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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 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 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.

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.

The ISO certification as well as a successfully reviewed Technical File is required for a company to sell any medical device in the European Union and Canada.

Our Team offers a variety of Consulting Services and Solutions.

IQMS consists of full-time trainers and consultants with a unique combination of manufacturing experience, business and financial expertise, and a "hands-on" approach creates a recipe for our clients' success.

We develop and help our clients implement a plan for exploiting those opportunities to achieve financially measurable success.

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