BS EN 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 requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of BS EN ISO 13485:2003 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 I SO 9001:2000 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 9001:2000 unless their quality management systems conform to all the requirements of ISO 9001:2000 (see Annex B).

All requirements of BS EN 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 (see 7.3), 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 this International Standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3].

If any requirement(s) in Clause 7 of this International Standard 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 [see 4.2.2 a)].

The processes required by this International Standard, 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 [see 4.1 a)].

In BS EN ISO 13485:2003 the terms if appropriate and where appropriate are used several times. When a requirement is qualified by either of these phrases, it is deemed to be appropriate unless the organization can document a justification otherwise. A requirement is considered appropriate if it is necessary in order for

- the product to meet specified requirements, and/or

- the organization to carry out corrective action.

This standard is identical to ISO 13485:2003

Cross References:
ISO 9000:2000
EN ISO 9000:2000
ISO 9001:2000
ISO 10012
ISO 11134:1994
ISO 11135:1994
ISO 11137:1995
ISO 13641:2002
ISO 13683:1997
ISO 14155-1:2003
ISO 14155-2:2003
ISO 14160:1998
ISO 14937:2000
ISO/TR 14969
ISO 14971:2000
ISO 19011:2002
90/385/EEC
93/42/EEC
98/79/EEC