![]() 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.Īll requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization. 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. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. Additional advantage during tenders’ procedures.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.Enhancing image of the organization, demonstrating adherence to the requirements of international standards, best practices, product quality and compliance with applicable legislative and regulatory requirements.Increasing product quality and its commercial value in terms of greater consumer confidence and, as a consequence increase sales volume.Systematization of the organization activities with a use of a process approach, improving the efficiency of resource management.High degree of harmonization of the standard with other international standards, including ISO 9001 and GMP, which simplifies the development of integrated management systems. ![]()
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