Developed by the International Organization for Standardization, ISO 9001 comprises a set of requirements that reflect time‐proven, universally accepted good business practices, the majority of which are mandatory. AS9100, ISO 13485 and ISO/TS 16949 standards utilize the ISO 9001 framework and have additional industry specific requirements.
The aim of a QMS is to assure that an organization consistently meets customer needs by controlling the core processes that affect them such as sales orders, design, production, inspection, delivery, etc.
The requirements also go beyond these “core” processes to address support processes like purchasing, training, calibration, maintenance, and performance metrics.
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