This nonconformity and corrective action procedure can assist your business comply with AS/NZS ISO 9001, Quality Management Systems clauses:
This procedure can also assist you establish the required processes for identifying, documenting and analysing non-conformities.
An AS/NZS ISO 9001 ‘type’ nonconformance refers to anything that does not meet the requirements of the AS/NZS ISO 9001 standard. In general terms:
When a nonconformity is identified, it is important to take quick and effective action to maintain compliance with requirements. Here are a few key steps to effectively manage a nonconformity.
When a nonconformity is identified, it is important to take quick action to isolate the nonconformity. This means identifying, controlling and correcting the affected product, service or area and putting it under control so that the nonconformity does not continue or spread. This may involve stopping production, removing finished products from the affected area, or taking other measures to prevent the nonconformity from spreading.
Determining the root cause of nonconformity is critical to ensure that corrective and preventive actions are effective in preventing recurrence. To do this, we need to ask why the nonconformity occurred. This may be done using a gap analysis tool or the ‘Five Whys’ method.
Once corrective and/or preventative actions have been agreed upon, step-by-step action plans should be developed (including the details of who is responsible) for implementing the corrective actions or preventative actions and the appropriate timing for the completion of such actions. Allowances should be made for tracking the status of action items until such action is completed.
Note: The records of actions, including the assignment of responsibility and appropriate timeframes should be maintained for a nonconformity. This will allow the tracking of the action status until corrected, closed out and verified as effective.
A means of review and close-out should be followed to assess the status of action items applied to both major non conformances and minor non conformances. The review should be recorded against the action item for verification purposes.
A conformity report of all action items that remain outstanding after planned completion dates should be presented for discussion at management review meetings. These reports should be retained as ‘documented information.’ The report should also be signed and dated by the person who was responsible for addressing the issue.
This 10-page AS/NZS ISO 9001 nonconformity and corrective action procedure can assist you to establish the required processes for identifying, documenting and analysing non-conformities and meeting the requirements of objective evidence by applying appropriate corrective or preventative actions.
This procedure can be applied to all non-conforming products, services, processes and any aspect of an AS/NZS ISO 9001, quality management system, inclusive of: