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Can a non-medical device manufacturer (mold making) be certified to ISO 13485?

J

jheinzen

#1
Does anyone know the current status of ISO 13485, I know it was in the process of being revised, but I would like to know if it is a DIS or FDIS?
Can a non-medical device manufacturer become certified to ISO 13485? I'm referring to a company that makes molds.
 
Last edited by a moderator:

AG Kumar

Starting to get Involved
#2
Hi Jheinzen

ISO 13485 is a Quality Management System standard specific to medical device industry, whose base is still ISO 9000 with few additions relevant to regulations and industry.

If the product what you specifiy has no relevance to an eventual device manufacturing, ISO 9000 is good enough to establish and get certified. Indeed, if your product is eventually used for a medical device, ISO 13485 may be applicable with the following situations

- As a supplier/ outsourced operation to a medical device manufacturer
- may be an integral part of a medical device manufacturing process

Hope this gives you an understanding.
 
J

jckca

#3
They can, as long as they are willing to do the work getting the appropriate policies in place and pay for the certification. If it is worth it is another question.
 

somashekar

Staff member
Super Moderator
#4
Can a non-medical device manufacturer become certified to ISO 13485? I'm referring to a company that makes molds.
Why... ? are you manufacturing / assemblying a medical device or a critical making a critical part that goes into a medical device ? From the word 'Mold making' I gather you are into molds and tools for which ISO 9001 is good and strong when you apply the QMS principles in its true spirits. I am unclear what business demand is wanting you to be ISO 13485 certified .....
 

AG Kumar

Starting to get Involved
#5
If we go through the Scope of the standard (ISO 13485), section 1.1 states "This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services"

Also the section 1.2 Application clearly states "All requirements of this International Standard are specific to organizations providing medical devices, regardless of the type or size of the organization"

Hence, going by this an organization that does not involve, at least, in any of the following activities can not go for ISO 13485 certification.

  • design and development, production, installation and servicing of medical devices
  • and the design, development, and provision of related services

Hope this gives you more clarity on the subject that is under discussion.
 
M

MIREGMGR

#6
As a 13485/MDD compliant medical device maker, we want our key subcomponent vendors to have appropriate quality systems. We prefer 13485 over 9001 whenever possible. The structural differences between 13485 and 9001 are well known. We see a subcomponent-vendor 13485 focus as beneficial to us, in that it coordinates better with our own focus.
 

Roland Cooke

Quite Involved in Discussions
#7
Most of the mold makers I deal with wouldn't have any business if they didn't hold ISO13485. It really depends on how you intend your business to progress.

What I would say is that even if you can attract medical customers without ISO13845 (and it's certainly possible), as MIREGMGR says there is an advantage in synergy, in understanding what your customers needs will be under ISO13485. There are definitely different/additional issues compared to "routine" molding.
 
J

jheinzen

#8
I certainly appreciate your reply an expertise.

So the mold can be considered as a 'medical device' per ISO 13485 clause 1.2?
 
M

MIREGMGR

#9
So the mold can be considered as a 'medical device' per ISO 13485 clause 1.2?
I gather that you're pursuing AG Kumar's comments above.

No, molds are not medical devices. However, moldmaking for medical device manufacturing is (in my view) a "related service".
 
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