Efficient approach to convert Quality System from ISO 13485:2000 to ISO 13485:2003

[medevguy]

I am looking for some suggestions on converting the Quality System based on ISO 13485:2000 to ISO13485:2003 (QSR is constant) in the most efficient way. I have the gap analysis done, and I don't think I have a whole lot to change. I do have a good understanding of the requirements in general, but One thing I am not too sure on the process appraoch - how do you show that? Flow charts? Something else?

I will appreciate any suggestions, experiences or insights. Thank you all. Great forum, I just found this.

[Viki N.]

Welcome!

If I understand what your asking asking about the process approach, a flow chart does nicely to identify your processses and their sequence/interaction. We did ours in the Visio software program, but you can use whatever program you're use to.

Not sure if I can help on your first question. We went from 13488;1996 to 13485:2003. I didn't even know there was a 2000 version of 13485. I would think you wouldn't have to change much other than the newer changes/additions.

Viki

[medevguy]

Thank you for the response. ISO13485 did not have a 2000 version, that was my typo. Anyway, it seems like you are in agreement that there is not a whole lot to change. Only part of confusion I have is that still the procedures are going to be the same or very similar to what they were before. Sure they may now fall under new umbrellas (sections of ISO), so how is that a process appraoch? It sounds like they started with intentions of following ISO9001:2000, but due to the push back from medical device industry in general and USFDA in particular it ISO13485:2003 really lost the meaning and sense of the process approach. I have seen flowcharts for each procedure at least 10 years ago at one company. Again, a confusion for me - just by including a flow chart of the procedure how does that become a process approach? When the same text is not? I think I will stick to creating a flowchart of the entire business process and call that my process approach. I will start with Concept/Realization of market need and end with Customer complaint. Off course, I will be shoing some feedback loops.

Anyone willing to share what do the flow chart(s) look like if you are using that approach.

[Wes Bucey]

In Reply to Parent Post by medevguy

Thank you for the response. ISO13485 did not have a 2000 version, that was my typo. Anyway, it seems like you are in agreement that there is not a whole lot to change. Only part of confusion I have is that still the procedures are going to be the same or very similar to what they were before. Sure they may now fall under new umbrellas (sections of ISO), so how is that a process appraoch? It sounds like they started with intentions of following ISO9001:2000, but due to the push back from medical device industry in general and USFDA in particular it ISO13485:2003 really lost the meaning and sense of the process approach. I have seen flowcharts for each procedure at least 10 years ago at one company. Again, a confusion for me - just by including a flow chart of the procedure how does that become a process approach? When the same text is not? I think I will stick to creating a flowchart of the entire business process and call that my process approach. I will start with Concept/Realization of market need and end with Customer complaint. Off course, I will be shoing some feedback loops.

Anyone willing to share what do the flow chart(s) look like if you are using that approach.

Let's make one thing clear: any organization could have used flow charts to describe their processes under the previous version of any of the Standards. One of the primary impetuses to process approach was the fact many organizations WERE already using flow charts to describe their operations.