ISO 9001 - Closing Non-conformities
Closing non-conformities (NC) in ISO 9001 refers to the process of resolving issues or problems identified during an audit or inspection that are not in compliance with the ISO 9001 standard. Non-conformities can relate to any aspect of a company's Quality Management System (QMS) that does not meet the requirements of the standard, including processes, procedures, documentation, or product or service quality.
Closing NCs involves identifying the root cause of the non-conformity, developing a corrective action plan, implementing the plan, verifying the effectiveness of the corrective action, and updating any related documentation. Once the corrective action has been implemented and verified, the NC can be closed out and documented in the audit report.
It is important for companies to promptly and effectively close non-conformities in order to maintain compliance with the ISO 9001 standard and to continually improve the effectiveness of their QMS. Failure to close non-conformities can result in non-compliance, which may lead to the loss of ISO 9001 certification and damage to the company's reputation.
Steps in closing Non-conformities
Closing non-conformities (NC) identified during an ISO 9001 audit involves the following steps:
Identify the root cause of the non-conformity - This involves identifying the underlying reason why the non-conformity occurred.
Develop a corrective action plan - This plan should address the root cause of the non-conformity and include specific steps to prevent it from happening again.
Implement the corrective action plan - This involves taking the steps outlined in the plan to correct the non-conformity and prevent it from happening again.
Verify the effectiveness of the corrective action - This involves checking that the corrective action has been implemented effectively and has addressed the root cause of the non-conformity.
Close the non-conformity - If the corrective action is effective, the non-conformity can be closed. This involves updating any documentation related to the non-conformity and closing it out in the audit report.
It is important to note that the auditor will typically review the corrective action plan and verify the effectiveness of the corrective action before closing out the non-conformity. If the corrective action is not effective or if the company fails to take corrective action within a specified timeframe, the non-conformity may remain open and the company may be required to undergo additional audits to ensure compliance with the ISO 9001 standard.
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