QMS requirements are expressed in Clause 4.0 which is further divided into six different clauses.
Develop a QMS (Clause - 4.1.1)

Develop, document and maintain organization's quality management system (QMS).
Identify organization's QMS documentation requirements.
List the documents that regulators expect company to maintain and other requirements.

Within roles of QMS; Clause - 4.1.2, standard says to employ a risk based approach to manage your organization's QMS processes.
Within Controlling outsourcing; Clause - 4.1.5, standard says to control the outsourced processes which influence product conformity.
Within Validation of software; Clause - 4.1.6, standard says to establish a methodology which is appropriate to the risk involved in the validation of software.
Records of the software validation results must be maintained, along with a conclusion.
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