Customer Property - ISO 13485:2016 Clause 7.5.10

#1
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?
 
Elsmar Forum Sponsor

William55401

Quite Involved in Discussions
#2
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.
 
#3
@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

Quite Involved in Discussions
#4
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.
 
Last edited:

Tagin

Trusted Information Resource
#5
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?
 
#6
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

Staff member
Admin
#7
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.
 
#8
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

Staff member
Admin
#9
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.
 
Thread starter Similar threads Forum Replies Date
C What falls under the 'Customer Property' according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 29
M Damaged Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 7
S ISO 9001 Clause 7.5.4 - Damaged or Lost Customer Property Record ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E ISO 9001 - 7.5.4 Customer Property - Services (e.g.: Training) on Rental Property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
G Customer Property Cl. 7.5.4 - Where does ISO 9001 stop and ISO 27001 start? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
D Customer Property Identification Requirement - ISO 9001 Clause 7.5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 77
J Customer Property ISO 9001:2008 Clause 7.5.4 - Does this include E-mails? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M 7.5.4 Customer Property - ISO 9001:2008 Intellectual Property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
D Can I exclude Customer Property? ISO 9001 Clause 7.5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
H Not having a form for Customer Property Damage - ISO 9001 Clause 7.5 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
P 7.5.10 Customer property - applies to leased/rented equipment? ISO 13485:2016 - Medical Device Quality Management Systems 10
lanley liao Does the customer`s trademark belong to customer-supplied property? Oil and Gas Industry Standards and Regulations 2
S Customer Property - If at all the customer return the product ISO 13485:2016 - Medical Device Quality Management Systems 2
A Identification of Customer Property: Customer-Supplied Thumb Drives & Ext Hard Drives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Receiving Inspection of Customer Owner Property IATF 16949 - Automotive Quality Systems Standard 5
E Owns Customer Property but No Product Integration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Uriel Alejandro 7.5.4 Customer Property in a Repair Station AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
M Does anyone have an example Customer Property Procedure AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
B Customer Property Exclusion as it applies to Personal Data ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Identification of Customer Property - Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Is a Drawing (Print) Customer Intellectual Property? ISO 13485:2016 - Medical Device Quality Management Systems 16
L Customer Property Checklist example wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
somashekar FDA cGMP on Feedback, Advisory Notice and Customer Property 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Customer Property Log example wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
E How Do You VERIFY Customer Property? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Customer Property Tools - par. 7.5.4.1 - Electronic identification of a certain tool IATF 16949 - Automotive Quality Systems Standard 6
P Supplier's Property - Does 7.5.4 Customer property apply to supplier's property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
N Customer Property Logs - Tracking customer property, specifically production tooling IATF 16949 - Automotive Quality Systems Standard 5
B What is Customer Owned Property for moulds and spare parts factory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Notification of lost/damaged Customer Property - Customer Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B Customer Property - The best way to inspect MLO and what acceptance criteria AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D TS 16949 Clause 7.5.4 Customer Property, Intellectual Property requirements IATF 16949 - Automotive Quality Systems Standard 5
D Clarification on "Customer Property" - TS 16949 Clause 7.5.4 IATF 16949 - Automotive Quality Systems Standard 4
6 Customer Property documentation (Audit Finding) - Clause 7.5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
H Can the documents supplied by the client categorised as customer property?? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H What can be customer supplied properties (property) for the software industry? Software Quality Assurance 18
K Customer Property - Notifying Customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Purchase Order and its relationship with customer property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Absence Of Any Form Of Customer Property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Identifying production dies to satisfy the 7.5.4 Customer Property clause ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P Customer Supplied Property - System breakdowns at every level including sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A How is Customer Property defined by TS 16949? IATF 16949 - Automotive Quality Systems Standard 6
G 7.5.4 Customer Property (Shipping Containers) IATF 16949 - Automotive Quality Systems Standard 2
K Defining Customer Property - Specifications, templates, patterns from customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
T Customer Property ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Claes Gefvenberg Customer Property - 7.5.4 (intellectual property) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Customer Property - 7.5.4 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Rude Customer Auditor General Auditing Discussions 18
M Customer Specific Requirements - Packaging Spec IATF 16949 - Automotive Quality Systems Standard 10
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3

Similar threads

Top Bottom