Quality management system auditing and ISO 19011: Fundamentals for future standardization of the method
DOI:
https://doi.org/10.59490/jos.2025.8154Keywords:
Audit, Audit method, Quality management system, QMS, ISO 19011Abstract
Auditing is used to assess whether the requirements laid down in standards are being met. This paper studies the process of auditing quality management systems (QMS) to enhance our understanding of the process and develop a systematic approach. We focus on the information gathering and judgement parts of it. We compare the scarce literature about QMS auditing with the management system auditing standards ISO 19011 and ISO/IEC 17021-1. We incorporate insights from philosophical literature to develop a process model regarding the main steps of reliable auditing: observing reality; recalling memory and understanding the observed reality; contemplating and understanding abstract objects; expressing what is understood; judging: comparing what is understood and concluding about fulfilment of a requirement; and expressing the judgement. The methods described in these two standards are insufficient. Future researchers can use our model in developing theory on conformity assessment. The International Organization for Standardization (ISO) may use it to improve its conformity assessment standards.
References
Abuazza, O.A., Labib, A. & Savage, B.M. (2019). Development of a conceptual auditing framework by integrating ISO 9001 principles within auditing, International Journal of Quality and Reliability Management, 37(2), pp. 328-353. https://doi.org/10.1108/IJQRM-06-2018-0154
Annett, J. (2002). Subjective rating scales, science or art?, Ergonomics, 45(14), 966-987. https://doi:org/10.1080/001400130210166951
Aune, B. (1972). Thinking, in: Edwards, P., (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 100-104.
Beckmerhagen, I.A., Berg, H.P., Karapetrovic, S.V. & Willborn, W.O. (2004) On the effectiveness of quality management system audits, The TQM Magazine, 16(1), 14 – 25. https://doi.org/10.1108/09544780410511443
Biazzo, S. (2005) The New ISO 9001 and the Problem of Ceremonial Conformity: How have Audit Methods Evolved?, Total Quality Management, 16(3), 381 – 399. https://doi.org/10.1080/14783360500054145
Boiral O. (2007). ISO 9000: Outside the Iron Cage, Organization Science, 18(1), 127-146. https://doi.org/10.1287/orsc.14.6.720.24873
Brody, B. (1972). Glossary of Logical terms, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 57-77.
Cameron, R.P. (2012) Intrinsic and Extrinsic Properties, in: LePoidvin et al. (Eds.). The Routledge Companion of Metaphysics, Routledge, London & New York, Chapter 26, 265-275.
Cano, S.J., Vosk, T., Pendrill, L.R. & Stenner, A.J. (2016). On Trial: the Compatibility of Measurement in the Physical and Social Sciences, Journal of Physics: Conference Series, 772, Art. No. 012025 https://doi.org/10.1088/1742-6596/772/1/012025
Carnerud, D. (2018). 25 years of quality management research – outlines and trends, International Journal of Quality & Reliability Management, 35(1), 208-231. https://doi.org/10.1108/IJQRM-01-2017-0013
Caws, P. (1959). Definition and Measurement in Physics, in: Churchman, C.W. & Ratoosh, Ph. (Eds.). Measurement. Definitions and Theories, John Wiley & Sons, New York NY / Chapman & Hall, London, 3 - 17.
Cartwright, N. & Chang, H. (2008). Measurement, in: Psillos, S. & Curd, M. (Eds.). The Routledge Companion to Philosophy of Science, Routledge, Abingdon & New York NY, Phil. Sciences,2010; 367-375. https://durham-repository.worktribe.com/output/1645319
Churchman, C.W. (1959). Why Measure?, in: Churchman, C.W. & Ratoosh, Ph. (Eds.). Measurement. Definitions and Theories, John Wiley & Sons, New York NY / Chapman & Hall, London, 83 – 94.
Conti, T. (2002). A road map through the fog of quality and organizational assessments, Total Quality Management, 13(8), 1057-1068. https://doi.org/10.1080/09544120200000002
Coombs, C.H. (1959). Inconsistency of Preference as a Measure of Psychological Distance, in: Churchman, C.W. & Ratoosh, Ph. (Eds.), Measurement. Definitions and Theories, John Wiley & Sons, New York NY / Chapman & Hall, London, 221 – 232.
Dennis, I. (2015) Auditing Theory, Routledge, New York & London.
De Vries, H.J. de, Denniz K. Bayramoglu & Ton van der Wiele (2012). Business and environmental impact of ISO 14001, International Journal of Quality & Reliability Management, 29(4), 425 – 435. https://doi.org/10.1108/02656711211224866
Dodd, J. (2012) Events, Facts and States of Affairs, in: LePoidvin et al. (Eds.). The Routledge Companion of Metaphysics, Routledge, London & New York, Chapter 31, 322-334.
Edwards, P. (Chief Ed.) (1972) (repr. 1996) Encyclopedia of Philosophy, 8, 2nd ed., MacMillan Publishing Co., New York & London.
Ellis, B. (1972). Measurement, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 130-133.
Fahmy Salama, K., Luzzatto, D., Sianesi, A. & Towill, D.R. (2009). The value of auditing supply chains, International Journal of Production Economics, 119, 34 – 45. https://doi.org/10.1016/j.ijpe.2008.12.018
Fish, W. (2010) Philosophy of perception. A contemporary introduction, Routledge, New York & London.
Fleck, L. (1983) Erfahrung und Tatsache, Suhrkamp, Frankfurt am Main.
Forstén, J. (1997) Position paper on the simplification on the conformity assessment processes and the EN 45000 series standards, Accreditation and Quality Assurance, 2(6), 1997, 311 – 312.
Forstén, J. (1998) Controlling the quality of testing, Accreditation and Quality Assurance, 3(7), 285 – 288.
Freyer, H. (1966). Theorie des objectieven Geistes, Wissenschaftliche Buchgesellschaft, Darmstadt. Gale, B.G., Boaden, R.J., Wilcox, M. & Mcquator, R.E. (1997). Total quality management sustaining audit tool: description and use, Total Quality Management, 8(6), 395-408. https://doi.org/10.1080/0954412979406
Gale, R.M. (1972). Propositions, judgments, sentences and statements, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 494-505.
Goldberg, Y. & Shmilovici, A. (2005) An expert system approach for quality assurance auditing, International Journal of Advanced Manufacturing Technology, 26(4), 415 – 419. https://doi.org/10.1007/s00170-003-2001-7
Giordani, A. & Mari, L. (2012). Property evaluation types, Measurement, 45(3), 437 – 452. https://doi.org/10.1016/j.measurement.2011.10.030
Giordani, A. & Mari, L. (2019). A structural model of direct measurement, Measurement, 145, 535 – 550. https://doi.org/10.1016/j.measurement.2019.05.060
Gutierrez Alcantara, F. M. (2013). Building a performance measurement internal auditing framework for the ISO 9001 quality management system, Diss. University of Nottingham.
Hartmann, N. (1938). Möglichkeit und Wirklichkeit, Walter de Gruyter & Co., Berlin.
Hartmann, N. (1962). Ethik, Walter de Gruyter & Co., Berlin.
Hay, D. (2020). The future of auditing, Routledge, London & New York.
Hay, D., Knechel, W.R., and Willekens, M. (eds.) (2014). The Routledge Companion to Auditing, London & New York.
Heras-Saizarbitoria, I., & Boiral, O. (2012). ISO 9001 and ISO 14001: Towards a Research Agenda on Management System Standards, International Journal of Management Reviews, 15(1), 47 – 65. https://doi.org/10.1111/j.1468-2370.2012.00334.x
Hirst, R.J (1972a). Illusions, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 130-133.
Hirst, R.J. (1972b). Perception, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 79-87.
Hirst, R.J. (1972c). Phenomenalism, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 130-135.
Hirst, R.J. (1972d). Realism, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 77-83.
Hirst, R.J. (1972e). Sensa, in Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 407-415.
ISO (2021) ISO survey: https://isotc.iso.org/livelink/livelink?func=ll&objId=18808772&objAction=browse&viewType=1 (consulted on 26 September 2021).
Jammer, M (1972). Motion, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 396-399.
Karapetrovic, S.V. & Willborn, W.W. (2000). Quality assurance and the effectiveness of audit systems, International Journal of Quality and Reliability Management, 17(6), 679 – 703 https://doi.org/10.1108/02656710010315256
Karapetrovic, S.V. & Willborn, W.W. (2001) Audit system: Concepts and practices, Total Quality Management, 12(1), 13 – 28. https://doi.org/10.1080/09544120020010066
Kuceja, A. (2017) Quality management system auditing: a critical exploration of practice, Diss. Gloucestershire.
Kuselman, I., Pennecchi, F., Bich, W. & Hibbert, D.B. (2016) Human being as a part of measuring system influencing measurement results, Accreditation and Quality Assurance, 21(6), 421 – 424. https://doi.org/10.1007/s00769-016-1239-3
Lenning, J. (2018). Auditing of explorative processes, Total Quality Management, 29(10), 1185 - 1199. https://doi.org/10.1080/14783363.2018.1487605
LePoidvin, R., P. Simons, A. McGonical and R.P. Cameron (Eds.) (2012). The Routledge Companion of Metaphysics, Routledge, London & New York.
Mactavish, C., McCracken, S. & Schmidt, R.N. (2018) External Auditors’ Judgment and Decision Making: An Audit Process Task Analysis, Accounting Perspectives, 17(3), 387 – 426. https://doi.org/10.1111/1911-3838.12182
Manders, B. (2015). Implementation and Impact of ISO 9001 (No. EPS-2014-337-LIS). ERIM Ph.D. Series Research in Management. Rotterdam: Erasmus Research Institute of Management. Retrieved from http://hdl.handle.net/1765/77412, 27 September 2021.
Mari, L. (2003). Epistemology of measurement, Measurement, 34(1), 17 – 30. https://doi.org/10.1016/S0263-2241(03)00016-2
Mari, L. (2005) The problem of foundations of measurement, Measurement, 38(4), 259 – 266. https://doi.org/10.1016/j.measurement.2005.09.006
Mari, L., Carbone, P., Giordani, A. & Petri, D. (2017). A structural interpretation of measurement and some related epistemological issues, Studies in History and Philosophy of Science, 65-66, Special Issue 46 – 56. https://doi.org/10.1016/j.shpsa.2017.08.001
Mari, L., Ehrlich, Ch., & Pendrill, L.R. (2018). Measurement units as quantities of objects or values of quantities: a discussion, Metrologia, 55(5), 716 – 721. https://doi.org/10.1007/978-3-030-65558-7_2
Mari, L., Maul, A., Torres Irribarra, D., & Wilson, M. (2017). Quantities, Quantification, and the Necessary and Sufficient Conditions for Measurement. Measurement, 100, 115-121. https://doi.org/10.1016/j.measurement.2016.12.050
Mari, L., Wilson M. & Maul A (2023). Measurement across the sciences. Developing a shared concept system for measurement, Springer, Cham (2nd Ed.).
Menger, K. (1959). Mensuration and other Measurement Connections of Observable Material, in: Churchman, C.W. & Ratoosh, Ph. (Eds.). Measurement. Definitions and Theories, John Wiley & Sons, New York NY / Chapman & Hall, London, 97 – 128.
Moser, P.K., D.H. Mulder and J.D. Trout (1998). The Theory of Knowledge, Oxford University Press, New York and Oxford.
Mulligan, K. (2012). Values, in: LePoidvin et al. (Eds.). The Routledge Companion of Metaphysics, Routledge, London & New York, Chapter 38, pp 401-411.
Nivolianitou, Z.S. & Papazoglou, I.A. (1998) An auditing methodology for safety management of the Greek process industry, Reliability Engineering and System Safety, 60, 185 – 197. PII:S0951-8320(97)00148-8
Nonaka, I. (1990). Management of Knowledge Creation, Nihon Keizai Shinbun-sha, Tokyo.
O’Connor, D.J. (1972). Substance and attribute, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 36-40.
Orth, B. (1974). Einf”uhrung in die Theorie des Messens, Verlag Kohlhammer, Stuttgart, Berlin, Cologne & Mainz.
Pendrill, L.R. (2018). Assuring measurement quality in person-centred healthcare, Measurement Science and Technology, 29(3), Article Number 034003 https://doi.org/10.1088/1361-6501/aa9cd2
Pendrill, L.R. & Fischer, W.P. Jr. (2013). Quantifying Human Response: Linking metrological and psychometric characteristics of Man as a Measurement Instrument, Journal of Physics Conference Series, 459, Article Number: UNSP 012057 https://ssrn.com/abstract=2340744
Pfanzagl, J. (1971). Theory of Measurement, Physica-Verlag, Würzburg & Vienna.
Pivka, M. (2004). ISO 9000 value-added auditing, Total Quality Management and Business Excellence, 15(3), 345-353.
Portides, D. (2010). Models, in: Psillos, S. & Curd, M. (Eds.). The Routledge Companion to Philosophy of Science, Routledge, Abingdon & New York NY, 385-395.
Prenesti, E. & Gosmaro, F. (2015). Trueness, precision and accuracy: a critical overview of the concepts as well as proposals for revision, Accreditation and Quality Assurance, 20(1), 33 – 40. https://doi.org/10.1007/s00769-014-1093-0
Prior, A.N (1972a). Correspondence theory of truth, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 2, 2nd ed., MacMillan Publishing Co., New York & London, 223-232.
Prior, A.N. (1972b). Negation, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 458-463.
Quine, W.V. (2012). On what there is, in: Kim, J., Korman, D.Z. & Sosa, E. (Eds.). Metaphysics. An anthology, 2nd Ed., Wiley-Blackwell, Malden (MA), Oxford & Chichester., 7-15 (originally published in 1948, Review of Metaphysics, 2, 21-38).
Refaat, R. & El-Henawy, I.M. (2019) Innovative method to evaluate quality management system audit results’ using single value neutrosophic number, Cognitive Systems Research, 57, 197-206. https://doi.org/10.1016/j.cogsys.2018.10.014
Searle, J.R. (1995). The construction of the social reality, The Free Press, New York (NY).
Shoemaker, S. (1972). Memory, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 265-274.
Simnett, R. & Trotman, K.T. (2018) Twenty-five-year-Overview of Experimental Auditing Research: Trends and Links to Audit Quality, Behavioral Research in Accounting, 30(2), 55 – 76. https://doi.org/10.2308/bria-52138
Solomon, I. & Trotman, K.T. (2003) Experimental judgment and decision research in auditing: The first 25 years of AOS, Accounting Organizations and Society, 28(4), 395 – 412. https://doi.org/10.1016/S0361-3682(02)00023-5
Stallard, M. M., MacKenzie, C.A. & Peters, F.E. (2018) A probabilistic model to estimate visual inspection error for metalcastings given different training, and judgment types, environmental and human factors, and percent of defects, Journal of Manufacturing Systems, 48(A), 97 – 106. https://doi.org/10.1016/j.jmsy.2018.07.002
Thomassen, A.L. (2012). Social Entities, in: LePoidvin et al. (Eds.). The Routledge Companion of Metaphysics, Routledge, London & New York, Chapter 51, 545-554.
Trotman, K.T., Tan, H.C. & Ang, N. (2011). Fifty-year overview of judgment and decision-making research in accounting, Accounting and Finance, 51(1), 278 – 360. https://doi.org/10.1111/j.1467-629X.2010.00398.x
Von Wright, G.H. (1977). Norm and Action, Routledge & Kegan Paul, London & Henley-on-Thames.
Willborn, W.W. (1990). Dynamic Auditing of Quality Assurance: Concepts and Methods, International Journal of Quality & Reliability Management, 7(3), 35-41
https://doi.org/10.1108/02656719010002407
Woozley, A.D. (1972). Universals, in: Edwards, P. (Chief Ed.). Encyclopedia of Philosophy, 4, 2nd ed., MacMillan Publishing Co., New York & London, 194-206.
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