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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

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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

 

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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

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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

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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

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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.

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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

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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

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TRAC Celebrates Tenth Anniversary

First, I would like to thank the 50+ clients that have believed in my company and enabled me to keep the business going strong heading into year 11. A special thanks to the number of customers that have been with me in various capacities since day one; your loyalty is greatly appreciated. I am also proud to announce a 100% certification track record with my clients across the international standards of AS9100/ISO 9001, ISO 13485, ISO 14001, ISO 45001, IATF 16949, and MIL-PRF-31032.

The company was founded September 30th, 2013, so while the actual 10-year anniversary was last September I am extending the celebration as there will be a special anniversary offer extended to all of my clients over the past 10 years. Separate emails will be sent out to these clients with details, but a summary of the offer is outlined below.

 

10-year QMS Upgrade

Every year I make changes to my core Quality Management System that improves, simplifies and increases efficiency. The system is also updated based on the constantly changing auditor preferences and interpretations of the standard(s). This will be a one-time QMS upgrade that incorporates all the improvements over the past 10 years and that can be accomplished over a one-month period via onsite and online meetings, including training to the new upgrades. Typical results are a 40-50% reduction in procedures, forms, tasks, etc., with an ROI of only 6-months or less. The number of clients in any given month will be limited to allow appropriate time to each client, but the offer will  be extended as many months as needed to accommodate all that are interested.

Once again, many thanks to my clients in helping to achieve this milestone, and I look forward to the next ten!

Steve

 

Contact me for all your quality needs

Steve@tracQMS.com

920-841-3478

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Join me today: IPC Webinar “The Importance of a Good PCB Design Package”

In conjunction with the IPC, join me on this live Webinar Wednesday, March 13th, 2024. Sign up using this registration link to the webinar https://www.ipc.org/event/importance-good-pcb-design-package

 

 

 

 

 

 

Topics Include:

  1. Customer Service Representatives Are Not Engineers
  2. Netlist does not match the manufacturing data
  3. Impedance stackups do not meet impedance requirements
  4. Not using the appropriate material set
  5. Customized CAM adjustments
  6. Designer not understanding fabricator capabilities
  7. Inheriting a design from a competitor
  8. Overdesigning a PCB
  9. Unmanufacturable designs
  10. Lack of designer/fabricator engagement

 

Contact me at:

Steve@tracQMS.com

920-841-3478

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ASC Receives ISO 13485 Certification

Press Release

March 17, 2023

West Chicago, IL

I am pleased to announce that client American Standard Circuits has achieved certification to ISO 13485 for the medical device industry. This latest certification adds to ASC’s AS9100 Aerospace, ISO 9001 Commercial, IATF 16949 Automotive and MIL-PRF-31032 Military certification

President and CEO, Anaya Vardya commented, “This certification represents a great deal of work and dedication from all our team members, along with Steve Williams of TRAC. They all put together a tremendous effort to reach this goal. It is my understanding that there are very few printed circuit board companies that have earned ISO 13485:16 Medical Certification which makes us stand out as a preferred medical electronics circuit board provider. As we continued to grow our medical business exponentially, we felt that this certification would go a long way in establishing our leadership in this marketplace. Now that we have made the investment in time and people to accomplish this certification we look forward to meeting and working with even more medical electronics companies.”

 

For more information about American Standard Circuits’ services or to ask one of their technology experts a question go to http://www.asc-i.com

Contact me to start your ISO 13485 Medical certification.

Steve@tracQMS.com

920-841-3478

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