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Definition of a non-conformity

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Guest user Created:   Oct 03, 2023 Last commented:   Oct 03, 2023

Definition of a non-conformity

Looking for a clear definition of non-conformance. Specifically related to medical device. Would you be able to provide a clear definition of a Major and a MInor non-conformance? I have looked at the ISO standards, as well as the FDA 21 CFR guidance. I am not seeing a clear definition for these two terms.
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ISO 13485 DOCUMENTATION TOOLKIT

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Kristina Zvonar Brkić Oct 03, 2023

In the context of medical devices, non-conformities refer to instances where a device does not meet the established requirements or standards. These non-conformities are classified into major and minor categories based on their significance and potential impact on patient safety.

Major Non-Conformity: A major non-conformity indicates a significant deviation from the established requirements. It poses a high risk to patient safety and may result in serious harm or adverse events. Major non-conformities typically involve critical aspects of the device's design, manufacturing, performance, or documentation. Correcting major non-conformities is of utmost importance to ensure the safety and effectiveness of the medical device.

Minor Non-Conformity: A minor non-conformity refers to a deviation from the established requirements that has a relatively lower impact on patient safety. While minor non-conformities do not pose an immediate risk to patients, they still need to be addressed to maintain compliance with regulations and standards. Examples of minor non-conformities may include minor labeling issues, documentation errors, or non-critical deviations in manufacturing processes.

It is crucial for manufacturers to properly assess and classify non-conformities as major or minor to ensure appropriate corrective actions are taken. Major non-conformities require immediate attention and remediation, while minor non-conformities should be addressed in a timely manner to maintain compliance and quality in the manufacturing and distribution of medical devices.

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Oct 03, 2023

Oct 03, 2023