What does ISO 9001 consider a non-conformity?
According to the standards set by ISO 9001, a nonconformity is defined as a failure to meet one or more of the requirements set by a governing body. When a company becomes ISO 9001 certified, they must adhere to a set of regulations and guidelines. Nonconformities occur when these mandatory requirements are not followed. There are several risks that can arise from an extremely small nonconformance problem. Many of these risks have been outlined in this Qualio Blog – The Risks of ISO 9001 Nonconformance (And How It Impacts Your Organization).
What happens if a non-conformity is found? What is a non conformance report?
If a non-conformity is discovered throughout an audit, the business receives a form called a non-conformance report (NCR). What is a non conformance report? It is a form that notifies them of all details related to the issue that has been uncovered. What must be done upon the realization of an issue is you must find the root cause. Then create a plan to eliminate these causes so this issue does not recur. Followed by implementing any corrective action needed to conform to the standards once again. There are 2 types of non-conformities that a business can be held with:
- Major Nonconformance: determined when there is a full breakdown of your Quality Management System (QMS), or at least something major is missing (Ex. Product delivered without completing required testing for entire order).
- Minor Nonconformance: some type of isolated incident does not meet the standards. The Quality Management System is slightly weakened, but no major differences will be noticed (Ex. An unauthorized change on a document).
How do nonconformities happen?
- Quality: Quality management system processes have detected a problem with the product itself.
- Environment: Some environmental risk was overlooked, or not prepared for properly.
- Health & Safety: Protective equipment is missing or does not work properly.
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