ISO 13485:2016 specifies requirements for a quality management system for medical devices where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements. The objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some requirements for medical devices and excludes some of the requirements of ISO 13485:2016 that are not appropriate as regulatory requirements. Organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 13485:2016 unless their quality management systems conform to all the requirements of ISO 13485:2016. All requirements of ISO 13485:2016 are specific to organizations providing medical devices, regardless of the type or size of the organization.
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