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What is ISO 9001?


ISO 9001
 is an internationally recognized standard for Quality Management Systems (QMS). It provides a structure and a set of principles that are meant to ensure a systematic approach to the management of organizations. Companies which meet these standards can earn an ISO certification – independent confirmation that they meet the requirements of ISO 9001. This gives customers and investors confidence in the company’s ability to provide quality products and services. ISO 9001 is the most widely used QMS standard in the world, with over 1.1 million certificates issues in 178 countries.

Quality

An ISO 9001 audit gives companies an objective look at their own processes. This is the case at Qorvo, a KaiNexus customer. Qorvo in their Oregon Operations factory, previously TriQuint, has been ISO 9001 certified since 1994. Sometimes they have full audits done, and sometimes there’s just a check-in, but every audit gives them a welcomed opportunity to prove to their customers – and to themselves – that they’re really as good as they think they are.

As Alice Quesenberry, Director of Etch Engineering at Qorvo, says, “It gets cluttered when you look at yourself.” She doesn’t want the auditors to just say that their manufacturing floor looks neat and organized; the ISO 9001 audit is meaningful because their outside perspective helps to identify opportunities for improvement that might otherwise be missed.  “The audit ensures that we truly do what we say we do."

The Guiding Principles

ISO 9001 is founded on eight universal management principles, each of which is supported by continuous improvement software:

  1. Customer focus

    A strong customer focus results in increased customer loyalty, improved customer service processes, and increased revenue resulting from a heightened ability to recognize new customer opportunities. Continuous improvement software empowers every employee to come forward with ideas to improve the customer experience.

  2. Leadership

    Employees should be actively involved in achieving goals clearly laid out by their leaders. The clear benefit of this practice is increased innovation and motivation amongst your employees, as well as increased communication and productivity. Continuous improvement software helps leaders clearly identify their goals, andempowers employees to participate in working to achieve them.

  3. Involvement of people

    Employees are the most important asset of any business, and their abilities should be utilized to their full effect. The clear benefit of this practice is increased innovation and motivation amongst your employees. The result is that employees are more likely to contribute original ideas and work their hardest. Continuous improvement software enables leaders to achieve the quick response timeshigh implementation rates, and positive feedback necessary to get more people involved.

  4. Process approach

    This approach is tied to efficiency and the understanding that the correct processes will speed up business activities. The result is, obviously, increased efficiency. Less apparent benefits include reduced costs – since resources are being used more effectively – and improved, consistent results. Continuous improvement software engages everyone in improving processes every day. 

  5. Systems approach to management

    ISO defines this principle as “Identifying, understanding, and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.” In other words, multiple processes are managed together – as a system – with the goal of improving efficiency. The result is a better understanding of how all the different elements of a business are tied together. Continuous improvement software systemizes the improvement process.

  6. Continual improvement

    We at KaiNexus are huge fans of continuous improvement. We believe that everyone should always be looking for ways to improve their organization’s products, services, or processes. With every member of an organization looking for ways to improve every aspect of it, new opportunities and improved performance can quickly arise. Continuous improvement software helps organizations make more of those improvements. 

  7. Factual approach to decision making

    It should be common sense to make decisions based on data and analysis, especially in a high stakes environment like the workplace. By implementing the other principles listed here, your organization will have become much more efficient, enabling employees to really stop and consider their decisions. Continuous improvement software increases the visibility into the improvement work and impact, helping leaders and employees to make informed decisions about where to focus their future efforts. 

  8. Mutually beneficial supplier relationships

    This principle refers to supply chains, recognizing the importance of the relationship between an organization and its suppliers. It’s a strong relationship between the two that will foster productivity and efficient practices. Continuous improvement software engages people in improving those relationships.

While it is certainly possible to achieve ISO 9001 certification without related software, several of the guiding principles are most easily achieved with a technology solution in place to support the effort. “Continual Improvement” and “Involvement of People” are two guiding principles that are greatly advanced with software that makes it easy for anyone in the organization to identify and act on opportunities for improvement.

 

Real-Life Examples

Qorvo

During past ISO audits, the Qorvo’s Oregon Operations relied on showing how many people were trained in their Continuous Improvement methodology and results from large projects along with positive movement in high-level metrics.  

Using KaiNexus as their CI enabling technology now affords them the opportunity to not only show how team members are working on specific improvement projects big and small, but also to show that their team level metrics are improving. They can provide detailed looks into the impact, scope, and engagement in their High Velocity Continuous Performance Improvement (HV CPI) program. KaiNexus’ easy to use reporting has a simple, systematic way to show individuals’ actions, the progress of opportunities for improvement, the impact, and the sharing of improvements.

Before, Qorvo could talk about improvements, but with KaiNexus they can show the entire process with evidence of the extensive collaboration.  This ability clearly shows the auditors that Qorvo Oregon Operations is committed to the ISO9001 guiding principles Continual Improvement and Involvement of People.

During Qorvo’s last ISO 9001 audit, the “lead auditor often stated that our systems are very good and, in some cases, the best he had seen in his many years of auditing,” including their use of KaiNexus when detailing their HV CPI journey.

Needless to say, they aced the audit.

Although ISO 9001 certification is not right for every organization, it can provide evidence that the company is dedicated to continuous improvement. Internally, staying compliant with the standards forces focus and discipline. Externally, it proves that you are serious about delivering quality with tested and documented processes which can earn your organization recognition, authority, and credibility.

The Standard Group

To receive and maintain ISO certification, organizations must first earn their certification which can take some organizations years to do. From there, the organization must maintain company certification for the next three years & is required to go through one audit each of these three years.

Although The Standard Group has been ISO certified since 2015, gathering and tracking all the appropriate materials required to maintain certification using Excel and Word documents started to become cumbersome and overwhelming. This audit process demands clear documentation of processes and evidence that is easy to look up and retrieve for the auditor.

With such an extensive process to prepare for the audit, the organization must have everything in order. Many of The Standard Group’s customers come to them strictly because they are ISO certified, so maintaining ISO certification is a big deal. However, Nick and his team struggled to maintain visibility into the information that ISO requires, causing delays and frustrations within the organization.

That’s why while prepping for their audit for this year, Nick decided to try using KaiNexus, which they already used for their continuous improvement work, to centralize and standardize their audit process. 

This year, they have slowly been integrating more and more of their ISO elements into KaiNexus so that their documentation and evidence are all in one place. 

Nick shared, "This was the year that I was able to feature all of the things that we have been putting together with our auditor and he was blown away! We passed our audit with flying colors!"

You can read more about how they streamlined their process in KaiNexus here.