What is ISO 13485?
ISO 13485:2016 delineates criteria for a quality management system, wherein an organization must exhibit its capability to furnish medical devices and associated services consistently meeting customer and relevant regulatory requisites. Such entities may engage in various life-cycle stages, encompassing design, production, storage, distribution, installation, or servicing of medical devices, along with ancillary activities like technical support. Moreover, suppliers or external entities offering product or quality management system-related services to such organizations can also leverage ISO 13485:2016.
The stipulations of ISO 13485:2016 apply universally to organizations irrespective of their size or type, unless explicitly stated otherwise. When requirements pertain to medical devices, they equally extend to associated services rendered by the organization.
Processes mandated by ISO 13485:2016, pertinent to the organization but not executed by it, remain the organization’s responsibility and are managed within its quality management system through monitoring, upkeep, and oversight.
Should regulatory norms permit exemptions from design and development controls, such exclusions can be justified within the quality management system. These regulatory provisions may suggest alternative approaches, necessitating incorporation into the quality management system. It falls upon the organization to ensure that claims of adherence to ISO 13485:2016 accurately reflect any exclusion of design and development controls.