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 ?
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 ?