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 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 ali the requirements of ISO 9001 (see Annex B).
1.2 Application
All requirements of this International Standard 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 this International Standard 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.