ISO 13485:2016 Key Points of Change and the Importance of Leadership in New Standard

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.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.  According to the new ISO13485:2016 standard, leaders establish unity of purpose and direction of the organization and should create and maintain the internal environment in which people can become fully involved in achieving the organization's objectives.  As such, Leadership now has defined responsibilities for ensuring quality execution such as: strategic alignment, specific resource support, staffing, oversight, measurement, and promotion of the quality system.