13485:2016 Non-Applicability

[PRFire]

We're in the process of reviewing our Company's quality manual and want to get thoughts on our Non-Applicability section:

The scope of our company's ISO 13485:2016 certification is basically Design and Development of IVDs, i.e., no product manufacturing.
I thought we could potentially exclude 7.5 altogether, but because the standard states " When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process." we could not list it as non-applicable.

Would it make sense to then list the following clauses as non-applicable?

7.5.2 - Cleanliness of product
7.5.3 - Installation activities
7.5.4 - Servicing activities
7.5.5 - Particular requirements for sterile medical devices
7.5.7 - Particular requirements for validation of processes for sterilization and sterile barrier systems
7.5.9.2 - Particular requirements for implantable medical devices
7.5.11 - Preservation of product

Every time we undergo a notified body audit, they have differing opinions on which of our non-applicable clauses should be included, prompting constant revisions to our Quality Manual so I'd love to get thoughts on this and the justification.

If any clarifications are needed, please don't hesitate to ask.

 

[Hi_Its_Matt]

The combining of services with products in the nonchalant manner 13485 does it is one of my biggest complaints about the standard. But anyways…

I believe the N/A’s you’ve listed are both logical and defensible. The company I work for is a design consulting company, and our scope is something like “provision of contract design and development services to manufacturers of medical devices (active and non-active, implantable and non-implantable).” We have these same clauses (except 7.11) noted as not-applicable. For 7.11, we have stated that it’s basically not-applicable, but we do apply the concepts to units we may build/bring-up in house for design verification purposes. We have never received much pushback.

 

[yodon]

If your name goes on the label ('legal manufacturer') then you're responsible for all those aspects. You may push them down to your contract manufacturer but, other than possibly the things around sterilization (if your product does not go through any), they are applicable.

If your name doesn't go on the label, that may be a different story.

 

[PRFire]

The combining of services with products in the nonchalant manner 13485 does it is one of my biggest complaints about the standard. But anyways…

I believe the N/A’s you’ve listed are both logical and defensible. The company I work for is a design consulting company, and our scope is something like “provision of contract design and development services to manufacturers of medical devices (active and non-active, implantable and non-implantable).” We have these same clauses (except 7.11) noted as not-applicable. For 7.11, we have stated that it’s basically not-applicable, but we do apply the concepts to units we may build/bring-up in house for design verification purposes. We have never received much pushback.

This was so helpful. Thank you!