ISO 9001 risk assessment and FMEA

Answer:

The standard requires organization to identify and address risks and opportunities related to the ability of the organization to meet its objectives. This basically means that you need to examine context of your organization and determine what are the risks and opportunities related to your business and plan actions to address them.

There is no requirement to use some methodology or full scale risk management, it is enough to organize brainstorming session with all relevant roles in your company to discuss risks and opportunities both on the level of process and on the level of the entire organization, the SWOT analysis can be a useful tool for conducting this assessment. Also, record from this meting and the SWOT analysis can be an evidence that you apply risk-based thinking.

FMEA is one way to address the requirement but it can't address the entire requirement simply beca use the FMEA is focused on risks only and can't be used for identifying opportunities, the second problem is that the FMEA is good tool only for determining risks in production and design and development process and it is not so useful for other processes. At this moment we don't have FMEA tool available on our website but we are in the process of developing ISO 9001 Documentation Toolkit Premium that will have extensive risk and opportunities procedure that will include FMEA.