ISO 13485:2016 specifies requirements for a Quality Management System to produce ISO 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 supplied by the organization. The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System. Here is what the five main sections are about: Clause 4 – Quality Management System (“Intersection”) Clause 4 targets two very specific aspects of a Quality Management System: General Requirements and Documentation Requirements. General Requirements. In evaluation of any ISO standard, there are a few systematic requirements that are the driving force for establishment and implementation of a Quality Management System.