Is It Possible to "Buy" a QMS?

In this episode of the Global Medical Device Podcast, Etienne Nichols engages with Sara Adams to discuss Quality Management Systems (QMS) in the medical device industry.

The discussion unveils the complexities and common misconceptions surrounding QMS, drawing an intriguing analogy between building a QMS and crafting sourdough bread. Sara shares her extensive experience with FDA inspections and audits, emphasizing the essential, tailored approach needed for effective quality management.

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Key Timestamps

• [02:15] - Sara recounts her experiences with FDA inspections.
• [05:30] - Etienne introduces the sponsor and the episode’s focus on QMS.
• [12:00] - Sara explains what a QMS is and is not, breaking down the layers of quality control.
• [19:45] - Discussion on the practical steps to build and customize a QMS.
• [34:10] - Sara’s sourdough analogy to illustrate the process of developing a robust QMS.
• [48:55] - Examples of how different QMS systems can meet specific regulatory requirements.
• [1:02:30] - Closing thoughts on keeping the patient in mind when building a QMS.

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Links:

• Follow Etienne on LinkedIn: Etienne Nichols

• Follow Sara on LinkedIn: Sara Adams

Memorable quotes:

• "You can't buy a QMS off the shelf; it's like trying to bake sourdough bread without understanding the process or the ingredients." – Sara Adams
• "The patient should be the focus of everything we do in the medical device industry." – Sara Adams

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Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsor:

This episode is brought to you by Cleio Medical Device Design. Discover how Cleio can transform your medical device concepts into market-ready products at www.cleio.com.

Transcript

Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. With me today is Sarah Adams, one of my favorite guests. And I'm glad that you're a recurring guest, Sarah. I told Sarah I wouldn't go into podcast mode, so we're going to just make this conversational, no podcast mode.

Sara Adams: I'm doing good. I'm doing good. Somehow Etienne surprises me and talks me into doing these things, and then we always end up having a good time and it ends up being fun.

Etienne Nichols: So, yeah, we always get good feedback on your, your episode, Sarah, you probably do my job better than I do.

Sara Adams: I disagree.

Etienne Nichols: So, the topic today, just so everybody knows who's out there waiting on pins and needles as she made me wait on pins and needles when we were talking about this, was quality management system, what is a QMS?

And people are probably thinking, what in the world? We know what a QMS is. Well, there's a miscommunication in the industry about what a QMS actually is. So, I saw a post on LinkedIn talking about how you can't buy a QMS off the shelf or an out of the box QMS.

And to a certain extent, I agree. But the disconnect I feel like we're getting in the industry is, what is a QMS? Is a QMS the words on the pages of your sops that describe your approach to quality?

If so, you can't buy that. But the other one is, is a QMS the place where you store your sops? And that place being tailored to FDA part 811, part eleven, maintains the traceability and maintains the change control requirements and so forth.

So, what is a QMS? And Sarah, who. I don't know anyone who's better suited to talk about quality management systems than Sarah, because she deals with hundreds of. Of different quality management systems and has I don't know how many hundreds of audits and inspections you've gone through.

So, Sarah, why don't you tell us what you think?

Sara Adams: It's definitely a lot of audits and inspections. I don't know the exact number on that. Well, first of all, you stole it. Because I define a QMS as a quality management system because that's what it is.

Right. And I think deeper than that, or deeper than, like, which one is it? Where does it land?

I think it's all those things. And I know that's kind of like a willy nilly, it depends on answer. But what I mean by that is it is the words on the page, and it is how you choose to interpret the regulation and what is applicable to you and what is not applicable to you. And it is also where you store that and how you make sure that your quality, and again, getting in the definitions, how you make sure you're meeting those regulations in procedural form and where you're housing those and how you are like a part of your process is how you're approving pieces of that quality management system. And so, I think it's all of those things, and they all kind of go together. Right.

Etienne Nichols: So, I disagreed with you yesterday when we were discussing this episode, and I think it's the way our brains.

I don't think it's a disagreement on the actual thing. So, like, when I look, what is a person? Is it. Is it their respiratory system? Is it their skeletal system?

Sara Adams: Oh, it's a whole thing.

Etienne Nichols: Right. I get that. It's all. But…so, you have an illustration that you wanted to use, so why don't we just dive into that? Because I think it's a good one.

Okay.

Sara Adams: I'm glad you think it's a good one.

Etienne Nichols: Before we get into it, part of the reason this matters to me is in the industry, there are people out there who are starting medical device companies. First, let's define the problem, right?

There’re people who have these medical device companies and they want to build a quality management system.

Sara Adams: And so, I'm going to interrupt you because I don't know that they all want to build a quality management system, but like, I hear that they want to do this the right way.

They want to get from the get-go, start things off and have.

Etienne Nichols: Right.

Sara Adams: Follow the rules, if you will.

Etienne Nichols: They recognize the necessity of building quality management system. So, they've recognized this necessity and they're starting down this road. And so, they're thinking, okay, do I purchase an eQMS? Do I borrow a friend of mine's SOP template who used to work at Medtronic?

Or do I just hire someone to do all this for me or what? What's the process? And some you can buy, some you have. You can't just get away with paying for everything. Okay, let's jump into your example, though.

Sara Adams: Yeah, I think like, and all I'm going to get the example. I'm glad you think it's a good example. I also expect like bazillions of comments and LinkedIn messages because I think people are either going to love this example or they're going to hate it. It's going to resonate or it's not going.

Etienne Nichols: That's fine.

Sara Adams: Yeah, but I, so again, like, I think there's this, I meet lots and lots of med device startup customers. I meet lots and lots of ones that are at post market. They have things on the market already.

Etienne Nichols: Right.

Sara Adams: I think by and large, for those who set out to, like, like you said, like they're going to do this the right way. There, they know that they need this. They recognize that they need to have a quality management system in place. There's some that think like, oh, easy, check the box. And I, it's not that easy.

Etienne Nichols: Right.

Sara Adams: And I think that's why the analogy is beautiful. So, I know it is 2024. So, for people who are listening to this, I realized that in 2020, the world shut down about this time, right?

And the world started diving into sourdough bread. I did not. I worked in manufacturing. I still went to work. I had two children at home who I was having to teach because schools were closed and our school continued.

They go to school, or we were the teachers at that point. They're young, but that's what we did. I had a kindergartner and so I missed the sourdough craze that said, I need a hobby.

And so, I had. We had dinner with a friend who is super into sourdough, and I just mentioned casually that I thought it would be fun to dive into sourdough. And so for about the last month, I have participated in this thing that the world participated in four years ago. Sorry I'm late to the party, but.

Etienne Nichols: You know, maybe that's. That's like a good metaphor for medical device companies. We tend to be a lot about.

Sara Adams: Four years late for the party. No joke. Or it takes us four years to put something in place, or, well, if we're talking QS…QMSR anyway, or longer. Anyway, the point here of what I'm saying is I was thinking about this podcast episode before we did it, and, like, what are we going to do?

Well, to be fair, I was turning out my sourdough bread so that it could sit in the oven. And like, oddly enough, my Internet went down upstairs. So, I've relocated to my kitchen.

You can kind of see my oven there. So, it's kind of funny that I'm sitting here with this example, but my friend gave me some sourdough starter. She literally imparted that to me at her house about a month ago.

Etienne Nichols: Wow.

Sara Adams: And so, I'm thinking about this in a QMS, from a QMS stand standpoint, or, you know, that from that standpoint, and I could have brought that, that QMS starter. That's literally what I just said out loud.

Sorry, I didn't. I could have brought that sourdough starter home and I could have just poured it in a loaf pan and put it in the oven. But anyone would tell you that's not how it works, right?

You don't get to just dump it in. Somebody else has done the work and I put it in the oven. So, if I'm likening this to a medical device context and a QMS context specifically, sometimes I may.

People, customers who have purchased templates from a consultant, from us, from their next-door neighbor who used to work at Medtronic. I don't know. I'm giving your example back to you.

At the event I meet them, and they have this expectation that, like, okay, yeah, here it is done. Sourdough starter, right? I can put this in the oven and it's good to go.

And that's not what happens, right? There's this piece of. Every device is uniquely different.

Just like, I can make sourdough bread, or I can make a loaf, or I can make cinnamon rolls or pizza dough.

Etienne Nichols: Right.

Sara Adams: With my starter, every device is different. And yes, there are a set of things that we need to do, but every company is potentially going to have exclusions, non-applications. I am. I have a friend, I live in Memphis, I have a friend who works in the baby space.

She's a creator in that space and she, as a medical device or wanted to go down this avenue, very low Class I. There's a specific part of the CFR for her.

Etienne Nichols: Right.

Sara Adams: And so, I mentioned that because her QMS, her procedures, her documents are not going to look the same as someone who's building the Class III. Man, this is the newest thing on the market. Nobody's ever done this before, right. There's going to be some exclusions that she's able to claim.

Going back to my sourdough, and I've like, sorry, Etienne, and I'm going to keep going until you interrupt me. But going back to my sourdough starter, I have to take that, and I have to feed it. And there's all these different methods on that. Etienne's not going to feed his sourdough the same way I'm going to feed my sourdough.

We are going to then take some of that and put in different ingredients. I made this joke when I was telling Etsy in this story, but I like coconut oil in some of my recipes.

I don't want to use vegetable oil. I'm trying to make this a little bit healthier. We use honey instead of sugar.

Etienne Nichols: Right.

Sara Adams: Things like that. I gave the example. Also, somebody's gluten free. They need to roll this out with gluten free flour instead of the other. You're getting your baking lesson today. You didn't know you were coming for that.

But my point with all of that is there's different ingredients that go into that starter or different ingredients that go into a template that you're going to use right, where you're going to custom make that for you.

Those are the. That's the work, right, of, like, I want to do this the right way. I'm just going to buy a template package; I'm going to put this in place and I'll be done right.

I'll just throw it in.

Etienne Nichols: Now.

Sara Adams: That gets to my…to my last point. I am going to then put that loaf of bread, cinnamon rolls, whatever I've made in the oven behind me. The oven is like my eQMS or my network drive or where I'm housing this QMS, right, or document storage, if I'm on paper and I've got to keep that forever.

My oven does different things. It does not suit unless someone can tell me and fill me in otherwise.

Etienne Nichols: Right.

Sara Adams: Like, it broils, it bakes. I don't know. It even proofs, I think. I don't use that button for my sourdough, but like all these different things that it does. Kind of liking likening that to your QMS where I'm going to take those procedures and I'm going to put them in a way in a place that is.

That follows regulations from that standpoint.

Etienne Nichols: Right.

Sara Adams: And I'm going to. I'm going to house it here, go here to approve things.

Etienne Nichols: So, some of the things that I might liken that too is your retention policy or can it hold it for two years? Was, is it going to meet the part eleven requirements? Signature, electronic signature and so forth.

Sara Adams: Yeah, I. When you said that this came to mind, I have someone that I was recently discussing their change order evaluation form. It's five pages long. And I said my answer back was why?

Like, like, why is it five pages long? If you're listening to this, I hope yours isn't five pages long. If it is, I have the same question for you, but again, that's like a great example.

Record retention is a great example of you're gonna custom build that to you. I can't. I don't.

Etienne Nichols: I'm gonna.

Sara Adams: When you say, Sarah, how long? How long should we store our documents? Or how long should our change order evaluation form be? My answer is always gonna be, it depends. And then I'm gonna follow it with, like, I know you don't love that answer, but it depends because what are we trying to solve?

Why are we doing this? Like, I know this is silly to put it in this example, but, like, for my product development friends, what's your user need? Why are you doing it this way?

Etienne Nichols: Right.

Sara Adams: You didn't have to do it that way. Or maybe you did have to do it that way because of the nature of the device that you're using. But I think, like this, there's a. There is a misconception that it is that all I have to do is have a document control procedure, and there's just lots of different ingredients that go into that. All I have to do is have a management.

Proceed. Management review procedure. There's a lot of different ingredients that go into that that are going to be custom fit to your organization and to the regulation so that you are meeting the intent of what it is requiring that you do in a way that works for your company.

If I had a dollar for every time I had to go in my previous company to the CEO and our operations and say, we could do this, this or this.

I like this because it's, like, going to be the most robust and you know what they heard, it's also going to be the most expensive. So, they would pick number three. And I don't. That wasn't every time. So, nobody, like, they did. We did a great job. I'm not saying that solution.

Etienne Nichols: Right?

Sara Adams: I'm saying you gave them choices, and they said, this is going to be the best one for us. And so, I think, like, where ums is get a bad rap is. Is twofold misconception. I think it's just going to be this throw. Throw the sourdough starter in the oven with no extra attention or care, or I'm going to, like, we have to have all these things, and it has to be a five page evaluation.

Etienne Nichols: I love that example. Really? Because, I mean, just to portray the metaphor a little bit.

Etienne Nichols: Yeah.

So, let's say you buy your oven. In my past, so I've. I've. I've slept outside, I've camped, you know, and I've cooked bacon over an open fire. I've never cooked it.

Sara Adams: There it is.

Etienne Nichols: It's beautiful.

Sara Adams: It's right behind that. Like, like, I didn't even plan to come downstairs and do this for my kitchen. So here we are.

Etienne Nichols: All right.

But if you kind of, like I said, torture that metaphor. I mean, maybe I buy that sourdough starter and I'm gonna go over an open campfire. I could probably make bread over an open campfire.

I could buy, except it depends on.

Sara Adams: If it's cold or hot outside.

Etienne Nichols: Right? Okay.

Sara Adams: Keep going.

Etienne Nichols: There's lots of things. And then you've got the. Just the standard oven, but then you know that. So, I was skiing and a friend of mine, his family owns a. It's like a $10 million condo in Beaver Creek.

And I'm one of the breakfast guys. So, there's like 13 guys. We go skiing and I'll make breakfast for everybody. I love that kitchen because there's a, there's an oven, you know, bigger than, you know, my wingspan, and you could cook all kinds of stuff in there. It's so fun. And, and to take that back to your illustration, you know, I've worked in paper, I've worked in SharePoint where we struggle with the part eleven side. I've worked in as high as agile oracle SAP and so forth.

And what does the medical device company need? You know, is that, that starter dough, you buy those templates and then you throw it in some oven where you think that's all you need to do.

But between buying the starter dough, buying the oven, there's a certain amount of work a medical device company has to do that's specific to that company.

Sara Adams: Yeah, I think, like, you know, so I've worked across the board, too, starting. I have one example where we started in paper, and we moved into an eQMS. And I think, like, they're trade-offs. Can you do paper?

Sure. It also comes with frustrations. It comes with coffee stains. I always give that example. Like, I was notorious for spilling coffee on my. On my document that I was supposed to be approving.

I can't tell you how many times I had to hunt down documents. Like, where is this? I gave it to Etienne, and he got some stoves. Etienne and I didn't work together, but.

Etienne Nichols: You know what I mean?

Sara Adams: Like. Like, if we had, we might not be doing this. You know, I put post it notes on documents to say, please, after you sign this return to Sarah Adams desk. Post it notes are like an expletive in a quality engineering world.

Etienne Nichols: Right.

Sara Adams: We don't use post it notes except when we're trying to hunt down documents. And so, do you have to have an eQMS? No. Like, do it on paper. I SharePoint. We can come back to that one.

Cause, you know, Etienne and I had some disagreements on this one yesterday, but then we go into, like, a part eleven compliance solution. Some of the ones that you named Greenlight, anything like that.

I think there's a trade-off for, like, efficiency.

Etienne Nichols: Right?

Sara Adams: Like, I can do paper. It's going to be cheaper. But is it? Because I got to pay for all the paper, and also, I can do electronic, and it's going to make it faster, but there's. There's going to be a cost associated with that, too. But at some point, there's a break even.

Etienne Nichols: Right. And.

Sara Adams: And, like, I've. I've told this story. We had about 40 people when I first started. We grew to, like, 400 people. And so there just comes a point where it's that oven. Like, what that oven is matters.

Etienne Nichols: Right?

Sara Adams: And so, if you need a bread process. Yeah, yeah. Like the campfire site or you need this one.

Etienne Nichols: Right.

Sara Adams: If I'm going to start making bread professionally, which I'm not. Don't start that rumor. But, like, I'm going to need more than this. Right. Going back to SharePoint, and I'll just touch on that briefly. I meet a lot of people who have been using SharePoint, and they show me their signatures, right? Like, I'm like, how are you approving that in SharePoint?

Well, we just sign off on it.

Etienne Nichols: Okay.

Sara Adams: What does that look like? Because you're spread out all over the country. And they will. I've seen everything. I've seen documents where people have a picture of their signature, and they drag and drop that into the document so that it shows. And I can get in a really big argument about; that's not part eleven compliant. That is not a signature. Asking me about the time that my floor operators decided they would print their batch record, sign their name for the day, for the portion they're doing, and then make photocopies of it because that was faster.

So, like, that just. Yeah, no big deal.

Etienne Nichols: What would be wrong with that in an auditor and inspection?

Sara Adams: Ooh, well, if you're sneaky. What I mean by that is if you only bring copies into the room, an auditor might not figure that out, right? That truth transparently. If I'm showing you a copy of a copy, they don't know that's not an original signature.

Unless you. Unless it looks like a picture, right? Like, unless it looks like that in the other. Like if I was asked to produce a record with your signature on it and all I can produce is a photocopy of your signature.

That's not a signature.

Etienne Nichols: Right.

Sara Adams: Like part of GMP. We are signing for the work we are doing. Your signature is saying, I agree with this. I did this. Whatever I'm signing off on is that work and has to do with, like, adulterated signatures.

I could sign somebody else's initials.

Etienne Nichols: Right?

Sara Adams: Or you're photocopying your initials kind of thing. So, like, going back to the SharePoint file.

Etienne Nichols: Well, one other thing there. So there. There’re three situations that we're thinking about when we're, when we're, when we're talking about adultery signatures or doing things the right way. There's. Can I get away with it?

There's always going to be those companies that say, can I slip this past an auditor? If you're in that camp, you're probably not listening to this podcast.

Sara Adams: But I was thinking about me.

Etienne Nichols: Let's assume you are. So, you slip past, and maybe you have, if you apply that same level of thinking to your product, there's a potential that you could have something bad on the market.

And if you do now you have the potential for a product liability case, which is different than failing an audit. So now for sure, those lawyers who are going to look at those signatures,

there’re some things there. So, there's not being a lawyer, but.

Sara Adams: Yeah, yeah. That are deeper than even just an audit from that respect.

Etienne Nichols: But I mean, throughout the third thing, because. Because all of these are very self centered. You know, I want to slip past an audit. Okay, so that's you worrying about yourself, trying to get.

Get something out there. You're worried about a product liability case. You're worried. Again, you're worried about your internal company. The third one is what we should be thinking about is, what if we have this kind of mentality?

Sara Adams: What's that?

Etienne Nichols: What? Yeah. The patient.

Sara Adams: The patient.

Etienne Nichols: Anyway, I didn't mean to interrupt you. Sorry.

Sara Adams: No, I interrupted you with the patient. I knew. I knew. That's what you're gonna say, right? Like I tell everybody, the patient is literally the person that you should be thinking about the entire time.

And if you have to put yourself, family, friend, loved one, whoever that is in that picture, then do it. Like, if you have to do that to do the right thing, then do it. I also. Etienne knows this. I'm super black and white. Things are color coded. I like order. I'm a very good quality engineer. If I just described you, and I think that, like, for me, there's a.

Etienne Nichols: Right.

Sara Adams: There's a reason that we do the right choice. We don't. We're not that first camp.

Etienne Nichols: Right.

Sara Adams: But at the same time, like, thinking about the patient and what those. What our choices, how I told somebody this the other day, we're not, like, we're not making oven mitts.

We're not making sourdough bread.

Etienne Nichols: Right.

Sara Adams: We're making things that affect people's life in a good way or a bad way, if we don't do. If we don't do the right thing.

Etienne Nichols: Yeah.

Sara Adams: I was going to say back on the signature note, just to add to that, I did have an. I had eight FDA inspections in my time period, and that was. That makes it sound bad.

It was not. We were contract manufacturers, so we had lots of different reasons that the FDA would show up, and we also had different branches of the FDA that would show up.

And so, one time, an inspector showed up and asked for every investigator.

Etienne Nichols: I guess we're supposed to call investigator. Sorry, go ahead.

Sara Adams: I don't know what we're supposed to call them anymore anyway, but she showed up and she asked for every record we had ever processed for a specific product.

We had to. We had to call the. I won't say their name, like. But the supplier who stored all the records that we used. Right. And have pallets delivered. And I know this is crazy, but she did go through many of them.

We also had another inspector that looked through every. She was going to stay until every record was looked through. Investigator, whatever the right word is for every record. And so, in that case, like, she didn't want to see copies.

We had to bring in real, real records.

Etienne Nichols: Life. And.

Sara Adams: Yeah, I just think that could put you in a. In a really bad place. I know we're talking deeper than that, but initially, in a really bad place with an auditor.

Etienne Nichols: Well, you know, we're talking about. Sometimes I talk to people who are on paper, and like you said, maybe they can pull off that campfire approach for a while.

As a mechanical engineer, you know, I was just on the cusp of having to learn to use a drafting board. I did learn a little bit. So, I. If I really try hard, I can have good handwriting with the block letters and so forth, but.

And I have used handwritten drawings and mocked up some different things. I. Wow, it's been a long time. But I also learned SolidWorks. And I tell you, those old school engineers, they were awesome the way they could handle paper and, you know, the. The massive drawings. But no engineer worth his salt today is going to go back that I know of.

Sara Adams: I I will echo that. So, I thought you were going to go somewhere different. We'll have that on a different podcast about mechanical engineers. Etienne knows this, but my husband is as a mechanical engineer, and so it's always funny to me.

I have a biomedical engineering degree, and we. I would say this about biomedical. We learn just enough in all the different areas. So, what I mean by that is, like, we did SolidWorks for a minute, and we did. I actually took a drafting course as an elective because my mom has a civil. Civil engineering degree, and I thought that sounded fun. And so, I did the block letters and all that stuff, too, but it was just, like, dabble.

Like, just enough to, like, get your hands wet, and then you could appreciate the finer things and other things in life, too. But, yeah, I think that's a great example of kind of like, you understand. I don't know. I'm going back to the example, to Etienne, and this may be over some people's. Like, people may not feel this the way I do, but it's almost like that example of, like, the calculus teacher made you do learn how to get the derivative the very, very long way.

And then I was. I remember being so angry when I went back in, a senior in high school, and the next day, she showed me, like, yeah, x squared. You just moved the two down in front.

It's two x. And it was like, what? You made me do all this other stuff. I think, like, that feels like paper versus an eQMS to me, right? Like, of, like, yeah, sure.

You can sit there and prove the limit.

Etienne Nichols: I don't know.

Sara Adams: I'm going way deep, and this is probably the first time I've used calculus in a very long time. But, like, that example sticks out for it as well.

Etienne Nichols: Yes, absolutely.

Oh, man. No, that's really good. Okay, so we've. We've got the. I hope this makes sense. I hope this helps people, because to your point, let's go back to the original. Can you buy original question out of the box.

Sara Adams: I don't remember what I told you yesterday. No. Yes. No. It depends. You can buy an oven, but you cannot buy.

You cannot buy a finished set of procedures without input from your company. And maybe that's a consultant who can help you, but they're still asking you questions about your company so that you can meet the regulations that you're required to meet.

How would you say that?

Etienne Nichols: I think you're right. I think there are portions that you can buy if you look at a QMS.

Sara Adams: Yeah, for sure.

Etienne Nichols: Let's say a cutting edge, MedTech specific QMS that's up to date, state of the art, using that state of the art term, not meaning. Not meaning the absolute newest thing out there, but state of the art, the standard, what you would expect from a medical device company.

There are portions that you might not be able to. That you. That you won't be able to buy, but there are portions you can. So, like you said, the oven, but you're going to have to put that input in. What's the temperature?

How long do you want it to bake? All those.

Sara Adams: The ingredient that would be.

Etienne Nichols: Who needs to approve your design and design, controls, documentation, the planning and so forth. Yeah.

Sara Adams: And I think, like, there are, like, green light is. Is custom built for the med device space. And so, there are things we refer to them as. Customers refer to them as guardrails.

Like, I'm. I'm gonna. I need this because the standard says I need that. So, some of that is prebuilt into the eQMS. Like, that's not prebuilt into a SharePoint file.

Etienne Nichols: Right.

Sara Adams: Can you still do it there? Yes, but it's not going to be those specific guardrails.

Etienne Nichols: I can't tell you how many times when I was. You know, there are different places whether it's looking at working with a company to see how they're handling things. Like, okay, is this the most current revision?

Well, let me see. You know. And it's a little bit of dragging. I do like. I love that about Greenlight Guru, how you have the revision. You have the. The current, the. The newer. The man, I'm messing up the terminology, but superseded and so on.

Sara Adams: I'm going to add to. In our paper-based system, we had. I always joke with it with. With customers that come in that are paper based. And I asked them; do you have blue books on the floor?

Some of them look like I'm crazy. And then some of them are like, yes. Like, really? Wow. I thought that was just us anyway. But the point being, like, you've got to get.

If you're in a manufacturing space, you've got to get those procedures to the people, even if they're on the SharePoint file. And so, we would print those four versions and put them in the works, work cells, if you will, and then they use those to get their actual batch records,

work instructions, whatever they were looking at in inspections, in notified body audits, and all of those things. The easiest finding for an auditor was to go check those books. Give me a master list with all the versions.

Give me your blue book. That's what we called them, right. And let me. Let me find one. I'm a flip till I find one, right? Because people are people. And I think what you're trying to say is Greenlight provide, that's one of the values of an EQ mess.

Or, like, greenlight, where you can't, like, you're preventing that version, that superseded version of getting to the wrong place by controlling permissions by Greenlight is doing that for you. And that.

That comes directly from the standard.

Etienne Nichols: Right.

Sara Adams: That's like, prevent.

I lost it when I came to the kitchen. It was right next to me upstairs. But prevent the misuse of those documents. That's a piece of that. Making sure you've got the right versions accessible.

Etienne Nichols: Yeah. And I love that you brought out how green light grew is specific to the MedTech industry. I don't know if we're the only ones built specific for med tech anymore.

We're certainly. I would say we were.

Sara Adams: I don't. Yeah.

Etienne Nichols: And the only for a long time. I should probably know this, but. But anyway. Yeah. Built on ISO 1345 and part 820. Of course, there's that harmonization.

Sara Adams: I was going to say that.

Etienne Nichols: February. February. What is it? February 2026.

Sara Adams: 2026. And also, I was thinking about this, too. I. Some of my customers know this because they've heard me laugh about it. I can't say it at the end. I do not know why these people named it.

The QMS are. That does not roll off my tongue. I can. You know how, like, ISO 1345, we flippantly say that. It's really funny to me when somebody says ISO 134, like. Like, I don't know, you just have the way that you say it.

Etienne Nichols: Right.

Sara Adams: And so, for this, I just. The QMSR is for me to say why we didn't call it. I think it's because it was the QSR. So why is it not the QMSR? Somebody's probably going to send me a message about that. I'll just accept it.

Etienne Nichols: Yeah. And I want to. I'm going to hear whatever messages you get that QSR. I mean, I even hear people say, oh, QSR isn't the quality system regulation, it's the quality system record, you know, whatever.

But, uh, yeah, yeah.

Sara Adams: Anyway, it's there. I'm going to get there, QMSR. If I can just say QMS, which also is the subject of this entire podcast that we've been talking about, and then add an r to the end of it.

That's how I'm writing my mind.

Etienne Nichols: Maybe it's the QMS that's been pirated from 1345 and pirates like the word are. I don't know. Okay, we should probably stop there. Thank you so much. This has been really.

Sara Adams: Of course, for me personally, they're always fun. I always get fearful they're not going to be, and then they're always like, that was fun. Let's do it again.

Etienne Nichols: Yeah. So those of you been listening, you've been listening to the global medical Device podcast. We hope this has been helpful in some way. Definitely flood Sarah's inbox on LinkedIn.

Sara Adams: No, please don't.

Etienne Nichols: Sarah, any last pieces of advice? Because I know you work with a lot of companies, and you see a lot of things any less. Pieces of advice for the audience today?

Sara Adams: What resonates is the last piece is to keep the patient in mind. Mind that the decisions that you make affect something bigger than yourself and bigger than an auditor and bigger than an inspector.

And I don't think anyone wants to put just the sourdough starter alone in the oven.

Etienne Nichols: Right.

Sara Adams: That's not going to come out with a quality product that any user, I'm going to say my kids or whoever, enjoys deeper than that, we're not making sourdough or making medical devices that are lifesaving and impact the quality, the value of life.

Etienne Nichols: And.

Sara Adams: And we need to resonate. We need to think about the patient as we build out and think about the why behind why, why we're building out these quality management systems.

Etienne Nichols: At some point, we'll have to talk about mechanical engineers versus biomedical. We won't unpack that today. We'll need your husband on the episode.

Sara Adams: He will not come.

Etienne Nichols: All right. We'll let you get back to it. Thank you so much for listening, and we will see you all next time. Take care.

Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Just look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening, and we'll see you next time.

About the Global Medical Device Podcast:

The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

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