Understanding and avoiding deviations and nonconformities
Deviations, nonconformities, errors, findings, observations, and other terms are often used mistakenly synonymously. Even standards explicitly contradict each other when defining individual terms. This article clarifies, 1. Nonconformities: The basics 1.1 Definitions 1.1.1 Nonconformity ISO 9000:2015 defines nonconformity as “non-fulfilment of a requirement.” It equates this term with “error.” ISO 13485 contradicts this. This standard…
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