Internal Audit Assessment Criteria - ISO 13485:2016

AndyN

Moved On
I think you miss the irony, Mark. Flossing teeth is a maintenance activity. Once into adult life, teeth don't change (much). The QMS is usually a much more dynamic entity than teeth will ever be. Now if your teeth were continually being replaced, the food eaten was changed dramatically, cleaning devices and toothpaste effectiveness was improved, then I might agree that flossing would need to be adjusted. For the most part, teeth are just teeth and flossing is just maintenance. Audits are done for many reasons, and maintenance is but one. There are many more interesting reasons for doing them.
 

Mark Meer

Trusted Information Resource
I think you miss the irony, Mark. Flossing teeth is a maintenance activity. Once into adult life, teeth don't change (much). The QMS is usually a much more dynamic entity than teeth will ever be. Now if your teeth were continually being replaced, the food eaten was changed dramatically, cleaning devices and toothpaste effectiveness was improved, then I might agree that flossing would need to be adjusted. For the most part, teeth are just teeth and flossing is just maintenance. Audits are done for many reasons, and maintenance is but one. There are many more interesting reasons for doing them.

I disagree (among other things with your definition of "irony" :p).

First, you concede that maintenance is a reason - albeit not the only one - for audits. On this ground alone, I think my reasoning still stands.

Second, while a quality system can be more dynamic (certainly more complicated), I've seen both quality systems that are pretty stable, and dynamic lifestyles that certainly affect oral hygiene. It seems like you're arguing that food eaten doesn't change, and cleaning technologies don't improve. In this age of fad-diets, and overwhelming and ever-expanding choices in both the foods and oral-hygiene aisles, I don't know that this is a sound argument.
 
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