6/4/2023 0 Comments Iso 13485 quality manualWhile it remains a stand-alone standard, ISO 13485 is generally harmonized with ISO 9001. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that may not be appropriate. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements.
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