The essence of retaining documented information as evidence of the conformity of products and services with the accepted criteria is embedded within the overarching requirements of Clause 8.7, "Control of nonconforming outputs."
The standard mandates organizations to establish, implement, and maintain a documented process to handle nonconforming products or services. This process includes identifying nonconformities, taking appropriate actions to mitigate any arising issues, and documenting the nature of nonconformities along with any subsequent actions taken, including concessions obtained.
Here’s a detailed look at what this involves:
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Identification and Documentation: Organizations are required to identify nonconforming outputs promptly and to document the nature of the nonconformity. This documentation is crucial for traceability and for planning subsequent actions to manage the nonconformity.
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Control and Correction: After identifying a nonconforming output, appropriate controls must be applied to prevent its unintended use or delivery. The organization must then take action to correct the nonconformity. This might involve making the nonconforming product conform, segregating it, informing affected parties, or obtaining authorization for its acceptance under concession.
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Dealing with Consequences: Organizations must evaluate the impact of the nonconformity on other products or services and take action as necessary. This ensures that any potential negative effects are contained and rectified.
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Retaining Documented Information: This is where the concept of retaining documented information comes into play. Organizations must keep records of the nature of nonconformities, the actions taken to address them, and any concessions obtained. This documented information serves as evidence of the actions taken to ensure quality and compliance and supports continuous improvement efforts by providing data for analysis.
By requiring the retention of documented information, ISO 9001:2015 ensures that organizations have a traceable, verifiable record of how nonconformities are managed. This documentation is essential for internal review and analysis, for demonstrating conformity to external parties, and for identifying opportunities for improvement.
The requirement to document and retain records of how nonconformities are managed is implicit in the control of nonconforming outputs. This practice underpins the quality management principle of evidence-based decision-making and supports the overall goal of continuous improvement within the QMS.