ISO 13485 specifies the requirements for a quality management system where an organization must demonstrate its capacity to consistently provide medical devices and related services that meet customer and regulatory requirements. Such organizations may be involved in one or more stages of a medical device’s life-cycle, such as design and development, production, storage and distribution, installation, or servicing, as well as design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be utilized by suppliers or external parties that provide products or services related to quality management systems to such organizations.
A company does not need to be actively producing medical equipment in order to pursue ISO 13485 certification. Compliance with this ISO standard is viewed as a step towards fulfilling the inline standard requirements of Global Harmonization Task Force Guidelines (GHTF).
Incorporating the certification standard sets out a pragmatic strategy for medical equipment manufacturers to adopt the Medical device directives. It will also aid in demonstrating the organization’s commitment to safe manufacturing practices and the quality of the equipment thus produced.
The ISO 13485 document specification continues to be a standalone document; however, its applications and specifications are frequently coordinated and harmonized with ISO 9001.