ISO 13485 Non-applicable clauses

zguy123

Registered
Hey Everyone,

I have been reading this forum for awhile and really appreciate all the help it contains, had a question come up that I would really appreciate some feedback on.

I was unfortunately met with a bit of anger and felt my auditor was being combative when I asked the same of them so figured I would try you fine folks for a screener before we push back.

Our company provides a service related to finished, packaged medical devices. We were proposing to include in our Quality Manual scope that only a single part of a clause in 7.2 was not applicable. Something along the lines of 7.2.1 d) only. Is it specifically not allowed to to take a partial not applicable to a clause. Must you NA a full clause only?

The last paragraph in Section 1 of the standard that talks about the not applicables is written a bit unclear and confusing regarding this fact in that "if any requirement is not applicable...the organization does not need to include such a requirement in its quality management system...for any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

Is this to mean that I don't need to comply with a specific part of a clause if it doesn't apply but can't specifically call it not applicable in the Quality Manual scope?

Thanks everyone!
 

Sidney Vianna

Post Responsibly
Leader
Admin
You can exclude a specific requirement, which can be a sub section of any clause in the standard. Your interpretation is correct
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
The QM describes the context of your organization and the scope of the system. Auditors usually look at it first to get a 100,000 foot view of "whats going on here" We don't provide service or installation so we call them out as excluded in our QM. If auditor has a question we state "Our device requires no installation and is not serviceable"
 
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