Customer Property - ISO 13485:2016 Clause 7.5.10

[ManavPenubaku]

Hello everyone,

Thanks in advance for your help. I'm trying to develop a method for the collection of records related to customer property but I'm unsure if clause 7.5.10 applies. Does the clause only apply to customer property that is incorporated into the product or does it also apply to a purchased product returned to the company for service/maintenance as well?

 

[William55401]

Short answer. It depends.

Longer answer. What do you make? For example, single use disposables would likely have no customer property. If you are building and servicing electromechanical devices, during the depot service process, your firm is in control of customer property until it is returned to the customer. Please share a bit more on your products and what processes may have customer property as an input. If there are no customer property related processes in your org, you can justify an exclusion / not applicable statement for this requirement.

Hope this helps.

 

[ManavPenubaku]

@William55401, thanks for your response. My company does make an electromechanical device. It's an external knee prosthesis and we schedule yearly servicing on the device, so the servicing process in essence has customer property as an input. We handle service requests by email or through JIRA service management. Will storing the correspondence with the customer regarding loss/damage be a sufficient record of the activity?

 

[William55401]

You are welcome. Storing correspondence is part of demonstrating compliance but not the whole story. You org needs to develop a QMS procedure that explicitly addresses each of the 7.5.10 requirements. The customer correspondence and the returned device are Inputs to your QMS process. You will likely have a form that captures each individual 7.5.10 requirement. The work flow may trigger additional correspondence especially if the device is beyond repair.

 

[Tagin]

It's an external knee prosthesis and we schedule yearly servicing on the device, so the servicing process in essence has customer property as an input. We handle service requests by email or through JIRA service management.

To expand on William's advice... In that service process, how do you:

• identify the device?
• verify the device?
• protect the device?
• safeguard the device?

And, if a device is lost, damaged or otherwise found to be unsuitable for use, what do you do? What records are created?

 

[ManavPenubaku]

You are welcome. Storing correspondence is part of demonstrating compliance but not the whole story. You org needs to develop a QMS procedure that explicitly addresses each of the 7.5.10 requirements. The customer correspondence and the returned device are Inputs to your QMS process. You will likely have a form that captures each individual 7.5.10 requirement. The workflow may trigger additional correspondence especially if the device is beyond repair.

To expand on William's advice... In that service process, how do you:

• identify the device?
• verify the device?
• protect the device?
• safeguard the device?

And, if a device is lost, damaged or otherwise found to be unsuitable for use, what do you do? What records are created?

Thanks for the advice, I will consider these aspects while drafting the procedure and forms to comply with the clause.

 

[somashekar]

Thanks for the advice, I will consider these aspects while drafting the procedure and forms to comply with the clause.

Hello Manav.
Let me share my approach.
If the servicing is a part of your QMS, then address the requirements of clause 7.5.4. adequately. Here you will certainly include the requirements as said in 7.5.10, because what you will service is customer property. Therefore you have effectively performed the process interactions between clause 7.5.4 and clause 7.5.10 as far as servicing is concerned.
You asked ... Will storing the correspondence with the customer regarding loss/damage be a sufficient record of the activity?
Yes it will meet the requirement
Coming to 7.5.10 requirements other than servicing, let us know if you handle and manage any other customer property.

 

[ManavPenubaku]

Hello Manav.
Let me share my approach.
If the servicing is a part of your QMS, then address the requirements of clause 7.5.4. adequately. Here you will certainly include the requirements as said in 7.5.10, because what you will service is customer property. Therefore you have effectively performed the process interactions between clause 7.5.4 and clause 7.5.10 as far as servicing is concerned.
You asked ... Will storing the correspondence with the customer regarding loss/damage be a sufficient record of the activity?
Yes it will meet the requirement
Coming to 7.5.10 requirements other than servicing, let us know if you handle and manage any other customer property.

Hello Somashekar,

I will look into clause 7.5.4 and check if the requirements are handled adequately.
We also collect customer data during registration and device data to do remote troubleshooting of issues faced by the customer. How should these be handled under 7.5.10?

 

[somashekar]

Hello Somashekar,

I will look into clause 7.5.4 and check if the requirements are handled adequately.
We also collect customer data during registration and device data to do remote troubleshooting of issues faced by the customer. How should these be handled under 7.5.10?

If this data you collect is a part of your servicing actvity, then cover the data protection and safeguading in the servicing process. In the 7.5.10 part, let it be known clearly to all who are concerned if you have customer property in 1. Production control and 2. Servicing activities. You can then within these processes documentation tell how you will identify, verify, protect and safeguard them. Link the customer communication process (7.2.3. advisory notices) to your Production control and servicing activities to report any lost, damage or unsuitable cases, and when you make such communications, maintain them as records.

 

[Tagin]

If this data you collect is a part of your servicing actvity, then cover the data protection and safeguading in the servicing process.

This is a good point. In the US, HIPAA could be relevant if the device stores patient information.