A Quality Management System (QMS) is a system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. ISO 9001:2015 defined approach to QMS is the most commonly used. However, not all processes defined by ISO 9001:2015 may be pertinent to your organization.
So, the question is: What are the processes needed for your Quality Management System? And the answer is, “it depends”. It depends on what your organization does. If your company designs products, then you would need a Design Process. If your company develops software solutions, you will need a software development process, etc.
A process interaction chart such as a turtle diagram can be used to show your process inputs and desired outputs and help you determine what types of controls are needed. For example, an input to the software development process can be a customer software request and an output can be a software product solution. A successful customer experience is one way of determining if your process was effective.
Refer to ISO 9001:2015 for more information on processes required for your QMS. If you have any professional help with your QMS, reach out to our experts at Conformity Tech.