Definition Servicing - Definition - ISO 13485 Clause 7.5.1.2.3 - Servicing Activities

J

Jhintze

#1
Does anyone have a good definition of "servicing"? I want to state that it is maintenance or repair on after market items but would like know what others have used.

Also, does anyone have a template for a Servicing SOP?

Thanks in advance,
JH
 
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somashekar

Staff member
Super Moderator
#2
Re: ISO 13485 7.5.1.2.3 Servicing Activities

Hi and welcome to the cove ...
Does your medical device have moving or rotating parts or have a situation where in some drift are known to happen, and do they need periodic check, and fix for the safe and effective use of the device. Do you provide this as a part of your warranty coverage activity and further as a part of your AMC activity. If these are performed by an untrained person or in a wrong manner., would it jeopardize your device and directly effect the patient or user ?
When you determine such an activity your QMS should consider servicing. :2cents:
 
J

Jhintze

#3
Re: ISO 13485 7.5.1.2.3 Servicing Activities

Hi Somashekar,

Thanks for your reply.
The service to the device is performed by a contract manufacturer. The risk analysis is performed by the customer as part of their DHF.
I agree that the risks of the maintenance/repair need to be addressed & I would reference the pFMEA for the work that the contractor is performing. It should be included or there should be a separate one for the work.
 

somashekar

Staff member
Super Moderator
#4
Re: ISO 13485 7.5.1.2.3 Servicing Activities

It should be included or there should be a separate one for the work.
The servicing SOP can be in any way best suited for use by the personnel who are to perform the servicing activity. This will be a part of your QMS documentation and will get all the respect that it deserves in terms of approval, revision control, available at the point of use...
 
#5
As per 13485 2016, the implications of servicing does not restricted to just control of machine. if a manufacturing company plans to set up its own only diagnosis unit and documents it in scope , this clause will cover it. Any opinions from expert on this.
 
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