Documenting clause 8.1

Thank you in advance for your guidance.

Answer:

Clause 8.1 have general requirements for process control and document information required are applicable to all process in the QMS (Quality Management System).

First, the standard requires organization to determine and keep documented information to extent necessary to have confidence that the process is carried out as planned. This means that you need to determine what processes and activities need to have documented procedures or wok instruction or any other document that will describe how the process or activity is conducted. The key phrase here is "to extent necessary", this means that you don't have to document all processes or all activities but rather those that are complicated, or rarely performed so there is a greater chance of nonconformity occur rence. Example of such document are production procedures, quality plans, etc.

The second requirements is to demonstrate conformance of products and services to their requirements, this is usually record of quality control or quality inspection performed on the end of production process. This can also be approval for shipment or delivery.

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