ISO 9001:2015 Clause 10.2.1 provides a detailed procedure that organizations must follow when a nonconformity occurs, including those arising from complaints. This clause is integral to the Quality Management System (QMS) as it outlines the steps for addressing and preventing the recurrence of nonconformities. Here's a detailed breakdown of the actions required under this clause:
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React to the Nonconformity: Immediately upon the identification of a nonconformity, the organization must take action to control and correct it. This involves containing the effect of the nonconformity to prevent it from affecting further processes or products and taking steps to correct the issue.
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Evaluate the Need for Action: The organization must assess the nonconformity to determine the need for action to eliminate the causes of the nonconformity. This is to ensure such nonconformities do not recur or occur elsewhere. The evaluation should consider the severity and impact of the nonconformity.
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Determine and Implement Action: Once the need for action is identified, the organization must determine and implement the appropriate corrective action to address the root cause of the nonconformity. This step is crucial for preventing recurrence and may involve changes in processes, practices, products, or services.
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Review the Effectiveness of the Corrective Action: After implementing corrective actions, the organization must review these actions to ensure they have been effective in preventing recurrence of the nonconformity. This review is critical to verify that the root cause has been addressed.
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Update Risks and Opportunities: The organization should consider the nonconformity and corrective action process as an opportunity to re-evaluate and update the risks and opportunities related to its QMS. This ensures that the system remains effective and aligned with the organization’s context and strategic direction.
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Make Changes to the QMS: If necessary, based on the nature of the nonconformity and the corrective actions taken, the organization may need to make changes to the quality management system. This could involve updating procedures, documentation, or practices to incorporate the learnings from the nonconformity and corrective action process.
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Documentation: The organization is required to maintain documented information as evidence of:
- The nature of the nonconformities and any subsequent actions taken.
- The results of any corrective action, including the effectiveness of such actions.
Clause 10.2.1 emphasizes a proactive and systematic approach to managing nonconformities, ensuring that they are addressed promptly and effectively to prevent recurrence. This approach is foundational to the continuous improvement ethos of ISO 9001, aiming to enhance quality and customer satisfaction continually.