Module 19 2021

01/06/2021

What does Quality actually mean?

Why do we need a Quality Culture?

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Why have a Quality Management System

Insight

“all manufacturers should have a quality management system and a post market surveillance systemwhich should be proportionate to the risk class and type of device in question” Art. 31

“There is no ‘one size fits all’ Quality Management System. The extent at which an organisation

controls their processes is

dependent on the nature, size and complexity of an organisation.”

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