Expert Assessment of Conditions for Accredited Quality Management System Functioning in Testing Laboratories

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Abstract

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.

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  • [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)

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