BS EN ISO 13485:2012 - Page 2

Medical devices. Quality management systems. Requirements for regulatory purposes. | Status: Revised, Superseded, Withdrawn

1 Scope

1.1 General

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 ofISO 9001that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity toISO 9001unless their quality management systems conform to all the requirements ofISO 9001(see Annex B).