Management system

A quality management system under ISO 13485 is one kind of management system. Several can be integrated into one, for example quality and environment.

set of interrelated or interacting elements of an organization to establish policies and objectives, and processes (3.24) to achieve those objectives Note 1 to entry: A management system can address a single discipline or several disciplines, e.g. quality management, financial management or environmental management. Note 2 to entry: The management system elements establish the organization’s structure, roles and responsibilities, planning, operation, policies, practices, rules, beliefs, objectives and processes to achieve those objectives. Note 3 to entry: The scope of a management system can include the whole of the organization, specific and identified functions of the organization, specific and identified sections of the organization, or one or more functions across a group of organizations. [SOURCE: ISO 9000:2015, 3.5.3, modified — Note 4 to entry has been deleted]

ISO 19011:2018, clause 3.18