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


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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.


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You do not make anything that is classified as a medical device in and of itself, but only input material.
You might feel the need to be ISO 13485:2016 certified not because of direct advantages, but because it is a customer requirement (from actual legal manufacturers of medical devices).
For this eventuality under scope 1, the last paragraph notes you can claim non-applicability (if the justification is documented in your quality manual) of any requirement in clauses 6, 7 or 8.
Your hook into this would be "not applicable due to the activities undertaken by the organization" as you don't have anything to do with interfacing medical devices (as well as a plethora of the other finished medical device specific requirements). Do align with your customers and whether they can qualify you as a supplier when you claim that non-applicability.

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