Change management procedure when 7.3 is not applicable

MDRepair Canada

Starting to get Involved
#1
Dear all,
A created a SOP related to change management procedure but I'm not sure it is needed considering we do not have any design or development (7.3 is not applicable to us).
I don't want to create anything that is not needed for the QMS (knowing changes related to documentation are documented somewhere else).
what do you think?
Many thanks for your helps!
Best regards,
MD
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Good day MD, I am sorry for the delay in this response.

The word change is used 14 times in the body of ISO 13485:2016, with only five being in the Design clause section. One of these places is 5.4.2, specifically
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Is your new SOP about changes to infrastructure? Infrastructure is part of the QMS (6.3). While this clause does not specifically require an infrastructure change management SOP, controlling changes to infrastructure in order to help ensure their continued support of conformity to product requirements, etc. etc. seems like a perfectly reasonable approach to me. If your SOP is all about safety and environmental compliance, it occurs to me that keeping your organization compliant to these regulations represents reasonable risk based thinking (another "shall") as a business case.

Not everything good thing we do is because of a shall in the standard.
 

Philip B

Involved In Discussions
#3
We don't design our own devices either but we still have a change management procedure. To demonstrate an effective QMS you need to control changes. We cover changes to the QMS processes, assembly, sterilisation, packaging, labelling, suppliers, documentation and software (used in assembly).
 

MDRepair Canada

Starting to get Involved
#4
Thank you Jen for your answer.
Actually I mention changes in different existing SOPs (Management Review, IT, etc.). The only thing that the Change SOP is explaining is how to perform a change request (with a change request form, validation of change, etc.) but i don't see concrete example of when this change request can be used considering the size (small) and the activity of the company (repair and servicing of MDs).
 

Tagin

Trusted Information Resource
#5
Thank you Jen for your answer.
Actually I mention changes in different existing SOPs (Management Review, IT, etc.). The only thing that the Change SOP is explaining is how to perform a change request (with a change request form, validation of change, etc.) but i don't see concrete example of when this change request can be used considering the size (small) and the activity of the company (repair and servicing of MDs).
Do you never receive updated/revised repair procedures from the mfr for the MDs you service? How are those changes managed?
Adding a new MD to your repair services is a change.
As Jen mentioned, infrastructure changes.
Do parts from suppliers ever change? How are part changes controlled?

Change management is also as much about preventing unintended change as it is about properly handling intended changes. So, to me, change mgmt should indicate or address controls that prevent unintended changes.
 
#6
Do you never receive updated/revised repair procedures from the mfr for the MDs you service? How are those changes managed?
Adding a new MD to your repair services is a change.
As Jen mentioned, infrastructure changes.
Do parts from suppliers ever change? How are part changes controlled?

Change management is also as much about preventing unintended change as it is about properly handling intended changes. So, to me, change mgmt should indicate or address controls that prevent unintended changes.
I totally agree with you. Personally change Management is one of the clauses that are applicable to most of the companies regardless of the scope of the business.. I see it as measure in place to deal with unexpected event into your system. Thank you
 
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