5 Steps on the Path to ISO 9001:2015

(Image courtesy of ISO.)

Standards are the keystones of quality in manufacturing.

That’s why manufacturers who achieve certifications from the International Organization for Standardization (ISO) proudly identify themselves as ISO-certified. The fact that companies tend to tout their ISO certifications also indicates the difficulty of achieving them; if it were easy to become ISO-certified, you can bet that manufacturers wouldn’t put so much effort into spreading the word.

So, what’s actually involved in earning an ISO certification?

Okuma America Corporation recently earned the ISO 9001:2015 Quality Management Certification and is the first machine tool builder to do so, according to the company. The standard is based on a number of quality management principles, including a strong customer focus, the motivations of top management, the process approach and continual improvement.

ENGINEERING.com had the chance to discuss the ISO certification process with Okuma’s Michael Lail, QA Compliance Manager and Terri Phillips, QMS Coordinator.

IW: Why did Okuma pursue the ISO 9001: 2015 certification?

ML: We wanted to demonstrate to our customers that we’re continually improving our processes, but it benefits us as well as them.

IW: What was involved in the certification process?

ML: There are five steps.

First, you have to get training on what the new standard is about. That can come in different ways—people can get trained at community colleges or there are consultants that can do training. ASQ can do training, but first you have to understand what the new standard requirements are.

The biggest benefit for us came from the second step: gap analysis. This tells you where you’re at, and what you need to be doing. The gap analysis usually has what the requirement is, so you have to answer whether you meet that requirement. If not, you need to figure out what you’re going to implement in order to cover that requirement.

(Image courtesy of Okuma.)

The next step is updating documentation, where you physically go and update all the documentation or make any changes that need to take place, such as definition changes or changes that need to be made as a result of the gap analysis.

Then you need to do internal audits to the new standard, before you do external audits to make sure everyone is following the new procedures you have in place. Finally, you have an external audit to the new standard.

IW: Can you elaborate on why gap analysis was such a beneficial step?

TP: The standard is a guideline, so we had a committee that took what we currently had under the 2008 standard and compared it to the 2015 standard. There were some discussions about whether something really fit, whether we really covered something or not, so there’s interpretation involved in that. Those were the interesting discussions.

As an example, something that’s newer under this standard is the focus on the context of the organization. When we started talking about who our interested parties are—who’s interested in how our company operates—there were differences of opinion, and we needed to document that. Those were the lively discussions, since the committee was making decisions by consensus.

IW: What benefits does Okuma expect to derive from having the ISO 9001:2015 certification?

(Image courtesy of Okuma.)

ML: The first thing would be continuous improvement of our own internal processes, as well as meeting our customers’ requirements. Some of our customers are in automotive or aerospace; with those standards also changing, some of them are required to purchase machines from ISO-certified companies. There’s also consistency in what we do, meaning that if you have a process in place that’s repetitive and there’s a problem, you can quickly find it and solve it. It means one order is the same as the next when you process it through the system.

TP: Even if a customer doesn’t require ISO certification, because we are continually improving our processes and evaluating our risks, it benefits all our customers—even the ones who don’t know what ISO is.

IW: What advice would you give to other companies who are considering pursuing ISO 9001:2015 certification?

ML: Form a team and work closely with management. If you have internal auditors, use their knowledge and expertise to help answer questions and address issues that come up in gap analysis. The last thing is to celebrate your success once you get your certification. We have a big banner and there are quite a few things we’ve done to celebrate.

TP: I think prior to the release of the standard there was all this speculation about what it was going to mean—everything from, “It’s the greatest thing since sliced bread,” to “It’s the end of the world.” But it’s not that daunting; just take a deep breath and, like Michael said, form a team and get into that gap analysis.

IW: So, on a scale with, “The greatest thing since sliced bread,” at one end and, “The end of the world” on the other, where do you think ISO 9001:2015 ultimately falls?

(Image courtesy of Okuma.)

TP: I think there are some significant improvements. It requires us to document some things that we’d always done, but in the background. There’s a focus on risk-based thinking—now you have to formalize those risks and what your mitigation is, and to consider the context of your organization and how you relate to your stakeholders, your customers and your suppliers. It really illuminated some grey areas. I didn’t take any negatives away from it.

IW: Is there anything else that makes ISO 9001:2015 notable?

ML: The whole idea behind the new standard is to put all the ISO standards in alignment with each other, where it used to be that each was siloed. Now they use the same nomenclature and the same definitions across each one of the different standards. For example, ISO 9001 goes along with ISO 16949 automotive standard.

IW: Did that affect the way you approached the certification process?

ML: Not for us, since ISO 9001 is the base, but it would for customers that have other ISO certifications. They’re going to see the bigger benefit from that.

TP: ISO 14000 is the environmental standard; there are a lot of companies certified to it, but it was significantly different from ISO 9001 in the ways Michael was describing. Now they’re more aligned. We only have the ISO 9001:2015, but our parent company in Japan has both.

ML: It also makes it easier to talk to other companies about quality, since you’re both using the same nomenclature. In other words, if they use a word, the same definition applies across the board. You understand what a corrective action is for all standards.

IW: Would you say it’s improving communication across organizations?

ML/TP: Yes.

For more information on ISO certifications, visit the organization’s website.