Damaged Customer Property - ISO 13485:2016 Clause 7.5.10

mwb0585

Starting to get Involved
#1
Hello everyone,

Thanks in advance for your help. Background: I work for a company that helps OEMs design medical devices. We have a 13485:2003 cert that allows for 'provision of design and development services for medical devices.' We do not do any manufacturing, although we may build prototypes.

Very frequently, our customers provide us devices which we tear apart, to see how they work. They may also buy oscilloscopes or other test equipment which we use on their projects.

ISO 13485:2016 Clause 7.5.10 Customer Property says companies must identify, protect, and safeguard customer property. It also says that if customer property becomes damaged or unsuitable for use that "the organization shall report this to the customer and maintain records."

As we prepare to update our certification to ISO 13485:2016, I believe we should claim that all of Clause 7.5 (including 7.5.10) is not applicable, as we do not engage in Production and Service Provision.

Obviously, we do obtain customer property. And if we accidentally damage something that shouldn't be damaged, we will do our best to report it to the customer. However, I do not believe we should be held to the record keeping requirements of Clause 7.5.10. (Do we have to keep records if we break a $20 multimeter? That seems excessive.)

So, can we exclude (or claim non-applicability of) clause 7.5.10?
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
We have a 13485:2003 cert that allows for 'provision of design and development services for medical devices.'

...snip....

As we prepare to update our certification to ISO 13485:2016, I believe we should claim that all of Clause 7.5 (including 7.5.10) is not applicable, as we do not engage in Production and (in) Service Provision.
:confused:
Can't reconcile that. You are a service provider, thus 7.5 obviously applies to you. Ditto for 7.5.10.
 

mwb0585

Starting to get Involved
#4
:confused:
Can't reconcile that. You are a service provider, thus 7.5 obviously applies to you. Ditto for 7.5.10.

See we have always (since before I was here) interpreted 'design service' to be different from 'services provision' in the new 7.5 The latter would include things like cleaning, maintenance, repair, sterilization, etc. All the things that impact individual units intended for distribution. These are the tangible services that get performed on devices. Let's look at the individual sub-clauses and see if any of them apply. I'll save 7.5.1 for the end.

7.5.2 Cleanliness of product. Not applicable, because we do not help our customers determine what type of cleanliness or sterilization will be required for the finished product.

7.5.3 Installation. Not applicable, because we do not help our customers determine how the devices will need to be installed.

7.5.4 Servicing. Not applicable, because we do not help our customers determine how the finished device will be serviced. We also do not "service" devices ourselves.

7.5.5 Requirements for sterile medical devices. Not applicable, as we do not sterilize devices.

7.5.6 Validation of processes for production and service provision. Not applicable, because we do not produce or service devices. We do not help our customers develop their manufacturing processes. We just create design packages (requirements, specifications, drawings etc). (One wouldn't validate a design process. Our design process is established, and fully compliant with clause 7.3.)

7.5.7 Requirements for validation of processes for sterilization and sterile barrier systems. Not applicable, we do not design packaging or sterile barrier systems.

7.5.8 Identification. Not applicable, because all product within our facilities are considered prototypes and not for human use or distribution.

7.5.9 Traceability. Not applicable, material traceability is not required for prototypes.

7.5.10 Customer Property. Maybe applicable We do not receive customer property for use in producing or servicing devices. Yes, we do receive customer property to use as we design new products. And this is the clause I am questioning the applicability of.

7.5.11 Preservation of Product. Maybe applicable All material within our facility is considered prototypes not intended for human use or commercial distribution. We have electrostatic discharge (ESD) procedures in place to help "preserve" our prototypes from damage, but this is really more of a 6.3 Infrastructure type thing than 7.5.11. But we don't have special packaging or

Coming back to 7.5.1 Control of Production and Service Provision. Our design service is 'planned, carried out, monitored, and controlled' wholly within clause 7.3.

So would you still say we are a 'service provider?' What part of 7.5 would be applicable?
 

mwb0585

Starting to get Involved
#5
Perhaps you will consider introducing a $ threshold (something reasonable) in your relevant SOP. This can be included in your standard contract template so that the customer is informed and in agreement upfront.
So this is basically what we currently do, just unofficially. What I am mainly concerned about is the record retention requirement in 7.5.10. This type of situation happens so infrequently, that it's tough to get people to remember that it is a "special situation" that could require keeping some records.

If we damage something a customer gave us to use during design and development, of course we are going to let them know. We usually offer to replace it. Sometimes they don't care, as it is a trivial cost compared to the whole project. We just don't have the most robust record keeping system for this, and we usually address things over phone/email.

It just seems like it would be easier to claim non-applicability of the clause, because it geared towards property intended for use on, incorporation in to devices.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
The latter would include (...) All the things that impact individual units intended for distribution. These are the tangible services that get performed on devices.
Your product is device design / device specifications. Where certain clauses obviously don't apply to such products (eg installation), you can exclude them. If 9 clauses out of 10 in a specific section are N/A (and I'm not saying they are, it's just an example), so be it. It doesn't mean that you can exclude the single one that isn't N/A. It's not a "majority rules" situation.
 

Ronen E

Problem Solver
Staff member
Moderator
#7
We just don't have the most robust record keeping system for this, and we usually address things over phone/email.
This seems to be the root cause, and I bet it also affects other aspects / processes in your org. The 2 issues below are actually very common in small orgs, and present an opportunity for improvement / PA:

Issue #1: Issues are discussed and agreed over the phone without a corresponding recording of those agreements in writing (could be email, for that matter).

Issue #2: Email is used extensively for conducting activity and capturing information in writing, but is not handled accordingly in terms of maintenance (backup, retrieveability etc.)

It just seems like it would be easier to claim non-applicability of the clause, because it geared towards property intended for use on, incorporation in to devices.
Easier, yes. Unfortunately standard compliance doesn't always allow the easier way. The reason you gave seems like your own interpretation; I can't currently see it substantiated by a standard or regulation that I know of (would be glad to learn).
 

Wes Bucey

Quite Involved in Discussions
#8
So this is basically what we currently do, just unofficially. What I am mainly concerned about is the record retention requirement in 7.5.10. This type of situation happens so infrequently, that it's tough to get people to remember that it is a "special situation" that could require keeping some records.

If we damage something a customer gave us to use during design and development, of course we are going to let them know. We usually offer to replace it. Sometimes they don't care, as it is a trivial cost compared to the whole project. We just don't have the most robust record keeping system for this, and we usually address things over phone/email.

It just seems like it would be easier to claim non-applicability of the clause, because it geared towards property intended for use on, incorporation in to devices.
I think I understand your "organization thought process" on this matter: "We don't want to sweat the small stuff!"

May I suggest a relatively simple "work around?" DON'T BORROW CUSTOMER EQUIPMENT OF ANY VALUE ($0.01 TO $1,000,000.00) UNLESS YOU ARE WILLING TO MAINTAIN A STRICT RECORD OF RECEIPT, USE, RETURN (including any maintenance, calibration, damage, etc. incurred while in your possession.)"

In my experience, companies such as yours say to a customer, "We need [__] to perform this service. We 'could' buy it, but then we'd have to charge you. You can save money if you either lend us your existing one or buy it for us to use and then you own it when we're done using it."

The practice extends from little $20 multimeters on up to tens of thousands of dollars for tooling dies and computer-controlled machining mills or turning centers.

In my own high-tech machining company, we stopped that practice and deployed a slightly different one. If special tooling, equipment or test devices were needed ONLY for a particular customer's requirement, we explained the circumstances up front and billed it as a separate line item. When finished with the customer's requirements, we offered to ship the special item, as is, damaged or not, at the customer's expense, along with the customer's order or service provided. Sometimes, when using special materials (gold, platinum, silver, titanium) we'd also offer to ship the scrap as well at the customer's expense.

(Most times, customers were agreeable. If not, no deal.)

On the other hand, if we could foresee a use for the special item on another project, we pro-rated a portion of the cost between project costs and our general equipment overhead, similar to charging "machine time" to a project.

In any event, for ten years, we simply refused to use "customer's equipment." (Similarly, for various reasons I could explain in another thread, we didn't use "customer material" to make products.)
 
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