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QMS for a repair/servicing company

MDRepair Canada

Starting to get Involved
#1
Hi!
I am currently starting to implement a QMS i a MD repair company: no manufacturing, no design and development, only repairing MD for hospitals and clinics.
I have some questions because i am confused on how to comply with some requirements:
  • Which chapter of the standard can i exclude?
  • Medical device file, as we do not own any MD, do we need to have a MD file? If yes, what information do we need to put?
  • Risk management, many requirements are related to design or to MD itself. We have started to define some risks but most of them are general (organizational risks, supplier, etc.). Any example of risks related to a repair company?
Many thanks in advance for your help!
MD
 
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atitheya

Quite Involved in Discussions
#2
In my opinion, and depending on the devices covered in your scope, and, the regulatory requirements in your area of operations, in general, you may want to consider -

1. Only design and development ISO13485:2016 clause 7.3 can be excluded, and that if you are not making any changes or additions to the design.

2. You will need to maintain a medical device file for such devices that includes information as specified in clause 4.2.3. However, to my mind,

a. While considering 4.2.3 c, you will need to include procedures for repair and servicing instead of manufacturing. Other items I.e. packaging, storage, handling remain. Distribution may change to delivery depending, again, on your scope.​
b. In 4.2.3 f, you will need to describe your procedure for service provided by you post the repair and service of the device. (Also see point 3)​
c. Having a medical device file will also facilitate the review of requirements and ensure 7.2.2 e - organization’s ability to meet the defined requirements (In your case repair and service).​

3. Clause 7.5 will include your operations, I.e. repair and service of the device. At the same time 7.5.4 will relate to the service provided by you post such repair and service of the device.

4. Risk management - You will need consider the effect of your work on the existing risks, and also to identify and manage any new risk that may come up as a result of your repair and service activity.

These are just some thoughts, let’s hear from the experts.
 
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