This International Standard 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 requirements and regulatory
requirements applicable to medical devices and related services.
The primary objective of this International Standard is to facilitate harmonized
medical device regulatory requirements for quality management
systems. As a result,
it includes some particular requirements for medical devices and excludes some of
the requirements of ISO 9001 that are not appropriate as regulatory requirements.
Because of these exclusions, organizations whose quality management systems conform
to this International Standard cannot claim conformity to ISO 9001 unless their
quality management systems conform to all the requirements of ISO 9001.
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