Possible to get ISO 13485 certified with only OEM Product?

#1
Hello,

One company with 4 people, zero own made product, as the legal manufacturer all products are completely made at CM. Can sign quality agreement with CM. Currently the company has an inventory room, an office and a lab for some R&D stuff only.

1. Is it possible to get ISO 13485 Certified?
2. Possible certified to full scope? "Manufacture, R&D and distribution of ............"
3. Since the legal manufacturer has zero production and design, in the quality agreement. The processes like design control, design change and CAPA need only be reported and agreed by the legal manufacturer?

Thanks
 
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somashekar

Staff member
Super Moderator
#2
Hello,

One company with 4 people, zero own made product, as the legal manufacturer all products are completely made at CM. Can sign quality agreement with CM. Currently the company has an inventory room, an office and a lab for some R&D stuff only.

1. Is it possible to get ISO 13485 Certified?
2. Possible certified to full scope? "Manufacture, R&D and distribution of ............"
3. Since the legal manufacturer has zero production and design, in the quality agreement. The processes like design control, design change and CAPA need only be reported and agreed by the legal manufacturer?

Thanks
1. Yes, it is posible
2. Yes, to the full scope
3. Please see 4.1.5 of the standard. The Quality agreement that shall be established is just one aspect. The required documentation towards how you will establish controls over your CM towards all the clauses of the standard as well as the competency of your 4 people in exercising the controls will be important. How the controls are actually exercised (suitable records) at the CM, the audits that are carried out at your CM by you or your representative, and the QMS of your CM are to be considered. If your CM has an accredited ISO 13485 certified QMS from a recognized CB, and the same is a quality agreement requirement, it will greatly be a positive control.
Talk with your CB and explain threadbare your approach.
 
Last edited:

William55401

Involved In Discussions
#3
Great answer above. All portions of a QMS, with the exception of Management Responsibility, can be outsourced. Supplier controls are key. How will your firm demonstrate supplier oversight?
 

Rincewind

Involved In Discussions
#4
I am slightly confused about the "Certification to full scope"-part.
Is it really possible to get "manufacturing" on the certificate if no manufacturing is happening, I remember having discussions about that point with a CB and they said they will not do that if no manufacturing is happening.
 

somashekar

Staff member
Super Moderator
#5
I am slightly confused about the "Certification to full scope"-part.
Is it really possible to get "manufacturing" on the certificate if no manufacturing is happening, I remember having discussions about that point with a CB and they said they will not do that if no manufacturing is happening.
Apart from what is said in clause 4.1.5, the scope of the standard ISO 13485 in clause 1 clarifies the following in a paragraph ...
The processes required by this International standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
 
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