Distributors and ISO 13485 - DHF and DMR Responsibilities

O

orangeisenergy

#1
#1
If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there? Can the manufacturer hold the DHF and DMR, or do we need them since our name will be on the label? Can we just distribute and maintain our portion of the traceability and call it good?

:popcorn:
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Hi,

orangeisenergy said:
If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there?
Click to expand...
Being the legal manufacturer (your name on the product), you are responsible. As far as ISO 13485 is concerned there are no requirements other than you following your own SOPs regarding selection, approval and control of your suppliers (the co-manufacturing company is your supplier). Of course, your purchasing controls should be aligned with ISO 13485.

orangeisenergy said:
Can the manufacturer hold the DHF and DMR, or do we need them since our name will be on the label?
Click to expand...
DHF and DMR are part 820 (FDA) terms, not ISO 13485, though ISO 13485 has similar concepts. Again, you have the ultimate responsibility, so if you don't physically hold and control the files, you'll at least have to have strong provisions in place to ensure real time accessibility and being fully and continuously up to date with any content change.

orangeisenergy said:
Can we just distribute and maintain our portion of the traceability and call it good??
Click to expand...
As long as your supplier (co-manufacturing company) covers the areas which you don't, so that ISO 13485 is fully complied with, and you have provisions in place to ensure that this will be the situation at all times, it's OK. The ultimate responsibility is yours. How you go about making sure you keep up with it has some degrees of freedom. The key word is Control.

Cheers,
Ronen.
 
Last edited:
somashekar

somashekar

Staff member
Super Moderator
#3
#3
orangeisenergy said:
If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there? Can the manufacturer hold the DHF and DMR, or do we need them since our name will be on the label? Can we just distribute and maintain our portion of the traceability and call it good?

:popcorn:
Click to expand...
All the requirements of the ISO 13485 are there for you.
What is your scope of ISO 13485 QMS as on your certificate ? (Gives a good insight)
I am a little surprised that the company manufacturing for you is not ISO 13485.
There seems to be a lot of "Outsourcing" in your QMS, and it is good to know how the controls are placed and how they are operating and being effective in your QMS.
I hope you can give more details to say how the processes are stitched together between you and the manufacturer.
 
O

orangeisenergy

#4
#4
somashekar said:
All the requirements of the ISO 13485 are there for you.
What is your scope of ISO 13485 QMS as on your certificate ? (Gives a good insight)
I am a little surprised that the company manufacturing for you is not ISO 13485.
There seems to be a lot of "Outsourcing" in your QMS, and it is good to know how the controls are placed and how they are operating and being effective in your QMS.
I hope you can give more details to say how the processes are stitched together between you and the manufacturer.
Click to expand...
Our scope is ?the design, development and manufacture of in-vitro microbiological diagnostic testing media.?
Does this include veterinary devices, or is this just for devices for humans?
Does a PCR type in vitro diagnostic test for animals fall in this scope?

This is the only outsourcing we do. And this is a new venture for everyone here. The company that is going to manufacture the new product for us has never manufactured before. They have been strictly R & D by contract previously. They do not hold a ISO13485 certification.
 
somashekar

somashekar

Staff member
Super Moderator
#5
#5
Does this include veterinary devices, or is this just for devices for humans?
Click to expand...
If your scope is what you said in your ISO 13485 certificate, then it implies that the testing media is used for human beings. It matters little if it can also be used for veterinary application.
Does a PCR type in vitro diagnostic test for animals fall in this scope?
Click to expand...
No, if it is exclusively for animals. Your quality manual can mention this with a simple reasoning. (I am sure you treat this no differently in QMS though)
Your scope implies that the DHF and DMR are your records. They must be under your records control. It matters little who actually made those records. You own it.
The company that is going to manufacture the new product for us has never manufactured before. They have been strictly R & D by contract previously. They do not hold a ISO13485 certification.
Click to expand...
This may be against your evaluation and selection of the company to manufacture. However if this is your organization requirement, define your criteria for contracting with that company. Establish new manufacturing contracts keeping in view your volumes, the infrastructure and work environment requirements and validation responsibilities clearly outlined. Drive them towards ISO 13485 certification with a time line project (preferably with your CB)
You can search here in the cove for a copy of good manufacturing quality agreement.
 
Last edited:
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#6
#6
orangeisenergy said:
Our scope is ?the design, development and manufacture of in-vitro microbiological diagnostic testing media.?
Does this include veterinary devices, or is this just for devices for humans?
Click to expand...
The scope includes whatever you clarify it does. You should be communicating it clearly to all stakeholders; in the case of ISO 13485 it is essential you communicate it clearly to your CB, so that they can audit you accordingly and state the right scope on your certificate. If you are enhancing your product line it should be discussed with the stakeholders, including your CB, and acted upon as necessary in real time (i.e. perhaps earlier than the annual surveillance audit). Apparently the scope you quoted above is not sufficiently clear in your current situation. IMO in the current context it is in your interest to further clarify that your ISO 13485 scope excludes products intended for animal use only. This would avoid ambiguity.

Cheers,
Ronen.
 
Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#7
#7
somashekar said:
Drive them towards ISO 13485 certification with a time line project
Click to expand...
IMO this is not a must. Before making any decision in that regard, the real needs and consequences are better considered. What real need drives the requirement for them to have ISO 13485 certification? Perhaps ISO 9001 would suffice instead?
 
somashekar

somashekar

Staff member
Super Moderator
#8
#8
Ronen E said:
IMO this is not a must. Before making any decision in that regard, the real needs and consequences are better considered. What real need drives the requirement for them to have ISO 13485 certification? Perhaps ISO 9001 would suffice instead?
Click to expand...
Agree ... :yes:
Why I recommend to orangeisenergy is for the following reason.
1. The question is with ISO 13485 standard as the basis
2. They are on the product label and are ISO 13485 company
3. Significant processes are outsourced, and the QMS status of that company is not clear. It is however clear that they are new to manufacturing
4. Evaluation and selection criteria of the manufacturer is perhaps the ongoing association in design and development. No evidence of any other criteria
5. Information about quality management system requirements in purchasing is not evident to me

If the regulatory requirement is the US FDA, then ISO 13485 or ISO 9001 is not a requirement for either of the companies. Yes, perhaps ISO 9001 would suffice, but just an other few steps will take them to ISO 13485.
ISO 13485 certification mostly is from the business risk based decision.
 
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