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

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

Author(s): Daniel Jalnasow
Subject(s): Economy, Business Economy / Management
Published by: ЮГОЗАПАДЕН УНИВЕРСИТЕТ »НЕОФИТ РИЛСКИ«
Keywords: Quality management system (QMS); Large multinational; multi-branch organization; Medical Products Handling; ISO 13 485: 2016; Medical devices; Quality management systems

Summary/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.

  • Issue Year: 16/2019
  • Issue No: 2
  • Page Range: 167-178
  • Page Count: 12
  • Language: English
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