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ISO 9001 : 2015 sets out the criteria for a quality management system and describes best practices for efficiently and effectively achieving high customer satisfaction. This standard is based on a number of quality management principles including a strong customer focus, risk assessment, the motivation and implication of top management, the process approach and continual improvement. 

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ISO 13485 : 2016 sets out the requirements for a quality management system specific to the medical devices industry.

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