ISO 9001 Implementation

Hello, everyone, and thanks for listening to the Quality Hub chatting with ISO experts. I’m your host, Xavier Francis, and I’m here with Bruce Newman, Lead consultant and one of our longer-tenured consultants here at Core Business Solutions. So glad you could be with us today, Bruce.

Yeah, I’m happy to be here with you. I hope. I hope I can enlighten our listeners on some of the aspects of the implementation of different systems.

Yes. Thank you. That’s exactly today’s title. Today’s show is entitled From Planning to Implementation. How to Get From Planning Your QMS to Implementing One. Now, if you’ve listened to the Quality Hub before, you know that we’ve been interviewing our guests with a focus on starting your quality management system. We’re going to be continuing that journey here today with Bruce.

Bruce Yeah, well, I go way back. I started in quality before ISO had even been launched. I’m working with automotive companies. I’ve worked with yacht companies, Medical Devices, you name it. What I have found is that if you’ve got good quality skills, it’s easy to learn different products and processes and apply those skills. So it’s not a bad field to be in as far as versatility and job security.

Okay. And how long would you say you’ve been here? I mean, you’re doing this.

I’ve been with Core for six years. Okay. And then about 45 years before that. Managing different quality systems.

So last week’s podcast, we started planning our quality management system. Now we want to focus on implementation this week. Can you tell us what the three main thrusts might be at this stage?

Okay. The idea here is that we want to put into action the different things that we’ve put down on paper, I guess you could say.

Okay.

So, one thing I need to have is a good relationship with the client. I want them to understand that we’re not about changing things you do. We’re about taking advantage of the things you do well, which if you’re a solid business, there are a lot of good things you’re doing.

Yeah. I think one of the things that we talked about with some other people was, you know, you start with what you have now.

Exactly. So once that documentation is complete to me, that is part of the groundwork that you complete during planning and all that’s designed to make the process of registration go simply. So now all we need to do is get you comfortable with that documentation and with using the tools that we’ve put down on paper.

So you want to get those controls, those processes, and things like that in place, that’s going to keep your QMS moving forward.

Right. So we’ve identified the key processes that impact the quality of your product or service. So what we want to do is put together some signals that tell us when things are going well and when they’re not going so well. And, when we notice that things are going not so well, we want to fix that.

Right?

Right. The opposite of that now is something that a lot of people neglect when things go unexpectedly great. That’s cause for an investigation as well because maybe there is something that we’ve done a little differently that improved the process that we want to institutionalize and maybe document and continue.

Yeah, maybe implement it in other parts of the company.

Exactly.

All right. Well, that’s great. You just mentioned documentation. I know we spoke in the past podcast about why it’s so important and why it’s part of the quality management system if you’re looking at 9001. So now, why is controlling that documentation so important?

Well, the importance, there are a few things. One, we want people who are subject matter experts in charge of their documentation. We want them to be the ones that generate it and revise it to approve any revisions.

Okay.

Now, the other thing is that we don’t want anybody using out-of-date documents. So that’s the whole point behind maintaining the revision levels. Let’s say, for example, we’ve got a final inspection process that is a checklist of items to inspect and maybe we’ve got a design change that takes place with one of our products. So we need to change the specifications or even add an inspection point if we’ve got people out there inspecting using the old document, there’s a good chance we’ll ship nonconforming products because they don’t have the latest and greatest.

Exactly.

Right. So you need to control these documents. So one point would be so you have the right revision when you’re doing some work based on it if it’s work instructions.

Exactly.

And then what if it’s another type of documentation? What’s the importance of controlling it that way?

Well, like, for example, a procedure or the quality manual, if we make any changes to instructional or procedural type documents. Again, we don’t want people following the wrong procedures.

Correct. You want them to use the most up-to-date ones.

Primarily these documents. Once somebody knows their job, they’re not referring to documents like this day in, day out. But the secret is that they’re good for training. So when we bring new employees in, we don’t want to be training them to out-of-date processes or methods of doing things. We want them trained in the latest and most current versions of those documents.

Right. And a lot of times you are saying the subject matter experts, you know, or what we call SMEs. They might be the people doing the job. So they might say, Hey, I’m going to revise this. You know, management’s like, yep, go right ahead. It’s revised.