IMPLEMENTATION OF ISO 13485:2016 IN MEDICAL PRODUCTS HANDLING MULTINATIONAL CORPORATION

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

Economics and Management, 2019, vol. 16, issue 2, 167-178

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.

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. (search for similar items in EconPapers)
JEL-codes: L15 (search for similar items in EconPapers)
Date: 2019
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