Sector specific applications of ISO 9001

ISO has a range of standards for quality management systems that are based on ISO 9001 and adapted to specific sectors and industries, including the ISO 13485 standard. ISO 13485 specifies the requirements for a quality management system that any organization operating in the medical devices sector needs to demonstrate.

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High level structure

ISO 9001 follows the High-Level Structure (HLS), the uniform main structure for all (new) ISO management system standards. HLS means that approximately fifty percent of the standard text for the various ISO standards is the same and fifty percent specific for the subject. This makes it easier to use one ISO management system standard next to the other.