AQL stands for Acceptable Quality Level and is sometimes translated as “permitted reject rate.” The AQL determines when a batch of parts or products is rejected or accepted based on a random sample inspection. However, auditors regularly no longer accept the AQL. What to do? This article provides answers. 1. Who is affected by the…
DetailsISO 14971 defines the terms “hazard” and “hazardous situation.” Nevertheless, medical device manufacturers often find it difficult to assign concrete cases to either of the two categories. This article provides help. 1. Definition of hazard and hazardous situation The ISO 14971 defines: The standard provides examples of hazards (see Fig. 1): The example of “information”…
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