ISO9001 certification necessary for R&D? Design development facility

B

BRIAN777

#1
If my organization is acting only as a design development facility and we have our corporate location (already ISO9001 certified) manufacture our design, do we have to be ISO9001 certified as well?

Also, because the device we design is a medical device, would the manufacture (corporate) need to be ISO13485 compliant?

Can they get the CE mark without the ISO13485 registration?
 
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M

Martijn

#2
I presume the manufacturing ISO 9001 certificate scope excludes design? If not, you should be part of their management system. If design is indeed excluded there is no specific requirement that you have ISO 9001 as the research department.

Most important question is what the customer wants in this case. If a customer actually reads the certificate the manufacturing site sends them, they might figure that design is not included, and might find it a bit odd.

I don't know a thing about ISO13485, so no help there.

And finally, CE marking: check this website http://www.newapproach.org/Directives/DirectiveList.asp

It says medical devices need to comply with the following European guidelines. These guidelines will explain what is required for EC marking for these specific product groups. There is a specific guideline on applying the markings themselves.

90/385/EEC Medical devices: Active implantable
93/42/EEC Medical devices: General
98/79/EC Medical devices: In vitro diagnostic

There might be other guidelines that apply to your product as well, low-voltage equipment, machinery guideline, etc.. This website might also prove useful: http://www.conformance.co.uk/directives/ce_list.php

regards, Martijn
 

Al Rosen

Staff member
Super Moderator
#3
If my organization is acting only as a design development facility and we have our corporate location (already ISO9001 certified) manufacture our design, do we have to be ISO9001 certified as well?
No, but they must flow down the individual requirements for design to you.

Also, because the device we design is a medical device, would the manufacture (corporate) need to be ISO13485 compliant?

Can they get the CE mark without the ISO13485 registration?
Not necessarily, but they must be able to show compliance to the MDD requirements for the EU. ISO 13485 is an easy way to show this. There are numerous discussions about this subject in the Medical Devices Forum.
 

Paul Simpson

Trusted Information Resource
#4
If my organization is acting only as a design development facility and we have our corporate location (already ISO9001 certified) manufacture our design, do we have to be ISO9001 certified as well?
Can't really help with the medical devices advice - not my field of expertise. My take on the design aspect is that you should be included as part of the overall company certificate as the core processes of producing safe devices for the market relies on adequate design control.
:2cents:
 
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