What Is A Basic Approach To Documenting And Evaluating Business Process Risks Within An ISO9001 QMS?

By Ed McCusker

By Ed McCusker

Published on: April 27, 2020

By Ed McCusker

Published on: April 27, 2020

The 2015 version of the ISO9001 Quality Management System standard requires that organizations address risks and opportunities. This is partially documented below in Clause 6.

6.1.1 When planning for the quality management system, the organization shall consider the issues

referred to in 4.1 and the requirements referred to in 4.2. and determine the risks and opportunities that need to be addressed…

The standard requires that an organization address risks and opportunities that provide assurance that the quality management system can achieve its intended result(s), enhance desirable effects, prevent or reduce undesired effects and achieve improvement.

A very straight forward way to determine the risks and opportunities that should be acted on as a priority are to list each one in a table format as shown below. Then assign a value from 1 to 4 for each assessment category.  After that we can add up the totals and assign priorities for improvement.

The categories for risk and opportunity evaluation suggested are:

  • Customer Impact: How much does the customer care?
  • Changeability Index: Can you fix it?
  • Performance Status: How broken is it?
  • Business Impact: How important is it to the business?
  • Work Impact: What resources are available?

Using this approach we can be sure we are addressing the most important issues confronting the business with the limited resources we have at our disposal.


Process / ActivityCustomer ImpactChangeability IndexPerformance StatusBusiness ImpactWork ImpactTotal Rank


Peter Sheren is a quality and manufacturing professional with over 30 years of experience in a variety of industries and technologies, operating as an integral member of management teams to develop organizational quality, lean production, and technical operations functions. Peter has also gained extensive knowledge and insight into the power of using the vaunted Toyota Production System to create a lean management system that is focused on waste elimination through empowering the entire workforce. He also has expertise in implementing ISO9000 Quality Management Systems in numerous companies including multi-plant operations.

At Storti, we believe that if we are not offering you value than we aren’t doing our job. By implementing a high quality QMS system we can significantly lower your risk and save you money at the same time. To learn more about our services and how we can help please contact us at info@stortiservices.com or 844-478-6784.