ISO 13485 specifies requirements for a quality management system that can be applied by an organization involved in one or more stages of the medical device lifecycle. Although ISO 13485 is based on the principles of ISO 9001 and the PDCA cycle, ISO 13485 places far more demands on a complete QMS, and thus puts manufacturers and other organizations in greater need of documentation.

The third edition of the standard also strengthens the already implemented process-oriented approach. Consistent and predictable results are achieved more effectively and efficiently when activities are understood, managed and controlled as coherent processes that function as a coherent system. ISO 13485 explicitly requires processes for which documented procedures must be implemented and maintained. The process landscape includes both supporting processes (for example, the process of controlling documents) and value-adding processes that describe the entire lifecycle of the medical device – from conception to the end of product life and disposal.

The scope of ISO 13485:2016 does not solely apply to manufacturers. Suppliers and third parties providing goods and services associated with the quality management system for medical devices manufacturers may also apply the standard and have their conformity certified by a notified body. Suppliers can significantly reduce the audit effort of their customers by means of their own certification, which demonstrates conformity with ISO 13485.

As an active member of the standardization group ISO TC210/WG1, we are one of the authors of this internationally recognized standard. Get your information firsthand instead of the Internet or third parties. Our consultants and project engineers support medical device manufacturers and suppliers in implementing the relevant requirements of ISO 13485.