ISO 9001 Non-Conformity and Corrective Action is an integral part of the implementation of the ISO 9001 Quality Management System.
In the ISO 9001:2015 Standard, clause 10.2.2, it states “The organizations shall retain documented information as evidence of a, the nature of the non-conformities and any subsequent actions taken; b, the results of any corrective action.”
Nonconformities can range from minor non-conformities to major non-conformities. What separates a minor nonconformity from a major non-conformity is the amount of corrective action required to fix the problem. A major non-conformity is something that affects the entire functioning of an organization as a whole whereas a minor non-conformity is something that affects a particular area or part of an organization.
For example, not having records of doing management reviews is considered to be a major non-conformity as it can affect the entire operation of an organization. However, if an organization had its management review, but a particular item is not addressed in the management review, it is considered a minor nonconformity.
Non-conformities can be identified through many sources such as internal audits, external audits, warranty claims, customer complaints, legal issues, etc. Whenever non-conformities are identified, organizations are required to properly document them through a Non-Conformance Report (NCR). A review needs to be conducted to identify the cause of nonconformity. There may be another area within the organization where a similar kind of non-conformity is occurring. Organizations are required to come up with a route-cause analysis. Corrective actions are actions taken after the fact to fix the problem. Preventive action will eliminate the problem from re-occurring.
An example can be an automaker recalling a defective airbag. An immediate recall and fixing the cars in the market with a defective system is an example of corrective action. The automaker evaluating the cause of the non-conformity, and identifying the defective part or area of their process that caused the defective airbag is called the route cause analysis. Implementing necessary actions to eliminate the problems to ensure the problem from reoccurring and reviewing the effectiveness of the corrective action is the preventive action.
LMG provides assistance with internal audits, management review meetings, and identifying areas that are non-conforming. Identifying those areas that need improvements and coming up with corrective actions will better prepare you for a successful certification audit.