO 14001, OHSAS 18001 and ISO 31000. In: 5th Engineering International Conference on Education, Concept, and Application of Green Technology (2017)Google Scholar
  42. 42.
    Muthusamy, G., Palanisamy, C., Mohanraj, M.: A comprehensive model and holistic approach for implementing an integrated management systems. J. Comput. Theor. Nanosci. 15, 392–401 (2018). Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.University of Sao PauloSao PauloBrazil

Personalised recommendations