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ISO 9001 QMS – Putting it All Together
Episode 4 – ISO 9001 QMS – Putting it All Together
ISO 9001 QMS
Our special guest, Norm Verbeck, an experienced Quality Management consultant at Core Business Solutions, will provide us with an in-depth understanding of how to effectively organize and streamline your objectives, documents, and measuring procedures. Norm will also demonstrate how to analyze valuable customer and supplier data, and he’ll also reveal how our powerful software compliance platform, CORE, can assist you in achieving these essential goals.
Core Business Solutions publishes ISO Certification podcast episodes weekly. You can find more episodes here.
Episode 4 Key Content
Today’s show is entitled Putting It All Together. We know there is so much to do and we’ll talk about some of the steps on how to manage it all. But first off, let’s learn a little bit more about our guest, Norm. Can you tell us a little bit about yourself?
Sure, Xavier. So most of my experience involved the manufacturing industry. I have about 25 years of experience working in a variety of functions ranging from production management, to quality management, and continuous improvement. And even in my later years in supply chain management as well.
Well, that’s great. Lots of experience there. And we’re really glad for you to be here with us today. So in the past podcast, we’ve talked about objectives, documents, measuring management, and more. It can seem like there’s a lot to anybody who’s just starting in the quality management system. Could you start with how we put all this together?
Sure. So again, as you mentioned, it can be kind of overwhelming to start with. Yes. Two of the main sections all kind of go through a little bit today one of them is making sure that you determine your company’s quality objectives. Okay. So that’s one of the first things because anything you put in place should be striving to try to improve.
So you’re picking what you want to focus on at this point.
So, yeah, we recommend usually somewhere around 3 to 5 objectives. Okay. And then those should be kind of focused on four different areas. So you want to establish a target, and a plan, determine who’s responsible for monitoring and reporting out on objectives, and then determine how they do report out to top management.
So basically who their management is or is that the data that they should be reporting?
The data primarily reporting. And we usually like to focus now on things that a company might have already in place because obviously, they’re going to have some previous history.
Right. We’ve talked about my document, and what you’re already doing to start with.
Exactly. And then the next second area that you typically focus on is the development of your control of documents and records and how that’s going to look. So under previous versions of the standard documentation requirements were pretty stringent.
Right. I know there was a whole lot in the past.
Yes. And now they’re a little bit not simpler per se, but they’re a little less stringent. So it’s kind of up to the company with what they find value in to incorporate into what they’re going to do.
Write in the 2015 standard. They’ve reduced, if you will, the documentation needed a little bit, as we’ve mentioned before, they let you kind of figure out how you want to do it.
Exactly. So you can kind of look at it from a business perspective as far as what’s driving value or what’s bringing value to your company. So all those standard offering procedures and work instructions aren’t required by ISO. You know, whatever your company determines to be useful in documenting the standardized way that you communicate to train employees. That’s what you want to focus on.
So it doesn’t mean you can’t document work procedures and stuff like that. It probably would be a good idea to do some of those, and that’ll help with training in the future. But it doesn’t mean you’re required to do it as a trust.
Yep.
Exactly.
Right. It’s not prescriptive. But again, not how but what you should do.
Exactly.
So even though documentation has been reduced, there’s still a fair amount. How can we simplify that document control?
So again, when you’re reviewing your documentation, you know, one thing is it’s a good opportunity to kind of reduce things if things aren’t bringing value or things are just kind of collecting dust, you know, people aren’t reviewing certain documentation. Maybe they’re outdated. But one of the most important things is, you know, we want to keep it keep documentation of your customers or your management system.
Simple. So you don’t need to over-document your system, you know, with countless procedures, things that aren’t utilized, or things that can make your system difficult to maintain. So with the flexibility of the new standard, it’s good to primarily drive value for all types of business. And so, you know, it’s not prescriptive per se, but businesses can determine, you know, what they want to do to meet the requirements within.
Right. It’s not prescriptive. But again, not how but what you should do.
Yep.
So, you know, one thing is it’s a good opportunity to kind of reduce things if things aren’t bringing value or things are just kind of collecting dust, you know, people aren’t reviewing certain documentation. Maybe they’re outdated. But one of the most important things is, you know, we want to keep it keep documentation of your customers or your management system.
And it provides a good base for you to be able to provide documentation and evidence of your document control.
We can go right in there and print off the stuff or show what you need when you’re in an audit, internal or external audit for the documentation needed. And also I know that there’s revision control in there. There are also ways that you can ask for authorizations.
Yep.
We also have acknowledgments in there. So let’s say you have revised something and you want everybody to know there’s a new revision on it. You can send something out. Everybody will get an email saying, Hey, you need to acknowledge this document has been updated and you’re aware of it.
Yeah, absolutely. And that can also serve as your records of, you know, the acknowledgments and training.
Right. Right. For the training. If there is something new that they need to look at and review.
And even within the revision process itself, like when you’ve made changes in the document if you’d like to get feedback from other people on those changes, you can also send out notifications to people and they can provide comments. All that’s captured within the cover sheets of the document.
Right? Right. And when it’s finally approved, that person that says, okay, this is good, it’s the way it should be, it’s done. They can approve it. So you know that you all are on the same page when it comes to this, this documentation, whether it’s for training, any of that type of stuff.
Absolutely.
All right. So 9001, we’ve talked about documentation today and some of how you can control it, and why it’s important to control it. 9001 also has a look at data about our customers and our suppliers. Now, how do we go about analyzing all of this customer and supplier data? Can you give me a little rundown about how we do that?
Absolutely. So customer supplier data can be evaluated either utilizing forms where you’re capturing data in relation to either customer feedback or supplier performance. But then this documentation is primarily captured in forms that people are filling out.
It’s like a questionnaire perhaps. Yep. If it’s a customer questionnaire or something like that.
In those forms, then you can either implement those manually using, you know, paper form on your computer, on your network. Alternatively, forms can also be electronic and those can be captured in, for example, the core compliance platform. So we have great audit forms that are available on that topic. It’s captured in the order forms, which then actually allows you to be able to do some trending and analysis of what the feedback is over time.
Let’s say you’re doing something that’s based on a five-point rating. You know, one’s terrible, five’s great. It’ll give you the average of what you have within a certain time frame or over the entire life or, you know, you can you can pass out data as you need to. So look at it. Stay on top of that kind of stuff very easily.
Absolutely. Yes. I mean, and everything’s very sortable as far as, you know, you can sort by ratings by particular customers if you want to focus on one customer as far as what their feedback has been over, say, five years.
Oh, That’s good. I mean, I know sometimes as we continue to evolve in our and our businesses, you know, we get focused on catching new customers. You know, that one big customer that we were great with, you want to make sure you’re still keeping them happy as well so you can look at, hey, why is our rating gone from a five to a three and a half over this time frame since we’ve had this customer, what aren’t we doing?
Data. And that’s where it kind of gets a little difficult if you are just keeping in completed forms on your network. That data can’t be passed from, right?
You can’t. You can’t. You’re at your metric. Analyze. This is not going to be as complete.
Absolutely.
So when you’re putting all of this stuff together, what’s a good way to finalize all this documentation?
So before finalizing, of course, we kind of talked a little bit about making sure there is a mechanism to enable people to provide feedback, to make sure things are pretty much standardized. And, you know, you want to.
Review that, you want to review those documents to ensure they’re what you want them to be.
And beyond that, once it’s kind of like the feedback I’ve been given, the documents kind of been revised within the final stages. At that point, you’re ready to go through and approve and release documents. So it’s really important to have a clear approval process and then determination for the appropriate people. They’re going to be required to approve those documents.
So you might just have one. You might have a handful, a committee of sorts if you will, that everybody has to say this. This seems complete to me. Yeah. After you’ve gone through and had the review process, get the feedback made, and any changes, now everybody is on the same base. Let’s approve it. And we know that’s the one to use.
And then at that point, once the approvals are received, you release the document within a system like Core, and filers are then locked down, and that prevents any future unintended change. And so you can no longer upload files to the cover sheet once it’s locked down.
That doesn’t mean you can’t make revision changes. It just means that the revision is now complete and can’t be changed.
That’s exactly right. So you kind of lockdown. And then previous to when you go through an approval process, when the documents are in draft status review, you could continue to upload a revised document or not necessarily revise, but another.
Variation of.
That variation. So it’s not necessarily bumping it to the next round number with those changes until it’s released. Once it’s released fully, then at that point, it’s going to be a revision of a change.
That’s another reason it’s so important to get that finalized approval to know this is what we’re going to go with for this revision.
That’s right. And within Core, for example, when that periodic review cycle hits, if it’s, you know, whether it’s one year, two years, six months, you go in a new or complete a periodic approval. So basically saying that the document is still up to date and there are no changes needed at this point. So recovery starts the clock then based on the frequency determined.