ISO 13485:2016 and regulatory requirements - Contract Manufacturing

G

gmaltby

#1
Hi,

We are a contract manufacture who are currently iso 13485:2003. Our transition to 2016 is in September. Although 13485 we do not manufacture any medical devices. I have listed all regulatory elements within the standard as N/A within our manual as we do not work to any reg requirements. Is this acceptable??
 
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Marcelo

Inactive Registered Visitor
#2
Hello, and welcome to the Cove!

I'm pretty sure some certification body will accept what you did as ok (I've seen crazier stuff accepted :p), but ISO 13485 does not have an option for that. You can have NA clauses in clause ˆ, 7 or 8 depending wither in the nature of your device (sterile, for example), or activities you do not perform (such as several if you are not a manufacturer).

Even as a contract manufacturer, you probably have several regulatory requirements applicable to you. For a general example, a contract manufacturer performs manufacturing in the name of the "legal"manufacturer, and thus the contract manufacturer complies with regulatory QMS requirements for the activity they perform (although the full responsibility is still with with the "legal"). That's one of the reasons we added a "quality agreement" to the third party activities requirements in 4.1.5, the most important thing this quality agreement has is a definition of which activities and responsibilities of each party in relation to compliance with regulatory requirements.

So, per 4.1.1 you have to define your role in the applicable regulatory requirements (as I mentioned elsewhere, this is probably the most important clause of the 2016 version of the standard) and contract manufacturer is a clear role in several regulatory systems. Then you have to determine and comply with (per 5.2) the regulatory requirements for each of those roles (probably together with you contracting clients as they will define in quality agreements what regulatory requirements you need to comply with).

So, no, in my opinion, it's not acceptable.
 
G

gmaltby

#3
I understand what you are saying but we manufacture essentially tubing. We have no idea in most cases what this tubing is even used for so cannot comply to regulatory requirements as we do not know what they would be. In addition no customer has ever requested we meet any specific regulatory requirements?
 

Marcelo

Inactive Registered Visitor
#4
Ah ok, you do not manufacture a device. But then are you really a contract manufacturer (third party) for tubing or a supplier?
 

Marcelo

Inactive Registered Visitor
#6
Sorry, which one? They are two different things.

- Contract manufacturer for tubing (which manufacturers a tubing following "legal"manufacturer design and requirements)

Or

- Tubing (your own design and requirement) supplier (that complies with customer requirements)?

If a contract manufacturer, you do have regulatory requirements to fulfill, even if your "legal"manufacturer has never asked for that (this is a usual problem because most of the time they don't know).

If you are a supplier, you won't have in principle regulatory requirements to comply.

Also, for a contract manufacturer, there's no "customer", you are them (you act on their behalf).
 

Marcelo

Inactive Registered Visitor
#8
I understand what you are saying but we manufacture essentially tubing. We have no idea in most cases what this tubing is even used for so cannot comply to regulatory requirements as we do not know what they would be. In addition no customer has ever requested we meet any specific regulatory requirements?
So you do have regulatory requirements to comply with, as you are doing the work they should be doing (which is the idea of the third party mentioned in 4.1.5 of ISO 13485).
 
G

gmaltby

#9
In what sense? For example they send us a request to manufacture 4.0 x 7.0mm tubing with a defined tolerance in a specific material nothing more? How would we know what regulatory requirements are required as we have other information?
 

Marcelo

Inactive Registered Visitor
#10
In what sense? For example they send us a request to manufacture 4.0 x 7.0mm tubing with a defined tolerance in a specific material nothing more? How would we know what regulatory requirements are required as we have other information?
They should have a quality agreement with you that tells you which regulatory requirement you would fulfill in their name. As I mentioned, it's more their problem than your, but this does not mean that you do not have any applicable regulatory requirements to fulfill.
 
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