Integrating ISO 9001 and Industry 4.0. An implementation guideline and PDCA model for manufacturing sector

References

• Alič, M. (2018a). Use of IT in ISO 9001 systems for better process management. In L. D. Kounis (Ed.), Quality management systems: A selective presentation of case-studies showcasing its evolution (pp. 83–114). Intech.
   Google Scholar
• Alič, M. (2018b). Integration of the ISO 9001 QMS with the company’s IT business system. Total Quality Management & Business Excellence, 29(9-10), 1143–1160. https://doi.org/10.1080/14783363.2018.1487216
   Web of Science ®Google Scholar
• Asif, M. (2020). Are QM models aligned with industry 4.0? A perspective on current practices. Journal of Cleaner Production, 258, 1–11. https://doi.org/10.1016/j.jclepro.2020.120820
   Web of Science ®Google Scholar
• Behmer, F., Jochem, R., & Hanke, H. (2016). Planning and reorganising quality management organisations - an empirical analysis of current practice. Total Quality Management & Business Excellence, 27(7-8), 963–978. https://doi.org/10.1080/14783363.2016.1202754
   Web of Science ®Google Scholar
• Bhat, V. S., Bhat, S., & Gijo, E. V. (2021). Simulation-based lean six sigma for industry 4.0: An action research in the process industry. International Journal of Quality & Reliability Management, 38(5), 1215–1245. https://doi.org/10.1108/IJQRM-05-2020-0167
   Web of Science ®Google Scholar
• Bortolini, M., Ferrari, E., Gamberi, M., Pilati, F., & Faccio, M. (2017). Assembly system design in the industry 4.0 era: A general framework. IFAC-PapersOnLine, 50(1), 5700–5705. https://doi.org/10.1016/j.ifacol.2017.08.1121
   Google Scholar
• Bravo, R., Lloréns Montes, M. I., J, F., & Ruiz Moreno, A. (2017). Open innovation and quality management: The moderating role of interorganisational IT infrastructure and complementary learning styles. Production Planning & Control, 28(9), 744–757. https://doi.org/10.1080/09537287.2017.1306895
   Web of Science ®Google Scholar
• Burgess, C. J. (2000). Using artificial intelligence to solve problems in software quality management, Technical report – University of Bristol – UK, Retrieved 10 December 2020. https://doi.org/10.5555/895654.
   Google Scholar
• Cândido, C. J., & Ferreira, L. M. (2021). ISO 9001 internal decertification motivations: Exploring barriers and benefits of certification as withdrawal antecedents. Production Planning & Control, 34(4), 330–344. https://doi.org/10.1080/09537287.2021.1916638
   Web of Science ®Google Scholar
• Carnerud, D., Mårtensson, A., Ahlin, K., & Slumpi, T. P. (2020). On the inclusion of sustainability and digitalisation in quality management–an overview from past to present. Total Quality Management & Business Excellence, 1–23. https://doi.org/10.1080/14783363.2020.1848422
   Google Scholar
• Chiarini, A. (2019). Why are manufacturing SMEs cancelling their ISO 9001 certification? Research from Italy. Production Planning & Control, 30(8), 639–649. https://doi.org/10.1080/09537287.2019.1566840
   Web of Science ®Google Scholar
• Chiarini, A., & Kumar, M. (2021). Lean Six sigma and industry 4.0 integration for operational excellence: Evidence from Italian manufacturing companies. Production Planning & Control, 23(13), 1084–1101. https://doi.org/10.1080/09537287.2020.1784485
   Google Scholar
• Ciano, M. P., Dallasega, P., Orzes, G., & Rossi, T. (2021). One-to-one relationships between industry 4.0 technologies and lean production techniques: A multiple case study. International Journal of Production Research, 59(5), 1386–1410. https://doi.org/10.1080/00207543.2020.1821119
   Web of Science ®Google Scholar
• Dalenogare, L. S., Benitez, G. B., Ayala, N. F., & Frank, A. G. (2018). The expected contribution of industry 4.0 technologies for industrial performance. International Journal of Production Economics, 204, 383–394. https://doi.org/10.1016/j.ijpe.2018.08.019
   Web of Science ®Google Scholar
• Dias, A. M., Carvalho, A. M., & Sampaio, P. (2021). Quality 4.0: Literature review analysis, definition and impacts of the digital transformation process on quality. International Journal of Quality & Reliability Management, 39(6), 1312–1335. https://doi.org/10.1108/IJQRM-07-2021-0247
   Web of Science ®Google Scholar
• Durana, P., Kral, P., Stehel, V., Lazaroiu, G., & Sroka, W. (2019). Quality culture of manufacturing enterprises: A possible way to adaptation to industry 4.0. Social Sciences, 8(124), 1–25. https://doi.org/10.3390/socsci8040124
   Google Scholar
• European Union. (2016). Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, Retrieved 22 January 2023 from https://eur-lex.europa.eu/eli/reg/2016/679/oj
   Google Scholar
• Fonseca, L., Domingues, P., Nóvoa, H., Simpson, P., & Sá, J. D. G. (2022). ISO 9001: 2015: The view from the conformity assessment community. Total Quality Management & Business Excellence, 34(5-6), 558–579. https://doi.org/10.1080/14783363.2022.2073212
   Web of Science ®Google Scholar
• Funk, M., Kosch, T., Kettner, R., Korn, O., & Schmidt, A. (2016). MotionEAP: An overview of 4 years of combining industrial assembly with augmented reality for industry 4.0, in Proceedings of the 16th international conference on knowledge technologies and data driven business, Hochschule, Offenburg.
   Google Scholar
• Gilchrist, A. (2016). Industry 4.0: The industrial internet of things. Apress.
   Google Scholar
• Gligor, D. M., & Autry, C. W. (2012). The role of personal relationships in facilitating supply chain communications: A qualitative study. Journal of Supply Chain Management, 48(1), 24–43. https://doi.org/10.1111/j.1745-493X.2011.03240.x
   Web of Science ®Google Scholar
• Glogovac, M., Ruso, J., & Maricic, M. (2022). ISO 9004 maturity model for quality in industry 4.0. Total Quality Management & Business Excellence, 33(5-6), 529–547. https://doi.org/10.1080/14783363.2020.1865793
   Web of Science ®Google Scholar
• Guest, G., Bunce, A., & Johnson, L. (2006). How many interviews are enough? An experiment with data saturation and variability. Field Methods, 18(1), 59–82. https://doi.org/10.1177/1525822X05279903
   Web of Science ®Google Scholar
• Guest, G., MacQueen, K. M., & Namey, E. E. (2012). Introduction to applied thematic analysis. Applied Thematic Analysis, 3(20), 1–21.
   Google Scholar
• Guh, R. S. (2003). Integrating artificial intelligence into on-line statistical process control. Quality and Reliability Engineering International, 19(1), 1–20. https://doi.org/10.1002/qre.510
   Web of Science ®Google Scholar
• Haddud, A., & Khare, A. (2020). Digitalizing supply chains potential benefits and impact on lean operations. International Journal of Lean Six Sigma, 11(4), 731–765. https://doi.org/10.1108/IJLSS-03-2019-0026
   Web of Science ®Google Scholar
• Han, H., & Trimi, S. (2022). Towards a data science platform for improving SME collaboration through industry 4.0 technologies. Technological Forecasting and Social Change, 174, 121242. https://doi.org/10.1016/j.techfore.2021.121242
   Web of Science ®Google Scholar
• Hernad, J. M. C., & Gaya, C. G. (2013). Methodology for implementing document management systems to support ISO 9001: 2008 quality management systems. Procedia Engineering, 63, 29–35. https://doi.org/10.1016/j.proeng.2013.08.225
   Google Scholar
• Illés, B., Tamás, P., Dobos, P., & Skapinyecz, R. (2017). New challenges for quality assurance of manufacturing processes in industry 4.0. Solid State Phenomena, 261, 481–486. https://doi.org/10.4028/www.scientific.net/SSP.261.481
   Google Scholar
• ISO/IEC. (2016). ISO/IEC Directives, part 2 - Principles and rules for the structure and drafting of ISO and IEC documents, ISO/IEC, Geneva, CH, Retrieved 19 January 2023, from https://www.iec.ch/members_experts/refdocs/iec/isoiecdir-2%7Bed7.0%7Den.pdf
   Google Scholar
• ISO – International Organization for Standardization. (2015). Quality management systems – Requirements, Retrieved 26 November 2021, from https://www.iso.org/obp/ui/#iso:std:iso:9001:ed-5:v1:en
   Google Scholar
• ISO – International Organization for Standardization. (2021). The ISO survey, Retrieved 19 January 2023, from https://www.iso.org/the-iso-survey.html
   Google Scholar
• ISO – International Organization for Standardization. (2023). ISO 9001 and related standards - Quality management, Retrieved 19 January 2023, from https://www.iso.org/iso-9001-quality-management.html
   Google Scholar
• Javaid, M., Haleem, A., Singh, R. P., & Suman, R. (2021). Significance of quality 4.0 towards comprehensive enhancement in manufacturing sector. Sensors International, 2(100109), 1–13. https://doi.org/10.1016/j.sintl.2021.100109
   Google Scholar
• Jeschke, S., Brecher, C., Meisen, T., Özdemir, D., & Eschert, T. (2017). Industrial internet of things and cyber manufacturing systems. In S. Jeschke, C. Brecher, H. Song, & D. Rawat (Eds.), Industrial internet of things, springer series in wireless technology (pp. 3–19). Springer.
   Google Scholar
• Kagermann, H., Wolfgang, W., & Helbi, J. (2013). Recommendations for Implementing the Strategic Initiative INDUSTRIE 4.0, Retrieved 20 December 2021, from www.plattform-i40.de/finalreport2013
   Google Scholar
• Koh, L., Orzes, G., & Jia, F. (2019). The fourth industrial revolution (industry 4.0): technologies disruption on operations and supply chain management. International Journal of Operations & Production Management, 39(6/7/8), 817–828. https://doi.org/10.1108/IJOPM-08-2019-788
   Web of Science ®Google Scholar
• Lambert, G. (2015). Giving ISO 9001 a fresh sparkle, International Organization for Standardization, Geneve, CH, Retrieved 25 January 2023, from https://www.iso.org/news/2015/11/Ref2014.html
   Google Scholar
• Lau, H. C., Ho, G. T., Chu, K. F., Ho, W., & Lee, C. K. (2009). Development of an intelligent quality management system using fuzzy association rules. Expert Systems with Applications, 36(29), 1801–1815. https://doi.org/10.1016/j.eswa.2007.12.066
   Google Scholar
• Milošević, I., Ruso, J., Glogovac, M., Arsić, S., & Rakić, A. (2021). An integrated SEM-ANN approach for predicting QMS achievements in industry 4.0. Total Quality Management & Business Excellence, 33(15-16). https://doi.org/10.1080/14783363.2021.2011194
   Google Scholar
• Pho, H. T., & Tambo, T. (2014). Integrated management systems and workflow-based electronic document management: An empirical study. Journal of Industrial Engineering and Management, 7(1), 194–217. https://doi.org/10.3926/jiem.846
   Google Scholar
• Rabionet, S. E. (2009). How I learned to design and conduct semi-structured interviews: An ongoing and continuous journey. The Qualitative Report, 14(3), 203–206.
   Google Scholar
• Radziwill, N. (2018). Feature quality 4.0 - let's Get digital: The many ways the fourth industrial revolution is reshaping the way we think about quality. Quality Progress, 51(10), 24–29. https://doi.org/10.48550/arXiv.1810.07829
   Google Scholar
• Ranjith Kumar, R., Ganesh, L. S., & Rajendran, C. (2021). Quality 4.0 – a review of and framework for quality management in the digital era. International Journal of Quality & Reliability Management, 39(6), 1385–1411. https://doi.org/10.1108/IJQRM-05-2021-0150
   Web of Science ®Google Scholar
• Roblek, V., Meško, M., & Krapež, A. (2016). A complex view of industry 4.0. Sage Open, 6(2), 1–11. https://doi.org/10.1177/2158244016653987
   Web of Science ®Google Scholar
• Romero, D., Stahre, J., Wuest, T., Noran, O., Bernus, P., Fast-Berglund, Å, & Gorecky, D. (2016). Towards an operator 4.0 typology: a human-centric perspective on the fourth industrial revolution technologies, In Proceedings of the International Conference on Computers and Industrial Engineering (CIE46). Tianjin, China, 29–31.
   Google Scholar
• Saihi, A., Awad, M., & Ben-Daya, M. (2021). Quality 4.0: Leveraging industry 4.0 technologies to improve quality management practices – a systematic review. International Journal of Quality & Reliability Management, 40(2), 628–650. https://doi.org/10.1108/IJQRM-09-2021-0305
   Web of Science ®Google Scholar
• Satoglu, S., Ustundag, A., Cevikcan, E., & Durmusoglu, M. B. (2018). Lean transformation integrated with industry 4.0 implementation methodology. In Industrial engineering in the industry 4.0 Era (pp. 97–107). Springer. https://doi.org/10.1007/978-3-319-71225-3_9
   Google Scholar
• Sisodia, R., & Villegas Forero, D. (2019). Quality 4.0–How to handle quality in the industry 4.0 revolution, report E2019:128, Department of Technology Management and Economics Chalmers University of Technology, Göteborg, Sweden. Retrieved 20 March 2022, from https://odr.chalmers.se/bitstream/20.500.12380/300650/1/E2019_128.pdf
   Google Scholar
• Sony, M., Antony, J., & Douglas, J. A. (2020). Essential ingredients for the implementation of quality 4.0. The TQM Journal, 32(4), 779–793. https://doi.org/10.1108/TQM-12-2019-0275
   Google Scholar
• Tarigan, Z. J. H., Suprapto, W., & Basana, S. R. (2019). The effect of procedure change, TQM and ERP implementation to company performance on manufacturing industries, In IOP Conference Series: Materials Science and Engineering. In The 2018 5th International Conference on Advanced Materials, Mechanics and Structural Engineering October 2018, Seoul, South Korea, 473.
   Google Scholar
• van Hoek, R. (2019). Exploring blockchain implementation in the supply chain: Learning from pioneers and RFID research. International Journal of Operations & Production Management, 39(6/7/8), 829–859. https://doi.org/10.1108/IJOPM-01-2019-0022
   Web of Science ®Google Scholar
• Velandia, D. M. S., Kaur, N., Whittow, W. G., Conway, P. P., & West, A. A. (2016). Towards industrial internet of things: Crankshaft monitoring, traceability and tracking using RFID. Robotics and Computer-Integrated Manufacturing, 41(1), 66–77. https://doi.org/10.1016/j.rcim.2016.02.004
   Google Scholar
• Waring, T., & Wainwright, D. (2008). Issues and challenges in the use of template analysis: Two comparative case studies from the field. Electronic Journal of Business Research Methods, 6(1), 85–94.
   Google Scholar
• Yadav, N., Shankar, R., & Singh, S. P. (2021). Critical success factors for lean six sigma in quality 4.0. International Journal of Quality and Service Sciences, 13(1), 123–156. https://doi.org/10.1108/IJQSS-06-2020-0099
   Web of Science ®Google Scholar
• Yussupova, N., Kovács, G., Boyko, M., & Bogdanova, D. (2016). Models and methods for quality management based on artificial intelligence applications. Acta Polytechnica Hungarica, 13(3), 45–60.
   Web of Science ®Google Scholar
• Zhong, R. Y., Xu, X., & Wang, L. (2017). IoT-enabled smart factory visibility and traceability using laser-scanners. Procedia Manufacturing, 10(2), 1–14. https://doi.org/10.1016/j.promfg.2017.07.103
   Google Scholar