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Implementation Of Iso 13485:2016 In Medical Products Handling Multinational Corporation

Author

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  • DANIEL JALNASOW

    (Faculty of Economics, South-West University "Neofit Rilski", Blagoevgrad)

Abstract

The report is focusing on quality management system implementation in a transnational company. This organization, which we refer to as Corporation X (hereinafter referred to as CX), is a large multinational, multi-branch organization. It operates over 250 subsidiary companies in what is termed "the CX family of companies". The corporation operates in three broad divisions; CX is operating in 60 countries and is selling products in more than 170 countries now - in 2019.The quality system, which is under implementation is ISO 13 485: 2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.

Suggested Citation

  • Daniel Jalnasow, 2019. "Implementation Of Iso 13485:2016 In Medical Products Handling Multinational Corporation," Economics and Management, Faculty of Economics, SOUTH-WEST UNIVERSITY "NEOFIT RILSKI", BLAGOEVGRAD, vol. 16(2), pages 167-178.
    • Handle: RePEc:neo:journl:v:16:y:2019:i:2:p:167-178
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    More about this item

    Keywords

    Quality management system (QMS); Large multinational; multi-branch organization; Medical Products Handling; ISO 13 485: 2016 - Medical devices - Quality management systems - Requirements for regulatory purposes.;
    All these keywords.

    JEL classification:

    • L15 - Industrial Organization - - Market Structure, Firm Strategy, and Market Performance - - - Information and Product Quality

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