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Review
. 2020 Dec 31;71(4):312-319.
doi: 10.2478/aiht-2020-71-3449.

Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

Zdenko Franić  1 , Tomislav Bituh  1 , Ranka Godec  1 , Mirjana Čačković  1 , Tomislav Meštrović  1 , Jerko Šiško  1
Affiliations
Review

Experiences with the accreditation of the Institute for Medical Research and Occupational Health, Zagreb, Croatia

Zdenko Franić et al. Arh Hig Rada Toksikol. .

Abstract
in English, Croatian

Accreditation in accordance with the international General Requirements for the Competence of Testing and Calibration Laboratories (HRN EN ISO/IEC 17025 standard) has become a widely accepted method of quality management and objective evidence of technical competence, knowledge, and skills of testing and calibration laboratories. In 2010, the Institute for Medical Research and Occupational Health (IMROH) had its management system accredited against the HRN EN ISO/IEC 17025 standard for the following scopes: determination of radioactivity, testing of ambient air quality, and testing in the scope of ionising radiation protection. This accreditation encompassed three laboratories: Radiation Protection Unit, Environmental Hygiene Unit, and the Radiation Dosimetry and Radiobiology Unit. In accordance with the rules of the Croatian Accreditation Agency, the second re-accreditation is due in 2020. This paper describes and discusses the quality management system at IMROH over the ten years of its implementation. We share our experiences about non-conformities discovered during regular work, internal audits, and external audits performed by the Croatian Accreditation Agency. The accredited management system significantly improved the performance of the accredited units, and the Institute increased its visibility and marketing advantage, consequently improving its market position.

Akreditacija u skladu sa zahtjevima međunarodnog standarda HRN EN ISO / IEC 17025 (Opći zahtjevi za osposobljenost ispitnih i umjernih laboratorija) postala je praktična i široko prihvaćena metoda upravljanja kvalitetom i objektivni dokaz tehničke osposobljenosti, znanja i vještina u ispitnim i umjernim laboratorijima. Institut za medicinska istraživanja i medicinu rada (IMROH) akreditirao je 2010. godine svoj sustav upravljanja u skladu sa zahtjevima HRN EN ISO / IEC 17025 norme za sljedeća područja primjene: određivanje radioaktivnosti, ispitivanja kvalitete zraka te ispitivanja u području zaštite od ionizirajućega zračenja. Akreditacija je obuhvaćala tri laboratorija: Jedinicu za zaštitu od zračenja, Jedinicu za higijenu okoline i Jedinicu za dozimetriju zračenja i radiobiologiju. U skladu s pravilima Hrvatske akreditacijske agencije, u 2020. godini planira se druga reakreditacija Instituta. U radu je opisan sustav upravljanja kvalitetom u IMROH-u i iskustva stečena tijekom desetogodišnjeg razdoblja. Analizirane su nesukladnosti otkrivene tijekom redovitog rada, u internim auditima te u vanjskim auditima koje je provodila Hrvatska akreditacijska agencija, tj. nacionalno akreditacijsko tijelo u Hrvatskoj. Može se zaključiti da je akreditirani sustav upravljanja značajno poboljšao rad uključenih akreditiranih jedinica, a Institut je povećao vidljivost na tržištu i marketinšku prednost te posljedično poboljšao svoju tržišnu poziciju.

Keywords: ISO norms; measurement traceability; quality management; testing laboratories.

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Figures

Figure 1
Figure 1
Number of accredited bodies in Croatia after the establishment of the accreditation system
Figure 2
Figure 2
Non-conformities found by internal and external auditing teams in the 2010–2020 period. X-axis lists the requirements (by clauses) of the ISO IEC/17025:2007 standard (4.1–4.15 system management and 5.2–5.10 technical competences)
Figure 3
Figure 3
Recommendations given by internal and external auditing teams in the 2010–2020 period. X-axis lists the requirements (by clauses) of the ISO IEC/ 17025:2007 standard (4.1–4.15 system management and 5.2–5.10 technical competences)
See this image and copyright information in PMC

References

    1. United Nations Industrial Development Organization -UNIDO. Guide for the Development of National Quality Policies. Vienna: UNIDO; 2016.
    1. European Cooperation for Accreditation – EA. Accreditation in Europe - Facilitating regulatory compliance and international trad. Paris: EA; 2013.
    1. Zakon o zaštiti od buke [Law on Noise Protection, in Croatian] Narodne novine 30/2009.
    1. Uredba o razinama onečišćujućih tvari u zraku [Regulation on Air Pollutant Levels, in Croatian] Narodne novine 117/2012.
    1. Zakon o radiološkoj i nuklearnoj sigurnosti [Law on Radiological and Nuclear Safety, in Croatian] Narodne novine 141/2013.