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The ISO 9001 standard deals with quality management and is closely related to ISO 13485. The aim is the permanent improvement of the company’s own quality management system and the minimum requirements placed on it. This secures that the product or service quality can be guaranteed to a high degree. ISO 9001 applies not only to medical technology branche, but to all industries. With a strict focus on process orientation, DIN EN ISO 9001 prescribes a process-oriented quality management system that lists and analyzes all operational processes. It supports in identifying potential for improvement.

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