Learn Everything about ISO 9001 with Marla Nelson!
With almost 30 years of quality management experience in manufacturing, Marla Nelson shares what ISO certification is and why it is important to be certified in doing government contracts.
Marla Nelson graduated with a bachelor’s degree in Industrial Technology from Colorado State University.
She started off her career as a line former at the Dearborn Stamping Plant and became a quality manager and production superintendent, thereafter. Then, when the automotive industry was not doing well, she moved to Las Vegas and worked for a prime contractor for 13 years.
Currently, Nelson is the CEO of Advantage Quality Professionals Nevada and is a lead consultant at Core Business Solutions, a management consulting firm helping small businesses for their ISO 90001 certification needs.
WHAT IS ISO 9001?
ISO 9001 was established by the International Organization of Standards in 1987. It’s an international standard based on the seven world-class business practices, representing the risk-based approach to business excellence.
“Instead of just winging it and hoping that you produce the parts and offer the services that your customer wants, you have a very disciplined approach to how you put your processes together, how you document them, and how you provide excellence that you’re meeting all requirements.”
This standard was not necessarily a requirement for all companies but being ISO 9001 certified really proves a point that you have met the standard quality and requirements of your customers.
WHICH STANDARD IS BEST FOR YOUR BUSINESS?
Consider that the ISO 9001 is just the basic standard, it still has a lot of other standards under it so that it can cater other kinds of services.
If you are in the aerospace or are providing products and services to the military, then the AS9100 is the right standard for your business.
Then, if you are providing medical devices including N95 masks and all of the needed personal protective equipment, you need to get ISO 13485 certified.
Meanwhile, the ISO 9000 is more common in the creative and innovative type of industries that provide cannabis, cosmetics, CBD oil, and others. This standard is needed in order for these industries to exercise good manufacturing practices.
Lastly, with all of the incidents of data breaches in the cyber security industry, the Cybersecurity Maturity Model Certification (CMMC) was also established.
HOW TO FAIL THE CERTIFICATION AUDIT?
1. Be an ineffective leader.
In the audit, every single person in your company will be subject to an audit for the leadership interview. This means that all of your people need to face the auditor and not just your quality manager.
“They want to know how is the leadership making sure that everybody has the resources, that they need to be effective, how does the leadership let everybody understand, help everybody understand that they contribute to the effectiveness of the business.”
2. Don’t prepare for the audit, just wing it.
Regardless of how many times you have been audited, you need to always be prepared as to not waste your auditor’s and your team’s time and effort.
“That’s what you don’t want to do because you’re going to be wasting the auditor’s time and that’s one of the things they don’t like. If they ask you a question and you have no idea what they’re talking about because you haven’t read the standard, you haven’t prepared for this, you’re going to make their job harder, and it also puts pressure on the rest of the team because remember it’s not one person being audited, it’s the entire company. So, if you’re winging it, that means everybody else is winging it.”
3. Argue with your auditor.
Your auditor will never enjoy a healthy debate and no matter how much you want to argue with your philosophy on their requirements and other matters, you should never do it. Rather, just answer the questions and provide evidence.
“It really doesn’t matter if you think the context of the organization is stupid. It doesn’t mean anything. All it means, a lot it tells the auditor is that you haven’t read the standard and you don’t know what it is. So, Eric, I think just a few weeks ago on one of your podcasts you talked about a SWOT analysis: strengths, weaknesses, opportunities, and threats, right? That essentially is the context of the organization.”
4. Just buy an ISO certification in a box.
You should be the one to put everything together for your company and not just any other services you saw from the internet.
“All the documents that you create are supposed to represent your actual business practices. So, if you have a work instruction that says, “I put all rejects in this corner and put it on red paper with green ink,” your auditor is going to go the floor, be looking for rejects on red paper with green ink, and if it’s not you’re violating your own policies, and they might write you up for that, you might get a finding for that.”
THINGS TO REMEMBER!
1. Products don’t get certified.
When you get an ISO certification, you’re not certifying your products. Rather, you are certifying your process and organization as to say that you have the ability to meet your customer’s requirements.
2. Your consultant can’t certify you.
Your consultant’s job is to just define your process, do an internal audit of your whole organization, and make sure that you are meeting the standards. They’re not in your organization to certify your business because that’s the auditor’s job.
3. Be compliant.
If you are the one manufacturing raw materials, then you can directly have an established quality management system in order to get your organization compliant.
However, in the case where you are buying raw materials from another company, then you should check if they are certified in processing that raw material and reevaluate them every year, in order to know if they are still meeting the ISO standards.
If you want to watch the full video as Marla Nelson shares everything about ISO 9001 and how this affects your business in doing contracts with the government, then be sure to click the links below:
Sell parts components to Aviation and Defense industry