BS EN ISO 13485:2003
Medical devices - Quality management systems - Requirements for regulatory purposes

Standard No.

BS EN ISO 13485:2003

Release Date

2003

Published By

British Standards Institution (BSI)

Status

Be replaced 2012-03

Replace By

BS EN ISO 13485:2012

Latest

BS EN ISO 13485:2016+A11:2021

Scope

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. All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls. If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. The processes required by ISO 13485:2003, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.

BS EN ISO 13485:2003 history

• 1970 BS EN ISO 13485:2016+A11:2021 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
• 2017 BS EN ISO 13485:2016 Medical devices. Quality management systems. Requirements for regulatory purposes
• 2012 BS EN ISO 13485:2012 Medical devices. Quality management systems. Requirements for regulatory purposes
• 2003 BS EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
• 2001 BS EN ISO 13485:2001 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001
• 1997 BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices