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Quality Assurance is a usual concept in the world of business. All the studies performed on this subject emphasize the added-value of implementing a Quality Management System in a company. However, the real added-value that it brings to business is questioned when the Quality Management System has been put in place to obtain a certificate as a first objective.
The aim of this study is to answer the following basic question “How to organize Quality Assurance in a healthcare company to bring real value to the business?” in order to help a company which previously approached Quality Assurance mainly for compliance purpose.
To do so, a review of the literature was performed and three quality managers of companies working in the healthcare domain were interviewed in order to identify the main success keys to succeed in the approach of Quality Assurance at organizational aspect.
The outputs of the three interviews were cross-analyzed in parallel with the literature review to emphasis the main key elements of a Quality Assurance organization to succeed in the implementation of valuable Quality Management System.
As a result, 14 success keys were identified. For example: choose QA team members naturally devoted to quality as an added-value for the business, find the good balance between controlling and supporting, empower all the employees regarding quality, obtain management commitment and continuous support, define quality strategy and objectives aligned with the strategy of the company, evolve from the notion of departments to the notion of process to avoid working in silos and create a user friendly GUI for all employees to represent the cartography of the QMS.
The Quality Assurance approach is challenging and never-ending journey. These 14 success keys could help in organizing the Quality Assurance in order to bring real added value to the business. It is not a magic bullet but just a basis for reflection.

Total Quality Management --- Quality Management System --- Quality Assurance --- ISO 9000 --- Healthcare --- Organization Management --- Sciences économiques & de gestion > Gestion de l'entreprise & théorie des organisations