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Scope of ISO 13485 Registration and Component Makers

Aphel

Involved In Discussions
#1
Dear all,

Looking at the scope and the introdcution section of ISO 13485, the standard tells what chapters can be left out...for example 7.3 (development).

Basically, ISO 13485 is a standard for medical device manufacturers...but is it possible for companys, which are just suppliers (e.g. component manufacturers) for real medical device manufacturer to obtain an ISO 13485 certification? If yes - why?

Thank you very much in advance for your support.

Best regards,
Aphel
 
Elsmar Forum Sponsor
M

MIREGMGR

#2
Many providers of critical services for medical devices, i.e. sterilization, must hold ISO 13485 certificates.

Some makers of physical products that might be called components must hold ISO 13485 certificates because their products qualify as accessories as defined in MDD or by FDA, HC or other applicable national regulator.

Some other makers hold ISO 13485 certificates even though they don't make accessories or provide critical services. Holding a 13485 certificate instead of 9001 is sometimes said to be a stronger marketing statement if the company's primary market is medical device makers.
 

somashekar

Staff member
Super Moderator
#3
Dear all,

Looking at the scope and the introdcution section of ISO 13485, the standard tells what chapters can be left out...for example 7.3 (development).

Basically, ISO 13485 is a standard for medical device manufacturers...but is it possible for companys, which are just suppliers (e.g. component manufacturers) for real medical device manufacturer to obtain an ISO 13485 certification? If yes - why?

Thank you very much in advance for your support.

Best regards,
Aphel
What components and how much they affect the safety and effectiveness of the medical device into which they go ...
What is it that you look for in the QMS for these components within ISO13485, that is not mapped in the ISO9001 ?
If you list your components, we can put in more thoughts...
 

Aphel

Involved In Discussions
#4
Hello,

For example - if I am a manufacturing supplier in the medical device industry, and I want to become ISO 13485 certified - is it necessary to establish procedures for advisory notices...and also some other procedures, that are only relevant for legal manufacturers?

Thank you for your support!

Best regards,
Aphel
 

DannyK

Trusted Information Resource
#5
You should address it in your quality manual stating that you are not the "manufacturer" ( name is not on the label) and that it is the responsibility of the manufacturer to issue advisory notices.
 

Aphel

Involved In Discussions
#6
Hello.

What about a company who acts as supplier regarding sales and distribution activities on behalf of the legal manufacturer... is it possible to perform a ISO 13485 certification for such a company?

Thanks a lot for any comments!

Best regards,
Aphel
 

Marcelo

Inactive Registered Visitor
#7
The scope of the current version of ISO 13485 is only for manufacturers, but the certification processes are not related to the groups which creates the standard. So there?s certifications for ISO 13485 for several different players in the medical device lifecycle, including yours. I mean, if you contact a certification body and require an ISO 13485 certification, they will probably sell the service to you.

The next edition of ISO 13485 will expand the scope to any player in the medical device lifecycle, so it will be under the scope.
 

somashekar

Staff member
Super Moderator
#8
Hello,

For example - if I am a manufacturing supplier in the medical device industry, and I want to become ISO 13485 certified - is it necessary to establish procedures for advisory notices...and also some other procedures, that are only relevant for legal manufacturers?

Thank you for your support!

Best regards,
Aphel
Yes, you need to.
The bigger customer is the patient / user of your manufactured medical device, irrespective of you being on the label or not.
ISO 13485 is not directed towards legal manufacturer. Legal manufacturer is a regulatory word.
Think of advisory notice system as a part of your active communication when you suspect that a defective medical device has gone out of your boundaries.
Think of feedback system as a part of your active communication that you will establish to get feedbacks about your devices safety and effectiveness performance from your customer. You may also include into this some of the regulatory aspects feedback like the correctness and completeness of the DHR that you give to supplier along with your device deliveries.
 
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