Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am interested in understanding how people view these two terms from ISO 13485 as they are not specifically defined in the standard.

My thoughts are.....
Regarding an exclusion, the expectation is that you would normally comply with a particular element of the standard but you have a strong regulatory justification for not complying. Non-applicability would be used when something does not relate to, or affect or pertain to your QMS or device (e.g. a process like sterilization when none of your devices are sold sterile or require sterilization prior to use).

Am I understanding this correctly?

Exclusion are only possible if applicable regulatory requirements allow them (such as not applying design controls for some Class I devices in the US because FDA requirements allow this). 

Non-applixability originally was related to specific requirements for certain types of devices (such as sterile). If your device was not sterile, you can deem the requirement NA. 

As we increased the scope of the standard to other organizations besides the manufacturer, we needed to allow NAs for some clauses that the organization may not perform due to it's role in the med dev life cycle. 


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Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil
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Original Message:
Sent: 20-Apr-2018 15:53
From: Anonymous Member
Subject: ISO 13485 - Exclusion vs Non-applicability

This message was posted by a user wishing to remain anonymous

I am interested in understanding how people view these two terms from ISO 13485 as they are not specifically defined in the standard.

My thoughts are.....
Regarding an exclusion, the expectation is that you would normally comply with a particular element of the standard but you have a strong regulatory justification for not complying. Non-applicability would be used when something does not relate to, or affect or pertain to your QMS or device (e.g. a process like sterilization when none of your devices are sold sterile or require sterilization prior to use).

Am I understanding this correctly?

I generally agree here with Marcelo. 

To be clearer, an exclusion is generally to compliance with a regulation that would normally apply, but because there is an exception (or allowance) in the regulation that describes the exclusion you don't need to apply the requirement.

A non-application is where you are saying yourself, "that does not apply to me because..." The reasons can vary, but generally due to the role of your organization or characteristics of your product.

Thanks Marcelo for the points. Hope all is well in Brasil.

Anonymous, I hope this helps! Good luck!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 23-Apr-2018 09:16
From: Marcelo Antunes
Subject: ISO 13485 - Exclusion vs Non-applicability

Exclusion are only possible if applicable regulatory requirements allow them (such as not applying design controls for some Class I devices in the US because FDA requirements allow this).

Non-applixability originally was related to specific requirements for certain types of devices (such as sterile). If your device was not sterile, you can deem the requirement NA.

As we increased the scope of the standard to other organizations besides the manufacturer, we needed to allow NAs for some clauses that the organization may not perform due to it's role in the med dev life cycle.


------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 20-Apr-2018 15:53
From: Anonymous Member
Subject: ISO 13485 - Exclusion vs Non-applicability

This message was posted by a user wishing to remain anonymous

I am interested in understanding how people view these two terms from ISO 13485 as they are not specifically defined in the standard.

My thoughts are.....
Regarding an exclusion, the expectation is that you would normally comply with a particular element of the standard but you have a strong regulatory justification for not complying. Non-applicability would be used when something does not relate to, or affect or pertain to your QMS or device (e.g. a process like sterilization when none of your devices are sold sterile or require sterilization prior to use).

Am I understanding this correctly?

This message was posted by a user wishing to remain anonymous

Thanks for your responses. They make perfect sense.
Original Message:
Sent: 24-Apr-2018 07:18
From: Mark Swanson
Subject: ISO 13485 - Exclusion vs Non-applicability

I generally agree here with Marcelo.

To be clearer, an exclusion is generally to compliance with a regulation that would normally apply, but because there is an exception (or allowance) in the regulation that describes the exclusion you don't need to apply the requirement.

A non-application is where you are saying yourself, "that does not apply to me because..." The reasons can vary, but generally due to the role of your organization or characteristics of your product.

Thanks Marcelo for the points. Hope all is well in Brasil.

Anonymous, I hope this helps! Good luck!

------------------------------
Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States

Original Message:
Sent: 23-Apr-2018 09:16
From: Marcelo Antunes
Subject: ISO 13485 - Exclusion vs Non-applicability

Exclusion are only possible if applicable regulatory requirements allow them (such as not applying design controls for some Class I devices in the US because FDA requirements allow this).

Non-applixability originally was related to specific requirements for certain types of devices (such as sterile). If your device was not sterile, you can deem the requirement NA.

As we increased the scope of the standard to other organizations besides the manufacturer, we needed to allow NAs for some clauses that the organization may not perform due to it's role in the med dev life cycle.


------------------------------
Marcelo Antunes
Regulatory Strategy Consultant
São Paulo
Brazil

Original Message:
Sent: 20-Apr-2018 15:53
From: Anonymous Member
Subject: ISO 13485 - Exclusion vs Non-applicability

This message was posted by a user wishing to remain anonymous

I am interested in understanding how people view these two terms from ISO 13485 as they are not specifically defined in the standard.

My thoughts are.....
Regarding an exclusion, the expectation is that you would normally comply with a particular element of the standard but you have a strong regulatory justification for not complying. Non-applicability would be used when something does not relate to, or affect or pertain to your QMS or device (e.g. a process like sterilization when none of your devices are sold sterile or require sterilization prior to use).

Am I understanding this correctly?