ISO 9001 Risk Examples
As part of each client engagement, we go through a process of brainstorming what risks and opportunities should be considered as part of their Quality Management System (QMS). This activity begins with determining the organization's context, which includes defining the QMS and its processes. With these processes defined, and corresponding inputs / outputs identified, we can then begin to associate "what could go wrong" with each.
A few QMS risk examples are shown below, for an imaginary company created solely for this illustration, that I'll just call "XYZ Corporation". As it happens, "XYZ" has a fairly straightforward ISO 9001:2015 Quality Management System, developed around the manufacturing of everyday widgets...
Sales Risk Examples:
Customer Requirements Unclear
Purchasing Risk Examples:
Wrong Product Delivered
Substandard or Defective Materials
Production Risk Examples:
Wrong material used
Manufactured to obsolete drawing
Inspection Risk Examples:
Reject good product
Accept bad product
Miss inspection point
Unable to perform inspection
Delivery Risk Examples:
Lost in shipment
Damaged in shipment
Delivered to incorrect location
Identifying QMS risk doesn't have to be particularly difficult, and many different companies share similar risks, although each one will likely have different views on the corresponding impact. Just take your time, give a little thought, and start out by making a simple list. Also note that some occurrences are merely beyond our control, and there is no reasonable effort that would mitigate an impact on our QMS (e.g., meteor strikes, global war, plague and the zombie apocalypse).
Hope the risk examples above were helpful. Since ISO 9001 requires us to consider both risks and opportunities related to our QMS, we'll follow up with some additional examples shortly, as part of another post.
Our ISO 9001 Blog
Information, thoughts and periodic updates from MAS Solutions' QMS Consulting Group.
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