Internal Auditing

CETRA has had the pleasure of working with Frank Yazhari and his team for several years, and their support has been invaluable. Frank and his staff’s expertise as ISO 9001 auditors has helped us strengthen and streamline our quality management system. With their guidance, we’ve significantly reduced NCRs, improved our documentation, and built a more consistent and proactive approach to compliance. Frank and his colleagues are always responsive, knowledgeable, and genuinely committed to our success. We’re grateful for their partnership and highly recommend their services.

FY Consulting was referred to us by one of our competitors. it is many years later and we have never regretted the decision. We have utilized their Internal Audit (Medical Devices) services for the last 6 years. It was from 2019 that we shifted our QMS from US FDA QSR and ISO 13485:2016 to the Medical Device Single Audit Program (MDSAP) along with our ISO 13485:2016 QMS. For MDSAP we decided to comply to USA, Canadian, Brazilian and Australian requirements. We did not have enough qualified resources internally to properly fulfill our audit program but also wanted to have a ‘fresh set’ of eyes with the expertise to ensure our success. Well currently, we are still using FY Consulting and have had successful audits and a few backs to back audits with no Nonconformities. Thank you, FY Consulting for all the support!

As President and CEO, I am responsible for setting the strategic direction of the
company, ensuring operational excellence, and positioning ELYON for sustainable
growth while delivering consistent value to our customers.

In 2016, we made a strategic decision to formalize our internal systems and processes
to support growth and scalability. ISO certification provided a structured framework that
allowed us to consistently deliver high-quality outcomes while maintaining excellence in
execution across all customer engagements.

When we initially engaged FY Consulting, our expectation was to partner
with a firm that brought deep professional expertise aligned with ISO
standards and could help us build a complete, audit-ready Quality
Management System (QMS).

We evaluated success based on our ability to confidently pass audits, sustain
certification year over year, and—most importantly—operate a QMS that genuinely
supports our business operations rather than existing solely for compliance purposes.

We associated ISO certification with several key business goals:
Consistent and effective delivery of IT and professional services across
all customer contracts
The ability to scale and grow the business in a controlled, repeatable
way that supports revenue growth
Establishing credibility with new and existing customers, particularly in
competitive proposal environments, by demonstrating that our systems
are independently certified for quality management

In 2016, one of our directors was tasked with identifying a qualified firm to support us
with certification. Based on his assessment and recommendation, we met with the
owner of FY Consulting.
Following that discussion, I approved the decision to engage FY Consulting. We did not
evaluate alternative firms, as the initial meeting gave us confidence in their expertise,
approach, and alignment with our business needs.

The certification effort was supported by a cross-functional leadership team, including
the President, Operations Manager, and Human Resources.

The most significant early challenge was communicating the importance of certification
to the management team—specifically, helping them understand the why. Once the
purpose and long-term value of certification were clearly understood, alignment and
engagement across the team increased significantly.

The cost of certification directly supported business growth, proposal
competitiveness, and delivery consistency. ISO 9001 provided both
external credibility and internal operational discipline, making it a
high-value, long-term investment rather than a compliance expense. We
did not find anything missing in the process; the structure and outcomes
aligned well with our expectations and business objectives.

What has been most valuable in working with FY Consulting is the
trusted, long-term partnership we’ve built over nearly ten years. FY
Consulting has consistently provided invaluable guidance—not only in
achieving and maintaining ISO 9001 certification but also supporting us
with NIST 800-171 standards and compliance, security posture, and
overall operational discipline.
They take the time to deeply understand our business, our risk profile, and
our growth objectives, and they translate complex regulatory and
compliance requirements into practical solutions that actually work for our
organization. Their approach is never “one-size-fits-all”—it is thoughtful,
scalable, and aligned with how we operate day to day.
Beyond compliance, FY Consulting has helped us build internal capability
and confidence. Their support with internal audits, risk management, and
continuous improvement has enabled us to sustain certifications year after
year, reduce risk, and pursue government and enterprise opportunities
with confidence. We view FY Consulting not as a vendor, but as a true
strategic partner who has played a meaningful role in ELYON’s
operational maturity and long-term success.

Very prepared, very put together, had all the documentation in order, really coached us through the whole process, telling us each step by step what to expect, what we needed to do, what we had to do, what we didn't need to do.
Really professionals, really knowing exactly what it takes to get from zero to 60 and getting us into a position where we were able to actually get certified the first time around.
I really can't say enough good things about FY Consulting.

We’ve worked with FY Consulting for several years, and each engagement we’ve had an enjoyable experience. What we enjoy most about working with FY Consulting is their knowledge of the various appraisals and certifications. They make sure that we are kept informed of new updates or changes that might affect us. I would recommend FY Consulting to other companies and have done so. They are competitively priced and a great partner to work with.

Ron Panasiewicz did an amazing job for us over the past nearly five years- auditing both USA Tolerance Rings (IATF 16949:2016) and Sullivan Steel Service (AS9100D, AS9120B). He was excellent in so many ways- his approach, delivery, thoroughness, and availability to our schedule. That is why we continued with FY Consulting for all those years.

We have been working with FY Consulting since 2012 when they learned about our business and put together our quality program and manual. They helped determine what KPIs would work for us as well as getting us ready for our ISO audit. They followed up and helped us understand what to do when we had non-conformities.

FY consulting does our yearly internal audit as well as management review meeting. They are always on top of any changes to the ISO standards and make sure that our program is kept up-to-date. Since they have become so aware of our business, they are extremely helpful in finding new processes for continual improvement and determining risk management and how different risks would apply to our business.

I absolutely would recommend FY consulting to other companies. We have not had any non-conformities for a few years now and the ones we did have were very minor and easily corrected. Auditors have commented on how complete the internal audits and management reviews were done covering all topics that they were also covering during our yearly audit. FY Consulting has made what appeared to be a daunting task into a simple process that we have no problem keeping up with while at the same time reducing errors in our production process and increasing profits.

What was your experience working with FY Consulting?

Before FY Consulting, we had two failed attempts at ISO 9001 certification—one on our own and one with another consulting firm. In 2005 we engaged FY Consulting, and the difference was immediate. Frank, the owner, personally led the project, streamlined every process, and got us certified on the very first attempt. What really stood out was how efficiently he designed our system: the methods he put in place were so effective that we’ve never had to hire additional staff to maintain compliance. We achieved certification quickly and have kept it uninterrupted for almost 20 years, all without adding headcount.

What do you value most about working with the FY Consulting team?

The expertise, long-term partnership, and the real cost savings they deliver. Frank built us a lean, common-sense system in 2005 that eliminated waste and made ongoing compliance simple. Because of the streamlined processes he and the team implemented, we’ve never needed to bring on extra people to manage ISO requirements—even through multiple standard revisions. Nearly 20 years later, they still know our business inside out, respond instantly when we need them, and continue to save us significant time and money every single year.

Would you recommend FY Consulting to other companies, and if so, why?

100% yes—I already recommend them every chance I get. After failing twice before, Frank and the FY Consulting team got us ISO 9001 certified on the first try in 2005 and built us a system so efficient that we’ve never had to hire additional staff to stay compliant. That alone has saved us tens (if not hundreds) of thousands of dollars over the years. If you want certification done right the first time plus ongoing support that actually reduces your costs and headaches, FY Consulting is simply the best.

Thanks,

FY Consulting was initially referred to us from a business associate. At the time, we had just completed our two-year development of our processes and had a major investment in employee training for ISO 9001. The first consulting group we used had us unprepared for the initial audit. We failed that audit and received several major nonconformities. The day FY Consulting visited us and reviewed our quality management system, we realized that our system had been developed for a company with significantly more employees. FY consulting helped us streamline our QMS to align it with the size of our organization. Subsequently, we achieved certification with no significant issues and utilized them as an external provider to maintain our QMS, for the next 9 years. I would recommend FY Consulting in a second!

In 2017, we retained FY Consulting at the recommendation of our registrar, to transition our ISO9001/AS9100 systems to their latest revisions. Frank and his team not only helped us make this transition seamlessly, but also streamlined our quality management system to reduce complexity and maintenance efforts. Ever since 2017, they have been helping us to maintain our certifications.

Frank didn’t see problems, he saw solutions. That mindset, rare among consultants, made a real difference. He was consistently reliable and responsive throughout our ISO certification process. His expert guidance was instrumental to our success, and his clear, timely support helped us reach our goals efficiently. Frank’s implementation style minimized stress and significantly reduced the time required to get things done.

Frank's expertise streamlined our internal processes, leading to greater consistency, fewer errors, and reduced waste. He helped us improve our business to be able to deliver the highest quality at the lowest price. This lead to increased market share.

I worked with Frank for over 20 years and together we achieved multiple certifications: ISO 9001- Quality; ISO 16949 Automotive; ISO 13485 Medical and ISO 1400 Medical.

Frank also helped us maintain our certifications by providing annual internal auditing and risks assessment support for over 15 years.

With Frank’s support, we achieved KPI scores in the top 5% of our industry, as measured by independent benchmarking data.