In quality management system (QMS), a non-conformity is a deviation from a specification, a standard, or an expectation. A non-conformity is any failure to meet a requirement. A requirement can be that of a customer’s, statutory or regulatory body, ISO 9001 or your organisation.
ISO 9001:2015 standard wants an organisation to identify non-conformity, identify correction, determine the cause for the Non-Conformance, evaluate the possibility of taking corrective actions, take corrective actions and assessing the effectiveness of the corrective actions.
In an organisation, you may find a non-conformance in service, a product, a process, from a supplier, or in the system itself. It occurs when something does not meet the specifications or requirements in some way. And this non-conformance Does not depend on the size or type of business.
Any non-conformity at any stage in the entire process, from raw material to the processing to the end product, can affect our product performance or services or business growth.
When a non-conformity occurs, including those arising from complaints, the
React to the nonconformity, and as applicable
Evaluate the need for action to eliminate the causes of the rejection so it does not recur or occur elsewhere
Implement any work needed,
Review the effectiveness of any corrective action taken
Update risks and opportunities determined during planning, if necessary
Make changes to the quality management system, if necessary.
How effectively you address a non-conformity may become a distinguishing factor between a successful and not so successful company. Thus, for an organisation checking for any non-conformity in the processes & the corrective actions are taken plays a significant role in its success.