Updating QM to 13485:2016 - We do not make medical devices

Hello All,

I am updating our quality manual from ISO 13485:2003 to the 2016 version.

We are a medical plastics compounder. We make the plastic pellets that medical device manufacturer’s use to make their medical devices. We do not made medical devices.

With that said, there are several clauses in section 7 we are excluding.

Our quality manual was basically the standard written in a different tense. So my question is….

When it comes to sections that I can’t exclude, but they mention medical devices – should my quality manual still call out that? I am thinking not, but was hoping for your thoughts.

For example – I am updating the QM right now with section 7.3.7 Design and Development Validation. We line up fine with the first part – but then it goes into saying that evaluations are needed to be performed on the “medical device” and connected or interfacing “medical devices”.

Do I have to keep “medical device” in that section?

Do I simply replace it with our product “compounded plastic”?

Since we do not make medical devices – can I exclude this portion? Do I need to include it at all?

Thanks in advance! Transition audit is coming up soon.

 

I am a stranger of ISO 13485. However, the quality manual which was basically standard written in a different tense may be not a desirable one for the pratical use.
Nevertheless with regard to your question above, I agree with you on this term changing thing. Actually in my opinion, you should do some modification based on the real situation.

 

ISO 13485 only permits exclusion of design and development if applicable regulatory requirements permit so. You need to verify if applicable regulatory requirements permit so, then you can exclude, it the case.

You can also have non applicable requirements in clause 6, 7 or 8 due to activities your organization perform in the device lifecycle, which seems to be the case of your organization.

 

hello
if you are not medical devices manufacturer then why are you implementing 13485 as it is only for medical devices manufacturers. you first need to define your products either it fulfill the definition of medical devices or not?
if yes then go for 13485 and if not then you dont need 13485 just go for 9001 and your concerned standards.

 

Does your product can also be used for other products e.g. dash board parts for cars or plastic parts of airplanes? IMHO your organization is not a medical device manufacturer. What if you supply also to automotive and the aviation industry? Would that mean your organization might be required also to get certification to IATF 16949 and AS 9100?