Process

The outputs of one process are usually the inputs of another, which is why quality systems are built and audited as linked processes rather than separate documents. Risk management itself is defined as a process in ISO 14971.

set of interrelated or interacting activities that use inputs to deliver an intended result Note 1 to entry: Whether the “intended result” of a process is called output, product or service depends on the context of the reference. Note 2 to entry: Inputs to a process are generally the outputs of other processes and outputs of a process are generally the inputs to other processes. Note 3 to entry: Two or more interrelated and interacting processes in series can also be referred to as a process. [SOURCE: ISO 9000:2015, 3.4.1, modified — Notes to entry 4, 5 and 6 are deleted.]

ISO 14971:2019, clause 3.14

a set of interrelated or interacting ACTIVITIES that transform inputs into outputs [ISO 9000:2000, definition 3.4.1] NOTE The term “ACTIVITIES” covers use of resources.

IEC 62304:2006+AMD1:2015, clause 3.14

set of interrelated or interacting activities that use inputs to deliver an intended result [SOURCE: ISO 9000:2015, 3.4.1, modified — Notes to entry have been deleted]

ISO 19011:2018, clause 3.24