Non Applicability of Clauses in ISO13485 for Medical Devices

L

lisashort2000

Registered
#1
#1
Can anyone tell me the interpretation of Non Application when it comes to clauses 4 & 5. The standards states clauses 6, 7, & 8 can be a non application, but can any other part of the standard become a non application? Such as 4.2.3 Medical Device File?
 
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somashekar

somashekar

Leader
Admin
#2
#2
NO. Its is very clear that clause 4 and 5 cannot be non-applicable. You need to maintain a medical device file per 4.2.3, based on the role you are undertaking about the medicla device.
 
L

lisashort2000

Registered
#3
#3
Thank you so much. This is also my interpretation, however we have had 2 auditors insist this needs to be a non application. I cannot wait to hear from others as well, but I am aligned with your thinking.
 
D

DannyK

Trusted Information Resource
#4
#4
Somashekar is right.
From ISO 13485:2016
1. Scope (last paragraph)

If any requirement in Clauses 6, 7 or 8 of this International Standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
 
L

lisashort2000

Registered
#5
#5
Again, exactly what I stated during the audit. We did not get a NC for it, however there was a sense that this needed to be non applicable. I 100% read it and interpreted it to mean, the only clauses that can be non applicable lie within 6,7, & 8
 
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