13485 Clause 6.3 - Not Applicable


I work for a startup Med Device company that outsources 100% of device manufacturing and about 75% of the product development. We have only a 5000 sq ft. building for the 25% of development (non-production/acceptance testing) and R&D activities, marketing, sales, and Regulatory activities. My question is, can we have a 13485 Section 6.3 Infrastructure and 6.4 Work environment and contamination control, listed as Not Applicable in the QA Manual?


I would say it depends upon your release to market activities, if these activities are conducted onsite then 6.3 & 6.4 should be applicable. Unless of of course the release to market activities are also sub-contracted.


Trusted Information Resource
If you outsource manufacturing activities, you are still responsible for it. Therefore you cannot claim that it is not applicable.
You can state in your quality manual that you outsource this activity and maintain control through supplier audits, quality agreements, etc....


Involved In Discussions
As others have indicated, outsourcing an activity doesn't mean it's outside of your quality system. The standard asks you to define requirements and maintain records; none of that is contingent on the activities themselves being on-site at your headquarters. It's also fairly clear that R&D, marketing, and regulatory activities are all pretty key areas to achieve conformity to product requirements, so this would apply internally as well.

Why would you want to omit these sections in particular? They're not terribly complicated.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
Typically as the name on the product label the things I have seen outside the scope of a QMS are installation and servicing. For example, our product has neither requirement and it's not offered. The FDA expects YOU to manage your suppliers to assure they meet the requirements and suggesting its n/a would be alarming to me. Why would you want to N/A those anyways? They are rather straightforward requirements and basic requirements even nonmedical companies adhere to.
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