ISO 13485

ISO 13485 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 ISO 13485 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 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 reflect exclusion of design and development controls.

If any requirement(s) in Clause 7 of ISO 13485 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, 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.

Gaining certification to ISO 13485 will help your organization do business in this highly regulated sector. Whether you are looking to operate internationally or to expand locally to accommodate new business, ISO 13485 will help you demonstrate to customers and regulators that you are committed to quality.

The regular assessment process will ensure that your processes are continually checked for effectiveness and provide the opportunity to avoid unpleasant regulatory surprises. Certification can improve overall performance, remove uncertainty and widen market opportunities.