Quality Manual for a Virtual Company (Medical Device)

K

KellyLS

#1
Hi all!
I have several virtual company medical device startups I'm setting up QMS for, and I'm struggling with what a quality manual looks like for this? They will "own" the 510K filing and technical file, but the product will be made and distributed by contracted 3rd parties. I understand the notion of strong supplier quality systems and solid quality agreements, what I'm trying to figure out is what to do with these production sections of the manual and the company SOPs that basically just say it's all done at the CMO. Do we list our requirements as per the regs then, and point to SQA to manage and monitor? Do we exempt it completely from the manual? Examples of how you've done this that have made regulators happy would be greatly appreciated!
 
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mihzago

Trusted Information Resource
#2
If the companies you're working with comply with the QSR, then as is stated in 21 CFR 820.1 Scope (a)(1) ... If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.

ISO13485 has a similar provision. The 2016 version even allows you to exclude other sections than previously allowed section 7.

What I typically do is list any exclusions or non-applicabilities in the scope section of the manual.

There are still many requirements that the virtual manufacturers must comply with including Management Responsibility, Design and Development (Design Controls), Purchasing Controls, Document Controls, Records, CAPA, Personnel, Audit, etc.
 

somashekar

Staff member
Super Moderator
#3
Please see clause 4.2.2 of the ISO 13485:2016.
For your benefit I am having the same here below:
4.2.2 Quality manual
The organization shall document a quality manual that includes:
a) the scope of the quality management system, including details of and justification for any exclusion
or non-application;
b) the documented procedures for the quality management system, or reference to them;
c) a description of the interaction between the processes of the quality management system.
The quality manual shall outline the structure of the documentation used in the quality management system.
 
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