Planning changes in ISO 9001

Could you explain to me what can cause a change to QMS? and where the change can happen in QMS？Should I need to have documented information for changes(e.g. change management procedure)?

Answer:

Changes in the QMS can be caused by the organization itself wanting to improve its processes, the customer who wants to ensure that provided products or services meet its requirements, or changes in the relevant legislation. The changes can happen in the processes, their sequence and interaction, documentation or any other aspect of the QMS.

The standard does not require any document for this requirement, but it can be beneficial to have some kind of record to demonstrate that the changes are carried out according to the plan and in compliance with the standard.

For more information, see: QMS Change Management in 7 steps https://advisera.com/9001academy/blog/2016/11/29/qms-change-management-in-7-steps/

These materials will also help you regarding change management in ISO 9001:
- Fre e online training ISO 9001:2015 Foundations Course https://advisera.com/training/iso-9001-foundations-course/
- Conformio (online tool for ISO 9001) https://advisera.com/conformio/ "