Measuring and monitoring equipment - Understanding which procedures to be compliant with ISO 13485

[bob44]

I'm starting off development of our QMS (we are pre-revenue medical device company) with trying to understand which procedures to be compliant with ISO 13485 are relevant to our situation.
My first thought is and sop related to "Measuring and monitoring equipment" would not be needed since we have a contract manufacturer for our product. Did I guess right?
If not, do I somehow have to refer to their procedures etc...?

 

[indubioush]

You must be able to show objective evidence that you, as the medical device manufacturer, meet the requirements for control of monitoring and measuring equipment. If your organization can control equipment without a separate procedure, you do not need one. You work with a contract manufacturer. How will you ensure they are compliant to the requirements for control of equipment? Minimally, the answer to this question needs to be in your quality manual.

 

[bob44]

So, interpolating the above, our system needs to somehow affirm that by some process we use, the CMO's processes related to Measuring and monitoring equipment are validated/appropriate somehow? Would that be a restatement of what they do (seems inefficient) or a reference to their SOP(s) and attachment of those in our SOP?

 

[indubioush]

It seems like you do not know what your process will be. Your documentation will reflect what you actually do and plan to do. How are you going to ensure your contract manufacturer follows the requirements of ISO 13485 for equipment? Will you audit them? Will you approve their documentation? Will you travel to their facility to perform equipment IQ? Once you figure out what you will actually do, you will document that process. If having a statement in the quality manual will suffice, that is fine. If you have a more elaborate process, you may want to have a separate document. Or if you just plan on auditing them, make sure you have a audit procedure that ensures you audit their equipment process when you visit them.

 

[yodon]

Good responses by @indubioush - just want to piggy-back a little. It's expected now that you execute a Quality Agreement with your CM. That can be the linkage between your Quality System.

Just as an aside, monitoring and measurement equipment isn't necessarily limited to the CM. Will you be doing any in-house testing (as part of design V&V or part of any acceptance procedures - using M/M equipment)? Will you receive returned product and do any analysis (that uses M/M equipment)? Think through the entire product lifecycle.

 

[Ronen E]

My friend has a bad tooth. I'm not a dentist, but I had a look and I think I know how to solve it. I also read quite a lot online so I think I know what's required and how to do it myself. How hard can it be?... I also found some tools in my shed and in my kitchen bottom drawer that I think are going yo be useful. And I have some pain killers I got from the local pharmacy a while ago.

Me and my friend know that it's best to go to the dentist, but that's so expensive. Hey, what's the big deal? I've got good hands and with a little bit of common sense and online reading anyone can do a filling. Right?

I only have one question - do you guys think I better use a tungsten file or a molybdenum alloy one? I found an online essay discussing the pros and cons for each, but it costs $9.99, and I'm trying to save. Why pay when you guys have such a wealth of knowledge?... Seems such a waste!

 

[bob44]

My density is too high to understand your post Ronen.