Top 5 Mistakes in Building a QMS

A QMS should serve the business—not become another business the company has to manage.

One of the biggest mistakes companies make when building a Quality Management System is confusing compliance with effectiveness. A QMS should provide structure, consistency, and continual improvement while helping people do their jobs better. ISO describes a QMS as a collection of processes and procedures designed to help an organization consistently meet requirements and improve performance.

Here are five common mistakes to avoid:

1. Building the QMS Around the Standard Instead of the Business

A standard provides requirements and a framework—it shouldn’t dictate every detail of how a company operates. Start with the company’s processes, customers, risks, and objectives, then build the QMS around them.

Ask: What does our business actually need the system to accomplish?

2. Creating Too Much Documentation

More procedures don’t automatically create better quality. Excessive forms, approvals, and records can turn the QMS into an administrative burden.

Documentation should support the process, provide needed evidence, and help people perform their work consistently.

If nobody uses it to improve the business, question why it exists.

3. Leaving Employees Out of the Design

The people performing the work often understand the process better than anyone else. Excluding them can result in procedures that look good on paper but don’t work in practice.

Build processes with the people who use them, not simply for them. ISO’s quality principles emphasize engagement of people and a process approach. (ISO)

4. Measuring Everything Instead of What Matters

A mountain of data doesn’t necessarily produce better decisions. Focus on meaningful measures that reveal whether the business is achieving its objectives—such as defects, customer complaints, delivery performance, supplier performance, and corrective-action effectiveness.

Measure what matters. Then use the information to act.

5. Treating the QMS as a Finished Project

A QMS should evolve with the company. ISO’s process approach incorporates Plan-Do-Check-Act and continual improvement rather than treating the system as static.

Regularly ask:

Does this process add value? Can we simplify it? Is it producing the results we need?

The Bottom Line

The goal isn’t to build the most complicated QMS. It’s to build one that works.

The best QMS isn’t the system employees work for. It’s the system that works for the company.

With the release of ISO 2026, reach out to the industry’s top QMS expert to halp navigate your upgrade and avoid these mistakes.

920-841-3478

Steve@tracQMS.com

/by

What Would The Founding Fathers of Quality Think of AI?

Back in December of 2019 through March of 2020, I wrote a series in my I-Connect007 column on the Founding Fathers of Quality. With AI taking over the world, I wanted to posit how these quality gurus would apply this technology to their core quality management philosophies.

Old Philosophies, New Tools

Quality management as a discipline was built by a handful of people who never touched a neural network, yet whose ideas map onto artificial intelligence with almost eerie precision. Dr. Walter Shewhart, Dr. Edwards Deming, Dr. Joseph Juran, Philip Crosby, Dr. Kaoru Ishikawa, and Shigeo Shingo each built a philosophy around a specific lever for improving quality: statistical rigor, reducing variation, prioritizing effort, eliminating defects, involving the workforce, and error-proofing the process itself. AI doesn’t replace any of those levers. It sharpens each one, and imagining how each figure would actually put it to work says as much about their original thinking as it does about the technology.   CLICK HERE TO READ THE COLUMN

Reach out for all your quality needs and to prep for the upcoming 2026 version of ISO 9001.

920-841-3478

Steve@tracQMS.com

 

/by

Elite RF receives AS9100D: 2016 Certification

PRESS RELEASE

The Right Approach Consulting

August 31, 2026

Hanover Park, IL

I am proud to announce that client Elite RF, an industry-leading RF amplifier and generator manufacturer, has received certification to AS9100D 2016. This was not your typical QMS upgrade for a couple reasons. First, after receiving ISO 9001: 2015 two years ago, Elite RF moved all manufacturing operations in-house. The second was the decision to upgrade the QMS to certify the QMS to both AS9100D for Aerospace and ISO 13485: 2016 for medical device manufacturing concurrently. This success of this project was due to 100% engagement by the entire workforce and management team. The certification audit for ISO 13485: 2016 is currently being scheduled to complete their trifecta of quality certifications. Special thanks to Deep Patel, COO, for spearheading the project internally and inspiring a quality culture throughout the organization.

Ami Patel, Chief Administrative Officer & Partner, stated: “Achieving AS9100 certification is an exciting milestone for Elite RF and reinforces our commitment to quality and reliability in the aerospace and defense industries. As we work toward ISO 13485, we look forward to bringing that same commitment to our growing medical market and continuing to deliver products our customers can trust. Special thanks to our quality management consultant Steve Williams of TRAC  for his guidance through our QMS certification journeys.”

About Elite RF

Elite RF specializes in solid-state RF and microwave power amplification technology with a strong emphasis on customer satisfaction. Utilizing their in-house team of RF engineering experts and advanced quality-controlled production facility, they offer robust RF amplifiers up to 40GHz and 100kW of power. From custom requirements to off-the-shelf availability, Elite RF collaborates with their customers to offer a cost-effective amplifier with industry leading warranty.

For more information go to: http://www.eliterfllc.com

Contact Steve for all of your QMS needs.

Steve@tracQMS.com

920-841-3478

/by
,

PCB Vertical Integration: From a Master’s Thesis to Reality

Vertical integration in PCB fabrication is a genuinely contested strategic question with real tradeoffs on both sides. The core tension: fabricators that integrate up into design and down into assembly gain margin and stickiness, but risk diluting their manufacturing focus and alienating the EMS and design-house partners they depend on. My latest IConnect PCB007 column on The Pros & Cons of PCB Vertical Integration compares the results of my MBA thesis 25 years ago to today’s reality. Has anything changed? Read the article and find out by clicking on this link: THE PROS & CONS OF PCB VERTICAL INTEGRATION

Reach out to the industry leader for all of your quality and leadership needs at:

Steve@tracQMS.com

920-841-3478

/by
, ,

Reflections on 50 YEARS in the Business, Part 3

The final installment of this three-part series looking back on my 50 years in the business will focus on my current state; small business owner of a Quality Management consulting business, Author and Certified Leadership expert. Click here to read Part 3

Put my 50 years of experience to work for you!

Steve@tracQMS.com

920-841-3478

/by

Get Ready for ISO 9001 Version 6

We are well past the normal 5-7 years that a new revision of the ISO 9001 international quality standard gets released. Word on the street is that it may be finished toward the end of 2025 with implementation starting in 2026. CLICK HERE  to continue reading my column on a history of ISO revisions and what significant changes we can expect in the upcoming Version 6.

Screenshot

 

Reach out to the industry’s foremost expert on quality management to start planning on your ISO/AS9100 upgrade to the new requirements

Steve@tracQMS.com

920-841-3478

/by

Occupational Health & Safety: What is ISO 45001 and why do you need it?

ISO 45001 provides significant value to organizations looking to reduce workplace incidents and demonstrate OH&S commitment. ISO 45001 can be seamlessly integrated into your current QMS as an IMS (Integrated Management System). No need to change your QMS structure, numbering scheme or functionality, I work with you to painlessly integrate these into the existing management system.

ISO 45001 establishes criteria for an OH&S policy, objectives, planning, implementation, operation, auditing and review. Key elements include leadership commitment, worker participation, hazard identification and risk assessment, legal and regulatory compliance, emergency contingency planning, incident investigation and continual improvement. Whether you have a union environment or  local requirements, keeping your employees safe is not only a moral and ethical responsibility, but just good business. Near misses, lost time due to accidents and loss in morale are costs that directly erode the bottom line.

ISO 45001 Quality Management Certification Badge. Vector illustration.

Whether you currently hold ISO 9001, ISO 13485, AS9100 or IATF 16949, trust the industry expert, TRAC, to guide you through this transition quickly and efficiently.

Benefits

  • Framework to proactively manage OH&S risks
  • Reduced workplace incidents and injuries
  • Demonstrated commitment to worker health and safety
  • Ensured compliance with OH&S regulations
  • Increased organizational resilience
  • Reduced costs through continual improvement of OH&S performance

Reach out for a free phone consultation to get started.

Steve Williams

President – The Right Approach Consulting

Steve@tracQMS.com

920-841-3478

/by

Milwaukee Electronics Achieves AS9100D: 2016 Certification

PRESS RELEASE

The Right Approach Consulting

July 10, 2025

Milwaukee, WI

Milwaukee Electronics Achieves AS9100D: 2016 Certification. I am proud to announce that the Milwaukee division of client Milwaukee Electronics has upgraded their QMS from ISO 9001: 2015 and received certification to AS9100D: 2016 from certifying body TUV Rheinland. Corporate Director of Quality Bob Willenbring, the quality team and entire leadership team were highly engaged with the goal of driving organizational improvement during this transition. I would like to extend my thanks to the team for their hard work and dedication throughout this project.

“A huge thank you to Steve Williams and The Right Approach Consulting for his leadership and guidance as we achieved our AS9100 certification in six months!  Steve’s expertise and ability to help our team understand the requirements and meet them in a way that fit our organization was instrumental to this achievement!”

Bob Willenbring, Quality Director, Milwaukee Electronics.

About Milwaukee Electronics

A message from CEO Jered Stoehr:

“Milwaukee Electronics was founded in 1954, offering services in circuit board design and PCBA assembly to the mining industry in the Wisconsin, USA, region. My father, P. Michael Stoehr purchased the company in 1985 with the mission of creating a business that would put customers first and be a fulfilling place to work for the employees serving those customers.

As the second generation to take the Chief Executive helm, it is very important to me to carry on my father’s customers-first legacy and to ensure that Milwaukee Electronics maintains the entrepreneurial spirit that has allowed the company to continually expand its range of services, maintain decades long customer relationships and provide careers for many dedicated employees.”

Milwaukee Electronics has three manufacturing facilities, Milwaukee WI, Portland OR and Tecate Mexico, a Tech Center in Pune India, and a Purchasing Office in Singapore providing services including:

  • Program management including supply chain and logistics management
  • Quick-turn prototype and on-demand manufacturing
  • End-to-end electronics manufacturing services including PCBA, box build and test

For more information go to: https://www.milwaukeeelectronics.com

Contact me to start your AS9100 journey.

920-841-3478

Steve@tracQMS.com

/by

Environmental Management: What is ISO 14001 and why do you need it?

Implementing ISO 45001 provides a framework for organizations to design and implement an EMS, and continually improve their environmental performance. ISO 14001 can be seamlessly integrated into your current QMS as an IMS (Integrated Management System). No need to change your QMS structure, numbering scheme or functionality, I work with you to painlessly integrate these into the existing management system.

Many of my clients are getting pressure from their customers, industry and/or local city or village regulatory agencies to attain this certification to improve their environmental compliance. ISO 14001 is a separate certification that encompasses various aspects from resource usage and waste management to monitoring environmental performance and involving stakeholders in environmental commitments.

Whether you currently hold ISO 9001, ISO 13485, AS9100 or IATF 16949, trust the industry expert, TRAC, to guide you through this transition quickly and efficiently.

Benefits

  • Enhanced environmental performance
  • Regulatory compliance
  • Risk management
  • Cost savings
  • Operational excellence
  • Stakeholder and customer trust

Reach out for a free phone consultation to get started.

Steve Williams

President – The Right Approach Consulting

Steve@tracQMS.com

920-841-3478

/by

Get the TRAC Solution For Most Companies Biggest Problem

One of the most common issues among manufacturing companies is the inability to permanently solve quality issues. Click here to download the program outline.

How many times have you put a solution in place to correct a quality issue only to have it pop back up weeks, or months later? Probably much more than you wish to share. Whether internal scrap and rework, customer returns or process improvement, this issue crosses all industries, but the more complicated the processes involved, the bigger the issue. The primary “root cause” of this is the lack of formal training in the process of root cause analysis. TRAC has created a customized RCA & 8D training program that will be branded to your organization and pay for itself in 30 days.

Reach out to schedule this root cause analysis and 8D training for your organization and start saving money and increase customer satisfaction.

Steve

920-841-3478

Steve@tracQMS.com

 

/by