New QMS...Old Projects

QuinnM

Involved In Discussions
#1
Hi,

We will be releasing a new QMS, 13485, this week. We have projects that started over a year ago. These projects do not have any QMS documentation. We have not released any products, but want to. We will retroactively create the QMS documentation for these projects.

When releasing the QMS should I also create documentation, such as non-conformance forms, or CAPAs to address the projects that do not have QMS documentation?

What is the best method to integrate projects that started before the QMS started?

Quinn
 
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shimonv

Trusted Information Resource
#2
This sounds like a big mess...
As a principle, you should avoid back dating.
A high-level practical advise: Even though the product development is nearly finished you should think of it as the end of "research phase" and run it quickly through the design and development procedure of your new QMS and record the results using the new templates with current date.
 

QuinnM

Involved In Discussions
#3
Mess Yes.
I have no plans to back date. R&D phase reviews could be days apart. In real time this may have taken months for each phase review.
"Research phase" is the plan and it will be documented at a high level in the QMS.

Thanks
Quinn
 

Gisly

Starting to get Involved
#4
Maybe just a rephrasing of what shimonv already said:

Would suggest you make a separate "quality plan" where you describe how you would get your product/project documentation transitioned to a compliant state towards ISO13485, and maybe more importantly compliant with applicable regulations such as MDR, QSR etc. I guess you already have such a plan in the workings, and such a plan would show that you did your transition of legacy projects in a controlled manner.

To my understanding a certification audit would look at the current state and well being of your QMS an not the state it was long time back so "remaking" documentation does not make sense.
 

Tagin

Trusted Information Resource
#5
When releasing the QMS should I also create documentation, such as non-conformance forms, or CAPAs to address the projects that do not have QMS documentation?

What is the best method to integrate projects that started before the QMS started?
Just because a project started prior to the QMS doesn't make it nonconforming. You may want to document a procedure for onboarding these projects into the QMS.
 

Tidge

Trusted Information Resource
#6
It's gap assessment time, potentially followed by some remediation.

I'm not a big fan of jumping into the CA/PA space, but a single corrective action that identifies the individual projects which require assessment is probably the only way to keep track of what could become a mess later.

Even if the projects started pre-QMS, in order to complete under a QMS they need to be executed according to a plan. Existing plans should be updated, and could be done without needing a CA, but I wouldn't expect the different projects to close all the potential gaps without some non-project-specific oversight.
 
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