Documents requred by clause 4.4

Answer:

This clause has overall requirements for entire quality management system. Requirements for this clause are related to every part of the quality management system, and can be met indirectly through documented procedures, policies and records.

When it requires organization to maintain documented information to support the operation of its processes, this means that you need to decide what documentation (procedures, SOP, work instruction, etc) are necessary for running the processes and to create them. Another requirement is to retain documented information to have confidence that the processes are being carried out as plan and this means that you need to decided what records are needed and to create them according to your needs.

For more information, see:
- New approach to document and r ecord control in ISO 9001:2015 https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/