(CONTACT UNIT OF QS ZURICH AG, SWITZERLAND)
ISO 13485 is an international standard that specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation, and servicing of Medical Devices. This standard can also be used by international and external parties, including certification bodies, for assessment of the organization's ability to meet customer and regulatory requirementsapplicable 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.
Find out how much ISO 13485 certification could cost your business.
benefit of ISO 13485 certification, ISO 13485 requirements, ISO 13485 certification requirements, ISO 13485 consultants, ISO 13485 consultant, ISO 13485 consultancy, ISO 13485 certification consultants, ISO 13485 certification process, ISO 13485 certification process steps, ISO 13485 process, ISO 13485 process map, Medical Devices, iso 13485 quality system, Medical Devices system iso 13485, benefits of iso 13485 Medical Devices system