We Achieved ISO Certification! Now what?

November 16, 2022

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What are ISO 9001 and ISO 27001? Once you have them, what can you do with them? These are the questions you’ll hear Mark Alpert answer in today’s episode.

Mark Alpert is the Director of Quality at Greenlight Guru and has a background working for a Notified Body, and was most recently the Vice President of Business Assurance Division for TUV SUD America.

Listen to the episode to hear what Mark has to say about how he uses a quality system as a competitive advantage, what companies should be doing after they achieve certification, and how a quality system connects to the business strategy of the company.

Listen now:

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Some of the highlights of today’s show include:

  • What ISO 9001 and ISO 27001 are and what they’re needed for

  • The challenges of going through the ISO processes

  • What happens when a company achieves certification

  • The disconnect between business strategy and quality management

  • How to overlap systems or create strategic alignment

  • What to include or not include in an audit

  • How having a quality management system drives continuous improvement

  • Pitfalls that companies get to once they get the certification

  • Advice for other companies going through this process


Mark Alpert LinkedIn

Etienne Nichols LinkedIn

Etienne Nichols Email

Greenlight Guru Academy

Greenlight Guru

Memorable quotes from Mark Alpert:

“What drew me to Greenlight was the fact that we weren’t certified.”

“Achieving (ISO) certification is not the destination. It’s the beginning.”

“It’s quality management, but it’s business management.”

“If you’re looking at your processes and you think everything’s under control, create the gap.”


Announcer: Welcome to the Global Medical Device Podcast, 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.

Etienne Nichols: Hey everyone, welcome back to the podcast. My name is Etienne Nichols and I'm the host of today's episode. In today's episode, I got to speak with Mark Alpert on the topic of ISO certifications and what the journey looks like after achieving ISO certification. And the background from this is, he just received ISO 9001 and ISO 27001 certifications, so we wanted to talk about that. What's the next steps? Mark Alpert is the director of quality at Greenlight Guru, and he has a background working for a notified body, most recently the Vice President of the Business Assurance Division for the TUV SUD America. We covered a lot of ground. We talked about things like how the best companies are using their quality system as a competitive advantage and the difference between ISO 1345 and ISO 9001 certification and the steps companies should be making and taking immediately after achieving that certification and much more. So without further ado, please enjoy this episode with Mark Alpert on achieving ISO certification. Hey everyone, welcome back. This is Etienne Nichols, the host of today's episode. Today with me is Mark Alpert. Mark and I, we get to work together every now and then. It's always a treat. We have like TGI... It's not TGIF, it's TGIM. We're always thankful that Mark is on the team, on the Guru side. So Mark is the director of quality here at Greenlight Guru and we've just achieved some major milestones at Greenlight Guru and I want to talk about why that is it's going to be applicable to you as a medical device company, but we're going to take a little bit of a circuitous route. But first of all, Mark, glad you're on the podcast. How are you doing today?

Mark Alpert: I'm great, Etienne, thanks so much for having me. I'm excited about this great topic to share with our listeners.

Etienne Nichols: Yeah, I mentioned the milestones. I didn't say what they were, but we have achieved ISO 9001 and ISO 27001. I don't know if you want to talk about maybe a little bit about what those are and why do we even need those? What led to this point?

Mark Alpert: Yeah, I'd be happy to. So ISO 9001 for those who don't know, as a version of ISO 1345. So all of our customers who manufacture, produce medical devices or the medical device industry needs to comply with the requirements of 13485. Very specific to the medical device industry, we're a software development company. Although all our customers think we're a medical device manufacturer, we're not. It's just all our customers happen to be medical device companies, but we don't fall within the scope of 1345. We're a software development. We develop SAS products. And so we fall into the scope more of ISO 9001, which defines the more of the general requirements for a quality management system. And so very horizontal standard 9001 could be applied to so many different industry segments and so many different kinds of companies, where 1345 is really more vertical and addresses specifically our customers and the medical device industry. I sold 27001 just to throw that in because it may be less familiar to our audience. That's the criteria of the requirements that are defined for an information security management system. So it's ISO 9001 as a foundation, plus the additional requirements for companies who need to protect data or have data that want to maintain the integrity, the security, and the availability of that data. And of course for our customers who are utilizing our platform for really a lot of their IP and a lot of their critical information, their design history files, their internal processes, employee, maybe customer, maybe supplier information, they want to know their data's safe and they want to know it's accessible and we're doing all we can do and so not to protect that data for them and so that was why we decided to pursue ISO 27001 along with our QMS.

Etienne Nichols: So essentially our customers should have a lot more, well hopefully they already had some faith in us, but this is just that next level.

Mark Alpert: It's exactly right. It's making sure that we're doing the right things in terms of data security. And so most companies will maybe pursue them individually. We took it because we had the luxury of starting from scratch. So we took a more integrated approach and we created one comprehensive management system that complies with both 9001 and 27001, all in one fell swoop. Had our certification body in and went through the pain of our certification audit and came out the other end successful. But it makes for a more comprehensive approach to help meet our customers needs.

Etienne Nichols: So you come from a notified body background. So I'm curious, I don't know that I want you to necessarily air Greenlight Guru's dirty laundry, but what was, I don't know, the good, the bad, the ugly as you went through that process. What were some of the challenges and some of the things that you thought were pretty impressive?

Mark Alpert: Yeah, so fine line between what those things were that I perceived as a challenge and what was impressive. I think like most companies, what drew me to Greenlight was the fact that they weren't certified. So two pieces, one, now here's a company in the quality management system space. Our product is a platform that helps customers comply with these requirements, yet not necessarily implemented internally. And so as a young company being so focused on designing with new features and supporting our customers and getting new customers and supporting their implementation, kind of the whole internal operations, nobody was really focused on that until the company got to a certain size, until our customer base grew to the point where they started asking some questions about, " Hey, how are you controlling your processes internally? What assurance can you provide me that there's reliability and repeatability and you're addressing defects within your system?" It was like, " Oh, well it's time for us to drink from the same bucket, or drink the same champagne that our customers are." And what drew me here was the fact that I had the opportunity to start from scratch. And so with so many companies that have a QMS in place, and if there's issues to address, it's a construction project and you start with the demolition and tear it all down where that wasn't going to happen here. And so I perceived it as a luxury to be able to start from scratch and work with a whole bunch of people who come from the industry and whose product it is, is to address these very issues. And so luxury and one of the big challenges that I maybe overestimated about how much expertise around quality management there was internally, certainly within customer success team, the gurus and some of the sales folks. But when you talk about development and engineering and even some of the executive levels are senior management, they're good at SaaS, they're good at software development, they're good at the software industry, not necessarily the medical industry and not necessarily making that connection like, " Oh, maybe we should be our own customer." And" Oh, maybe this would benefit us." And so there were some challenges along the way and some of those typical conversations that every director of quality has within their own organization to talk to folks within the different functions. They're asking, " Hey, what's in it for me? Why do I want to participate? Well, why do we want to use this as a tool?" And so I had those discussions inside a company that sells this stuff and that was interesting. And of course everybody was quick to climb on board because I just had to make that point. And so why aren't we reaping the same benefits that we're telling our customers they will enjoy through the use of our platform. And so I had a nice internal sales that I could use, so to speak, to help drive it. And the other nice part was that the processes, and I think a lot of our customers, unless they're real startup, run into the same thing that the processes are in place to a certain degree and maybe most times just not formalized, but quality management is not rocket science. And it's like companies just start to develop good manufacturing practices or good lab practices or good software development practices. And so they might be a little bit inconsistent, they might be a little bit hit or miss, some more formal, some less formal, but they're there. And so to my surprise, or maybe not to my surprise, maybe to my enjoyment or my, I guess it's the right word, that there were more there than I thought once I started digging into it. And really I came in and I conducted a gap analysis to, so what do we have? How far away are we? How big are these gaps? And there was more there. And so now you begin the process of formalizing that stuff. Why do we have to do this four different ways? How about we pick a way, take the best of each of them, and let's come to consensus on a process. And there you go. Now you're in a full- fledged into the whole activity behind implementing a quality management system.

Etienne Nichols: So I almost made the, maybe I did make the mistake earlier in our conversation when I said, " Okay, we made it. Now what's the difference?" But that's not really the case. You don't just make it once you achieve that certification. Now what? Now that we've achieved ISO certification, and maybe we can talk about in the context of Greenlight Guru, but also in the context of those companies who are ISO 1345, maybe the different overlapping bridge concepts. What happens once you achieve certification? Are you there or is there more work to do?

Mark Alpert: Yeah, no, no. Tens more work to do. And every one of our customers face this. And so it's very applicable to whether it's 9001, 27001 or 1345 or other industries if you're in the aerospace or the automotive or whatever, absolutely applicable to them as well. And yeah, achieving certification is not the destination, it's the beginning. It's like our customers who need to comply with the requirements of a standard in order to market their products around the world, both management systems and product related. I don't want to say you check those boxes, but you demonstrate compliance and it puts you in a position to be able to fix the appropriate marketing to your product or prove that there's systems in places to sort of control and to govern the work that goes on a day to day basis. So same with us. That to me, that's a project. Being able to comply with the requirements of the standard or again, product or process gets you to the starting line, it draws the toe in the sand. And if you're building a house, where do you start with? The foundation, right. You build the foundation, now you've got something to put the walls and the ceiling and everything else on, that's certification. It's putting that foundation in place. And armed with that foundation now you build other initiatives, now you build processes to drive continuous improvement, now you mature the systems. And typically what happens, and I'm sure with all of our customers as well, there's a business strategy. The leaders of the business set a strategic direction. They define the goals for the business and that exists up there. And then that somewhere along the line it's like, " Hey, we need certification, for whatever reason, marketing reasons, customer reasons, regulatory reasons, let's go get that." And it's treated as a compliance issue. So there is this foundation that I just described, all these informal processes that are going on with the organization. You do a gap analysis to determine the compliance between what you're doing and the requirements of a standard. You address those gaps, close those gaps, and you pursue certification. But it's not necessarily in line with that corporate strategy. And so by maturing the system, bringing the alignment between that management system that has just been implemented and the corporate strategy and ensuring that there's complete alignment between the two. And that provides a ton of energy, a ton of leverage, a ton of all sorts of things that the company that can enjoy or utilize in terms of now addressing market needs and customer needs and on and on and on. So that certification is just the beginning. And then the fun really begins.

Etienne Nichols: Can you give me an example of that disconnect between maybe that business strategy and the quality management system that you're talking about? I'm just trying to wrap my head around that a little bit.

Mark Alpert: Yeah, sure. So from a strategic perspective to be, well our strategy to be the number one EQMS provider in the world, it's our vision. Okay. So how does that translate down through the organization? How does that create the alignment between that business goal, so to speak, and the work that's going on day in and day out down on the floor, so to speak. And it's really the quality management system that could be utilized to create that alignment. So how does that vision or that mission translate into some strategies? Let me back up just a sec. How does that vision or that mission translate into something that's measurable? How do you develop a strategy to implement in order to achieve those targets or those goals or those measures? How does that strategy then translate into some specific actions that folks throughout the entire organization are doing sort of on a day to day basis? So the actions that we're doing on a day to day basis and not in lieu of, in support of, executing on a strategy to meet some targets, to move the organization towards its stated goals, missions, visions, whatever it is. So in an immature organization, so one of the characteristics of high performing organizations is that alignment is really being able to demonstrate the alignment between a business goal, it's measurement, how it's translated across the organization at different functional levels, how strategies are developed, and then executed, deployed, and then measured. The sure fire sign of an immature organization is the lack, as the opposite is having, okay, so we achieved all these, we put all this stuff in place and we achieved certification. How does that help provide leverage to move the organization towards its stated goals and missions? And for more immature organizations, that connection hasn't been made yet. And that's one of the things, immaturing the system. Does that make sense?

Etienne Nichols: It does. So my mind's going a little bit of a horizontal direction. So I hear what you're saying about the strategy, connecting that, maybe driving it down the commander's intent to the boots on the ground, if I was to speak in the layman's terms. But then there's another aspect of, if I just zoom out and look at the entire business, you have your quality management system, we typically apply that to the regulations for, well, going back to ISO 1345, because it's what I'm most comfortable with, but as it pertains to the development of that medical device, what about the other aspects of the business? I know finance, they have their certain type of auditing, they probably have their own SOPs documents and so forth. What's your approach or thought on overlapping those systems? Is it one system or is that another one of those areas of strategic alignment that you're talking about?

Mark Alpert: Yeah, it's absolutely one of those areas of strategic alignment because if the mission or the vision is to be the number one EQMS provider in the world for our purposes, to be-

Etienne Nichols: The med tech lifecycle.

Mark Alpert: Lifecycle platform. So basically just saying quality, then all of the functions that have a role in helping us to achieve that target are part of the system. And so quality people have done it to themselves. And the standards are perfect example, because the term qualities in the title. It's quality management, but it's business management. There's aspects of the standard 9000, 1345, 27001, all of them that affect all aspects of the business. It's looking at your business like the value stream of the entire business and the inputs and the outputs of each of the functions that start with the marketing and creating the branding and creating awareness and having that translate into orders and activity now internally to provide product to meet those orders and those customers needs all the way to the after sale servicing is all part of the management system. And so while different functions might use different tools, and so from finance, there's plenty of regulatory requirements and finance and they have their tools, marketing folks have their tools, sales folks have their tools, engineers have their tools. All those tools in total just make up portions of the management system. And so that management system should take all those function areas into account. We have SOPs for finance, we have SOPs for sales, we have SOPs for marketing. And the more traditional areas that you're thinking about in terms of product development, engineering, all that kind of quality itself, all that stuff, they're all, if there's a function in this company that has to do with meeting our mission and our vision, they're part of the management system.

Etienne Nichols: So I think I'm 95% behind what you're saying. I want you to resolve the 5% for me. So there's-

Mark Alpert: Give it a try.

Etienne Nichols: There's a nagging question in my mind that says, okay, philosophically I agree with what you're saying, but at some point the FDA may come audit me and I would like to leave as much out of my QMS or my auditable system, for lack of a better word, what they're going to look at, what they're going to inspect as possible just to protect myself. How do you answer that question or what does that look like when you talk about including or not including something?

Mark Alpert: Yeah, so peace, I hear you. And I'll agree with 2. 5% Of that. So yeah, clearly this isn't going to come out, but the less you serve up during a regulatory audit, almost the better in trying to keep things focused. But on the other hand, when we had our certification audit sales was included, sales was actually a half day conversation with our certification body and customer success was included.

Etienne Nichols: No kidding.

Mark Alpert: And marketing was included. So if it does get reeled in because they're auditing and they're pulling on the string and they're seeing where it goes, and it's like, " Oh, so it's your sales team that's responsible for the contract review to ensure that you have the capability and the capacity to be able to deliver what you're advertising on your website or in your marketing materials. Why don't we talk to sales and let's understand how they're part of this process and what value or whatever the question is that they're bringing to this process better." Better those policies or those procedures or those work instructions, those forms are in place, they understand their roles, they can talk to them and they can demonstrate the good work that they do as part of the system that is delivering defect free software in our case. Does that make sense? Or-

Etienne Nichols: It does. It does. And so I guess, I don't know if it's Phil Crosby who said this, but one of those quality gurus, someone said quality is everyone's job. But that's essentially what you're saying. If you want to deliver a quality product, it takes the entire company. Let me take a step back though. And the philosophy that you're telling me and that the 2. 5% in my mind didn't like at first was, or maybe this is the 2.5% is arguing with is, maybe I tended to look at that quality management systems like we're just meeting regulatory requirement. But the way you're approaching it is this is a business management system that helps our entire business run smoother and more efficiently. Is that accurate?

Mark Alpert: Yeah, that is. You just hit the nail right on the head. And as it relates to the comment that we made earlier, that compliance piece, the project aspect of complying, all right, we're in compliance. We comply and we're going to continue to comply now until we create a new product or there's changes or updates or revisions to the existing products, then we have to make sure, okay, we are making our product wireless now. Okay, let's make sure we comply with all the requirements for wireless. So now what? Now that we comply, we've been able to demonstrate that compliance, do things stop? No. So now it's about driving improvement across the entire organization, the entire organization, and all of the functional areas that have a hand in helping to create, well certainly position us as the number one provider in the world. And so particularly on an ongoing basis. So once we've achieved compliance, boom, toe drawn in the sand, we're there, we've got the foundation. Now how are we building cycles of improvement on top of that foundation? And why are we just going to focus on the aspects that fall, are more the traditional compliant that we're thinking of right now? Why not include the entire organization? And now, because it's not for regulatory requirements, it's for our own, hey, we have the goal to be number one. And in order to be number one, we need to be able to develop some disciplines around continuous improvement and how to set some new targets and how do not to view those targets as brick wall, but to view those targets as something that we want to create in a way that we achieve that target. And then good, you made a target now, boom, create the next target, achieve that target now create the next target. And that's continuous improvement. And that's sort of a characteristic between the good companies and the great companies, the top performing companies that woven into the fabric of how they work every day, that eye on continuous improvement and looking for those opportunities to be more accurate, more effective, more efficient, less cost, whatever the case may be. And to see trends going in the right direction. Well, either way, I guess whether the trend could be going, that goodness could be in either direction, but it's definitely, there's a discipline there. And to your point, it's not like culture, it's not just the responsibility of the president of the organization or the CEO of the organization, weaving quality into how we work every day is not the role of the quality department. It's got to be everybody's responsibility and how we view our work and how we're open to the think about work in new ways and look for opportunities to help drive improvement. And why limit that to a couple of key or a couple of, I don't know if key is the right word, but the, what's the right word? The most-

Etienne Nichols: Obvious or-

Mark Alpert: Yeah, the obvious. Thanks. Yeah, the most obvious functions. Everybody can participate in that, so include everybody.

Etienne Nichols: Yeah, no, that's a good point. Okay. So one of the things you mentioned though there was about the continuous improvement. And I think when you're in quality, you equate quality with continuous improvement when you're living and breathing it. But from maybe someone from just a step away from that, what does it look like as far as the quality management system actually driving that continuous improvement? Do you have some examples of how that actually happens? How having a quality management system or robust one drives that continuous improvement?

Mark Alpert: Yeah, sure. As part of the quality system and as part of, let's say the compliance phase, you put processes in place. Those processes are kicking out data, it's inherent in the process and what we identified is the quality metrics. What are the metrics to you as a functional manager, as a supervisor of a certain function that allows you to know whether or not the process is effective? So now we're kicking out all this data and actually to our sign of immature processes versus mature process, most companies are collecting a lot of data that they're not using for decision making or for the purpose of determining how well something's functioning, which is inefficiency, right? It's costing time, it's costing money. Get that drive that out of the system and stop collecting that data. So that data that you're collecting, that you're utilizing to make decisions about the adequacy or the performance of your processes, are they adequate? From a quality management system then going forward, it's about expanding that and not better defining the metrics. The metrics are the metrics, but finding better ways to collect the data and finding better ways to identify gaps. You're looking for gaps in performance. So the metrics are telling you the data that you're collecting, you're viewing on a trend basis, for example, it's telling you, here's our non- conformances, or here's our inventory turns, or here's the aging of our CAPAs, or whatever the case may be. Here's our time it takes to respond to a customer complaint or our customer satisfaction data. So that's good. We've got the baseline. What is it we aspire to be? What is it we want to create? And it's almost sometimes better or more, it produces better results to begin with the end and understand. So start with a clean slate. What is it we want to create? What do we want to be thought of in the industry? What is our performance levels? What is the risk we're willing to assume, ask these good questions. And then based on what it is we aspire to be or where we aspire to get to, okay, now take a look at current reality and be brutally honest about the as is state and how are we currently performing. All right, so if this is what we want to create and this is where we want to be, and zero defect really means zero defect for us, where are we? Is it two defects? Is it 102 or 1002? So now we know where we are and where we want to be, and we've now recognized that gap and it becomes, then it's just a simple matter of, okay, what does it take to close that gap? Creating the action planning, assigning the responsibilities, putting the resources in place, making investments if necessary in order to close that gap.

Etienne Nichols: So when you see that kind of gap, so we know where we want to be, we know where we are, we see a considerable gap, I guess in my mind that almost looks like the preventative part of a Kappa, but what do you see as far as handling that maybe on a tactical level? We kind of talked about the strategy, but how does that happen?

Mark Alpert: Yeah, so you're exactly right. It's more closely kind to the preventative of the CAPA. The difference is the preventative part is really based on, what most happens to most companies comes the CA part. So something happened, there was an event and there was another event and there was another event and there was another event and we've fixed it five times. And how many companies stopped to go, okay, does anybody realize we fixed this five times last quarter? What is it within the system, what is it within the process that's causing this variation? And why isn't our process capable enough to produce accurate parts or whatever it is? So, okay, now let's look at the process and that becomes the preventative part. Let's take action at a higher level on the process to improve the capability of the process to stop fixing, fixing, fixing, fixing. And even better, more mature companies, it doesn't start with the CA. It starts with the idea of what is we want to create. There's always going to be fires, there's always going to be things to fix. And top performing companies are not in the fix it business. They look at what it is we want to create and focus the resources on creating something that is better, more accurate, more efficient, more achievable. And then all those little fires and all those fixes go away because we've created something more capable, a more efficient, a more effective process that all those fires and all those fixes just went by the wayside now and we don't bother with or they don't happen anymore. We've driven those out of our system.

Etienne Nichols: Well this has blown my mind a little bit because when you think about the numbers of, you know CAPA's a big deal as far as the number of companies that aren't doing it right, and preventive is not something you hear a lot. In fact, if you go to the FDA numbers, I feel like it might even be an order of magnitude less of preventative CAPA's that than the CA part. And if I go upstream of that, I think you hit the nail in the head as far as why. So you're looking at the best practices where you know where you are, you know where you want to be. I think a lot of companies look at this is where we are, we have three or four defects per 1000. We don't want to get any worse than that. That's really what it is. And they're waiting for it to get worse so they can do the CA part, whereas you're saying skip to the prevented part, almost let your QMS drive you forward.

Mark Alpert: And if three or four parts per million or per 1000, whatever it is, if that's good enough, that's for you right now and that's the risk in your investment. Because when you go from three or four down to two, now you're talking, that's some investment that's going to be required and making things more comprehensive. But in those cases where you don't perceive a gap, there's two ways to create a gap. It's either based on the data is suggesting it, we're not performing where we want to be, or there's a strategic way to create the gap, which is create the gap. Strategically say, " Hey, we mean zero defect, we mean we want to be number one in the industry. We mean something that from a strategic perspective just creates the gap that needs to be addressed." So if you're looking at your processes and you think everything's under control, create the gap.

Etienne Nichols: Nobody's perfect.

Mark Alpert: Oh actually it's very interesting you brought that up. You probably noticed there was a white paper that went out today from Nick that was, " Does your CAPA program need a CAPA? And that's where most companies are. It's fix it and fix it and fix it and fix it. And that's the tip of the iceberg. It's the part we can see. It's the part we react to. As opposed to all the rest of the iceberg that's under the water that you can't see. And that's the trick, right? Diving down below the surface of the water to say, " What the heck is going on with the process? Let's stop fixing it. It's taking time, it's taking money. What within the process is causing that variation? And let's take corrective action at the process level, improve the process, make it more capable, and we stop to fix it, fix it, fix it, fix it."

Etienne Nichols: That's so cool. So I want to go back and flip the question on its head a little bit. So we talked about once you get to ISO, whether it's 9001, 1345, either one of those, depending on the applicability, some of the best practices, what you do forward, that's your line in the sand, this is how you should move forward. With your experience, have you seen companies get to that point? And then there are expected pitfalls that a lot of companies seem to get into. A lot of companies you just know once they get there they may slack off in XYZ area. But what were your thoughts?

Mark Alpert: Yeah, there are definitely some pitfalls that you see. And so to me, I guess that maturity aspect of the systems. If you're abiding by the quality management system and the continuous improvement that's built into it, you'll get there. So to me it's a question of it's sooner or later you would think that the processes will just mature to the point where you're like, " Oh, oh, now I get it." So the question which comes, how long does that take? For some companies it could take a career. For other companies it's like, " Okay, we get it. How do we utilize this management system as the leverage, as big long stick to help move the entire organization towards its stated goals and objectives?" And probably the biggest pitfalls along the way, I can think of two or three the top of my head. So one, people get very busy doing the operations and it's just doing the work that needs to be done. And that takes up their entire day and probably more. And I refer to all, there's a lot of people that refer to it, I just certainly didn't make that up. So that's working in the business. It's performing the tasks that are defined for you and that's what you come in, you put your head down, you do all those tasks. There's a difference between working in the business and working on the business. And working on the business is coming up for air and looking at what you're doing and doing and doing and that 12 step process that you're doing over and over and over again. And thinking about it, how can I think about this differently? How can I make this 12 step process an eight step process with the same level or maybe improved accuracy and improved efficiency that will drive complexity out of the system, out of the process, that will reduce the number of errors that happen out of the process, that creates capacity, which allows us to do more with the same level of effort. And so for management to send the message that working on the business is as important or deserves enough of your time as working in the business and really your day to day tasks are made up of elements of both and working in the business and of course the work that needs to be done, but taking the time to think about what you're doing, because nobody knows better than you do after you've done it for 10 hours a day where the opportunities for improvement might lie. And so think about that and think about how can I improve this process or the outputs of your value added become the inputs of the next team down the line. There's lots of opportunity within that white space where you're doing something and you hand it off and the next group picks up and does their thing to it. What could I do better that makes the next sort of step in the process down the line more effective, more efficient, more accurate, more whatever. And back to what we were talking about earlier now when you're viewing the organization as a value stream and you start thinking about from a marketing to after sale service and all those little white spots in between those handoffs and what we could do better in that area to improve for the next group down the line, huge improvement, huge improvements can happen within the organization. Huge opportunities for improvements, let's say that. So thinking about working on the business in addition to working in the business because we all get so busy doing what needs to be done. And then just some of those myths, it's management's not serious, this will go away, it's an extra thing to do, I don't have the authority, I can't make these kinds of decisions, I don't have the authority. And we could bust every one of those myths and every one of those little pitfalls that organizations just tend to fall in and all that can be eliminated from the right kinds of communication from the top and the message around true quality. So it is one of our core values and we're very good at talking about true quality as it relates to our customers. What does that mean for us internally? How do we translate true quality internally to use as our own competitive advantage out in the marketplace? Because we're in a competitive market, there's a lot of companies that provide same kinds of platforms. What's going to separate us? What makes our product the one worth buying? And so how does that message get translated from the top down again throughout the entire organization to say, " No, it's okay to focus on the business and no, this is not a fad. And no, we're not just talking quality. No, it's everybody's responsibility and creating the culture around quality." So communicating the right kind of communication and often communication with creating clarity across the organization and alignment across the organization so people know what the strategies are, people know what the targets are, people know how their tasks are affecting that strategy, all that stuff can go away really easily. Companies aren't good at that stuff.

Etienne Nichols: Yeah, I love that you mentioned that working on the business versus in the business. It makes me think of a conversation I recently had with someone about the definition of work, when you're a thought worker in some or whatever you want to call yourself, I was like, " Man, I just can't seem to work on the plane. I can't force myself to get the thing out and do it." So they said, " Well, I usually like to work on the plane. I'll read a book that I haven't been able to get to." I'm like, " Well yeah, I read a book that's applicable to what I'm doing, but I never thought about that as work." But if what I'm reading could accelerate what I do when I'm doing my jobs, it is work. It's just a different kind of work. It's like you said on the business versus in the business, that improvement, I love that.

Mark Alpert: Yeah, great example.

Etienne Nichols: So any other recommendations or any advice? You just went through this process, I know we had a lot, you basically overhauled it, or not overhauled, you inspected the entire vehicle of Greenlight Guru. So you may have already done this before, maybe you haven't learned anything, but I suspect that maybe you did, any advice or recommendations you have for companies going through a similar process?

Mark Alpert: So I'm not sure I have those answers yet. So I have been through this a few times before in trying to position the organization, trying to keep, I don't know if this is going to come out, but again, so we achieved our certification and so there's a lot of folks that, okay, job well done, we got it, we don't got it. We got the start of it. And how to keep that on the front burner and articulate the importance now of where we go next and what this means to the organization and how it fits into the organization and how it provides the leverage for the organization to move towards the goals and objectives and that vision and to develop that discipline around constantly achieving our targets. And how to use the energy that's created between defining the should be or the could be and the as is creates a lot of tension. And it's not intended to be tension that gives you the headache. It's intended to be the intention that creates some energy pulling us towards that goal. And so how to recognize that tension, how to use that tension as an energy source to improve the organization and not just as something to bat people over the head with. But as I guess, not to go keep going around in circles, but as an energy source and not use your powers for good. Use that power for good. So putting those disciplines in place for being able to set targets, develop the initiatives and the plans to achieve those targets and pat yourselves on the back and celebrate that win and set the next target. And put yourself, the company in positions to be measurably better next period, next quarter, next year, next whatever than you were this quarter or this year. And it doesn't have to be great, big, huge steps in improvement if you're measurably better next year than you were this year. To me that's continuous improvement. And there's a step function, right? And some years are going to be bigger improvements and some years are going to be smaller, but that builds a more sustainable future for the organization, right? A brighter, more sustainable future for the organization because we're continually improving. And so it's the process around continuous improvement. So thinking about what the process, and there are tons of them out there. Processes, models, it could be as simple as I just stated. Identify a gap, identify the actions that need to be taken to close that gap. Good. But doing that on a bigger level and doing it on an organizational level as opposed to, " Hey, how do we reduce inventory?" Fantastic. You know what, that's improvement. You reduced five turns down to three up to eight turns or whatever it is, that's improvement. It ought to be celebrated, but that in itself might not move the whole organization towards being number one in the industry. So I'm talking about coordinating all those improvements across the company to align with some very high level goals and objectives to move the entire organization towards its stated goals. So thinking about it on the grander level and building the disciplines around those processes that put you in a position to be measurably better next year than you were this year.

Etienne Nichols: I love that. If I was to basically distill what I've learned from you today into one thing, it's like you don't put your quality management system in the corner. It needs to align with the top level vision. You go all the way upstream to that vision. Is that really the true vision that you want? Is it attainable, for lack of a better word of it, is it attainable? Is it true vision? All these different things, can it flow down? The whole thing needs to be able to align. I love that.

Mark Alpert: That's right. And that alignment. Those are the highest performing companies that create that alignment and harness that alignment to just create incredible results. And that's what we're striving to do. And so that's that for us, the so what is, now how do we put those processes in place that really start to drive some of those high performing processes and some incredible results?

Etienne Nichols: Well, cool. Mark, thank you so much for spending some time with us today and congratulations on reaching the beginning.

Mark Alpert: Thank you so much.

Etienne Nichols: I'm excited to see where the future goes. This has been really fun for me anyway. So those of you who've been listening, you've been listening to the Global Medical Device podcast. We'll put links in the show notes so that you can find Mark. He's busy, but maybe he won't mind. Reach out to him. Feel free to talk to him. I know he loves to talk quality, so awesome. Thank you so much. We'll let you all get back to it. We'll see you next time.

Mark Alpert: All right, thanks Etienne.

Etienne Nichols: Thank you so much for listening. Just a few points that I took away from this conversation. We're achieving ISO certification is just the beginning. From then on, you need to can be continually dedicating yourself to continuous improvement. Your quality system needs to tie back to your corporate strategy if you really want to be as effective and efficient as you could be in the market. If you really enjoyed this episode as much as I did, I hope you'll reach out to Mark Alpert on LinkedIn and let him know. Also, I'd personally love to hear from you via email, Ettien. nichols @ greenlight. guru, or look me up on LinkedIn. You can learn all about what we do if you head over to www.greenlight.guru. Anyway, finally, one last thing. If you enjoyed this episode, please consider leaving us a review on iTunes. It helps others find us. It also lets us know how we're doing. Thanks again. Hope you all have a great rest of your week.

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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Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...

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