ISO 13485:2003 QMS Flow - I have just put together my first draft

Hello all. I have just put together my first draft of our QMS flow for the new 13485 (we already comply with the FDA CFR, among other regs). It is my intention to have individual process flows for the area represented. For the parallel process on the bottom of the page, I intend to make a statement that "These are applied during main processes as described in relevant documentation". I would really like it if I could get some of you to take a look at this and provide me with your expert opinions and suggestions. It's a visio file, so if you can't get to it let me know and I will upload a pdf of it. Any takers??

NOTE: 060209 - Attachments removed because of errors noted by poster.

If you'll put it in a pdf I'll take a look at it...

I need to upgrade my Visio.

howste said:

If you'll put it in a pdf I'll take a look at it...

Click to expand...

I attached a word doc with the image. Hopefully you will be able to read this. Please let me know. Thank you!

Overall, I think it looks good. Just a few questions for clarification:
1) Shouldn't manufacturing be somewhere between receiving inspection and final inspection?
2) Is the flow always one direction? I only see one place where there is a "feedback loop."
3) "Clinical product" and "explants" don't sound like processes to me. All of your other process names have an implied action. You might consider a more process-descriptive name for these. Also, the use of the word "system" seems out of place to me for the manufacturing planning and control process.

Anyway, there's my - I'd like to hear what others think.

In my mind, manufacturing /test should be between receiving inspection and final inspection.

Why does "shipping" and "explants"(complaints) both feed into "outputs" then monitoring & measurement. Are there inputs to monitoring & measurement from all inspection & test points prior to shipping as well as "service & repair", "complaints" and "internal audits"?

Well, I read your input (thank you by the way), and decided my flow diagram was missing a lot. So I scrapped what I had and started over. I'm much happier with this one. I made it into a cross functional process flow. Each of the blocks becomes its own high level process. See what you think??

NOTE: 060209 - Attachment removed due to errors noted by author.

Will you also be compiling a document tree to accompany the process flow?

reginawags said:

Will you also be compiling a document tree to accompany the process flow?

Click to expand...

That's a good idea. I was going to include in each of the boxes which next level SOP was required to support that higher level governing process. Would that work?

That is a good way to start, you will find that there are many documents that support a system, so the highest level document, perhaps a policy, would be the one to reference. The policy should then reference the work instructions or other procedures that define the details of the system.