To Exclude Or Not - ISO 13485 7.5.3.2.2 and 8.2.4.2 - Plastic Pellets

NikkiQSM

Quite Involved in Discussions
#1
Hello Cove People,

Hoping I can get some advice on implementing our system from ISO 9001 to 13485 - A little background on our company is that we are a plastics manufacturer mainly focused on medical compounds. We do NOT make medical devices, we just make the plastic pellets that eventually become the medical devices (i.e. catheters)

Now, I understand I can exclude anything in section 7 of the standard as long as I have a good reason.

I was going to exlude clause 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices This clause basically states that we will have records regarding materials used and environment conditions. And it states that our distributors (truck deliver vendors) are to maintain records of when and where they deliver our product.

Although we technically already have this clause covered, I was going to exclude it mainly because, again, we do NOT make medical devices, just the material that eventually becomes the medical device.

Now I have come across this clause: 8.2.4.2 Particular requirements for active implantable medical devices and implantable medical devices "The organization shall record the indentity of personnel performing any inspection or testing."

Again, we have this covered and would adhere to this requirement. I am just a little confused because I would think I would either have to include or exclude both, not just one. And of course, I don't think that I can exclude anything besides a requirement in section 7.

So should I just include both, even though the title of the clause states implantable devices, even though we do NOT make devices?

Thanks for any help!!!

Nikki
 
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T

treesei

#2
Re: To Exclude Or Not... That is the ?

By theory, a material manufacturer needs not include these clauses. However, if it has customers that use its material in such special devices, the customers may ask the supplier for some extra support.:2cents:
 
#3
Re: To Exclude Or Not - ISO 13485 7.5.3.2.2 and 8.2.4.2

I would suggest that if your materials are used to create implantable products then you should have full batch traceability. So for a particular batch of plastic pellets you would keep records of the constituent chemicals (manufacturer, type, batch, expiry dates etc) plus processing conditions, plus records of who has "signed of" the record of this information.

So, in effect, you are complying with those clauses.
 

Marcelo

Inactive Registered Visitor
#4
The main poblem regarding the application of ISO 13485 in these cases is: ISO 13485 was created to be applied to the manufacturer (meaning, the company responsible) for the medical device. It does not use these terms because it tried to avoid problems in harmonization due to different legal terms.

With this in mind, you can exclude anything you want and do everything you want.

If you are under some kind of cettification sheme which requires you to comply wwith ISO 13485, then things is a little diofferent.


Anyway, just to make some points clear:

Now, I understand I can exclude anything in section 7 of the standard as long as I have a good reason.

No you can't, not i ISO 13485. The way to read ISo 13485 is:

If regulatory requirements (applicable to the "manufacturer", that was the idea) permit, you can exclude design controlst - 7.3 - from the system. This was done to align with the FDA QSR, which does not require design controls to class I devices.

You cannot exclude anything besides 7.3 and again, just if applicable regulatory requirements prmit it, to claim compliance with ISO 13485.

There's another case, which is non-applicability of a requirement. Again, this is only for Cluse 7, and this is related mainly to things like the "active implantable" and "sterile" requirements, and also some process requirements such as service.

In these case, meaning, depending on the nature of the devie, you can deem the requirement non applicable. For example, if the device isn't sterile ou implantable, you can eem the related clauses non-applicable. If service is not a requirement, you can deem the clause non-applicable too.
 

somashekar

Staff member
Super Moderator
#5
we just make the plastic pellets that eventually become the medical devices (i.e. catheters)
Your products are far away from being any medical device. Application of the ISO13485 by you falls very close to what the ISO9001 requires + some specific requirements of ISO13485.
Please do nothing about what ISO13485 specifically calls for certain types of medical devices. You have a very natural justification of non applicability of all such clauses.
Keep it simple and good luck .....
 
R

Roland Cooke

#6
1) No

2) Very no


1) You can only EXCLUDE design control, and then only if applicable regulations permit you to do that. Now you can argue that a clause is NON-APPLICABLE, provided you give a robust justification. In this case, that shouldn't be an issue.

2) You can only deem sub-sections of Clause 7 (Product Realisation) non-applicable. So 8.2.4.2 will apply to you.
However since you don't make implants you won't ever need to record the identity of anyone involved in inspection or testing. However doing that anyway might not be a bad idea for your organization (you decide).
 
C

cartman1417

#7
Since I am new to the Quality Regulation, I have question about how to exclude stuff from the quality manual?

For example, on similar lines to the topic of this thread, we are a medical device company and we are going to manufacture Class IIa diagnostic device for vaginal examination.

So the clauses about implantable devices do not apply to our company.

So my question is, how to I exclude stuff from the quality manual?

Do I just delete the sections in 7 and 8 that do not apply? Or should I keep the headings and just write "Not Applicable" in the paragraph as content?

If I delete section 8.2.4.2, should I give justification at the beginning in the exclusion section?
 

NikkiQSM

Quite Involved in Discussions
#8
This is only my opinion, but its worked for me:

Note any exclusions, with reason for exclusion, in the Scope of your Quality Manual.

I would still leave the heading of the clause you are excluding in the correct spot, in the manual, and write - "Excluded - See Scope" under it.

Again, just what has always worked for me.
 

somashekar

Staff member
Super Moderator
#9
So the clauses about implantable devices do not apply to our company.

So my question is, how to I exclude stuff from the quality manual?
You exclude stuff by stating in the quality manual under a separate table which you may call "Non-applicability and justification"
Quote the ISO13485:2003 clause number and its heading text and state the same very reason why you say diagnostic device for vaginal examination are not applicable to the requirements as said in the stated clause text.
Since it is your QM aligning to the ISO 13485:2003 standard, be specific and clear about your justification concerning to your medical device.
When you justify for below....
7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices
The same stands for this also...
8.2.4.2 Particular requirement for active implantable medical devices and implantable medical devices
 
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RCW

Quite Involved in Discussions
#10
There's another case, which is non-applicability of a requirement. Again, this is only for Cluse 7, and this is related mainly to things like the "active implantable" and "sterile" requirements, and also some process requirements such as service.
2) You can only deem sub-sections of Clause 7 (Product Realisation) non-applicable. So 8.2.4.2 will apply to you.
However since you don't make implants you won't ever need to record the identity of anyone involved in inspection or testing. However doing that anyway might not be a bad idea for your organization (you decide).
Okay, so my company does not manufacture active implantable medical devices. I can claim that 7.5.3.2.2 is non-applicable but I can't claim 8.2.4.2 because that is not in Clause 7.
Therefore I need to make the provision to record the identity of personnel performing any inspection or testing of active implantable medical devices even though my company does not produce them.

Is that as stupid as it sounds? How do I explain how I do something when I don't have a requirement to do it other than one sentence out of a specification?!
 
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