Continuous Improvement – Operational Improvement

Using ISO 9001’s Risk & Opportunity Assessment to Plan for Pandemic Preparedness

The risk and opportunity process that is part of ISO 9001 is intended for companies to identify, rank, manage and monitor quality related and business risk. There are probably very few companies that considered COVID 19 as part of a normal risk assessment. Whether your business was completely shut down, operating on an adjusted schedule, or running at full capacity throughout the lockdowns, modifications were made to your usual processes. Production was impacted. Your employees were impacted personally and professionally. Your financial stability was impacted.

Anticipating how a pandemic presents a threat to your organization is most definitely a risk that needs to be identified and addressed as part of your risk and opportunity assessments in your quality management systems. As organizations anticipate surveillance and certification audits in the coming months and years, it is not illogical to think that an auditor will ask questions about how you considered pandemic preparedness as a risk to the organization. Be sure to consider how you can use your risk and opportunity process to supplement your business continuity plan.

As you evaluate your risks and opportunities consider the challenges that you have addressed and solved in recent months:

Was your supply chain interrupted?
Did customers have different demands and expectations?
What lessons did you learn?
What corrective actions did you take?
Did you need to create new policies or procedures?

If you need support or ideas on how to integrate pandemic preparedness into your risk and opportunity process, we can help. You can contact Mark Henline at or 304-685-2205.