Risk Management at the Notified Body in the Aspect of Its Impartiality

• Autorzy: Zając Romana , Božek Pavol

Identyfikatory

DOI

10.32056/KOMAG2021.3.4

• Języki publikacji: EN

Abstrakty

EN

State-of-the art management systems are oriented onto supporting a competiveness of organizations and a continuous quality improvement of products, services and processes. One of essential elements of management is the risk management process which enables to manage uncertainty and risk in relation to the conducted activity by an organization. Managing risk assists organizations in setting strategy, achieving objectives and making informed decisions. Managing risk is part of governance and leadership, and is fundamental to how the organization is managed at all levels. It contributes to the improvement of management systems. A competent use of risk management mechanisms enables each organization to use its potential to a full extent and undertake proper decisions. The issues concerning a standardization of requirements in the case of standards from the management scope; in particular from the point of view of issues connected with risk management, are presented in the first part of the article. A model of the process, oriented onto a risk in the quality management system which enables to conduct managing activities in the situation of uncertainty and to take decisions oriented onto preventing mistakes in managing the organization and onto ensuring the appropriate quality, is described. The subject – matter concerning risk analysis, in particular from the point of view of meeting the EA Guidelines, concerning horizontal requirements related to the bodies assessing the conformity for notification purposes, is brought nearer. The most essential requirements, which must be met by such a body to guarantee a competent and impartial process of the product assessment, are described. In the following chapters the basic elements of the risk analysis process are discussed and an exemplary description of the risk assessment methodology is presented.

Słowa kluczowe

EN

quality management system; notified body; process approach; risk analysis

PL

zarządzanie; jakość; analiza ryzyka

• Wydawca: Instytut Techniki Górniczej KOMAG
• Czasopismo: Mining Machines
• Rocznik: 2021
• Tom: no. 3
• Strony: 34--44
• Opis fizyczny: Bibliogr. 26 poz., rys., tab.

Twórcy

autor

Zając Romana

• KOMAG Institute of Mining Technology, 44-100 Gliwice, Pszczyńska 37, Poland

autor

Božek Pavol

• Slovak University of Technology, J. Bottu 25, 91724 Trnava, Slovakia

Bibliografia

• [1] ISO 9001 Quality management systems - Requirements.
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• [4] The ISO survey of management system standard certifications – 2019 – explanatory note. Pdf (accessed: September 2020)
• [5] https://www.iso.org/committee/54996.html (accessed: 14.09.2020)
• [6] ISO/IEC Directives Part 1. Consolidated ISO Supplement. Procedures specific to ISO. Annex SL (normative) Proposals for management system standards. Eleventh edition 2020. https://www.iso.org/sites/directives/current/consolidated/index.xhtml#_idTextAnchor535
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• [8] ISO/IEC 17065 Conformity assessment - Requirements for bodies certifying products, processes and services
• [9] ISO/IEC 17020 Conformity assessment - Requirements for the operation of various types of bodies performing inspection
• [10] ISO/IEC 17021 Conformity assessment - Requirements for bodies providing audit and certification of management systems
• [11] ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
• [12] Kaczmarek T.: Zarządzanie ryzykiem. Ujęcie interdyscyplinarne Wyd. Difin, 2010. ISBN 978-83-7641-280-14
• [13] Popova, L., Yashina, M, Babynina, L., Ryzshakova, A., Yefremova, N., Andreev, A.: The Quality Management Development based on Risk-based Thinking Approach according to ISO 9001. Quality-Access to Success, 2019 Volume: 20, Issue: 170, Pages: 58-63
• [14] Figiel A.: Technical safety of machinery and equipment in the aspect of the activities of the KOMAG Division of Attestation Tests, Certifying Body. Mining Machines 2020, No 1, https://doi.org/10.32056/KOMAG
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• [16] Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93
• [17] Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/E
• [18] EA-2/17 M: 2020: EA Document on Accreditation for Notification Purposes. https://europeanaccreditation. org/wp-content/uploads/2018/10/ea-2-17-m.pdf
• [19] ISO 31000:2018-08 Risk management - Principles and guidelines
• [20] EN IEC 31010:2020-01 Risk management - Risk assessment techniques
• [21] Samani, M. A., Ismail, N., Leman, Z., Zulkifli, N.: Development of a conceptual model for risk-based quality management system. Total Quality Management & Business Excellence 2019, Volume: 30, Issue: 5- 6 pages: 483-498. doi.org/10.1080/14783363.2017.1310617
• [22] Zając R., Wierzbicka D.: Wymagania normatywne i prawne dla podmiotów zaangażowanych w proces potwierdzania zgodności maszyn i urządzeń stosowanych w górnictwie. Bezp. Pr. Ochr. Śr. Gór. 2011 nr 8,
• [23] Galland, Jean-Pierre: The difficulties of Regulating Markets and Risks in Europe through Notified Bodies: European journal of risk regulation. Volume: 4 Issue: 3 Pages: 365-373 Published: SEP 2013: doi.org/10.1017/S1867299X00002634
• [24] https://ec.europa.eu/growth/tools-databases/nando/ [accessed: 14.09.2020]
• [25] https://ec.europa.eu/growth/toolsdatabases/ nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd=EPOS%5F54814 [accessed: 14.09.2020]
• [26] Algheriani Nuri Mohamed Saad, Majstorovic Vidosav D., Kirin Snezana, Spasojevic Brkic Vesna: Risk Model for Integrated Management System. Tehnički vjesnik 26, 6 (2019), 1833-1840. DOI. 10.17559/TV- 20190123142317, doi.org/10.17559/TV-20190123142317

Uwagi

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2021).