The ISO 13485-2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
An organization need not be in an active production stage of medical equipment in order to seek the ISO 13485 certification. Compliance with this ISO standard is regarded as steps towards meeting the inline standard requirements of Global Harmonization Task Force Guidelines (GHTF).
Incorporating the certification standard lays down a pragmatic approach for medical equipment manufacturers to inculcate the Medical device directives and also will help showcase organization’s commitment to safe manufacturing practices as well as indicate the quality of the pieces of equipment thus manufactured.
The ISO 13485 continues to remain a standalone document specification however, its applications and specifications are most of the times coordinated and harmonized with ISO 9001(Link to ISO 9001 page).
However, there are some key differences between ISO 13485 and ISO 9001