Does scope od ISO 13485:2003 cover both manufactures and distributors of MD or is limeted for manufactures only?:confused:

The answer is both, if the distributors are part of your company the you are are responsible for ensurng that they do, if not then it is their responsibility.

This is my understanding

Your might also want to consider 14001 as this applies to both with same rules as above

section 7.5.3.2.2 Para (2)

"The organisation shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and that such records are available for inspection"

does distributor may have certifikate iso 13485?

does distributor may have certifikate iso 13485?

If they are associated with your company depending on the scope of your certificate it may include them, would have meant they underwent a surveillance visit during initial assessment.

If they are 3rd party then when selecting distributors your SQA.. (Supplier Quality guys) may have selected them partly based on their current sertification status.

hope this has helped

From my experience the distributors are NEVER ISO 13485 certified.
that would also never be required that they have any quality management system.

some of the companies (and I presume this is sensible) require their distributor to sign a declaration that they will keep the records of the sales and that the products would be traceable. IMHO this makes some sence.

Any way, that would be extremelly odd to me if the auditors would require the distibutors of ISO13485 certified company to be certified as well.

:)

Distributors may be certified to ISO 13485. If the distributor has a private label that is manufactured somewhere else, to sell in Canada, they need to have ISO 13485 certification. They are considered as the manufacturer since their name is on the product.

Let's make sure:
I consider distributor a person who just sells the products and is NOT marked on the label.
In case it was to be on the label - marked as the manufacturer (Private Label Manufacturer) the situation is totally different...
:cool:

Yet if a distributor simply sells the products there is no need for him to be ISO certied. If it was required all the companies selling medical devices would have to be certified which is NOT the case.
:notme:

Let's make sure:
I consider distributor a person who just sells the products and is NOT marked on the label.
In case it was to be on the label - marked as the manufacturer (Private Label Manufacturer) the situation is totally different...
:cool:

Yet if a distributor simply sells the products there is no need for him to be ISO certied. If it was required all the companies selling medical devices would have to be certified which is NOT the case.
:notme:

Well let's be a little careful here. :)

IIRC there is only one country in the world (Canada) that actually requires ISO13485 to be in place anyway.

But it is true, Canada does not allow "Sales of" to be in the certificate scope.

At first glance that might seem to rule out distributors. However there are still requirements on traceability, record-keeping, regulatory/vigilance communication etc etc, that would still likely apply to distributors. And indeed Canada does allow/insist "Distribution of" to be within the certificate scope.


As an ISO13485 registrar we tend not to be asked for ISO13485 by companies that only distribute, but it does happen from time to time.

We don't typically interpret distributors as being critical suppliers to our client-manufacturers. We would obviously reserve the right to audit if we felt it appropriate, for example if we became aware of customer complaints that weren't being forwarded onto the manufacturer.

We do tend to confirm agreements are in place between our clientanufacturer and their distributors, confirming that elements other than price(!) are covered, (as per the list above).

Presently, we are located in Canada and are certified ISO 13485. We are manufacturing and distributing the product in North America through our plant in Canada; our head office is in Europe and we would like to start distributing products to Europe through our head office (the product will still be manufactured here). During previous inspections, the office in Europe was never part of the audit as the scope of our certificate did not include them. However, if they are merely distributing the product, will they need to undergo ISO 13485 certification as well? Or will maintenance of distribution records be enough.

It all depends on who's name is on the product. If you are selling to Europe, more than likely you will need a CE mark and an authorized representative in Europe. The head office does not need to get certified ISo 13485.

Agree.Distributors can't be ISO 13485 certified

Agree.Distributors can't be ISO 13485 certified

I doubt this is true.

However it is true that distributors do not need ISO13485 under CMDCAS.