Definition Exclusion vs. Non-Application - Definitions in ISO 13485

somashekar

Leader
Admin
#1
Making reference to the ISO 13485 clause 4.2.2. (quality manual) and 1.2 (Application), I wish to have more clarity and understanding on the use of the words "exclusion" and "non-application", as used in the quality manual.
Is use of exclusion more with only the 7.3 exclusion ?
For example if 7.5.4 (customer property) is not applicable in my QMS would it be said as exclusion or non-application ?
Am I right in understanding that non-application has relevance only to the medical device specific requirements within the QMS scope ?
 
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Marcelo

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#2
Re: Need more clarity about what is "exclusion" and "non-application"

In ISO 13485, exclusions are only permitted if the applicable regulatory requirements allow, and then only for design controls (7.3). This was included because some regulations do not have requirements for design controls, or have them only for some classes of devices.

You are correct regarding non-application, it's relevant only to the medical device specific requirements (example - implantable devices) within the QMS scope.
 
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