When there’s a multitude of choices for suppliers to pick from, how do you stand apart from the competition? One industry signifier is an ISO Certification which acts as a benchmark for companies, demonstrating their commitment to maintaining high standards and continually improving their processes. To discuss these challenges, and more, we sat down with ISO expert, Kimberly Cunningham. Kimberly owns and operates a consulting firm that works with MTEC which is dedicated to helping organizations navigate the complexities of ISO certification. With her in-depth knowledge and hands-on experience, she guides businesses through the process, ensuring they meet the stringent standards set by the International Organization for Standardization. Here are her insightful responses* to questions arising within the manufacturing industry and explains the importance of ISO Certification.
For those unfamiliar, can you run through what ISO certification is, what it involves, and why it’s important?
ISO 9001 certification is a testament to your organization’s commitment to maintaining a robust quality management system. It demonstrates your dedication to continuous business improvement and a customer-first approach. This certification is increasingly becoming a prerequisite for businesses, as it assures customers of your commitment to excellence.
While ISO 9001 serves as a foundational certificate applicable to a vast array of commercial industries, there are also specific certifications tailored to regulated sectors like aerospace and medical devices. Thus, irrespective of your business domain, there exists an ISO certification that can validate your commitment to quality and continual improvement.
What makes these certifications so important?
Obtaining ISO certification instills a structured approach to enhancing your business operations. It necessitates the use of specific tools that validate your progress, including measurable goals and metrics. Moreover, this process encourages proactive identification and management of potential risks that could hinder your business’s growth.
The certification also emphasizes the importance of addressing non-conformities, ensuring they are rectified and prevented from recurring in the future. To ensure adherence to established processes, self-audits are mandated. Furthermore, regular management reviews are required to assess the effectiveness of your quality management system continually. These reviews serve as a platform to analyze your performance metrics and identify areas for further improvement, thereby fostering a culture of continuous advancement within your organization.
Can you tell us a little bit about your work at ISO Integration?
As the owner of a specialized consulting firm, I offer my expertise to businesses aiming to secure ISO certification, as well as those seeking to enhance and maintain their existing quality management systems. Furthermore, I provide internal auditing services, leveraging the flexibility offered by ISO standards, which permit outsourcing these critical evaluations.
What are some of the common issues your clients are coming to you with?
Numerous businesses are seeking ISO certification, often prompted by customer requirements to obtain it. However, smaller organizations may lack the necessary resources, knowledge, and expertise to conduct the internal audits integral to this certification process.
Can you walk us through the different types of ISO certifications and who would benefit from them most?
Every business, regardless of its nature, stands to gain from securing the fundamental ISO 9001 certification. My experience spans a diverse range of industries, from machine shops and alternative energy firms to hospitals. Organizations in the aerospace and medical device sectors would find it advantageous to pursue additional certifications, given their growing prevalence. Possessing these certifications not only enhances a company’s reputation but is also frequently a prerequisite demanded by customers.
What is the biggest misconception your clients have about becoming ISO certified?
A common misconception among businesses is that obtaining ISO certification entails extensive documentation, which is not necessarily the case. Another prevailing myth is that the certification process is prohibitively expensive. However, by implementing strategies such as a GAP analysis and leveraging support from third-party entities like MEP centers, the certification can be achieved at a cost that’s manageable and worthwhile.
What do you find are some of the most difficult aspects of becoming ISO certified?
The key to success in ISO certification lies in the full commitment and belief of top management in the system, which must permeate throughout the entire organization. If management doesn’t adhere to the system, it’s unrealistic to expect an operator to have faith in it. Moreover, it’s the management team that allocates the resources for implementing the system.
One of the challenges in attaining ISO certification is truly grasping the approach, which includes designing your business processes, considering your inputs and outputs throughout these processes, identifying process owners, establishing effective process measurements, and concentrating on the communication flow between processes. In the past, businesses often operated in isolated silos, but today there’s a need for departments to be more interconnected and maintain robust communication lines to enhance efficiency and seamlessness.
All of these steps can seem really overwhelming. What type of advice do you have for those who are looking to become ISO certified and how they can best approach it?
I would initially suggest the use of turtle diagrams, a tool designed to map out each process in your business. This tool allows you to objectively analyze what information is being input and output, the necessary resources, and the most effective way to measure efficiency. It provides a high-level perspective that aids in comprehending the process approach.
It’s essential to pinpoint individuals who can lead this initiative. The endeavor requires process-oriented people to take charge and assume responsibility. That’s why many companies see the value in engaging a consultant who can lend their expertise to an internal audit team. A robust internal audit team is vital for system maintenance. Implementing a new system demands some degree of monitoring as it’s easy to revert to old habits without appropriate guidance, which is where auditing plays a role. It isn’t a one-off task but a commitment to ongoing process enhancement.
What types of checks and balances can be put in place to make sure a company doesn’t fall back into hold habits?
Frequent audits, management assessments, and evaluations of objective metrics should be conducted more often in the initial stages to confirm that your targets are being achieved.
If not mandatory, what value can be gained by manufacturers who seek out ISO certifications?
ISO certification can significantly enhance your entire organization. It can streamline processes, offer a systematic method for driving improvement, and chart a course for expansion.
Lean Manufacturing and ISO can be effectively paired as they aim to achieve similar objectives. Both methods reinforce each other, and when combined, their impact can be substantial. Lean provides numerous tools to eliminate waste and boost efficiency, while ISO provides the structure for sustained improvement by incorporating regular check-ins into your processes. Each methodology comes with its unique tools, like Value Stream Mapping for Lean and internal audits for ISO.
What is involved in these internal audits?
An internal audit is an examination of a process that involves scrutinizing the intended procedure or plan, ensuring its adherence, and verifying the efficiency of communication throughout the process. This includes the information received from the preceding process and what’s passed on to the subsequent process. The aim of internal audits is to find proof of compliance and effectiveness in abiding by the ISO standards.
Common client mistakes?
Ineffective corrective actions can prevent a problem from being resolved permanently. If the root cause isn’t thoroughly examined, the issue is likely to resurface. It’s crucial to identify the cause and ensure the problem doesn’t recur. This is a common issue in many companies. For example, if an out of tolerance condition repeatedly causes a part to fail to meet specifications, it’s necessary to delve into what exactly is occurring. Many companies might quickly attribute this to human error and opt for retraining. However, that’s usually not sufficient, and the investigation shouldn’t stop there. Instead, you should question how the error happened and employ The Five Whys, a mental exercise that prompts you to keep asking “Why?” until you find the real root of the problem for correction. By only addressing problems at surface level, you’re likely overlooking a plethora of other issues that could be easily rectified with process modifications.
Another frequent mistake is that employers don’t invest enough effort in adequately training their employees. People need training not just on the processes, but also on how to correctly execute the tasks within them. Training follow-up is essential to ensure harmful habits aren’t being developed. This should be conducted periodically for all employees.
At MTEC, we understand the complexities of being a manufacturer, especially when striving to meet ISO certification standards. With numerous elements to monitor and an array of factors that impact your business’s success, it can be overwhelming. If you need guidance in evaluating your operations, improving your manufacturing processes, or navigating ISO certification, we’re here to help. If you are interested in this service and setting up a complimentary visit to discuss in further detail, please call Phyllis Levine, Director of Operations, at (845)391-8214 Ext. 3001 or via email to phyllis.levine@hvtdc.org.
*This article and its responses are based on an interview conducted with Kimberly Cunningham and are not her words directly.