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QT9 QMS  50 min · On-demand  QMS Audit Module

 
 
Management Review & B.I. Dashboards: Connecting Quality Data to Leadership 

August 12, 2025

✓ The chapters, transcript, and Q&A below are freely accessible — no form required
Chapters
0:00 Introduction to management reviews and ISO requirements
4:52 Creating management review records and defining attendees
9:47 Preparing management review inputs and supporting reports
14:36 Using Audit Prep to identify overdue records and risks
20:18 Business Intelligence dashboards and management review reporting
26:42 Mapping ISO management review inputs to QT9 review tabs
33:11 Creating management review actions, CAPAs, and follow-up tasks
41:05 Tracking open management review issues and documenting outputs
46:08 Management review best practices and closing remarks
Full Transcript

So good morning or good afternoon everyone and welcome to the webinar. We are very glad that you have joined us today. In today's session, we are going to be focusing on the management review module in QT9 QMS. We will also briefly look at our new audit preparation module and our business intelligence tool.

Before we start, would like to go through some of the tools available to you in this webinar. First, take note of the orange arrow on the vertical toolbar. This is important because this arrow will either expand or collapse.

This arrow will either expand or collapse ⁓ the toolbar view. When you expand the toolbar view, this will allow you to ask questions in the lower right hand corner. We do have staff available throughout the presentation to answer your questions. Just to note, this webinar is being recorded and will be posted on your QT9 newsfeed.

One more item I would like to go through before we get into the main content is our webinar series. These are free webinars that we offer to our customers that help you to get the most out of your QT9 QMS software. Because we have so much to cover today, we'll be focusing only on the main topic. If you have additional questions after this webinar, you can schedule a one-to-one session with our training team by emailing qmssupport at qt9software.com or reach out to your customer success representative.

The last thing I would like to point out here is that at the end of the session, you will be invited to take a brief survey. It's really important for us to gather feedback. It is much appreciated and so we can tailor future webinar content.

So just looking at the webinar outline. So here is an outline of what we will be covering today. Number one, introduction to the management review process. Secondly, how to prepare for the management review meeting. We'll be looking at our audit prep module, which is brand new since the V17 update yesterday. We will look at our business intelligence tool, how to run the management review meeting. Note preparation is done prior to the meeting. Proposed actions are confirmed, added to, and agreed.

and how to follow up after the management review meeting.

So the management review process, so just have, excuse me, just have a look at that. The management review process is, ⁓ what is it? So it's the management team of a company, which will be defined in your SOP, typically a list of titles or functions. We'll review the QMS at defined intervals, defined meaning, for example, annually or twice per year, say June and December. This review is intended to check that the QMS is suitable.

effective, adequate and aligned with the company overall vision or strategy. Taking the example from ISO 9001-2015, but all of the standards have some form of management review process. Here is the general requirement for 9001, so it's 9.3 management review general. So management shall review the organization's quality management system at planned intervals, so defined intervals

to ensure its continued suitability, adequacy, effectiveness and alignment with the direction of the organisation. Then of course, in 9.3.2, we have the inputs and 9.3.3, we have the outputs and we will get to these a little bit later on.

So just before we move into the main content, I want to just talk about the difference between paper and electronic when it comes to management review, ⁓ because a number of you on this call may have managed this process using a paper based system. I certainly did in the past. So it makes it easier to ⁓ translate the paper based system into the EQMS system because the principles and approach are very similar.

So a typical approach in a paper-based system, the quality manager or quality rep either prepares reports from each department or requests them. They will compile the data, maybe a PowerPoint presentation to arrange the data in an orderly fashion for the meeting. An agenda is prepared, which is included in the presentation. The manager prints out a pack of the information which needs to be reviewed and makes a copy then for each member of the management review team. The management team is assembled. All items are reviewed and actions agreed.

And as well as documenting actions, meeting minutes may also be documented.

So the downsides of this, of course, is that it's labor intensive. It often puts the burden on one person to prepare all the reports, documenting the minutes and the actions, as well as following up on the agreed actions, usually using Excel. A lot of one-to-one interactions, following up with people, reminding them of their open items. So it's more time consuming, whereas electronic EQMS is more efficient and accurate. So I will show you how QT9 QMS Management Review Module can achieve the same objectives.

both with less time, more accuracy, better information for decision making and more efficient way of following up on actions, all while remaining compliant to whichever ISO or quality standards apply in your company. So what is the management review module? So the management review module in QT9 QMS allows you to centralise all your inputs, track your action items, meet your ISO standards, meet your compliance requirements, depending on the standard that is applying in your company.

It keeps a record of your review, the timeline. Of course, everything has a timeline in QT9, as with all our modules. An easy way for management to get real-time access to top-level QMS information. And of course, using the Management Review Module means that you are always audit ready.

So what I'm going to do now is I'm going to actually get into the module itself. Let me just check this is showing up for everybody. So I want to just firstly note that we are in just make sure the screen is large enough. We are in V17 since yesterday. So if you have if you missed the webinar for V17, it's still there on the QT9 newsfeed. If you want to have a look at a summary of the main features for version 17.

So I will first show you the management review module and how the record is first set up. So this may be found under ISO functions management review. If this module is not showing up for you, please contact your global administrator. This is the designation. When I open the module, you will see all of the management reviews completed in your company. You can filter by site, as you can see here, and you will also see all open and completed for you.

So you can see that you can filter by site, you can filter by ID. So each management review meeting gets a unique ID number. And I'll show you that when we're actually creating a record. You can also see that the date of the meeting is here. ⁓ Also, the status of the meeting is completed or not completed. So to create a new management review record, you just simply hit this button here, create new MRM. The number, by the way, will remain at zero until you have actually saved the record.

So select site, this is important because when you, I'll show you in the different tabs, you can link to records, for example, with corrective actions, risk assessments, but it will link to the records for that site. So that's the significance of selecting the site here. We can give it a name. I'm just going to call it MRM for management review meeting. And I'm going to say Q3 2025.

and I'm going to give it a date at the end of September. Now, of course, you can amend this date while the record is still open. So when you finalize the date ⁓ and then you can edit it to reflect the date that you actually had the meeting. And I'm just going to hit on save. The MRM number now will update and it will be to the next number, which is MRM number 11. I will now add the attendees. So the attendees are added here. So I'm just.

quite simply going to add a few names just for illustration purposes. So I usually recommend adding the function or the title of the attendee. So again, this helps to illustrate that you have the full management team. So again, in your SOP, you will typically list out who comprises our management team or our top management team. These are the functions that should be represented at the meeting. So this is why I do recommend this. I'm just going to put in one more name here.

and just select Add Attendee. Now you can also remove attendees if you accidentally put somebody in, just select and remove. You can also do that. You can continue adding here as long as the record is open. ⁓ And also in the notes section here. So here is where you can have the meeting minutes. You can have the agenda. You can have general notes. You know, for example, because this is a cloud-based system, you could have somebody calling in from a different location. You may want to say that.

You might have a designate representing somebody else at the meeting and you can make a note of that. Or you could just have the agenda in here. Now, by the way, you can also attach the agenda on to related files because like in all the modules in QT9 QMS, you have this option of using maybe a hybrid, something you've been using in your old system you want to continue using. You can actually attach it on here. But for this example, I'm just going to again using ISO 9001. I'm going to just select the inputs from that standard.

So I'm just copying and pasting in here so you can see what it looks like. So basically, these are the inputs. So in terms of like an auditor, internal external auditing, they're looking for items that will match up to these inputs. And I'm going to talk about this a little bit later on as well in this presentation. So what I want to do now, I'm just going to save this and I'm actually going to go back to the presentation because I want to talk a little bit about the preparation side and

then we will move on to the actual tabs. So just moving back to the presentation and this is if you take away one thing from this webinar today, I would say it is preparation is key for this meeting. This is a quote from one of my former managers. When you come to me with a problem, have the problem clearly defined and described and then maybe have some suggested solutions.

So I've always followed this principle, it especially applies here in the context of preparing for the management review meeting. This is a high level meeting and you will typically have the entire management team sitting in a meeting room. need to ensure that they have good data in order to review and make good decisions in a timely and efficient manner.

So just moving on to the next slide here. talking about the module preparation. So this is the management review module. So this applies to all management review modules, essentially your management review SOP or equivalent. So while the MRM module actually requires no setup, so some of our modules, you have to do categories, types and so on. The management review module is actually ready to go out of the box. But I do recommend outlining clearly an SOP where the inputs should go.

I will show some examples of this later on. So again, just clearly outlining how this module is used. And then the other set of aspect is setting up user defined fields if needed. These are totally optional, by the way, but I will show you these in the practical example.

Then we have the meeting preparation. I'm looking at this from two sides. I'm looking at it from the point of view of gathering the information. essentially again, management review comprises that you look at the data, the reports, the graphs, really top level information that you can make decisions on, but also setting up the management review record. So I will show you exactly in practical terms how this is done.

Kind of two sides to it, but I'm going to start off with this meeting preparation, the reports and the data.

So just moving on, there are five different areas. So I discovered when I was preparing for this webinar, there's actually five different sources of reports that we can garnish from QC9 in order to prepare for this meeting. So we have Excel exports from the module grids. We have reports from our QC9 reports module. We have reports from actually individual modules. We also have the audit prep module, which is brand new since yesterday.

And then finally, we have our business intelligence tool. Now this is an add-on. So again, please ask us for further information about this. You could consider all of this like the raw material for the meeting. Now, because we only have an hour for this webinar, I'm going to show you where we find the information which would be reviewed as part of the MRM. And then I will move on to the tabs. But in real terms, you would deal with each tab or agenda item separately.

So in essence, you would be moving over and back between the MRM record and the source information for the reports. I'm taking this approach just to best put across how the overall process works. ⁓ I also realized that the reporting size that I'll be showing next, it really deserves maybe a separate webinar. So if this is something that you think might be of interest to you, please put it in the survey comments at the end of this webinar.

So let's dive in. So I'm now going to move back to QT9. I'm going to just ⁓ submit on the home page there. And as I mentioned, there's five different types of sources of reports. And I'm going to start off with the very simple one, exporting information from the grids. So I'm just going to take the example of the corrective action status. So I'm going to go to ISO functions, corrective actions.

And here you can see that we have all of our corrective actions. Now I'm going to open up this filter to everything open. Of course, you can do different filters here. And as you know, many of you will be familiar with these grids, how they work. You can do your columns, turn things on and off, let's say take off customer and supplier, save your layout. And you can export the grid. Now, I will point out that if you are using this feature of exporting the grid, if you make changes to the grid layout,

just save those changes before you do the export. Even if it's something temporary, then you can save back without the column. But if you export without ⁓ saving the grid layout, it just will be missing that column you're looking for. It's just a tip. So I can export that grid. Now, what I'm going to do with all these exports is I'm actually going to show them to you right at the end. I exported them for part of this meeting. ⁓ They're really, it's a CSV export. I've just changed it to Excel and just kind of put in.

filters and stuff. It really just takes about a minute for each of these ⁓ Excel exports and then attach them onto the meeting records for the management review meeting. So I'll show you everything at the end. Now, just you can see that downloaded there. I'm just going to leave that. That is the first type. The second type of ⁓ source of information for reports and data would be the reports module, which is right down here at the left hand side main menu, right at the middle reporting.

Now, we do have these reports available for all of the modules in QT9 and the help file will explain to you all of these how all of these work. I'm just going to take the example of the audit results reporting. So I'm just selecting on this. And you can, of course, add conditions and clause groups and so on so forth. Again, the help file will talk you through all this, but just for the purpose of illustration, I'm going to keep this very simple.

And I'm just going to leave it at audit type. For example, you could do a date range or something like that. If you were using the audit module for your supplier audits, you could filter by that. I'm just going to leave it at audit type and I go into the equals first party. So I just want to look at our internal audit program and how we're doing. So you just scroll down. Again, you will notice I have the site selected. I'm just going to move on down and I'm just going to hit on generate report.

So here you can see all your information is showing up here. Again, you have the same ability to move this around with you can see you've saved grid layout, reset grid layout. But for what I want to do is actually want to export all this information. So I scroll all the way down, export to Excel. And again, you can see the download there. I have done this previously. So I'll show you the finished article at the very end. I'll show you all five different ports together. So that is one of the examples from the reporting module. But as you can see, there are many.

Many, many. The third type is actually directly from the module. So some of the modules in QT9 have nice reports that you can actually run directly from the module and customer surveys is one of them. So I'm just going to go right down to customers and I'm going to go to customer surveys. And I'm going to just select this one because we have a good few customers added to this one and it gives a good example. So I'm just going to click on this item here.

As you can see, it's a closed record and you can see we have customers added here. And by the way, these surveys, you can have multiple surveys, you can group your customers, you can, you we covered this in a webinar recently, but let's just say we had all of our customers here in this survey. So you just hit on this button here, survey results summary, and it's going to give you a nice little report telling you overall.

Your total customer satisfaction, 91.33%. So we are going to come back to this as an example a little bit later on. I'm going to use this as a live example. So again, I'm just going to close this down. Of course, you can export different formats here, but I'm just going to close this down for now. The fourth type is our audit prep module, which is our new module since yesterday. So it's under ISO functions and it's under audit prep.

So you can see there's a number of tabs here and they're all blank. So how do we get these populated? You quite simply select this button, run audit prep, and you can see it's as of date 12th of August 2025. And I'm just going to select the button and you'll see now that the records are now populating. So you can see we have documents that are overdue for review. We have overdue records, corrective actions, nonconformance deviations. And by the way, you can go directly to the record from here.

and update that record. So I wouldn't like to see all of these open items before an auditor management review, but you can go directly to the record from here. You can also export. So what I've done is I did a few exports from this page or this module here. And again, I'll show them to you right at the end. But you can look at things like overdue training. So, for example, with the documents, you can see these are all overdue for these employees. Overdue gauges. So these all these gauges here are out of calibration. Overdue equipment.

These are overdue for their maintenance. You got missing training here, so documents. Again, I'll show you all these in an export that I've done. You have this ability to export from all of these. And also finally, we have missing records. So this will actually show you where records have not been created for the current year. So again, a nice functional module which can be part of preparing your information for the management review meeting. Fifth type is our business intelligence tool.

So I'm just going to pop over to another site and yes, I am logged in. So this, I just have this on my default dashboard. So this is basically the BI tool homepage with my default dashboard. And as you can see, I have prepared one for management review. So you can essentially completely customize a report just for the management review meeting. So I'm just scrolling down here.

You can see I have customer feedback, have cars, I have NCPs, and these are all again under the heading of Management Review. So this is one dashboard that I have. If you haven't seen this tool before, you can drill down, you can drill up, you can see the way you can get this information, drill down to 2018, drill up. You can actually open up the graph. So I'm just going to take this example of this one. Just by simply selecting that arrow in the corner, you can actually change the visualization to, for example, I want to see it like this.

And then you can always go back to the original or, for example, like this show original. But I'm just going to go back and again show the overall. So for the purpose of this, and by the way, these dashboards are completely customizable by yourself. This is not something you have to go through us. We show you how to do it and you can build your own custom dashboards ⁓ per user, by the way. So it's per user logging in.

But in terms of this webinar today, the most exciting part of this for me is that I can actually export this data. So I can export this whole file into PowerPoint or PDF or even an image Excel, whatever you like. For now, for this purpose, I would export to PowerPoint. And again, I have done this already. So I'll show you right at the end. Just going to select. So it just takes a few seconds to cycle and pull the data together.

So these are live and interactive, by the way, these dashboards. ⁓ And I am now what I'm now going to do is I'm going to actually show you the files. I'm just going to go back to the home page here while that is cycling. And what I want to do is I want to show you those files that I promised. So the first type, which is the Excel. So just checking this is showing up for you guys. So this is basically an export from the corrective actions grid. So you can see just by adding filters.

You can go like this. can check what was description, what was the corrective action type, know, status open. These are all the open ones, of course, but you could do open versus closed. You can do date ranges and all this. a lot of flexibility really here. And you could also generate graphs, of course, from this also. So that's really the most basic type exports from the grids. Just going to shut this down. The next type was from the reports module.

So this was the audit results one that I exported and I just added some filters and ⁓ some lines here just to make it easier to look at. But what you can see here, for example, is that, for example, you can do a drop down on the element. So you could, for example, see how well your purchasing process is doing. You can see trends. You even have some FDA requirements there. So again, depending on as you know, you can use multiple standards in your audit module. You can see also how many

majors, how many minors, how many preventive actions were raised as a result of the audits. And again, you can, you know, I ran this report very quickly, but you can put in dates and timeframes when you're running that report. So this is a very nice report that's run from the audit module. In the actual live records that I didn't show you can actually jump directly to the corrective action from the module as well. So that's a useful feature. This is another one that I just ran earlier, just to show you that you can do these like

bar charts also in the reports modules. This is just corrective action charting. Just going to shut that down and I'm going to move on to the individual module. So this is we saw it briefly, but again, this is the customer survey results. And again, as you can see, it's nicely formatted. Of course, it would show your logo up here in the corner and of course the site it relates to.

The fourth type is the audit prep module. So I had a couple of different reports from here. So one of them was what was the overdue documents for documents of overdue to be reviewed. So as you can see, all those reds, they're all actually past date and these are upcoming. We also have things like missing document training. So here you can see, for example, that you can select by the employee name. So I could just, for example, select myself here and I can see that, yeah.

I'm overdue for training on these documents here. So again, there's a lot of information you can pull from that audit prep module. I'll just show you one more example, which is overdue equipment. But the same thing applies to overdue gauges for calibration. So again, you can add all these to the related files and I'll show you where we do that. So I'm just going to shut these Excel sheets down and get them out of the screen. And I'm just going to go back into the management review record.

I'm actually going to use one that is that I set up earlier because I do have a lot of ⁓ actions set up in this one. So it's MRM number seven. And I'll just show you under related files. That I basically attached all of those reports here. So you can see that. And again, this is this is unlimited. The number of files you can attach here is where you can attach if you want your agenda, your sign up sheet, sign off sheet.

you could attach like your PowerPoint presentation because it can be useful tools to use in addition to this module. ⁓ There is no limit to the number of files you can attach here. And there's an upper file size, as probably most of you know, 150 megabytes. But other than that, you've total freedom. You can upload images and so on here, any kind of format.

So I'm just going to leave it at that. I want to go back to the presentation because I want to explain a little bit about how these modules work ⁓ or these tabs work, I should say. so just.

going to go back here and on to the module preparation. So with the module preparation, again, this is a repeat of an earlier slide, but I just wanted to highlight that the inputs I'm now going to show you a way you can look at this. just looking at the ⁓ apologies, this is a busy slide, but I just wanted to illustrate how you can match up your inputs to the tabs. And this is how when I was writing SOPs for

this process, this is the approach I would have taken or something similar. In other words, it makes it very clear if the auditor said, well, where are you documenting, you know, 9.3.2 C2, you know, you can hear it's under objectives. That's a pretty straightforward one. But again, you can see all of these items. can move them out. You can decide which tab they should go into. And by the same token, you can flip this around and for each of the tabs identify which items should go into that tab.

And indeed, might be not applicable depending on your industry. So again, this is by the way, the numbering again is using ⁓ ISO 9001. So how the MRM tabs are set up. I didn't want to go through each and each tab individually because it's a little tedious to go through every single one in this. You know, we only have a short time for this webinar. So what I did was I divided them into categories and I'm going to show you examples of these different categories. So.

There are tabs that link to other modules, so for example, CAPAs, risk assessments. There are tabs that do not link to other modules. There's a user defined tab. So I'll show you all of these. By the way, all of the tabs allow you to document notes. So you can make a comment and note regarding each of the tabs. You can also create actions from each of the tabs and multiple actions. And by the way, you can also escalate an MRM issue to a corrective action also. So you have a lot, a lot of functionality with these tabs.

I also want to say that with these tabs, can have, there's many of them have prompts such as, you know, changes that could affect the quality management system and give you possible ideas. Are we up to date on evaluation of training effectiveness, which is, of course, mandatory in pretty much all the ISO standards I have encountered. Are there any new interested parties? Again, this might be just the ISO 9001 folks, but it gives you prompts.

for these questions. align with many ISO and other quality reg standards, not just 9001.

So I'm just going to go back to a record that I set up prior to this ⁓ one that we were looking at, MRM number seven. So I'm just going go back to the homepage and just navigate again, just so you remember where it is. So it's ISO functions, management review, and we are looking at MRM number seven.

So I want to, there is, you can look at these as an overview, by the way, if you go to ⁓ print.

So if you want to see everything on one page, you can easily do this.

So I'm just going to export this to PDF because it's just easier to scan through it. And you can see now it's downloading there as PDF. So I'm just going to make this a little bit bigger. So you can see that the notes come up at the top, the details, the date, the title, the attendees, and then it goes through. I won't go through everything now, but it goes through all of the tabs, all of the actions, all of the notes, so everything. So if you want to see everything together, not have to go through the tabs.

everything comes out on one page on this printout, including, by the way, the user defined fields and all your related files. So you can actually see which files were attached, which items were reviewed as part of this management review meeting.

So moving on to the tabs. So because QT9 QMS software is used across multiple industries, there will be some tabs that don't apply to some industries. As I mentioned, interested parties may not be relevant, for example, to medical device companies. And there will be companies here in this call who have management review input that may not fit into the predefined tabs. And here we have the user defined fields and I will show you how these are used. So I'm just going to go into my user defined field.

Now, these are set up, by the way, in global settings in the sort of be a global admin that sets these up. But as you can see, what I've done is I've put in some additional review items, ⁓ check the audit prep module for overdue documents, equipment, gauges, deviation. So again, just to bring in my audit prep module as a tool for entering data into this. So again, if there were overdue items, please enter the MRM number. These user defined fields completely customizable. You can add a narrative, by the way, under the section header.

which I find very useful. And then you have number one, two, three, four, but you can add multiple sections. You can also have open closed responses and things like that. So this is a closed response. This is an open response. And you can prompt, you know, it's just a prompt for the user as well as gathering information. So essentially what I want to say is that this module really can cater to all industries by using the following guidelines. Identifying where each input should go in terms of the module tabs. Identify tabs that may not be applicable.

and ensuring that the user defined fields are set up for items that are on the agenda but not in the predefined tabs.

So rather than go through each tab, the Help Center, by the way, will show step by step how these are completed. I'm going to take sample tabs based on the different categories I mentioned earlier. So example one, tabs that link to other records or draw information from another part of QC9. So an easy example here is policy. So this would be your quality policy.

So here you can see that the quality policy is pulling directly from your homepage so that automatically comes through so you don't have to go separately and look for it. And here I made a notes, there's no need to update our current policy. We have our approved copy attached to REV5 or you could just refer to.

then continue. So we don't need to add a quality policy issue. For objectives then, very similar. So you know on your homepage, you have an objectives page also. Again, they pull through automatically. You don't have to type this in and you could say document attached. So a lot of companies have this document like their KPIs as a control document. So I've just put in a reference to it. Did we meet your objectives? And again,

You can put any actions here. Typically, if you're not meeting any of your KPIs, you're expected to have some action responding to that. And the example that we're going to use a little bit later on uses this exact principle.

The next category tabs that do not link to other tab, other modules, but they do link to, for example, I'm going to use the example of customers. So while it's not going to link to, for example, a customer feedback issue, it does link to customers. So, for example, when I hit on this ad customer issue, you can see here that ⁓ you can select the customer.

By the way, I did omit to show you about the corrective actions and how this does link to records and live records and also the risk management does the same thing. So just to show you how this works. So you can add notes in here. And of course, you have with these text boxes as much information as you like to put in. So if I select add corrective action issue, now any of the tabs that link to records work in the same way. You can link to corrective action issue, let's say number 63.

and you just click on continue and it's going to just basically create a management review issue. You add in the information, save and you're done. But what if it's not a you know, a specific corrective action? It's a general issue. Well, it tells you at the top here ⁓ to import the issue, select the list and continue to start with the blank issue. Just click continue. So it's not specific. I have a general issue. So I just click on continue and you'll see then it will open up.

a record. So I'm not saving any of these guys. I will do this right at the end and I will show you in detail how all these tabs work. But I just want to give you a general sense of what these tabs look like. So again, you can override that. And by the way, this is where you can see your ability to create a corrective action from the MRM issue.

So I'm just going to move on to ⁓ tabs that have prompts and links to other modules as well. So the training one, for example, when I go into training. You can see that we have prompts here to the employees or the quality policy. Do we have any new employees? Are we up to date on training effectiveness? And again, I have an action in here and notes made in here. So again, they have some prompts in this tab. Suppliers also has prompts. So if I go to the suppliers tab.

And again, this would be external providers in the ISO 9000 and 9001 lexicon. So with supplier notes, you can see here what is the frequency of evaluation, annual, quarterly. You can put in your methodology. We've decided to separate again, making notes here. We did an issue here with the supplier. We added a supplier issue. And again, similar to customers, it doesn't link to a specific module, but it does link to the supplier's module and you can select your supplier here.

Then we have the risk tab, which actually has prompts and links to records. So it's both. So again, you can see is our risk assessment process effective? Do we have any increases and so on? So again, prompts, but you can also add a risk issue, which will look and again, this is site specific. So for example, just select this one and continue. So it's just going to basically pull the information across from that and it will link to that. ⁓

item afterwards when we save the issue, we'll link to that risk assessment. So I'm just going to cancel close this for now.

So I want to talk through another couple of tabs. So one of them is follow-up.

going to close this out. So follow up. So from all of the ISO standards would require you to follow up, look back. So your previous management review meeting, were there any open issues? So how do we do this? So very easy way to do it. Now, because this is demo site, I'm an MRM number seven. So you'd expect maybe the previous one might be MRM number six. Now it depends on how many sites you have. So you just have to check by your size the next number. So I'm just going to go back to the list. actually have

it opened a new tab here. So I'm just going to go to ISO functions management review and have a look at my list. So I can see here at number seven, this is the one I'm dealing with at the moment. So I can see that the previous one was number four. So again, it's the ID number for that record. It was management review December twenty twenty four. So how do I find out what were the issues? Are they open or closed? I could open the record, but that's definitely not the best way to do it, because again, this is a completed record.

So how you would do this is you can go here to ISO functions and MRM issues. So this is a separate module and it tracks the MRM issues. And again, you can select by size or you can put in all sites. So what I'm going to do is I'm going to, I want to see what is open from MRM number four. So I'm just going to go to all open. I'm going to go to all actually.

So the MRM that I'm interested in is number four. So I just type in four, search and enter. And so these in reality, would probably many more than this, but look, you can see that I have five items there. Some are open, some are closed. All I got to do is export that grid. And again, export the data. And again, I can show you this in the related files, but essentially it's going to export that list of information and show.

which items are open, which items are closed, who is responsible. So you can follow up and then I would attach it on to the management review record. So I can show you that right now. So if I go to the management review record, this is again our sample when we're using number seven, go to related files. And you can see here that we have ⁓ open issues from December 20, 24 MRM. And again, with these Excel files, I'm just adding maybe filters or, you know, so you can see there.

For example, can see closed, date closed, site name, status. So again, these are very easy to do and I would just attach them on. So in that tab, I'm just going to close this out also. In that tab, for example, for follow up, I've actually completed an action. I've said that there are still three items open. ⁓ See attached, you know, and again, you can refer, can, you can name them even. I've seen companies, for example, attachment one dash attachment to dash.

So it's easy to correlate the files with the tabs. But here you can see there are three issues still open, follow up and so on. I just want to explain that follow up tab. The other tab then, this will be of interest to the life science and medical device pharma people on the call. So this is really regulatory issues. Now, of course, other industries can use it too. What I put in the example of 9001, which is planned to upgrade in 2026.

But again, this is where you can make, because there are requirements for the life science that they do consider changes in the regulatory landscape. So this is where you would put those any regulatory issues here. User defined, we just had a look at. Related files, ⁓ just wanted to show you again. ⁓ Here's where you keep all your related files. You can keep your PowerPoint. And of course, we also have our timeline. Everything is tracked. As with all the modules in Q2.9, everything is tracked.

So can see all the way down since I started preparing this. So everything that is done is tracked and timeline.

So now that we've ⁓ discussed the tabs, I want to show you how to create an MRM issue. And remember, by the way, we're still in the preparation stage. We're still in the preparation stage for the management review meeting. what I'm going to do is I'm going to take the example of that customer survey results that showed us we had 90, 91 % satisfaction. And let's say our target is 95%. So this is the one here. So in practice, I would open this. I would look at it and say,

Okay, so with an overall 91.3 and our target's 95. You can also see that some of the customers did give us higher than that. So with 97, 97, but some of them were lower. So say three of them, we need to follow up with these guys and find out why they gave us a low, you know, what can we do to improve? So in terms of the action, I'm going to the customers tab. And I am going to add a customer issue here.

Now, just a note, you do have to select a customer here, even though we're dealing with multiple customers. And this, by the way, applies to all the other modules where you need to select one, but it's multiple. You can actually create a category called general, general customer, general product, general supplier. So I'm doing this in this case because I want to follow up with multiple customers. So I'm just going to give this to James Scott, and I am going to just say, I'm just going to copy and paste here for time purposes.

So reach out to any customer who overall scored us less than 95 % to find out how we can improve. So I'm just going to save that. actually have to put in a target completion date. So I'm going to say let's have the reach out done by next couple of weeks. Save.

So just to talk through the rest the tabs, now I've created an MRM issue. And again, again, I have done this. You can do this prior to the meeting and I do recommend the preparation. So I'm just going to open this one up that I just created and you can see action needed. So you can put in your action needed here. So what we plan to do, responsibility analysis, you can really use these two tabs as you wish, but for example, you could put in.

Maybe the department responsible here and maybe the person here might be one of James's team that's following up and not James himself. And so you could use these interchangeably. Again, there's a lot of information that you can pack into these records, but the minimum needed would be the follow up. So what do we actually do to follow up on this issue? And then the last or the second to last one here, improvement. So again, has the has.

Have we seen an improvement? So you could put in, yes, you know, we did another survey with these customers and the numbers came up. Again, I know I put in 28th of the eighth, but typically these MRM issues would have a kind of a longer time scale because they're bigger issues. They're kind of top level. But again, here's where you can create your corrective action. So let's say if I wanted to create corrective action, I've just selected that toggle there. So again, it's going to open up this. So I won't save this, but it's actually going now taking, for example, type.

and things like that priority from your corrective action module. So again, this is the integration that's I know it's throughout QC9, but this is one of the integrations. So I'm just going to cancel and close that out.

going to open that issue again and just finish out that record. So you can, of course, attach files and I am just going to put in a follow up. I'm just going to put in complete so that I can close the record and put in a complete change the status to closed and completion date. Now, as this is part of the prep, I wouldn't close a record out before the meeting, but just wanted to show you how you would actually close out one of the MRM issues.

So I would do this, what I just did, I would do this for all of the agenda items, maybe all of the tabs, again, depending on how you're approaching it, and then I would complete the MRM record.

So then I would actually have the meeting. So at the meeting then what you would do is you would go through each of the tabs, go through the actions, amend them. You know, they might say, okay, it's not Scott, it's John that should be doing this. That timeframe is not realistic. Let's push it out. Let's add some issues. Because again, the management team will have access to all of this information. So they can log in at any time. So you'd give them a heads up a few weeks prior to the meeting.

Please log in, look at the information, look at the proposed actions. They all have access to it. And then at the meeting, then you can confirm. So it really just saves time at the meeting. It's just a more efficient way of doing it. This is the way I would have done it in practice. And then when you have everything done, all your actions, you would just complete the record and then that's your close out. So by the way, just to note, once you complete, you can't modify anymore. So I'm just going to complete just to show you what happens. Are you sure you want to complete the record? And I'm going to say, OK, however.

The MRM issues that you created as part of this meeting remain open until they're closed. So I'm now going to go back to the presentation. So I just want to kind of just do a wrap up.

So just on this, I just want to summarize, because I know we covered a lot today, so I want to summarize. So this is my recommendation. Prepare the MRM record prior to the meeting, including the gathering, the reports and the data, and maybe proposing some actions. During the meeting, go through the actions and update accordingly, so to get the buy-in and agreement of the team. At the end of the meeting, then you would complete the MRM record just to show, again, you need to show this traceability at this point in time. We completed the meeting on this day and agree the actions.

Then follow up on the MRM issues. It's very easy to generate an Excel list of the open items and send to the management team. For example, monthly. However, however, and again, this is the benefit of an EQMS over a paper based system. You don't have to be going around to everybody and asking them, you know, what's the status, where are you? You've got three items open. Each person, for one thing, as soon as they're assigned an MRM issue, they get a notification through QT9.

And also it's going to remain on their to-do list until that action item is actually completed. And you get automated reminders as well. So I guess QT9 is kind of the bad guy is following up on the actions with the various responsible parties and making sure that it's staying, I guess, top of mind and it's not getting forgotten about. But as I said, it is still easy to generate a list of open items and, you know, maybe you're doing a quarterly review, a monthly review.

So look, is, ⁓ just wanted to, the final point I wanted to look at was the ⁓ management review outputs. So translating outputs. So this is the 9.3, again, just this is 9,001 standard. So the outputs, and this is a very important part of it as well. So the outputs of the management review should include decisions and actions related to, and again, you've A, B and C here, opportunities for improvement, any need for changes and resource needs.

So again, with the QRM, MRM tasks, have from the tabs, we have a tab for improvement, we have a tab for PARs, we have a tab for corrective actions, QMS changes, training or other tabs. Again, you can pop this into your user defined. You could even have in your user defined field a summary of the outputs so that you can very clearly indicate what were the outputs of this meeting. Of course, you have the minutes of the meeting, you have the meeting record itself, and you have the MRM issues.

You do need to retain documented information or records as evidence of the results of the MRM. And again, you have that in QT9 The MRM issue always has the issue type. So I'm just going to show you that in the next ⁓ page so that the original categorization remains with the MRM action. What do I mean by that? So when I look at the MRM issues, you can see the way the issue type is always there. So.

you can say, this was an MRM, this was a management review action relating to corrective action. This is relating to process performance. This is relating to product conformity. So again, these are all in the grids. These are available for analysis. And ⁓ it's easy to show then, OK, these were we've shown our inputs. Now we can show our outputs.

So that is all I have for today. So I want to thank you because I know we covered a lot. ⁓ If you would like any information sent on to you afterwards, please let me know, including the contents of today's presentation. I want to thank everyone for attending today's webinar. I hope you found this information useful. I want to point out again, if you have any questions or want to expand on your modules, some of you in this call might not be using the management review module already. Please reach out to us. We have the resources to help you.

You can also talk to your customer success reps. We're always here and ready to answer any questions you may have. As I mentioned earlier, there's a quick survey at the end of the session. We would very much appreciate if you would take a few moments to share your feedback with us. It's important for us to know how we are doing and where we can improve with these webinars. And again, everything we covered today is recorded. So I'm going to go ahead and wrap things up. ⁓ Thanks again for your time. And I look forward to seeing you again very, very soon.

and goodbye for now.

Questions From This Session

What is a management review in a quality management system?

A management review is a formal meeting where leadership evaluates the effectiveness, suitability, and performance of the quality management system. The review typically includes quality objectives, audit results, customer feedback, corrective actions, risks, supplier performance, training effectiveness and opportunities for improvement. 

How does QT9 QMS help prepare for management review meetings?

QT9 QMS centralizes management review inputs, reports, action items, and supporting documentation in one location. Users can gather data from corrective actions, audits, customer surveys, risk assessments, training records and other modules to prepare for management review meetings more efficiently. 

What is the Audit Prep Module and how does it support management reviews?

The Audit Prep Module helps organizations identify overdue documents, overdue corrective actions, missing training, overdue equipment maintenance, calibration issues and other compliance gaps. This information can be reviewed before a management review meeting to ensure leadership has visibility into quality system performance and audit readiness. 

Can management review actions be tracked in QT9 QMS?

Yes. QT9 QMS allows users to create Management Review Issues (MRM Issues) directly from management review discussions. These actions can be assigned, tracked, monitored, and followed through to completion while maintaining a complete audit trail of decisions and outcomes. 

How does QT9 QMS support ISO 9001 management review requirements?

 QT9 QMS helps organizations manage both management review inputs and outputs required by ISO 9001. The system provides a structured approach for documenting meeting attendees, review topics, performance metrics, action items, follow-up activities and records needed to demonstrate compliance during audits. 

Key Takeaways

Learn how to prepare and manage management review meetings in QT9 QMS
Use Audit Prep and reporting tools to gather management review inputs
Track management review actions, decisions, and follow-up activities
Improve audit readiness with centralized management review records and reporting

Presenters

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Angela O'Sullivan
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