Risk assessment, process control and management review in QMS

Answer:

Risk assessment in classical terms is not required by ISO 9001:2015, the only thing the standard requires is risk-based thinking. The standard does not require full scale risk management, or risk assessment methodology, the standard only requires organizations to identify risks and opportunities related to its ability to achieve its objectives and to create plans for addressing them. To meet the requirement for addressing risks and opportunities, it is enough to arrange the brainstorming session with relevant roles in your company and talk about risks and opportunities emerging form internal and external context of the organization. For more information, see: The Role of Risk Assessment in the QMS https://advisera.com/9001academy/blog/2014/01/07/role-risk-assessment-qms/

Process control is basically the activity or set of activities that will ensure that the process will deliver expected outputs. The controls may be engineering or technologica l meaning that some crucial parameter of the process will be controlled by using some technological solution or it can be administrative, meaning that the organization will prescribe the procedure or work instruction to ensure that the process is carried out as planned. Depending on the nature of the process and the nature of the process output the controls may vary. Here is the example of the control of purchasing process: How to control outsourced processes using ISO 9001 https://advisera.com/9001academy/blog/2015/05/05/how-to-control-outsourced-processes-using-iso-9001/

The purpose of the management review is to make assessment of the entire QMS and make decisions to improve the system. Similar to the previous version of the standard, the new version also requires records of management review and the standard also prescribes mandatory inputs and outputs of the management review. For more information, see: How to make Management Review more useful in the QMS https://advisera.com/9001academy/blog/2014/01/21/make-management-review-useful-qms/