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System proposal for implementation of risk management in the context of ISO/IEC 17025

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Abstract

Many higher education institutions in the world have testing laboratories linked, or not, to their teaching and/or research programs. However, only a small proportion of these laboratories have accreditation in accordance with the ISO/IEC 17025 standard. The ISO/IEC 17025 establishes the management and technical requirements necessary for the implementation and maintenance of a quality management system (QMS) in laboratories that perform testing, calibration and/or sampling activities, being used by them to demonstrate their competence in carrying out their activities. One of the requirements of the current version of the standard is the need to carry out risk management (RM), introduced with the demand for risk-based thinking. The objective of this research was to propose a system for the implementation of RM in laboratories, through mapping, identification, classification, critical analysis, and treatment of risks. The research considered the history of actions taken, the risks verified by the laboratory team, the evaluation of their impacts and the probabilities of their occurrence, their classification and the identification of actions necessary to accept, mitigate or eliminate these risks. The system proposed was applied in a testing laboratory at a university in southern Brazil, enabling the maintenance of its accreditation.

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Source: Adapted from [21]

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References

  1. Grochau IH, Ferreira CA, Ferreira ZJ, ten Caten CS (2010) Implementation of a quality management system in university test laboratories: a brief review and new proposals. Accredit Qual Assur 15(12):681–689

    Article  Google Scholar 

  2. International Organization for Standardization (ISO) (2017) ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories. Geneva

  3. Grochau IH, ten Caten CST, Forte MMC (2018) Motivations, benefits and challenges on ISO/IEC 17025 accreditation of Higher Education Institution laboratories. Accredit Qual Assur 23(3):183–188. https://doi.org/10.1007/s00769-018-1317-9

    Article  CAS  Google Scholar 

  4. Grochau IH, ten Caten CST, Forte MMC (2017) Current American landscape in laboratory accreditation according to ISO/IEC 17025. Accredit Qual Assur 22(2):57–62. https://doi.org/10.1007/s00769-017-1248-x

    Article  CAS  Google Scholar 

  5. Grochau IH, Leal DKB, ten Caten CST (2020) European current landscape in laboratory accreditation. Accredit Qual Assur 25:303–310. https://doi.org/10.1007/s00769-020-01440-w

    Article  Google Scholar 

  6. Ribeiro LMS, Beijo LA, Salgado EG, Nogueira DA (2019) Modelling of ISO 9001 certifications for the American countries: a Bayesian approach. Total Qual Manag Bus Excell. https://doi.org/10.1080/14783363.2019.1696672

    Article  Google Scholar 

  7. International Organization for Standardization (ISO) (2015) ISO 9001 - Quality management systems - Requirements, Geneva

  8. Cagnin F, Oliveira MC, Miguel PAC (2019) Assessment of ISO 9001: 2015 implementation: focus on risk management approach requirements compliance in an automotive company. Total Qual Manag Bus Excell. https://doi.org/10.1080/14783363.2019.1677151

    Article  Google Scholar 

  9. Wong SK (2017) Risk-based thinking for chemical testing. Accredit Qual Assur 22:103–108. https://doi.org/10.1007/s00769-017-1256-x

    Article  CAS  Google Scholar 

  10. Samani MA, Ismail N, Leman Z, Zulkifli N (2019) Development of a conceptual model for risk-based quality management system. Total Qual Manag Bus Excell 30(5–6):483–498. https://doi.org/10.1080/14783363.2017.1310617

    Article  Google Scholar 

  11. Zou X, Isa CR, Rahman M (2019) Valuation of enterprise risk management in the manufacturing industry. Total Qual Manag Bus Excell 30(11–12):1389–1410. https://doi.org/10.1080/14783363.2017.1369877

    Article  Google Scholar 

  12. Fonseca LM, Domingues JP, Baylina-Machado P, Harder D (2019) ISO 9001:2015 adoption: a multicountry empirical research. J Ind Eng Manag 12(1):27–50. https://doi.org/10.3926/jiem.2745

    Article  Google Scholar 

  13. Grochau IH, ten Caten CST (2012) A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories. Accredit QualAssur 17:519–527. https://doi.org/10.1007/s00769-012-0905-3

    Article  Google Scholar 

  14. Sedrez CS, Fernandes FC (2011) Gestão de Riscos nas Universidades e Centros Universitários do Estado de Santa Catarina. Revista Gestão Universitária na América Latina, Florianópolis, Edição especial 2011, p. 70–93. Available at: https://periodicos.ufsc.br/index.php/gual/article/view/24829. Access at: 10 Jul 2019

  15. Wen D, Sun X, Yan D (2020) The quality movement: where are we going? Past, present and future. Total Qual Manag Bus Excell. https://doi.org/10.1080/14783363.2020.1801342

    Article  Google Scholar 

  16. Casteleiro C, Mendes SL (2020) Exploring the influence of quality management systems in work engagement and psychological empowerment in private institutions of social solidarity. Total Qual Manag Bus Excell. https://doi.org/10.1080/14783363.2020.1832460

    Article  Google Scholar 

  17. Ikram M, Zhang Q, Sroufe R (2020) Future of quality management system (ISO 9001) certification: novel grey forecasting approach. Total Qual Manag Bus Excell. https://doi.org/10.1080/14783363.2020.1768062

    Article  Google Scholar 

  18. International Organization for Standardization (ISO) (2013) ISO/TR 31004 - Risk management ― Guide to the implementation of ISO 31000. Geneva

  19. International Organization for Standardization (ISO) (2018) ISO 31000 - Risk management ― Guidelines. Geneva

  20. International Organization for Standardization (ISO) (2009) ISO/IEC 31010 - Risk management — Risk assessment techniques. Geneva

  21. Pacana A (2018) Supervision of measuring equipment based on risk management and ISO 9001. Prod Eng Arch 21:8–11

    Article  Google Scholar 

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Acknowledgements

The authors gratefully acknowledge the financial support from the Luiz Englert Foundation and the Brazilian government agencies: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior – CAPES, and Financiadora de Estudos e Projetos – FINEP (SIBRATEC project).

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Authors and Affiliations

  1. PPGE3M, Federal University of Rio Grande Do Sul, Porto Alegre, RS, Brazil

    Fabiane Rodrigues da Silva, Inês Hexsel Grochau & Hugo Marcelo Veit

  2. PPGEP, Federal University of Rio Grande Do Sul, Porto Alegre, RS, Brazil

    Inês Hexsel Grochau

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  1. Fabiane Rodrigues da Silva
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  2. Inês Hexsel Grochau
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  3. Hugo Marcelo Veit
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Correspondence to Fabiane Rodrigues da Silva.

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da Silva, F.R., Grochau, I.H. & Veit, H.M. System proposal for implementation of risk management in the context of ISO/IEC 17025. Accred Qual Assur 26, 271–278 (2021). https://doi.org/10.1007/s00769-021-01484-6

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