First Management Review!

[iimp24ii]

Hi Covers!

Our company is new to medical devices and is not yet ISO 13485 certified.

As such, I'm preparing to conduct our first Management Review!

Are there any tips you would suggest I keep in mind as we start this process?

We're a small company of about 40-50 employees and have been in the medical supply chain space for a long time.

Any insight would be helpful!
TIA!

 

[GStough]

Hi Covers!

Our company is new to medical devices and is not yet ISO 13485 certified.

As such, I'm preparing to conduct our first Management Review!

Are there any tips you would suggest I keep in mind as we start this process?

We're a small company of about 40-50 employees and have been in the medical supply chain space for a long time.

Any insight would be helpful!
TIA!

First thing I would suggest is to get a copy of ISO 13485 and read Clause 5.0, paying specific attention to 5.6. Make sure you cover each item as you prepare for your meeting. Also, decide how often MR will be held, if this hasn't already been done. Using visuals in your presentation will convey well, and also know your audience to understand which type of visual is most appealing to them. Best of luck!

 

[iimp24ii]

Thank you, GStough!

I've been consuming Leslie Worthington's quality communication content and find that it helps to always be mindful of my audience, purpose and message.

That's something I feel would benefit a lot of people who write, not just quality people.

 

[Golfman25]

Your first? Do you mean to suggest in all the years they have been in business, they never did a review what's going on? I guess my point is, it is more likely than not management already reviews things, just not necessarily the complete "checklist" indicated in the standard. My first preference would be to incorporate the QMS management review into already established reviews. Just make sure everything required by the standard is reviewed.

 

[Ed Panek]

Be cautious with setting realistic objectives. ISO 13485 is a strategic decision for a company. Its possible year 1 will be challenging just educating staff on behaviors. Hire an unbiased auditor to be frank about your implementation and respond to their feedback for the internal audit. You may want to perform a few internal audits.

 

[indubioush]

My advice is to include all required management review and data analysis topics specifically mentioned in the standard even if they are not applicable to the organization at this time. For example, if there are no complaints because your company does not yet have customers, add this information to management review rather than not mentioning complaints at all. It is also helpful to have a slides template will all required topics. It is super low hanging fruit for an auditor to go down the list and check for each item. You may have an unreasonable auditor who gives you a finding for not including complaints in management review.

 

[FRA 2 FDA]

I was going to say exactly what @indubioush said. In addition, to help myself and the rest of our team since we were all new at management review not that long ago, I added notes on many of the slides as to what kinds of things would go on each one. Some of the topics as listed seem a bit ambiguous and the meetings from before I took over were a mish-mash of stuff.

 

[Randy]

Are there any tips you would suggest I keep in mind as we start this process?

Very simple, don't try to be smarter than the 13485 requirements in the Standard and use the requirements as a checklist or format. Everything in it has to be included in the review even if there's nothing to review. Add anything else you want, but the minimum is already being spoon-fed to you.