Expert assessment of conditions for accredited quality management system functioning in testing laboratories

• Autorzy: Mytych J. , Ligarski M. J.

Identyfikatory

DOI

10.2478/mspe-2018-0007

• Języki publikacji: EN

Abstrakty

EN

The quality management systems compliant with the ISO 9001:2009 have been thoroughly researched and described in detail in the world literature. The accredited management systems used in the testing laboratories and compliant with the ISO/IEC 17025:2005 have been mainly described in terms of the system design and implementation. They have also been investigated from the analytical point of view. Unfortunately, a low number of studies concerned the management system functioning in the accredited testing laboratories. The aim of following study was to assess the management system functioning in the accredited testing laboratories in Poland. On 8 October 2015, 1,213 accredited testing laboratories were present in Poland. They investigated various scientific areas and substances/objects. There are more and more such laboratories that have various problems and different long-term experience when it comes to the implementation, maintenance and improvement of the management systems. The article describes the results of the conducted expert assessment (survey) carried out to examine the conditions for the functioning of a management system in an accredited laboratory. It also focuses on the characteristics of the accredited research laboratories in Poland. The authors discuss the selection of the external and internal conditions that may affect the accredited management system. They show how the experts assessing the selected conditions were chosen. The survey results are also presented.

Słowa kluczowe

EN

quality management system; ISO/IEC 17025:2005; accreditation; testing laboratory

• Wydawca: STE GROUP
• Czasopismo: Management Systems in Production Engineering
• Rocznik: 2018
• Tom: nr 1 (26)
• Strony: 42--48
• Opis fizyczny: Bibliogr. 9 poz., rys., tab.

Twórcy

autor

Mytych J.

• Institute of Environmental Engineering Polish Academy of Sciences ul. Skłodowskiej-Curie 34, 41-819 Zabrze, POLAND tel. [phone]

autor

Ligarski M. J.

• Silesian University of Technology Faculty of Organization and Management Institute of Production Engineering ul. Roosevelta 26, 41-800 Zabrze, POLAND

Bibliografia

• [1] U. Ricci, “Establishment of an ISO 17025:2005 accredited forensic genetics laboratory in Italy”, Accred Qual Assur, vol. 19, iss. 4, pp 289-299, June, 2014.
• [2] K, Hullihen, V. Fitzsimmons, M. R, Fisch: “Establishing an ISO 17025 Compliant Laboratory at a University” in Proceedings of The 2008 IAJC-IJME International Conference, Paper # 059, IT 305, 2008, pp. 1-15
• [3] I. H Grochau, C. Schwengber: “A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories”, Accred Qual Assur., vol. 17 iss. 5, pp. 519-527, 2012.
• [4] A. Kessler, L. Siekmann, C. Weykamp, W.J. Geilenkeuser, O. Dreazen, J. Middle, G. Schumann, “External Quality Assessment Scheme for reference laboratories - review of 8 years' experience”, Clin Chem Lab Med, vol. 51, iss. 5, pp. 997-1005, 2013.
• [5] B. Breustedt, U. Mohr, N. Biegard, G. Cordes, “Quality management system and accreditation of the in vivo monitoring laboratory at Karslruhe Institute of Technology”, Radiat Prot Dosimetry, vol. 144, pp. 95-107, 2010.
• [6] General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025:2005, 2005
• [7] Environmental Protection Law (Journal of Laws 2001, No. 62, item 627, Act of 27 April 2001) (in Polish)
• [8] Regulation of the Minister of Health of 12 November 2015 changing the Regulation on safe conditions for ionizing radiation utilization for all medical exposure types (Journal of Laws 2013, No. 0, item 1015 as amended). (in Polish)
• [9] Act on Conformity Assessment System of 30 August 2002 (in Polish)

Uwagi

PL

Opracowanie w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).