Scope of ISO 13485 Certification needs the word Production.

Hello everyone,

we are a very small company (4 people), and started as a distributor for medical devices.

Meanwhile, we expanded our business and estabilished a contract with an asian manufacturer, providing 3 medical devices under our name. Also I need to say, that we do not design or develop.

Now, we intent to implement the ISO 13485 and want the scope to be similiar to this: "production and distribution of...". We need the word production included in our scope.

According to the ISO 13485, is there any problem with this? Technically our company is the manufacturer.

Best regards,

Paulo

Re: Doubt scope

dampiro said:

We need the word production included in our scope.

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Can you please elaborate on why you NEED to have the word production in the scope of certification? Is that because of a regulatory requirements such as the Canadian CMDCAS program? Does this post ring a bell concerning your situation?

Technically, based on what you describe, you have outsourced production. How do you control that the production processes comply with the applicable requirements of ISO 13485?

From Guidance Document GD207: Guidance on the Content of ISO 13485 Quality Management System Certificates Issued by Health Canada Recognized Registrars

The MDR do not require importers or distributors of medical devices to have a certified QMS. However, any importer or distributor of a Class II, III or IV devices that choses to become the Manufacturer by labelling and selling the device with their own name, trade-mark, design, trade name or other name or mark owned or controlled by them (see definition of a Manufacturer) shall comply with the QMS sections of the MDR and other applicable sections.

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dampiro said:

<snip> Now, we intent to implement the ISO 13485 and want the scope to be similar to this: "production and distribution of...". We need the word production included in our scope.

According to the ISO 13485, is there any problem with this? Technically our company is the manufacturer. <snip>

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Hello and welcome to the Cove

IMO, if you so desire, you can broaden the scope to include production. In regulatory terms, you ARE these devices' manufacturer (assuming you appear as such on the lebels). Besides, if you don't make finished medical devices, ISO 13485 does not make sense for you. It doesn't matter that you don't physically make them; the contract manufacturer is simply your extension, from a regulatory point of view. Note though that if you include production, all relevant requirements become applicable. This means that you won't get any exemptions for having actual production outsourced. On the contrary -- you should expect heightened scrutiny of behalf of the certifying org. They will look for effective controls over production, and since this production is thousands of miles away (and in a different culture), controls will have to be super-effective. Look at it as if your company will now have a remote manufacturing site.

Cheers,
Ronen.

Ronen E said:

On the contrary -- you should expect heightened scrutiny of behalf of the certifying org. They will look for effective controls over production, and since this production is thousands of miles away (and in a different culture), controls will have to be super-effective. Look at it as if your company will now have a remote manufacturing site.

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Not sure about this. If you are referring to a certifying organization as a certification body, most of them would consider an ISO 13485 certificate from an accredited CB for the contract manufacturer as "enough and adequate control", despite the fact that we do know for a fact that many certificates can not be trusted.

I still believe that there is a regulatory angle on the need for the word production to be in the scope of certification. While CB's might not make the distinction between (in-house) production and outsourced production, I do believe that regulatory bodies might differ in their approach.

Sidney Vianna said:

Not sure about this. If you are referring to a certifying organization as a certification body, most of them would consider an ISO 13485 certificate from an accredited CB for the contract manufacturer as "enough and adequate control", despite the fact that we do know for a fact that many certificates can not be trusted.

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This is interesting. I always thought that ISO 13485 compliance on the supplier's part is only one ingredient, and the customer (the legal manufacturer in this case) is nevertheless obliged to exercise adequate controls to make sure that its supplier's outputs are satisfactory. In my terminology "Effective controls" doesn't necessarily mean elaborated; if the supplier ISO 13485 outputs are satisfactory and integrate well with the customer's QMS, then a few simple clauses may be all that is required. Further, when I wrote "heightened scrutiny" I didn't mean going into the supplier's QMS in detail; rather, I meant that the interface between the supplier's and customer's QMSs is likely to be closely looked at. This is what I would have done. It seems that this is a very common weak link when collaborating over great distances and cultural gaps.

However, this is just my own interpretation.

Cheers,
Ronen.

dampiro said:

<snip> Now, we intent to implement the ISO 13485 and want the scope to be similar to this: "production and distribution of...". We need the word production included in our scope.

According to the ISO 13485, is there any problem with this? Technically our company is the manufacturer. <snip>

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You can have your scope of "Manufacture and sales of ... " in your scope when you have manufacturing in-house or outsourced.
Ask your CB how.
Keep your QMS ready with the controls that you extend and be able to demonstrate these being effective.
Quality management agreements that you establish between you and the manufacturing site can come handy as a framework for effective controls.

I agree with Somashekar's comments. I think the term "manufacture" has a broader connotation than "production". For example, the manufacturer may out-source production.

Laura Halper said:

I agree with Somashekar's comments. I think the term "manufacture" has a broader connotation than "production". For example, the manufacturer may out-source production.

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It is my impression that "Production" is less used and less well-defined than "Manufacturing" in the international medical devices regulatory context. Hence the confusion.

Yes, I think you are right. The regulations use the term "manufacturing", whereas ISO 13485 uses the term "production".

To further confuse things, the regulations use the term "manufacturer" in two ways -- the legal Manufacturer and also the person who physically makes the product. They may or may not be the same entity.

Laura Halper said:

Yes, I think you are right. The regulations use the term "manufacturing", whereas ISO 13485 uses the term "production".

To further confuse things, the regulations use the term "manufacturer" in two ways -- the legal Manufacturer and also the person who physically makes the product. They may or may not be the same entity.

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ISO 13485 uses both, sometimes interchangeably(?).

For instance:

NOTE Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.

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So it doesn't help clarifying the situation.

Seems that in the ISO 13485 context "Production" is more limited to the actual fabrication of devices, while "Manufacturing" sometimes applies in the broader context of the entire process that leads to placing the device on the market (and so, as you've pointed out, includes "legal manufacturing" as well).

I wonder if the next revision will resolve this confusion.

Cheers,
Ronen.