ISO 9001:2015 Clause 10.2.2 focuses on the requirement for organizations to retain documented information as evidence of the nature of nonconformities and any subsequent actions taken, including the results of any corrective action. This clause ensures that organizations not only address nonconformities and take corrective actions but also systematically document these instances and their outcomes. Here's a detailed breakdown:
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Documenting Nonconformities: The organization must maintain records of identified nonconformities. This documentation should include a description of the nonconformity, how it was discovered, and any relevant details that can help in the analysis and prevention of future occurrences.
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Actions Taken: Beyond merely recording the nonconformity, organizations are required to document the actions they took in response. This includes the immediate corrective actions to control and correct the nonconformity, as well as any long-term corrective actions implemented to prevent recurrence.
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Results of Corrective Actions: The organization must also document the results of the corrective actions taken. This ensures that there is evidence of the effectiveness of these actions in addressing the nonconformity and preventing its recurrence.
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Review and Analysis: The retained documented information provides a basis for review and analysis, not just of the specific incident, but also for identifying trends or systemic issues within the QMS. This can lead to further improvements in the system.
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Compliance and Audit Readiness: By retaining documented information on nonconformities and corrective actions, organizations ensure they are compliant with ISO 9001 requirements. This documentation is crucial during audits to demonstrate that the organization has an effective process in place for dealing with nonconformities.
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Continual Improvement: Ultimately, the requirement to retain documented information supports the principle of continual improvement within the QMS. By analyzing documented nonconformities and corrective actions, organizations can identify areas for improvement and implement changes to enhance the QMS's effectiveness and efficiency.
Clause 10.2.2 reinforces the importance of accountability and traceability in the quality management process, ensuring that every step taken in response to a nonconformity is documented, traceable, and contributes to the overall improvement of the quality management system.