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How do I promote my QMS?

dr1vn

Involved In Discussions
#1
I always believe in using the QMS and regulations to our advantage. So, in memo's and documents I want to say that my company manufactures its products under an ISO 13485 system. As well, I would like to promote that the ISO 13485 certification was under MDSAP But what's the correct way to say this? For example:

....manufactured under ISO 13485:2016, MDSAP...
....manufactured under ISO 13485, MDSAP...
....manufactured under ISO 13485, Medical Device Single Audit Program...

or something else.

Thanks!
 

dr1vn

Involved In Discussions
#3
Who's the intended audience of the memo's and documents? Will they understand your intended message?

Good point. My intent was to promote the fact that we have a quality system to other QA/RA folks and that we did an MDSAP certification. I just want to be sure I'm saying it correctly and consistently.

But now that you mention it, if a lay person reads this... should there be an explanation of the QMS?
 

Ed Panek

VP QA RA Small Med Dev Company
Trusted
#4
Your audience is broad so most readers may not understand any of the "jargon."

I would consider using a quote from the opening of the standard itself.

1 Scope
This International Standard specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical devices and related services that
consistently meet customer and applicable regulatory requirements. Such organizations can be involved
in one or more stages of the life-cycle, including design and development, production, storage and
distribution, installation, or servicing of a medical device and design and development or provision of
associated activities (e.g. technical support). This International Standard can also be used by suppliers
or external parties that provide product, including quality management system-related services to such
organizations.

This statement speaks to a large part of what a QMS is and why it could add value. No one cares you have a QMS; what they care about is why it adds value.
 

John Broomfield

Staff member
Super Moderator
#5
You should consider running a workshop for the leaders (by rank and influence) to develop their own way of explaining the value of their management system in terms that everyone understands.

With this resource you can then arrange awareness sessions for everyone.

Attend each session to monitor effectiveness and to answer any technical questions.

You may also consider videoing and editing the sessions to make a consistent message for new employees and suppliers.

Never deprive top management of a chance to show their commitment.
 
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